The Daily Biotech Pulse: Ziopharm To Start Blood Cancer Study, Chemocentryx & Soligenix Slump On Adverse Clinical Trial Outcomes

The Daily Biotech Pulse: Ziopharm To Start Blood Cancer Study, Chemocentryx & Soligenix Slump On Adverse Clinical Trial Outcomes

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Dec. 20)

  • Acceleron Pharma Inc XLRN
  • Adaptive Biotechnologies Corp ADPT
  • Allakos Inc ALLK
  • Alpine Immune Sciences Inc ALPN
  • AtriCure Inc. ATRC
  • Beam Therapeutics Inc BEAM
  • BioNTech SE – ADR BNTX (the company's coronavirus vaccine candidate received positive recommendation from the European Medicines Agency)
  • Bioanalytical Systems, Inc. BASI (reacted to its fourth-quarter results)
  • Castle Biosciences Inc CSTL
  • Cerevel Therapeutics Holdings Inc CERE
  • Checkmate Pharmaceuticals Inc CMPI
  • Clearpoint Neuro Inc CLPT
  • Crispr Therapeutics AG CRSP
  • Editas Medicine Inc EDIT
  • EXACT Sciences Corporation EXAS
  • Guardant Health Inc GH
  • Intellia Therapeutics Inc NTLA
  • Kodiak Sciences Inc KOD
  • Mersana Therapeutics Inc MRSN
  • Nantkwest Inc NK ( announced reverse merger with ImmunityBio)
  • Natera Inc NTRA
  • NeoGenomics, Inc. NEO
  • NGM Biopharmaceuticals Inc NGM
  • Orphazyme A S ADR ORPH
  • Otonomy Inc OTIC
  • Pacific Biosciences of California Inc PACB
  • PLx Pharma Inc PLXP
  • Precigen Inc PGEN
  • Pulse Biosciences Inc PLSE
  • Sangamo Therapeutics Inc SGMO
  • Sarepta Therapeutics Inc SRPT
  • Seelos Therapeutics Inc SEEL (announced the receipt of Israeli patent related to drug to treat neurodegenerative disorders)
  • Sigilon Therapeutics, Inc. SGTX
  • TG Therapeutics Inc common stock TGTX
  • Travere Therapeutics Inc TVTX
  • Turning Point Therapeutics Inc TPTX
  • Twist Bioscience Corp TWST
  • Vericel Corp VCEL
  • Vistagen Therapeutics Inc VTGN
  • XOMA Corp XOMA
  • Zai Lab Ltd – ADR ZLAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 20)

  • AVITA Medical Inc RCEL
  • Cortexyme Inc CRTX
  • Histogen Inc HSTO
  • Intercept Pharmaceuticals Inc ICPT
  • Opthea Spon American Depositary Receipts Representing 8 Ord Shs OPT
  • Reviva Pharmaceuticals Holdings, Inc. RVPH
  • Virios Therapeutics LLC VIRI (listed on Thursday)

Stocks In Focus

Ziopharm's Taiwanese Joint Venture Gets Nod For Commencing Blood Cancer Study

ZIOPHARM Oncology Inc. ZIOP said the Taiwan Food and Drug Administration has cleared an investigational new drug application from Eden BioCell, a joint venture between Ziopharm and cell therapy company TriArm Therapeutics, for its Phase 1 clinical trial to evaluate patient-derived CD19-specific CAR-T, using Ziopharm's rapid personalized manufacturing technology.

This is an investigational treatment for patients with relapsed CD19+ leukemias and lymphomas and the first clinical study of autologous non-viral CD19-specific CAR-T in Taiwan.

The stock was up 9.64% to $3.07 in after-hours trading.

Chemocentryx Says Avacopan Flunks Mid-stage Ultra-rare Kidney Disease Study

ChemoCentryx Inc CCXI and Vifor Fresenius Medical Care Renal Pharma announced topline data from the ACCOLADE Phase 2 clinical study of avacopan in the ultra-rare kidney disease C3 glomerulopathy, which showed the study did not meet the primary endpoint of showing statistically significant change from baseline to week 26 in the C3G histologic index for disease activity.

"Biopsies, taken at baseline and after 26 weeks of treatment showed that the placebo group worsened by 38% on average in the C3G activity score while the avacopan group improved by 2% on average," the companies said. This 40% average difference between the two treatment arms did not constitute statistical significance due to the high patient to patient variability, they added.

In after-hours trading, the stock plunged 7.92% to $55.

Amgen, AstraZeneca's New Drug to Treat Severe Oral Corticosteroid-dependent Asthma Fails In Late-stage Trial

Amgen, Inc. AMGN and AstraZeneca plc AZN announced the SOURCE Phase 3 trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid dose, without loss of asthma control, with tezepelumab compared to placebo.

The 48-week trial assessed the efficacy and safety of the potential new medicine tezepelumab compared to placebo in 150 severe asthma patients who required maintenance use of oral corticosteroids on top of standard-of-care. Tezepelumab's effect on other efficacy parameters was similar to those observed in previous studies, including the registrational Phase 3 NAVIGATOR study, the companies said.

Cardiff Oncology's Chairman Steps Down; Biopharma Appoints Rodney Markin as New Chairman

Cardiff Oncology Inc CRDF announced the stepping down of Dr. Thomas Adams as Executive Chairman and Chairman of the Board of Directors, effective immediately. Adams will continue to serve on the board, it added. Dr. Rodney Markin has been appointed as new Chairman, the company said.

Related Link: Sarepta, Amicus Top Biotech Picks Ahead Of Key Binary Events: Analyst

Unity Biotech Commences Phase 1 Study of Drug Candidate To Treat Diabetic Macular Edema

Ascentage Pharma, a clinical-stage biotech engaged in developing novel therapies for cancers, chronic hepatitis B and age-related diseases, announced that its licensee, Unity Biotechnology Inc. UBX has dosed the first patient in a Phase I clinical study of UBX1325 in patients with diabetic macular edema. UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to Unity by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. The milestone payment was made in common stocks from Unity, totaling 228,310 shares.

In premarket trading, Unity shares were up 9.81% to $5.82.

Soligenix's SGX942 Fails In Phase 3 Study In Severe Oral Mucositis In Head and Neck Cancer Patients

Soligenix, Inc. SNGX announced preliminary top-line results for its pivotal Phase 3 DOM-INNATE trial evaluating SGX942 in the treatment of severe oral mucositis, or SOM, in patients with head and neck cancer receiving chemoradiation. The primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance, although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group, it added. Despite this clinically meaningful improvement, the variability in the distribution of the data yielded a p-value that was not statistically significant.

The stock was slumping 41.61% to $1.60 in premarket trading.

Tonix In-licenses Tech to Use Oxytocin to Treat Insulin Resistance And Related Syndromes

Tonix Pharmaceuticals Holding Corp TNXP said it has acquired the exclusive license to the University of Geneva's technology for using oxytocin to treat insulin resistance and related syndromes, including obesity, from privately held Katana Pharmaceuticals, Inc. This license allows Tonix to expand its intranasal potentiated oxytocin development program, TNX-1900, into cardiometabolic syndromes, which include insulin resistance, impaired glucose tolerance, and obesity, it added.

The stock was adding 8.74% to 6 2 cents in premarket trading.

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