Short interest for Cyclacel Pharmaceuticals gives investors a sense of the degree to which investors are betting on the decline of Cyclacel Pharmaceuticals's stock. Short interest data is updated every two weeks.

Cyclacel Pharmaceuticals Stock (NASDAQ:CYCCP), Short Interest Report

Cyclacel Pharmaceuticals

Cyclacel Pharmaceuticals Inc is a clinical-stage biopharmaceutical company that develops targeted medicines for cancer and other proliferative diseases. The company develops several families of anticancer drugs that act on the cell cycle, including CDK (cyclin-dependent kinase) inhibitors, and PLK (polo-like kinase) inhibitors. The pipeline development programs of the company include fadraciclib, Sapacitabine, and plogosertib.

News

Press Releases

CYCC

CYCCP

Cyclacel Announces Presentation of Molecular Rationale for Clinical Development of CYC065 CDK Inhibitor in Leukemias, Lymphomas

Cyclacel Announces First Patient Dosed in IST of CDK Inhibitor Seliciclib in Cushing&#39;s Disease,

Cyclacel Pharma Reports CYC065 CDK Inhibitor Shows Terapeutic Potential in Acute Leukemias with MLL Rearrangements

Cyclacel Pharmaceuticals, Inc. - 6% Convertible Preferred Stock

Cyclacel Pharmaceuticals Inc

<h3>Gainers</h3>
<ul>
<li>PaxMedica (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PXMD#NASDAQ">PXMD</a>) stock increased by 110.9% to $0.87 during Friday's regular session. The company's market cap stands at $6.4 million. </li>
<li>Q32 Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QTTB#NASDAQ">QTTB</a>) shares rose 23.89% to $29.5. The market value of their outstanding shares is at $351.9 million. </li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>) shares increased by 20.45% to $21.2. </li>
<li>SenesTech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNES#NASDAQ">SNES</a>) stock rose 19.95% to $0.89. The market value of their outstanding shares is at $4.5 million. </li>
<li>Rani Therapeutics Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RANI#NASDAQ">RANI</a>) shares moved upwards by 17.48% to $5.25. The market value of their outstanding shares is at $136.7 million. </li>
<li>Allarity Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALLR#NASDAQ">ALLR</a>) shares moved upwards by 16.92% to $2.69. The company's market cap stands at $1.2 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Motus GI Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MOTS#NASDAQ">MOTS</a>) shares declined by 39.0% to $0.26 during Friday's regular session. The company's market cap stands at $1.3 million. </li>
<li>Monogram Orthopaedics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MGRM#NASDAQ">MGRM</a>) shares declined by 25.31% to $3.04. The market value of their outstanding shares is at $96.1 million. </li>
<li>BioSig Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BSGM#NASDAQ">BSGM</a>) shares decreased by 20.15% to $1.19. The company's market cap stands at $11.1 million. </li>
<li>Rallybio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RLYB#NASDAQ">RLYB</a>) shares fell 20.14% to $2.38. The market value of their outstanding shares is at $98.6 million. </li>
<li>Portage Biotech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTG#NASDAQ">PRTG</a>) shares fell 18.01% to $0.41. The company's market cap stands at $8.1 million. </li>
<li>Adial Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADIL#NASDAQ">ADIL</a>) stock decreased by 14.1% to $2.56. The market value of their outstanding shares is at $10.3 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Movers

ADIL

ALLR

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MGRM

MOTS

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PXMD

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12 Health Care Stocks Moving In Friday's Intraday Session

- New clinical, PK and PD data from novel CDK2/9 inhibitor fadraciclib monotherapy studies support ongoing development program in patients with solid tumors and lymphoma -
BERKELEY HEIGHTS, N.J., April 01, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, ", Cyclacel", or the ", Company", )))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced that new clinical, pharmacokinetic (PK) and pharmacodynamic (PD) data from the CYC065-101 study of fadraciclib as monotherapy was selected by the Scientific Program Committee for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 31-June 4, 2024 in Chicago.
Details of the presentations are as follows:
<figure class="table"> 
<table>
<tbody>
<tr>
<td>Title:</td>
<td>A phase 1 study evaluating the safety, pharmacokinetics, and efficacy of fadraciclib, an oral CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma</td>
</tr>
<tr>
<td>Abstract No.&nbsp;for Publication:</td>
<td>3125</td>
</tr>
<tr>
<td>Session Title:</td>
<td>Poster Session – Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology</td>
</tr>
<tr>
<td>Date and Time:</td>
<td>June 1, 2024, 9:00 AM - 12:00 PM CDT</td>
</tr>
</tbody>
</table>
</figure>
About Cyclin-Dependent Kinases and Fadraciclib Cyclin-dependent kinases (CDKs) are critical for cell cycle control and transcriptional regulation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased cancer cell survival. Fadraciclib is a highly selective, potent, orally and intravenously available, next generation inhibitor of CDK2 and CDK9. By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death through anaphase catastrophe of cancer cells at sub-micromolar concentrations.
To date single agent activity, including CR, PR and SD, has been observed in patients with advanced endometrial, squamous NSCLC lung cancer and T-cell lymphoma. Encouraging signals of activity were observed in patients with advanced cervical, hepatocellular, ovarian and pancreatic cancers.
065-101 Study of Oral Fadraciclib
Oral fadraciclib is being tested in a Phase 1/2 trial for the treatment of advanced solid tumors and lymphoma (065-101; <a href="https://www.globenewswire.com/Tracker?data=4O9UTRrc_Lbh9aVJZibg9hr-bEAnUq1rMw_QgFENmv1aR4VmOd1JEAADCHy5GVA57FjhIP8ytpq9VBdOJnh0gqbuqO9sMzavFqHKzgQ4BVFeDjmcfXwqo9-8p4Vvx-pRPDXMe8dCRlkiB7BODij9OeXGV_lyMdGUtKVFjjC0DtM=">NCT#04983810</a>). A total of 47 patients have been treated as monotherapy in this ongoing study. The study is enrolling unselected, all comer patients with advanced solid tumors and lymphoma.
The Phase 2 part of the 065-101 study is designed to further evaluate fadra safety and efficacy in up to 8 cohorts defined by histology and/or NGS. The study is powered to demonstrate response in the molecular subtype suggested by the Phase 1 data and others that may be sensitive.
CDKN2A, CDKN2B deletions
CDKN2A gene deletions occur in over 10% of several solid tumors, including glioma, head and neck, pancreatic, esophageal, lung (incl. squamous), bladder, hepatobiliary, breast, melanoma, sarcoma, and others. In addition, CDKN2A deletions have been reported in 46% of patients with PTCL-NOS, a subtype of lymphoma. CDKN2B deletions occur in over 10% of several solid tumors, including bladder, glioma, lung (incl. squamous), head and neck, pancreatic, melanoma, esophageal, sarcoma, hepatobiliary, breast, ovarian and others.

Biotech

General

Cyclacel Pharmaceuticals To Present New Clinical Data At 2024 ASCO Annual Meeting Highlighting Fadraciclib's Potential As A Precision Medicine For Cancer

Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, ", Cyclacel", or the ", Company", )))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced that preclinical proof-of-concept data with the Company's fadraciclib will be presented at the upcoming <a href="https://www.globenewswire.com/Tracker?data=KURYcXTAECgTx9KiHdZ8eDDE-hid2XQOrxKUfywrqTnWYTFB-bQBL5oYFrgL43p7M1i-0wXWlTJ51idtMMZlvlIlbRaYgMi1gYRRGKZzHt079gRrPSzUQCze3Qc_WhtdGX_Ts8vGPf0LORISopuC7j3Upr87lFsa4FPBQjnpt-UYYPLzdjbLPqS3MfsmLNIDZXo-4itOETODbC_-aYWkjR8onHSb5Xy4-nRIJTD597KzSC7xjx-X-l0z0jD8MddsV_X0as-lMg40jJnVQgH5asw9zo-6CbXSG14lHPXucxvby7KcAzyl6DrXmH7PqqX1TARd6b4OEpgmdFl9UGFnuhTXau8Cu_4xL4TxUd3d4nBfBSVHZcZ9pgVUs89vkIaiSW3x7vabwp27MKeHFw90Lw==">American Association for Cancer Research (AACR) Annual Meeting 2024,</a> being held&nbsp;April 5-10 in&nbsp;San Diego, California. The data will be presented at three poster sessions and report activity and antitumor effects of fadraciclib in biliary tract cancer, lung cancer, Richter transformation and lymphoma cell lines. &nbsp;
Details of the presentations are as follows:
<figure class="table"> 
<table>
<tbody>
<tr>
<td>Title:</td>
<td>The CDK2/9 inhibitor fadraciclib is active in Richter transformation and lymphoma cell lines by targeting both cell survival and proliferation</td>
</tr>
<tr>
<td>Abstract No:</td>
<td>518 / 15</td>
</tr>
<tr>
<td>Session Topic:</td>
<td><a href="https://www.abstractsonline.com/pp8/#!/20272/session/302">Session PO.ET05.01 - Cell Cycle, Transcription Regulation, and Anticancer Drug Action</a></td>
</tr>
<tr>
<td>Date and Time:</td>
<td>April 7, 2024, 1:30 PM - 5:00 PM PT</td>
</tr>
<tr>
<td>Location:</td>
<td>Exhibition Hall, Section 21</td>
</tr>
</tbody>
</table>
</figure>
&nbsp; &nbsp;
<figure class="table"> 
<table>
<tbody>
<tr>
<td>Title:</td>
<td>Elucidation of the fates of CDK2 inhibited aneuploid and residual lung cancers</td>
</tr>
<tr>
<td>Abstract No:</td>
<td>2117 / 8</td>
</tr>
<tr>
<td>Session Topic:</td>
<td><a href="https://www.abstractsonline.com/pp8/#!/20272/session/311">Session PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response</a></td>
</tr>
<tr>
<td>Date and Time:</td>
<td>April 8, 2024, 9:00 AM - 12:30 PM PT</td>
</tr>
<tr>
<td>Location:</td>
<td>Exhibition Hall, Section 30</td>
</tr>
</tbody>
</table>
</figure>
&nbsp; &nbsp;
<figure class="table"> 
<table>
<tbody>
<tr>
<td>Title:</td>
<td>Anti-tumor effects of fadraciclib, CDK2/9 inhibitor, in biliary tract cancer</td>
</tr>
<tr>
<td>Abstract No:</td>
<td>5711 / 11</td>
</tr>
<tr>
<td>Session Topic:</td>
<td><a href="https://www.abstractsonline.com/pp8/#!/20272/session/360">Session PO.MCB01.01 - Pharmacologic Targeting of Cell Cycle Proteins</a></td>
</tr>
<tr>
<td>Date and Time:</td>
<td>April 9, 2024, 1:30 PM - 5:00 PM PT</td>
</tr>
<tr>
<td>Location:</td>
<td>Exhibition Hall, Section 18</td>
</tr>
</tbody>
</table>
</figure>
About Cyclin-Dependent Kinases and Fadraciclib Cyclin-dependent kinases (CDKs) are critical for cell cycle control and transcriptional regulation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased cancer cell survival. Fadraciclib is a highly selective, potent, orally and intravenously available, next generation inhibitor of CDK2 and CDK9. By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death through anaphase catastrophe of cancer cells at sub-micromolar concentrations.
To date single agent activity, including CR, PR and SD, has been observed in patients with advanced endometrial, squamous NSCLC lung cancer and T-cell lymphoma. Encouraging signals of activity were observed in patients with advanced cervical, hepatocellular, ovarian and pancreatic cancers.
065-101 Study of Oral Fadraciclib
Oral fadraciclib is being tested in a Phase 1/2 trial for the treatment of advanced solid tumors and lymphoma (065-101; <a href="https://www.globenewswire.com/Tracker?data=PR_dAy-w0l89F0_hQ5ePrq-9EMTOk5FR9qwOTqAwGpI8rG5aVCTXHAbwHyvK_NSLQ7B5sfMgj047l192PqRfIo-IByZJU7XvkQl1NpqpiWToCITW3ST7xJOGCxM8zrV-qzmefigQs3H7ADZ4qny7ST-hBSW_-cQ3SLv2V6WnEIo=">NCT#04983810</a>). A total of 29 patients have been treated as monotherapy in this ongoing study. The study is enrolling unselected, all comer patients with advanced solid tumors and lymphoma.
The Phase 2 part of the 065-101 study is designed to further evaluate fadra safety and efficacy in up to 8 cohorts defined by histology and/or NGS. The study is powered to demonstrate response in the molecular subtype suggested by the Phase 1 data and others that may be sensitive.
CDKN2A, CDKN2B, MTAP deletions
CDKN2A gene deletions occur in over 40% of several solid tumors, including glioma, head and neck, pancreatic, esophageal, lung (incl. squamous), bladder, melanoma, and others. CDKN2B deletions occur in over 30% of several solid tumors, including bladder, glioma, pancreatic, esophageal, lung (incl. squamous), head and neck, melanoma, and others. MTAP deletions occur in over 25% of several solid tumors, including glioma, mesothelioma, pancreatic, bladder, esophageal and others. MTAP deletion confers dependency on the PRMT5 enzyme in cancer cells which was identified as a synthetic lethal target for MTAP deleted cancers.

Events

Cyclacel Pharmaceuticals Announces Preclinical Proof-Of-Concept Data For Fadraciclib To Be Presented At The American Association For Cancer Research Annual Meeting 2024

Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, ", Cyclacel", or the ", Company", )))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced that it received £2.3 million (approximately $2.9 million) as a research &amp; development (R&amp;D) tax credit from HMRC, the tax agency of the United Kingdom government. The tax credit is based on R&amp;D costs incurred in the year ended December 31, 2023. The Company expects to receive an additional approximately $0.8 million following confirmation of a change in the rate of tax credit regarding 2023 expenditures. &nbsp;
"The R&amp;D tax credit has been an important source of non-dilutive capital supporting Cyclacel's programs. We appreciate this governmental support as we evaluate potential precision medicine approaches for both our clinical candidates, oral fadraciclib&nbsp;and oral plogosertib, to address oncology indications with large unmet medical needs," said Paul McBarron, Executive Vice President, Finance &amp; Chief Operating Officer.

Cyclacel Pharmaceuticals Announces Receipt Of $2.9M R&D Tax Credit

<h3>Gainers</h3>
<ul>
<li>Atreca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCEL#NASDAQ">BCEL</a>) shares increased by 102.7% to $0.22 during Thursday's regular session. The company's market cap stands at $8.6 million. </li>
<li>Sagimet Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SGMT#NASDAQ">SGMT</a>) stock rose 36.13% to $7.12. The company's market cap stands at $163.0 million. </li>
<li>Cyclerion Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCN#NASDAQ">CYCN</a>) shares increased by 19.89% to $4.4. The market value of their outstanding shares is at $10.7 million. </li>
<li>Galera Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRTX#NASDAQ">GRTX</a>) stock moved upwards by 14.48% to $0.22. The market value of their outstanding shares is at $12.0 million. </li>
<li>Sera Prognostics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SERA#NASDAQ">SERA</a>) stock rose 14.45% to $5.78. The company's market cap stands at $181.1 million. </li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>) shares increased by 13.12% to $20.25. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>180 Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATNF#NASDAQ">ATNF</a>) shares declined by 26.7% to $0.22 during Thursday's regular session. The market value of their outstanding shares is at $2.2 million. </li>
<li>Cytokinetics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYTK#NASDAQ">CYTK</a>) stock declined by 23.15% to $78.11. The company's market cap stands at $7.6 billion. </li>
<li>Evoke Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EVOK#NASDAQ">EVOK</a>) shares declined by 20.18% to $0.75. The market value of their outstanding shares is at $2.5 million. </li>
<li>cbdMD (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/YCBD#AMEX">YCBD</a>) shares declined by 16.31% to $0.86. The company's market cap stands at $2.5 million. </li>
<li>Omega Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMGA#NASDAQ">OMGA</a>) stock declined by 14.49% to $4.31. The market value of their outstanding shares is at $237.6 million. </li>
<li>Edgewise Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EWTX#NASDAQ">EWTX</a>) shares declined by 13.06% to $9.66. The market value of their outstanding shares is at $613.0 million. 
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</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Thursday's Intraday Session

Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, ", Cyclacel", or the ", Company", )))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today that it has entered into a definitive agreement for the purchase and sale of 388,200 shares of the Company's common stock (or pre-funded warrants in lieu thereof) at a purchase price of $3.315 per share of common stock (or pre-funded warrant in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. The Company will also issue unregistered warrants to purchase up to 388,200 shares of common stock with an exercise price of $3.19 per share which will be immediately exercisable for a period of seven years following issuance. The closing of the offering is expected to occur on or about&nbsp;December 26, 2023, subject to the satisfaction of customary closing conditions. &nbsp;
In a concurrent private placement, the Company will also issue an aggregate of 7,956 shares of common stock at the same purchase price of $3.315 per share and warrants to purchase up to 7,956 shares of common stock with an exercise price of $3.19 per share to members of management.
Ladenburg Thalmann &amp; Co. Inc. is acting as the exclusive placement agent for the offering.

Offerings

Cyclacel Pharmaceuticals Announces $1.3M Registered Direct Offering Of Of 388,200 Shares At A Price Of $3.315 Per Share And Private Placement Offering Of 7,956 Shares Of Common Stock At A Purchase Price Of $3.315 Per Share

- Patient Pharmacodynamic Data Show Decrease in CDKN2A, CDKN2B, and PRMT5 Protein Levels - 
&nbsp;
- A Squamous Non-Small Cell Lung Cancer Patient with CDKN2B Deletion&nbsp;Achieved Marked Tumor Shrinkage after One Cycle -
- Retrospective Analysis Identified CDKN2A, CDKN2B and/or MTAP Deletions in Four Patients Previously Dosed with Fadra Achieving Responses or Stable Disease -
-&nbsp;Forthcoming Phase 2 Study to Further Evaluate Fadra Efficacy -
BERKELEY HEIGHTS, N.J., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, &amp;quot, , Cyclacel&amp;quot, , or the &amp;quot, , Company&amp;quot, , )))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today interim results from its Phase 1, dose escalation 065-101 study of fadraciclib (&quot;fadra&quot;) in patients with advanced solid tumors and lymphoma.
&quot;As we approach the end of the year we are excited to report that fadra continues to demonstrate anticancer activity as a single agent based on interim data reviewed to date from our 065-101 study,&quot; said Spiro Rombotis, President and Chief Executive Officer. &quot;The data suggest tumor sensitivity in patients with one or more of three abnormalities, CDKN2A, CDKN2B and/or MTAP deletion subject to confirmation in further studies. We believe there is great unmet medical need and industry interest in the cancer patient populations identified by these abnormalities, which are closely located on chromosome 9 and are often co-deleted. The Phase 2 part of 065-101 is designed to evaluate fadra safety and efficacy in cohorts defined by histology and/or next generation sequencing (NGS). In addition, our plogosertib dose escalation study is progressing well. Based on interim data reviewed to date, good tolerability and anticancer activity of plogosertib as a single agent have been observed in multiple patients with various solid tumors.&quot;
&quot;We are excited to see shrinkage of&nbsp;22%&nbsp;in the sum of all target lesions after one cycle of fadra monotherapy in a squamous non-small cell lung cancer (NSCLC) patient with CDKN2B deletion refractory to standard of care chemotherapy and immunotherapy,&quot; said Mark Kirschbaum, M.D., Chief Medical Officer. &quot;After retrospectively analyzing a subset of previously treated Phase 1 patients who experienced clinical benefit with fadra, we found four patients with CDKN2A, CDKN2B and/or MTAP deletions. These included an endometrial cancer patient who achieved CR and over three years of treatment in a previous study of fadra monotherapy and was found to have all three abnormalities. Further, pharmacodynamic data from patient biospecimens at dose levels 5 and 6A suggest that CDKN2A, CDKN2B, and PRMT5 protein levels are transiently decreased over the 4 to 8 hour half-life of the fadra dose, which we believe makes the tumor sensitive to CDK2 inhibition by fadra. Although these hypothesis-generating data are limited and cannot be generalized, we believe that patients with these types of tumors should be evaluated in the ongoing and subsequent studies.&quot;
065-101 Study of Oral Fadraciclib
In the ongoing 065-101 study of oral fadra, a CDK2/9 inhibitor, a total of 29 patients have been treated as monotherapy. The study is enrolling unselected, all comer patients with advanced solid tumors and lymphoma. Six patients have been treated on dose level 6A (125mg twice daily for 5 days per week, 4 out of 4 weeks). The sixth patient on dose level 6A with pancreatic cancer and CDKN2A deletion enrolled on the study experienced dose-limiting toxicity (DLT) of hyperglycemia. The patient, who has a diabetic profile history and was on metformin treatment, remains on study as blood glucose level was managed. A previous patient on dose level 6A with a pre-diabetic profile had DLT of hyperglycemia which also resolved rapidly.
The previous dose level 5 (100mg twice daily for 5 days per week, 4 out of 4 weeks) on this schedule accrued six patients with no DLT and per protocol is safe for continued development.
Dose level 6B (150mg once daily for 7 days per week, 4 out of 4 weeks) continues accrual with two patients treated, which are ongoing at three and five cycles of treatment.
To date single agent activity, including CR, PR and SD, has been observed in patients with advanced endometrial, squamous NSCLC lung cancer and T-cell lymphoma. Encouraging signals of activity were observed in patients with advanced cervical, hepatocellular, ovarian and pancreatic cancers.
The Company believes that fadra&#39;s inhibition of CDK2 and CDK9 may be superior to inhibiting either CDK2 or CDK9 alone. Fadra tablets can be given orally with repeat dosing which has led to transient suppression of anti-apoptosis proteins with generally good tolerability and no Grade 3 or higher hematological toxicity in the first cycle.
The Phase 2 part of the 065-101 study is designed to further evaluate fadra safety and efficacy in up to 8 cohorts defined by histology and/or NGS. The study is powered to demonstrate response in the molecular subtype suggested by the Phase 1 data and others that may be sensitive.
CDKN2A, CDKN2B, MTAP deletions
CDKN2A gene deletions occur in over&nbsp;40%&nbsp;of several solid tumors, including glioma, head and neck, pancreatic, esophageal, lung (incl. squamous), bladder, melanoma, and others. CDKN2B deletions occur in over&nbsp;30%&nbsp;of several solid tumors, including bladder, glioma, pancreatic, esophageal, lung (incl. squamous), head and neck, melanoma, and others. MTAP deletions occur in over&nbsp;25%&nbsp;of several solid tumors, including glioma, mesothelioma, pancreatic, bladder, esophageal and others.1&nbsp;MTAP deletion confers dependency on the PRMT5 enzyme in cancer cells which was identified as a synthetic lethal target for MTAP deleted cancers.
140-101 Phase 1 Study of Oral Plogosertib
In the 140-101 study of oral plogosertib, PLK1 inhibitor, as monotherapy, patients are being recruited at dose level 5. The anticancer activity observed at low levels of continuous exposure may be due to plogosertib&#39;s novel epigenetic mechanism.
To date, 15 patients have been recruited at five dose escalation levels. Encouraging signals of activity were observed in five patients with advanced biliary, ovarian, NSCLC and other cancers. The Company expects to announce details of plogosertib&#39;s differentiated, epigenetic mechanism and biomarkers which may identify patients with sensitive tumors, after preclinical studies at collaborating laboratories are completed.

Cyclacel Pharmaceuticals Reports Fadraciclib Phase 1 Data Suggesting Efficacy Against Tumors With CDKN2A, CDKN2B And MTAP Deletions

Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, ", Cyclacel", or the ", Company", )))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced that it received a notice from&nbsp;The Nasdaq Stock Market LLC&nbsp;("Nasdaq") indicating that the Company has regained compliance with Nasdaq Listing Rule 5250(c)(1) (the "Rule"), by filing its quarterly report on Form 10-Q for the period ended September 30, 2023, on November 29, 2023 with the Securities and Exchange Commission. &nbsp;
Nasdaq Listing Qualifications Department staff has determined that the Company complies with the Rule and advised that the matter is now closed.

Cyclacel Regains Compliance With Nasdaq Listing Rule Following Filing Of Its Form 10-Q With The SEC

<h3>Gainers</h3>
<ul>
<li>Intelligent Bio Solutions (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INBS#NASDAQ">INBS</a>) shares increased by 156.6% to $0.58 during Thursday's regular session. Trading volume for this security as of 12:31 EST is 168.8 million, which is 32447.6% of its average full-day volume over the last 100 days. The company's market cap stands at $2.6 million. As per the press release, Q1 earnings came out yesterday. </li>
<li>Tempest Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TPST#NASDAQ">TPST</a>) shares rose 33.32% to $3.76. As of 12:31 EST, Tempest Therapeutics's stock is trading at a volume of 49.6 million, which is 547.9% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $54.7 million. The company's, Q3 earnings came out yesterday. </li>
<li>Lantern Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LTRN#NASDAQ">LTRN</a>) stock moved upwards by 28.12% to $3.59. Trading volume for this security as of 12:31 EST is 276.1K, which is 1068.0% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $38.9 million. As per the press release, Q3 earnings came out yesterday. </li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>) stock rose 25.34% to $7.27. </li>
<li>Oncology Institute (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TOI#NASDAQ">TOI</a>) stock rose 23.36% to $2.27. As of 12:31 EST, this security is trading at a volume of 280.0K shares, making up 136.5% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $165.6 million. As per the press release, Q3 earnings came out yesterday. </li>
<li>OncoCyte (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OCX#NASDAQ">OCX</a>) stock rose 20.67% to $2.51. The current volume of 67.1K shares is 505.7% of OncoCyte's average full-day volume over the last 100 days (last updated at 12:31 EST). The company's market cap stands at $20.6 million. As per the news, the Q3 earnings report came out today. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Atara Biotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) stock decreased by 79.3% to $0.25 during Thursday's regular session. The current volume of 39.3 million shares is 3348.1% of Atara Biotherapeutics's average full-day volume over the last 100 days (last updated at 12:31 EST). The market value of their outstanding shares is at $25.4 million. </li>
<li>Ikena Oncology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IKNA#NASDAQ">IKNA</a>) shares fell 63.69% to $1.5. Trading volume for this security as of 12:31 EST is 1.7 million, which is 1917.2% of its average full-day volume over the last 100 days. The company's market cap stands at $65.7 million. As per the news, the Q3 earnings report came out today. </li>
<li>Acutus Medical (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AFIB#NASDAQ">AFIB</a>) stock decreased by 50.8% to $0.23. Acutus Medical's stock is trading at a volume of 1.0 million shares as of 12:31 EST. This is 1095.2% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $6.7 million. As per the news, the Q3 earnings report came out yesterday. </li>
<li>Assertio Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ASRT#NASDAQ">ASRT</a>) stock fell 44.84% to $1.18. The current volume of 7.0 million shares is 466.5% of Assertio Holdings's average full-day volume over the last 100 days (last updated at 12:31 EST). The market value of their outstanding shares is at $109.4 million. The company's, Q3 earnings came out yesterday. </li>
<li>Cardio Diagnostics Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDIO#NASDAQ">CDIO</a>) stock declined by 33.09% to $0.92. Trading volume for this security as of 12:31 EST is 14.2 million, which is 163.6% of its average full-day volume over the last 100 days. The company's market cap stands at $17.2 million. </li>
<li>BioVie (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIVI#NASDAQ">BIVI</a>) stock declined by 30.28% to $2.97. The current volume of 776.3K shares is 232.0% of BioVie's average full-day volume over the last 100 days (last updated at 12:31 EST). The company's market cap stands at $109.3 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

AFIB

ASRT

ATRA

BIVI

Cardio Diagnostics Holdings Inc. - Common stock

CDIO

IKNA

Intelligent Bio Solutions Inc. - Common Stock

INBS

LTRN

Tempest Therapeutics, Inc. - Common Stock

TPST

<h3>Gainers</h3>
<ul>
<li>Virios Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VIRI#NASDAQ">VIRI</a>) stock increased by 49.4% to $0.77 during Thursday's regular session. As of 13:31 EST, Virios Therapeutics's stock is trading at a volume of 7.7 million, which is 1977.7% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $14.8 million. </li>
<li>Alpine Immune Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALPN#NASDAQ">ALPN</a>) shares rose 34.12% to $14.11. Trading volume for Alpine Immune Sciences's stock is 2.4 million as of 13:31 EST. This is 665.8% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $694.2 million. </li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>) stock rose 30.57% to $9.14. </li>
<li>Panbela Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PBLA#NASDAQ">PBLA</a>) stock increased by 29.94% to $1.03. Trading volume for this security as of 13:31 EST is 48.7 million, which is 42903.2% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $3.0 million. </li>
<li>Kodiak Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KOD#NASDAQ">KOD</a>) stock rose 29.87% to $2.0. As of 13:31 EST, this security is trading at a volume of 10.4 million shares, making up 1800.6% of its average full-day volume over the last 100 days. The company's market cap stands at $104.9 million. </li>
<li>Omega Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMGA#NASDAQ">OMGA</a>) stock rose 29.49% to $1.75. Omega Therapeutics's stock is trading at a volume of 402.7K shares as of 13:31 EST. This is 235.3% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $96.3 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Outlook Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OTLK#NASDAQ">OTLK</a>) stock fell 47.3% to $0.33 during Thursday's regular session. Outlook Therapeutics's stock is trading at a volume of 48.2 million shares as of 13:31 EST. This is 498.3% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $86.6 million. </li>
<li>Acurx Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACXP#NASDAQ">ACXP</a>) shares decreased by 30.08% to $3.54. As of 13:31 EST, Acurx Pharmaceuticals's stock is trading at a volume of 1.9 million, which is 294.5% of its average full-day volume over the last 100 days. The company's market cap stands at $46.1 million. </li>
<li>Seres Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MCRB#NASDAQ">MCRB</a>) shares fell 25.35% to $1.07. Trading volume for this security as of 13:31 EST is 9.0 million, which is 360.4% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $137.8 million. As per the press release, Q3 earnings came out today. </li>
<li>Connect Biopharma Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNTB#NASDAQ">CNTB</a>) shares declined by 23.17% to $1.36. As of 13:31 EST, Connect Biopharma Hldgs's stock is trading at a volume of 64.1K, which is 118.0% of its average full-day volume over the last 100 days. The company's market cap stands at $74.8 million. </li>
<li>DarioHealth (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DRIO#NASDAQ">DRIO</a>) shares declined by 20.46% to $0.8. The current volume of 1.0 million shares is 786.1% of DarioHealth's average full-day volume over the last 100 days (last updated at 13:31 EST). The company's market cap stands at $21.8 million. The company's, Q3 earnings came out today. </li>
<li>Kintara Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KTRA#NASDAQ">KTRA</a>) stock fell 19.8% to $0.4. As of 13:31 EST, Kintara Therapeutics's stock is trading at a volume of 980.0K, which is 1112.1% of its average full-day volume over the last 100 days. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

ACXP

ALPN

CNTB

DRIO

Kintara Therapeutics, Inc. - Common Stock

KTRA

MCRB

OTLK

PBLA

VIRI

<h3>Gainers</h3>
<ul>
<li>Minerva Surgical (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UTRS#NASDAQ">UTRS</a>) shares increased by 111.8% to $0.42 during Friday's regular session. As of 13:30 EST, Minerva Surgical's stock is trading at a volume of 85.0 million, which is 3814.9% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $74.9 million. </li>
<li>CNS Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNSP#NASDAQ">CNSP</a>) stock rose 20.44% to $2.18. CNS Pharma's stock is trading at a volume of 1.6 million shares as of 13:30 EST. This is 48.5% of its average full-day volume over the last 100 days. The company's market cap stands at $9.0 million. </li>
<li>Kala Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KALA#NASDAQ">KALA</a>) stock moved upwards by 18.57% to $17.62. As of 13:30 EST, this security is trading at a volume of 196.9K shares, making up 33.7% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $41.3 million. </li>
<li>Praxis Precision Medicine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRAX#NASDAQ">PRAX</a>) stock moved upwards by 18.57% to $1.04. As of 13:30 EST, this security is trading at a volume of 1.3 million shares, making up 82.8% of its average full-day volume over the last 100 days. The company's market cap stands at $64.5 million. </li>
<li>Pasithea Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KTTA#NASDAQ">KTTA</a>) shares rose 18.53% to $0.41. Trading volume for this security as of 13:30 EST is 91.6K, which is 207.8% of its average full-day volume over the last 100 days. The company's market cap stands at $10.8 million. </li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>) shares increased by 18.23% to $12.97. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Bellicum Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BLCM#NASDAQ">BLCM</a>) shares declined by 63.7% to $0.25 during Friday's regular session. The market value of their outstanding shares is at $2.3 million. </li>
<li>Kiora Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KPRX#NASDAQ">KPRX</a>) shares fell 49.85% to $0.83. As of 13:30 EST, this security is trading at a volume of 3.6 million shares, making up 5902.0% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $1.6 million. </li>
<li>Oncorus (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ONCR#NASDAQ">ONCR</a>) shares fell 40.99% to $0.11. Trading volume for this security as of 13:30 EST is 3.6 million, which is 1320.2% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $2.7 million. </li>
<li>Sight Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SGHT#NASDAQ">SGHT</a>) stock decreased by 19.15% to $7.73. Sight Sciences's stock is trading at a volume of 273.4K shares as of 13:30 EST. This is 248.7% of its average full-day volume over the last 100 days. The company's market cap stands at $374.5 million. </li>
<li>Cue Health (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HLTH#NASDAQ">HLTH</a>) shares declined by 16.0% to $0.6. Trading volume for this security as of 13:30 EST is 1.0 million, which is 252.8% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $91.0 million. </li>
<li>Trxade Health (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MEDS#NASDAQ">MEDS</a>) stock declined by 15.28% to $0.33. Trading volume for Trxade Health's stock is 376.2K as of 13:30 EST. This is 93.4% of its average full-day volume over the last 100 days. The company's market cap stands at $3.3 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

BLCM

CNSP

HLTH

KALA

Kiora Pharmaceuticals, Inc. - Common Stock

KPRX

KTTA

MEDS

ONCR

PRAX

SGHT

UTRS

<h3>Gainers</h3>
<ul>
<li>Immutep (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IMMP#NASDAQ">IMMP</a>) stock rose 141.2% to $3.83 during Wednesday's regular session. Immutep's stock is trading at a volume of 53.7 million shares as of 13:30 EST. This is 57503.7% of its average full-day volume over the last 100 days. The company's market cap stands at $337.2 million. </li>
<li>Motus GI Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MOTS#NASDAQ">MOTS</a>) stock moved upwards by 37.22% to $0.99. Motus GI Hldgs's stock is trading at a volume of 14.7 million shares as of 13:30 EST. This is 44159.3% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $4.7 million. </li>
<li>Viracta Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VIRX#NASDAQ">VIRX</a>) shares increased by 36.54% to $1.7. The current volume of 1.3 million shares is 1652.3% of Viracta Therapeutics's average full-day volume over the last 100 days (last updated at 13:30 EST). The market value of their outstanding shares is at $65.2 million. </li>
<li>Rigel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RIGL#NASDAQ">RIGL</a>) stock rose 31.0% to $1.69. The current volume of 8.1 million shares is 305.2% of Rigel Pharmaceuticals's average full-day volume over the last 100 days (last updated at 13:30 EST). The company's market cap stands at $293.4 million. </li>
<li>Corvus Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRVS#NASDAQ">CRVS</a>) stock increased by 28.27% to $3.04. The current volume of 3.1 million shares is 589.4% of Corvus Pharma's average full-day volume over the last 100 days (last updated at 13:30 EST). The company's market cap stands at $141.5 million. </li>
<li>X4 Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XFOR#NASDAQ">XFOR</a>) stock moved upwards by 23.86% to $2.18. As of 13:30 EST, X4 Pharmaceuticals's stock is trading at a volume of 8.6 million, which is 377.0% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $266.4 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Mallinckrodt (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/MNK#AMEX">MNK</a>) shares declined by 15.3% to $1.6 during Wednesday's regular session. Mallinckrodt's stock is trading at a volume of 80.6K shares as of 13:30 EST. This is 200.0% of its average full-day volume over the last 100 days. The company's market cap stands at $21.0 million. </li>
<li>Citius Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CTXR#NASDAQ">CTXR</a>) shares fell 15.2% to $1.06. The current volume of 3.7 million shares is 298.0% of Citius Pharma's average full-day volume over the last 100 days (last updated at 13:30 EST). The company's market cap stands at $168.3 million. As per the news, the Q2 earnings report came out 3 days ago. </li>
<li>Intercept Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ICPT#NASDAQ">ICPT</a>) stock decreased by 14.47% to $13.87. Trading volume for this security as of 13:30 EST is 4.4 million, which is 576.0% of its average full-day volume over the last 100 days. The company's market cap stands at $577.9 million. </li>
<li>TScan Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TCRX#NASDAQ">TCRX</a>) stock declined by 12.54% to $3.49. As of 13:30 EST, TScan Therapeutics's stock is trading at a volume of 182.5K, which is 13.6% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $84.5 million. </li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>) stock declined by 11.6% to $9.8. </li>
<li>Venus Concept (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERO#NASDAQ">VERO</a>) stock decreased by 11.27% to $2.52. The company's market cap stands at $13.4 million. As per the news, the Q1 earnings report came out 2 days ago. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

CRVS

CTXR

ICPT

IMMP

RIGL

TCRX

VERO

VIRX

XFOR

12 Health Care Stocks Moving In Wednesday's Intraday Session

&ndash;&nbsp;Determination of Recommended Phase 2 Dose and Start of Phase 2 in 1Q 2023 for Oral Fadraciclib &ndash;
&ndash; 2/3 Partial Responses in Lymphoma and 11/15 Stable Disease in Advanced Solid Tumors&nbsp;&ndash;
&ndash; Expecting Key Data Readouts for Oral Fadraciclib in 2023&nbsp;&ndash;
&ndash; Expecting Preliminary Safety and Efficacy Update for Oral Plogosertib (formerly CYC140) in Advanced Solid Tumors in 1H 2023 &ndash;
&ndash; Existing Cash Until End of 2023 Support Multiple Data Readouts &ndash;
BERKELEY HEIGHTS, N.J., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, &amp;quot, , Cyclacel&amp;quot, , or the &amp;quot, , Company&amp;quot, , )))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today provided a business update reviewing 2022 achievements and outlining the Company&#39;s key business objectives for 2023.
&quot;2022 was a year of solid progress for Cyclacel highlighted by the clinical advancement of our two product candidates in Phase 1/2 clinical studies,&quot; said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. &quot;Both fadraciclib, our CDK2/9 inhibitor, and plogosertib (formerly CYC140), our PLK1 inhibitor, have shown differentiated and competitive profiles in their respective classes. We believe that fadra is the only transcriptionally active CDK inhibitor to have shown single agent responses in both liquid and solid tumors with a good tolerability profile. We are seeing preliminary indications of single-agent activity in the ongoing Phase 1/2 trial of plogosertib in advanced solid tumors and lymphoma. We also estimate that our cash runway will fund operations through the end of 2023, providing sufficient funding over this catalyst-rich period.&quot;
&quot;We believe that we are very close to identifying the recommended Phase 2 dose (RP2D) in the ongoing Phase 1/2 study of oral fadra for the treatment of advanced solid tumors and lymphoma,&quot; said Dr. Mark Kirschbaum M.D., Chief Medical Officer. &quot;Fadra is showing signs of single agent activity in several tumor types including PRs in 2/3 T cell lymphoma patients and stable disease in certain solid tumors. Oral fadra has also maintained an acceptable safety and tolerability profile across multiple dosing cohorts. We expect to enter the Phase 2 segment of the trial in the first half of 2023, after completing the rapid accrual we have seen in Phase 1, and reviewing the safety, pharmacokinetics and correlative study data. To accelerate Phase 2 enrollment, we have expanded the number of clinical trial sites participating in the trial including certain widely recognized U.S. and international cancer centers. We expect to provide a data update at a major medical meeting in the first half of 2023 and initial data from the Phase 2 in the second half of 2023.&quot;
&quot;We have also made encouraging progress with our second candidate, plogosertib,&quot; continued Dr. Kirschbaum. &quot;The dose escalation stage of our Phase 1/2 study in advanced solid tumors and lymphoma is enrolling well. Based upon the molecule&#39;s differentiated profile and early observation of efficacy with three patients on treatment for at least 3 cycles, we believe plogosertib has the potential to demonstrate single-agent activity across a broad range of cancers. We anticipate reporting preliminary safety and efficacy data from the dose-escalation stage of the ongoing plogosertib Phase 1/2 study within 2023.&quot;
2022 Key Achievements
Fadraciclib
<ul>
<li>Final dose-escalation level 6a to determine RP2D in the oral fadraciclib 065-101 Phase 1/2 study has enrolled 3 out of 6 patients</li>
<li>Broad activity observed in the first 5 dose levels: 2/3 partial responses (PRs) in patients with T-cell lymphoma; 4 patients with cervical, endometrial, hepatocellular and ovarian cancer showed stable disease with target lesion reductions; and a patient with pancreatic cancer achieved stable disease for 5 cycles</li>
<li>Achieved target engagement levels predicted to inhibit CDK2 and CDK9 for approximately 5 to 7 hours per dose on continuous dosing</li>
<li>At the Company&#39;s R&amp;D Day a principal investigator from Seoul National University Hospital showed preclinical data demonstrating sensitivity to fadra in biliary tract and pancreatic cancer cells obtained from patient specimens</li>
<li>A publication from The University of Texas MD Anderson Cancer Center reported preclinical data against chronic lymphocytic leukemia (CLL) cell lines showing that fadraciclib, as a single agent and in combination with the BCL2 antagonist, venetoclax, depletes anti-apoptotic proteins and synergizes with venetoclax</li>
<li>Reported positive preliminary data from the Phase 1/2 clinical trial of oral fadraciclib in patients with solid tumors and lymphoma at the ENA 2022 meeting</li>
</ul>
Plogosertib (formerly CYC140)
<ul>
<li>Announced dosing of first patient in Phase 1/2 study of oral plogosertib in patients with advanced solid tumors and lymphomas</li>
<li>No dose limiting toxicities observed to date in the first 3 dose levels</li>
<li>Stable disease at the first dose level in an ongoing patient with metastatic, KRAS G12V mutated, non-small cell lung cancer for 9 cycles and a patient with metastatic ovarian cancer for 5 cycles 
	&nbsp;</li>
</ul>
Corporate Highlights
<ul>
<li>On October 31, 2022 the Company held an R&amp;D Day (<a href="https://lifesci.rampard.com/WebcastingAppv5/Events/eventsDispatcher.jsp?Y2lk=MjA3NQ==" target="_blank">Webcast replay</a>) at which updated clinical and preclinical data on fadraciclib and plogosertib were presented</li>
<li>Announced the election by the preferred stockholders of Kenneth M. Ferguson, Ph.D. to the Board of Directors</li>
</ul>
Key Business Objectives for 2023
1H 2023
<ul>
<li>First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma</li>
<li>Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma at a major medical meeting</li>
<li>Report interim Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma 
	&nbsp;</li>
</ul>
2H 2023
<ul>
<li>Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma</li>
<li>Report interim data from dose escalation stage of 065-102 study with oral fadraciclib in patients with advanced leukemia
<ul>
<li>Report final data from dose escalation stage of 140-101 study with oral plogosertib in advanced solid tumors and lymphoma</li>
</ul>
</li>
</ul>

Guidance

Cyclacel Pharmaceuticals Reviews 2022 Achievements And Announces Key Business Objectives For 2023

Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, Cyclacel or the Company)))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported today preliminary dose escalation data from its ongoing 065-101 Phase 1/2 clinical study of oral fadraciclib, a cyclin dependent kinase (CDK) 2/9 inhibitor, for the treatment of patients with advanced solid tumors and lymphoma. Of the 18 patients evaluable for response, two out of three T cell lymphoma patients treated achieved partial response and 11 out of 15 patients with various solid tumors achieved stable disease. No dose-limiting toxicities have been observed thus far. Data were presented during a poster presentation at the 34th&nbsp;EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics, which is being held on October 26-28, in Barcelona, Spain.

Cyclacel Reports Preliminary Data From Phase 1/2 Clinical Trial Of Oral Fadraciclib In Patients With Solid Tumors And Lymphoma At ENA 2022

&nbsp;Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, &amp;quot, , Cyclacel&amp;quot, , or the &amp;quot, , Company&amp;quot, , )))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced it will present preliminary dose escalation data from its ongoing 065-101 Phase 1/2 clinical trial of oral fadraciclib for the treatment of patients with advanced solid tumors and lymphoma during a poster presentation at the upcoming 34th&nbsp;EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics, which is being held on October 26-28th, 2022, in Barcelona, Spain. 
&nbsp;
Details of the presentation are provided below:
<table>
<tbody>
<tr>
<td>Title:</td>
<td>A Phase 1/2, Open-label, Multi-center Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Fadraciclib (CYC065), an Oral CDK2/9 Inhibitor, in Subjects with Advanced Solid Tumors and Lymphoma</td>
</tr>
<tr>
<td>Abstract No:</td>
<td>50</td>
</tr>
<tr>
<td>Session Topic:</td>
<td>Molecular Targeted Agents 1</td>
</tr>
<tr>
<td>Date and Time:</td>
<td>Wednesday, October 26, 2022, 12:00 &ndash; 20:00 CEST</td>
</tr>
<tr>
<td>Location:</td>
<td>Exhibition Hall</td>
</tr>
</tbody>
</table>
About Cyclin-Dependent Kinases and Fadraciclib
Cyclin-dependent kinases (CDKs) are critical for cell cycle control and transcriptional regulation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased cancer cell survival. Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9. CDK2 drives cell cycle transitions and CDK9 regulates transcription of genes through phosphorylation of the carboxy-terminal domain (CTD) of RNA polymerase II (RNAP II). By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death of cancer cells at sub-micromolar concentrations. Fadraciclib is being tested in a Phase 1/2 trial for the treatment of advanced solid tumors and lymphoma (065-101;&nbsp;<a href="https://www.globenewswire.com/Tracker?data=X2cMu6rbaHS0h6z_QEgDOADkMC4OJGhRwSTWbw8VcsTGXjhp7qZBPUn6znJxmwaTkZM4HQskaHbK0KCF80xR9JP2Xo5zLZXt0gvOiAZVxIL4JT032k_QcSwL2OdQWjzIhDlhVRZ2y7IWuGZyWxLfpqTSVQDEckFgeyAJq3YjPlI=" target="_blank">NCT#04983810</a>) and a Phase 1/2 trial for the treatment of hematological malignancies (065-102;&nbsp;<a href="https://www.globenewswire.com/Tracker?data=meniIxq8vKLvaFVXGJRTreLqjWC9QYBEExazNz4rDfG-lqfCOzVWOZsDMqiD1UJaAweMww7-o9MZJmXs2N9hcLUziXDmovfUyJ52r0v3Cqcq8QC0HY-lfgnabukINkCnlIqMKyhY80ULG1i0o4fPEA==" target="_blank">NCT#05168904</a>).
Preclinical data suggest that fadraciclib may benefit patients with certain cyclin E-addicted or MYC-amplified solid tumors, including certain forms of breast cancer, neuroblastoma, ovarian cancer, uterine serous carcinoma and adult and pediatric hematological malignancies, such as ALL, AML, B-cell lymphoma, CLL, and multiple myeloma. Similarly to&nbsp;FDA-approved CDK4/6 inhibitors, fadraciclib may be useful in combination with other anticancer drugs, including HER2 inhibitors, such as trastuzumab, or BCL2 inhibitors, such as venetoclax.
In a prior Phase 1 open-label trial (CYC065-01), patients with high copy CCNE (cyclin E), MYC or MCL1 showed sensitivity to intravenously administered, single-agent fadraciclib. A heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib, subsequently achieved CR and continues on treatment with fadraciclib for over three years. An additional patient with cyclin E amplified ovarian cancer achieved stable disease with&nbsp;29%&nbsp;shrinkage in her target tumor lesions.

Cyclacel Pharmaceuticals To Present Preliminary Data From The Phase 1/2 Clinical Trial Of Oral Fadraciclib At The 34th EORTC-NCI-AACR Symposium October 26

&nbsp;
<h3>Gainers</h3>
<ul>
<li>Kiora Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KPRX#NASDAQ">KPRX</a>) shares increased by 37.9% to $0.5 during Wednesday&#39;s regular session. Kiora Pharmaceuticals&#39;s stock is trading at a volume of 7.0 million shares as of 13:30 EST. This is 2811.8% of its average full-day volume over the last 100 days. The company&#39;s market cap stands at $6.3 million.</li>
<li>Cidara Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDTX#NASDAQ">CDTX</a>) stock moved upwards by 29.74% to $0.61. As of 13:30 EST, Cidara Therapeutics&#39;s stock is trading at a volume of 544.6K, which is 190.6% of its average full-day volume over the last 100 days. The company&#39;s market cap stands at $42.1 million.</li>
<li>Stealth BioTherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MITO#NASDAQ">MITO</a>) shares increased by 28.33% to $0.34. Stealth BioTherapeutics&#39;s stock is trading at a volume of 18.7 million shares as of 13:30 EST. This is 882.4% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $25.0 million.</li>
<li>Rubius Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RUBY#NASDAQ">RUBY</a>) shares increased by 25.94% to $1.33. Trading volume for this security as of 13:30 EST is 3.6 million, which is 237.8% of its average full-day volume over the last 100 days. The company&#39;s market cap stands at $120.4 million.</li>
<li>HUTCHMED (China) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HCM#NASDAQ">HCM</a>) stock increased by 25.91% to $11.76. Trading volume for HUTCHMED (China)&#39;s stock is 2.2 million as of 13:30 EST. This is 337.7% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $2.0 billion.</li>
<li>Bluejay Diagnostics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BJDX#NASDAQ">BJDX</a>) shares rose 23.14% to $1.32. As of 13:30 EST, this security is trading at a volume of 492.5K shares, making up 211.7% of its average full-day volume over the last 100 days. The company&#39;s market cap stands at $26.5 million.</li>
</ul>
<h3>Losers</h3>
<ul>
<li>Rigel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RIGL#NASDAQ">RIGL</a>) stock declined by 56.6% to $0.76 during Wednesday&#39;s regular session. Trading volume for Rigel Pharmaceuticals&#39;s stock is 40.2 million as of 13:30 EST. This is 2078.8% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $131.3 million.</li>
<li>Ontrak (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OTRKP#NASDAQ">OTRKP</a>) stock declined by 23.57% to $3.13. Ontrak&#39;s stock is trading at a volume of 85.7K shares as of 13:30 EST. This is 350.3% of its average full-day volume over the last 100 days.</li>
<li>Accelerate Diagnostics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXDX#NASDAQ">AXDX</a>) stock declined by 22.72% to $0.89. Accelerate Diagnostics&#39;s stock is trading at a volume of 2.6 million shares as of 13:30 EST. This is 307.5% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $70.6 million.</li>
<li>Cosmos Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COSM#NASDAQ">COSM</a>) shares decreased by 22.43% to $0.83. Cosmos Holdings&#39;s stock is trading at a volume of 382.0K shares as of 13:30 EST. This is 44.0% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $15.5 million.</li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>) shares decreased by 14.33% to $6.1.</li>
<li>NantHealth (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NH#NASDAQ">NH</a>) stock declined by 12.59% to $0.55. The current volume of 81.5K shares is 84.6% of NantHealth&#39;s average full-day volume over the last 100 days (last updated at 13:30 EST). The market value of their outstanding shares is at $63.6 million. See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga&#39;s automated content engine and reviewed by an editor.

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- CYC140, a Potent and Selective PLK1 Inhibitor to Be Evaluated as a Single Agent Across Multiple Solid Tumor and Lymphoma Types in Streamlined, Registration-Directed Study -
BERKELEY HEIGHTS, N.J., April 19, 2022 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, &amp;quot, Cyclacel&amp;quot, or the &amp;quot, Company&amp;quot, )), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced dosing of the first patient in the Company&rsquo;s streamlined, multi-cohort Phase 1/2 study of oral CYC140 in patients with advanced solid tumors and lymphomas.
&ldquo;With the start of this trial, Cyclacel is now enrolling patients across three registration-directed studies to evaluate safety and efficacy of our two lead drug candidates, fadraciclib and CYC140, for the treatment of various solid tumors, lymphomas and leukemias,&rdquo; said Spiro Rombotis, Cyclacel&rsquo;s President and Chief Executive Officer. &ldquo;As with the fadraciclib studies, the Phase 1 stage of this trial will determine an optimal dosing regimen of oral CYC140 and provide insights with respect to safety, tolerability and clinical activity. The Phase 2 stage will enroll up to seven cohorts by histology and also a basket cohort. We expect initial data from this trial during the first half of 2023. We also look forward to reporting initial data from the fadraciclib clinical study in advanced solid tumors during the first half of 2022.&rdquo;
&ldquo;Overexpression of PLK1 is known to be important in many types of cancer,&rdquo; said Mark Kirschbaum M.D., Senior Vice President and Chief Medical Officer. &ldquo;We have optimized the properties of CYC140 to fit its apoptosis-driven mechanism, including a short half-life and differentiated structural and biological properties, compared to other PLK1 inhibitors in development. In preclinical studies CYC140 has demonstrated promising activity in multiple solid tumors and leukemias. The study has initially opened at City of Hope and&nbsp;MD Anderson Cancer Center&nbsp;with more sites to join later on. In addition to patients with certain PLK1 over-expressing tumors, the study will enroll patients with MYC amplified and KRAS-mutated cancers in which PLK1 inhibition may be effective. If successful, CYC140 may provide new treatment options for patients with advanced solid tumors or lymphomas.&rdquo;
&ldquo;As a key regulator of cell mitosis, PLK1 plays an integral role in prolonged survival of many cancer cells, including p53(-) and KRAS mutant genotypes,&rdquo; said Miguel Villalona-Calero, M.D., co-leader of the Development Cancer Therapeutics Program and Professor, Department of Medical Oncology &amp; Therapeutics Research at City of Hope, one of the largest cancer research and treatment organizations in the United States. &ldquo;The totality of preclinical evidence suggests that CYC140 has significant potency and single-agent activity. This novel agent warrants clinical investigation across multiple solid tumors and lymphomas.&rdquo;
The Phase 1/2 registration-directed trial, designated CYC140-101, uses a streamlined design and will first determine in a dose escalation stage the recommended Phase 2 dose (RP2D) for single-agent CYC140. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage CYC140 will be administered to patients in up to 7 mechanistically-relevant cohorts including patients with bladder, breast, colorectal (including KRAS mutant), hepatocellular and biliary tract, and lung cancers (both small cell and non-small cell), as well as lymphomas. An additional basket cohort will enroll patients with biomarkers relevant to the drug&rsquo;s mechanism, including MYC amplified tumors. The protocol allows for expansion of individual cohorts based on response which may allow acceleration of the clinical development and registration plan for CYC140.

Cyclacel Announces Dosing Of First Patient In Phase 1/2 Study Of Oral Cyc140 In Patients With Advanced Solid Tumors And Lymphomas

Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, &amp;quot, , Cyclacel&amp;quot, , or the &amp;quot, , Company&amp;quot, , )))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced a&nbsp;<a href="https://www.globenewswire.com/Tracker?data=0o7SFD7ERqp1olVQSbjIXLKSyoGd5WBq-Lqs5IqhK2LTwSH9Axwe2TAcJ2bw2E-UP6pFpLyPvzUkkxIZyS262Wut35hJu7dH0pgaX0VNvuTydu3xOeR4Yz8fpeLjwk8_" target="_blank">publication</a>&nbsp;in the journal&nbsp;Leukemia&nbsp;titled &quot;Cyclin-dependent kinase inhibitor fadraciclib (CYC065) depletes anti-apoptotic protein and synergizes with venetoclax in primary chronic lymphocytic leukemia cells&quot;. Fadraciclib is Cyclacel&#39;s novel CDK2/9 inhibitor, currently in two Phase 1/2 trials, one for the treatment of advanced solid tumors and lymphomas and another for hematological malignancies, including patients with leukemia being treated in combination with venetoclax.
&quot;Results from this research provide further mechanistic evidence in support of our ongoing Phase 1/2 clinical study of oral fadraciclib in select hematological malignancies,&quot; said Mark Kirschbaum, M.D., Senior Vice President and Chief Medical Officer of Cyclacel. &quot;The findings confirmed that fadraciclib suppresses MCL1 and synergizes with venetoclax, the only FDA-approved apoptosis enabling leukemia treatment. We have included a cohort within the proof-of-concept part of our Phase 1/2 study that will evaluate the combination of fadraciclib plus venetoclax in patients who have previously failed venetoclax-based regimens.&quot;
Researchers from the Department of Experimental Therapeutics and the Department of Leukemia at The University of Texas MD Anderson Cancer Center published preclinical data interrogating fadraciclib&#39;s mechanism of action against primary cell lines of chronic lymphocytic leukemia (CLL), both as a single agent and in combination with the BCL2 antagonist, venetoclax.
Results from the study confirmed that fadraciclib inhibited CDK9 mediated transcription, reduced levels of the short-lived anti-apoptotic protein MCL1, and induced apoptosis in primary CLL cells. The data highlighted the importance of continuous treatment to prevent recovery of MCL1 protein levels. Fadraciclib is the only transcriptional CDK inhibitor in clinical development that is being dosed on a daily schedule by mouth.
Fadraciclib was shown to combine synergistically with venetoclax, the only FDA-approved apoptosis enabling, leukemia treatment. Furthermore, it was demonstrated that the best synergy, with fadraciclib and venetoclax given at the same time, was achieved in 17p deleted CLL cells, which were not sensitive to either agent alone.
Fadraciclib also overcame protection mediated by stroma CLL cells and lymph node microenvironment. This may be important for clinical translation as venetoclax appears to be less effective in the lymph nodes.1
The data support the rationale for pursuing clinical development of fadraciclib, either alone or in combination with a BCL2 antagonist, for the treatment of CLL.

Cyclacel Pharmaceuticals Announces Publication Confirming Fadraciclib Suppresses MCL1 And Synergizes With Venetoclax In Chronic Lymphocytic Leukemia

&nbsp;
<h3>Gainers</h3>
<ul>
<li>Epizyme (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPZM#NASDAQ">EPZM</a>) stock increased by 14.2% to $1.41 during Wednesday&#39;s regular session. As of 12:30 EST, this security is trading at a volume of 9.6 million shares, making up 418.6% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $149.0 million.</li>
<li>Pharming (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PHAR#NASDAQ">PHAR</a>) shares rose 11.65% to $9.85. Trading volume for Pharming&#39;s stock is 54.4K as of 12:30 EST. This is 536.1% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $628.9 million.</li>
<li>Exicure (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XCUR#NASDAQ">XCUR</a>) shares increased by 10.66% to $0.23. Trading volume for this security as of 12:30 EST is 16.7 million, which is 263.9% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $25.2 million.</li>
<li>Entasis Therapeutics Hldg (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ETTX#NASDAQ">ETTX</a>) shares moved upwards by 10.37% to $1.6. The current volume of 7.4 million shares is 5410.2% of Entasis Therapeutics Hldg&#39;s average full-day volume over the last 100 days (last updated at 12:30 EST). The company&#39;s market cap stands at $76.2 million.</li>
<li>Nanobiotix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NBTX#NASDAQ">NBTX</a>) stock rose 9.13% to $8.72. The company&#39;s market cap stands at $303.5 million.</li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>) stock increased by 8.15% to $6.76.</li>
<li>&nbsp;</li>
</ul>
<h3>Losers</h3>
<ul>
<li>LogicBio Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LOGC#NASDAQ">LOGC</a>) stock decreased by 55.2% to $0.67 during Wednesday&#39;s regular session. LogicBio Therapeutics&#39;s stock is trading at a volume of 3.4 million shares as of 12:30 EST. This is 3512.1% of its average full-day volume over the last 100 days. The company&#39;s market cap stands at $22.1 million.</li>
<li>Xilio Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XLO#NASDAQ">XLO</a>) stock declined by 15.33% to $10.72. The company&#39;s market cap stands at $294.4 million.</li>
<li>Immix Biopharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IMMX#NASDAQ">IMMX</a>) stock decreased by 14.11% to $3.96. Trading volume for this security as of 12:30 EST is 966.5K, which is 8.7% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $29.9 million.</li>
<li>NeuBase Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NBSE#NASDAQ">NBSE</a>) shares fell 14.03% to $1.48. As of 12:30 EST, this security is trading at a volume of 115.7K shares, making up 71.6% of its average full-day volume over the last 100 days. The company&#39;s market cap stands at $48.3 million.</li>
<li>Dermata Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DRMA#NASDAQ">DRMA</a>) shares fell 13.18% to $2.07. The market value of their outstanding shares is at $17.2 million.</li>
<li>GBS (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GBS#NASDAQ">GBS</a>) shares declined by 12.89% to $0.89. Trading volume for GBS&#39;s stock is 153.9K as of 12:30 EST. This is 15.8% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $13.2 million. See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga&#39;s automated content engine and reviewed by an editor.

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Cyclacel Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>, NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCCP#NASDAQ">CYCCP</a>, &amp;quot, , Cyclacel&amp;quot, , or the &amp;quot, , Company&amp;quot, , )))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced dosing of the first patient in the Company&#39;s multi-cohort Phase 1/2 study of oral fadraciclib in patients with leukemias or myelodysplastic syndromes (MDS). 
&nbsp;
&quot;We are proud to have achieved this second key clinical milestone and corporate objective following the start of the oral fadraciclib Phase 1/2 solid tumor and lymphoma study last quarter,&quot; said Spiro Rombotis, Cyclacel&#39;s President and Chief Executive Officer. &quot;After opening these two streamlined, registration-directed Phase 1/2 studies with fadraciclib as planned, we will next evaluate the clinical potential of oral CYC140, our PLK1 inhibitor, first in solid tumors and lymphomas and then in leukemias. We look forward to providing periodic updates on our clinical progress and data from these open-label studies when available.&quot;
&quot;We are pleased to have dosed the first patient in this leukemia study and are delighted by the enthusiasm and strong interest from current and prospective investigators,&quot; said Mark Kirschbaum M.D., Senior Vice President and Chief Medical Officer of Cyclacel. &quot;The study has initially opened at City of Hope, a world-renowned cancer research and treatment organization, with more sites to join later. We are building a distinguished, global network of participating institutions for this leukemia study, the ongoing solid tumor clinical study and also for preclinical collaborations. We are excited to begin this second mid-stage study of fadraciclib with the objective of registration-enabling outcomes as a single agent and in relevant combinations, potentially offering a new treatment option for patients with leukemias, MDS and related disorders.&quot;
&quot;Based upon the mechanism of action and prior clinical activity shown to date, further exploration of this novel CDK2/9 inhibitor, both as a single-agent and in combinations, is warranted across a number of leukemias and MDS,&quot; said&nbsp;<a href="https://www.globenewswire.com/Tracker?data=WovATWL1nXKv15H7TsdauY-Z_oaECivkN2FGWOCYxl4jvw3iwMFQ4SrusM2nUQirOALx0PwqcgGoK-UZgkQyN9co-yIOlm-1NTVx2t6vOq4=" target="_blank">Brian Ball</a>, M.D., Assistant Professor, Department of Hematology and Hematopoietic Cell Transplantation at City of Hope. &quot;We look forward to enrolling patients in this trial, performing correlative studies, and evaluating potential treatment benefit for this experimental therapy, particularly in novel subsets of AML, which we have recently described and which may respond to inhibition of these targets.&quot;
The Phase 1/2 registration-directed trial, designated CYC065-102, uses a streamlined design and will first determine the recommended Phase 2 dose (RP2D) for single-agent, oral fadraciclib. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design, where fadraciclib, both as a single agent and in combinations, will be administered to patients in up to seven cohorts relevant to the drug&#39;s mechanism of action and informed by the clinical activity of fadraciclib in previous studies.
Single-agent cohorts will include patients with acute myeloid leukemia (AML) or MDS who have an inadequate response or have progressed on venetoclax combinations with hypomethylating agent (HMA) or low dose Ara C; relapsed/refractory AML or MDS patients with FLT3, KIT or MAPK pathways (including N and K RAS, BRAF, PTPN11, NF1). The trial will also include patients with chronic lymphocytic leukemia (CLL) who have progressed after at least two lines of therapy including a BTK inhibitor and venetoclax.
Combination cohorts for patients with AML or MDS are: fadraciclib and azacitidine for patients with AML or MDS who progressed with hypomethylating (HMA) treatments and also fadraciclib and venetoclax for patients that have progressed after venetoclax therapy. A further combination cohort of fadraciclib and venetoclax will enroll patients with CLL or small lymphocytic lymphoma (SLL) who have progressed after venetoclax therapy. An additional basket cohort will evaluate patients with biomarkers relevant to the drug&#39;s mechanism, including MCL1 and MYC.
The protocol allows for expansion of a cohort based on response which may allow acceleration of the clinical development and registration plan for fadraciclib.

Cyclacel Announces Dosing Of First Patient In Phase 1/2 Study Of Oral Fadraciclib In Patients With Leukemias Or Myelodysplastic Syndromes

Cyclacel Pharmaceuticals Inc. (CYCC) Q1 2023 Earnings Call Transcript

Cyclacel Pharmaceuticals Inc. (CYCC) Q2 2023 Earnings Call Transcript

Cyclacel Pharmaceuticals, Inc. PFD CONV EX 6% goes ex dividend tomorrow

Cyclacel Pharmaceuticals, Inc. (CYCC) Q3 2023 Earnings Call Transcript

Cyclacel Pharmaceuticals, Inc. (CYCC) Q4 2023 Earnings Call Transcript

Cyclacel Pharmaceuticals to Present at Biotech Showcase 2024

Cyclacel Pharmaceuticals Regains Compliance With Nasdaq Minimum Bid Price Requirement

Management

Cyclacel Pharmaceuticals Announces the Appointment of Brian Schwartz, M.D. as Chief Medical Officer

Cyclacel Pharmaceuticals to Participate in 2024 BIO CEO & Investor Conference

Cyclacel Pharmaceuticals Announces Receipt of $2.9 Million R&D Tax Credit

Health Care

Cyclacel Pharmaceuticals Announces Preclinical Proof-of-Concept Data for Fadraciclib to be Presented at the American Association for Cancer Research (AACR) Annual Meeting 2024

Cyclacel Pharmaceuticals to Release Fourth Quarter and Full Year 2023 Financial Results

Earnings

Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Cyclacel Pharmaceuticals to Present New Clinical Data at 2024 ASCO Annual Meeting Highlighting Fadraciclib's Potential as a Precision Medicine for Cancer

Financing

Cyclacel Pharmaceuticals Announces $8.0 Million Private Placement Priced At-The-Market Under Nasdaq Rules

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Cyclacel Pharmaceuticals Stock (NASDAQ:CYCCP), Short Interest Report

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