The Daily Biotech Pulse: ImmunityBio Reports Positive Readout, Valneva Starts Late-Stage Chikungunya Vaccine Study, Sio Gene Shelves Parkinson's Program

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

Stocks In Focus

ImmunityBio Announces Positive Phase 1 Data For Anktiva In HIV

ImmunityBio, Inc. IBRX announced positive Phase 1 study results that demonstrate the activation of CD4+ and CD8+ T cells and natural killer cells in people living with HIV by ImmunityBio's IL-15 superagonist Anktiva.

Anktiva stimulates latent HIV replication in CD4 memory cells allowing the previously hidden infected cells to be revealed and eliminated by CD8 and NK cells. This mechanism is key for killing cells that harbor latent virus, thereby reducing viral reservoirs in antiretroviral-suppressed HIV patients and ultimately ridding the body of the virus and the threat of re-activation. These positive clinical findings support ImmunityBio's "Kick-and-Kill" strategy to cure HIV.

The stock was up 3.44% at $6.02 in premarket trading.

Valneva Starts Phase 3 Study Of Single-Shot Chikungunya Vaccine Candidate In Adolescents

Valneva SE VALN announced the
initiation of a Phase 3 trial in adolescents for its single-shot chikungunya vaccine candidate, VLA1553.

Funded by the CEPI, the trial is intended to support the label extension in this age group following a potential initial regulatory approval in adults from the U.S. Food and Drug Administration. It is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations.

The stock was climbing 3.14% to $35.14 in premarket trading.

Sio Gene To Discontinue Parkinson's Disease Program, Announces CEO Departure

Sio Gene Therapies Inc. SIOX announced it is prioritizing AXO-AAV-GM1 and AXO-AAV-GM2, its clinical stage AAV gene therapy programs for GM1 and GM2 gangliosidosis. The portfolio prioritization, the company said, will extend its estimated cash runway into the second half of 2023, beyond multiple key clinical milestones for both gene therapy programs.

With this prioritization, the company intends to terminate its licensing agreement with Oxford Biomedica plc OXBDF for AXO-Lenti-PD, its lentiviral gene therapy program for Parkinson's disease.

The company also said it has appointed David Nassif, its chief financial officer and general counsel, as interim CEO and a member of board, following the resignation of its CEO Dr. Pavan Cheruvu. Cheruvu is leaving the company to pursue new opportunities, the company said. 

The stock was slipping 10.26% to $1.05 in premarket trading.

Anavex Announces Positive Late-Stage Results For Rett Syndrome Treatment

Anavex Life Sciences Corp. AVXL reported positive top-line results from the Phase 3 AVATAR trial of ANAVEX 2-73 in adult female patients with Rett syndrome, with the investigational asset demonstrating a statistically significant improvement over placebo for the primary efficacy endpoint as well as for all the secondary efficacy endpoints. Convenient once daily oral liquid doses of up to 30mg ANAVEX 2-73 was well tolerated with very good medication compliance.

The stock was slipping 3.59% to $12.61 in premarket trading.

Related Link: The Week Ahead In Biotech (Jan 31-Feb 5): Merck, Bristol-Myers Squibb, Lilly & Novartis Headline Large-Cap Biopharma Earnings News

Inventiva Gets $4.5M Milestone Payment From AbbVie Following Commencement Of Phase 2b Psoriasis Study

Inventiva S.A. IVA announced the receipt of a 4-million-euro ($4.51 million) milestone payment from AbbVie, Inc. ABBV. It follows the inclusion of the first patient with psoriasis in the ongoing Phase 2b clinical trial with cedirogant, which is jointly discovered by Inventiva and AbbVie for the treatment of autoimmune diseases.

Inventiva shares were up 5.3% at $12.72 in premarket trading.

Replimune Announces Departure Of Otello Stampacchia From Board

Replimune Group, Inc. REPL announced Otello Stampacchia of Omega Funds, has resigned from its board. Stampacchia joined the Replimune board in 2015, concurrent with Omega co-leading the company's seed financing.

Centogene Announces $62M Financing To Fund Growth

Centogene N.V. CNTG announced the closing of a 15-million-euro ($17 million) private placement financing from investors led by DPE Deutsche Private Equity, TVM Capital Life Science, and Careventures, as well as the entry into a $45-million senior secured loan facility provided by Oxford Finance.

"We are now looking forward to expeditiously delivering on the promise of strong growth in our core business in 2022 and strengthening CENTOGENE's position as the unique and essential partner for patients, physicians, and biopharma in rare, metabolic, and neurodegenerative diseases," said Kim Stratton, CEO of Centogene.

The company also said its Supervisory Board has nominated Stratton as CEO, transitioning from her previous designation as interim CEO, as well as nomination of Prof. Andreas Busch as a member of the Supervisory Board.

Bio-Techne Announces Dividend, Stock Buyback

Bio-Techne Corporation TECH said its board has decided to pay a dividend of 32 cents per share for the December quarter. The dividend will be payable Feb. 25 to shareholders of record on Feb. 11.

The board has approved a new share repurchase program authorizing the repurchase of up to $400 million of common stock.

The stock was advancing 1.16% to $380.76 in premarket trading.

Click here to access Benzinga's FDA Calendar.

Reviva Commences Pivotal Phase 3 Study Of Schizophrenia Treatment

Reviva Pharmaceuticals Holdings, Inc. RVPH announced the first patients have been dosed in a pivotal Phase 3 study and long-term safety trial to assess its new chemical entity brilaroxazine for the treatment of subjects with an acute exacerbation of schizophrenia.

Lava Commences Phase 1/2a Study Of LAVA-1207 In Prostate Cancer

LAVA Therapeutics N.V. LVTX announced dosing of the first patient in its Phase 1/2a clinical trial of LAVA-1207 in patients with metastatic castration-resistant prostate cancer. LAVA-1207 is a Gammabody that targets the prostate-specific membrane antigen and has demonstrated preclinical proof-of-concept driving antitumor responses in a variety of prostate cancer models.

In premarket trading, the stock was rising 3.62% to $5.72.

On The Radar


Catalent, Inc. CTLT (before the market open)

Related Link: BofA Bullish On This Gene Therapy Biotech Transitioning Into A Commercial Enterprise


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