The Daily Biotech Pulse: Adagio's Antibody Effective Against Omicron, Sarepta Terminates Gene Therapy Deal, AstraZeneca Inks Oncology Pact

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

Stocks In Focus

Adagio Says Lead Monoclonal Antibody Effective Against Omicron Variant

Adagio Therapeutics, Inc. ADGI said ADG20, its lead monoclonal antibody, has neutralization activity against the omicron variant of SARS-CoV-2. The company also outlined initiatives to address current and future SARS-CoV-2 variants of concern.

Adagio is evaluating ADG20 in its global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19. The company said it is engaging with the U.S. Food and Drug Administration regarding potential protocol updates to its global Phase 2/3 clinical trials, including an increased dose of ADG20 for the potential prevention and treatment of COVID-19 resulting from the omicron variant.

The stock was surging up 19.55% to $6.77 in premarket trading.

AstraZeneca Announces Positive Results For Booster Dose Of COVID-19 Vaccine, Oncology Drug Licensing Deal

AstraZeneca plc AZN announced that results from a preliminary analysis of an ongoing safety and immunogenicity trial showed that Vaxzevria, when given as a third dose booster, increased the immune response to beta, delta, alpha and gamma SARS-CoV-2 variants. The company also noted that a separate analysis of samples from the trial showed increased antibody response to the omicron variant.

Additionally, a separate Phase 4 trial reported in a preprint with The Lancet on SSRN showed a third dose of Vaxzevria substantially increased antibody levels following a primary vaccine series with Sinovac's CoronaVac.

Separately, AstraZeneca said it has signed a collaboration agreement with Scorpion Therapeutics to discover, develop and commercialize precision medicines against previously hard-to-target cancer proteins. Under the terms of the collaboration agreement, Scorpion will lead discovery and certain preclinical activities. AstraZeneca has the exclusive option to licence worldwide rights for up to three drug candidates.

Scorpion will receive an upfront cash payment of $75 million and is eligible to receive additional success-based payments in the form of option fees and milestone payments, as well as tiered royalties on net sales ranging from mid-single digit to low-double digits.

Salarius Beefs Up Oncology Pipeline With Proposed Acquisition Of Protein Degradation Portfolio From DeuteRx

Salarius Pharmaceuticals, Inc. SLRX announced a definitive agreement with DeuteRx to acquire an oral, small molecule targeted protein degradation portfolio. The acquisition includes a lead drug candidate that Salarius has renamed SP-3164, the related patent family, including issued composition of matter patents, and the opportunity to develop additional undisclosed cancer-fighting assets in the targeted protein degradation space.

Clinical trials of SP-3164 are set to begin in 2023.

Under the terms of the agreement, DeuteRx will receive from Salarius an upfront payment consisting of $1.5 million in cash and 1 million shares of restricted stock. Based upon the success of SP-3164, DeuteRx is also entitled to receive up to $53 million in future clinical and regulatory event-driven milestone payments and sales achievement milestone payments of up to $135 million, as well as escalating royalties on net sales.

Related Link: The Week Ahead In Biotech (Jan 10-15): JPMorgan Healthcare Conference Front And Center, Preannouncements Keep Coming

Gritstone Commences Phase 2/3 Study Of Vaccine-Immune Checkpoint Blockade Combo In Colorectal Cancer

Gritstone bio, Inc. GRTS announced the first patient has been enrolled for inclusion in the Phase 2/3 GRANITE-CRC-1L trial that evaluates the individualized neoantigen vaccine GRANITE in combination with immune checkpoint blockade for the first line maintenance treatment of newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer, This trial has registrational intent and has been discussed previously with the FDA.

Adagene Announces Commencement Of Phase 1b/2 Study Of ADG106-Opdivo Combo For Lung Cancer

Adagene Inc. ADAG announced the first patients have been dosed in a Phase 1b/2 clinical trial of the anti-CD137 agonist antibody, ADG106, in combination with Bristol-Myers Squibb Company's BMY Opdivo for patients with advanced non-small cell lung cancer who have progressed on prior therapies.

Puma Biotech Says Nerlynx Included In 2 NCCN Clinical Practice Guidance Updates For Breast Cancer Treatment

Puma Biotechnology, Inc. PBYI announced that the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (for the treatment of breast cancer have been updated for 2022 and include two important changes involving its Nerlynx.

The updates served to recommend extended adjuvant neratinib for patients with HR-positive, HER2-positive disease with a perceived high risk of recurrence, and the inclusion of dose escalation as an approach to improve the tolerability of neratinib in the treatment of adjuvant HER2-positive breast cancer.

The stock was rising 8.4% to $2.84 in premarket trading.

Sarepta, Lysogene End Licensing Deal With Respect To Gene Therapy Candidate In Rare Lysosomal Storage Disease

French gene therapy platform company Lysogene announced the termination of its license agreement with Sarepta Therapeutics, Inc. SRPT for LYS-SAF302, a Phase 2/3 asset for the treatment of mucopolysaccharidosis Type IIIA, effective as of July 11, 2022. This termination follows unsuccessful discussions for transferring back to Lysogene the responsibility for the global commercial supply of LYS-SAF302.

Can-Fite Announces Positive Preclinical Data For Psoriasis Drug

Can-Fite BioPharma Ltd CANF announced that pre-clinical studies with skin cells, modeling psoriasis in humans, show that Piclidenoson, its drug candidate for the treatment of psoriasis, destroys pathological skin cells.

NRx Sues Former Partner Relief, Alleging Breach, Repudiation Of Collaboration Agreement

NRx Pharmaceuticals, Inc. NRXP said it filed a lawsuit Monday against its former collaboration partner Relief Therapeutics Holding AG RLFTF, alleging breach and repudiation of the collaboration agreement. 

NRx seeks $185 million in reliance damages as well further punitive damages associated with what it said is libelous and extortionate behavior.

Prothena Gains On Fund Buying

Prothena Corporation plc PRTA disclosed in a filing that EcoR1 Capital, a biotech-focused hedge fund, bought 300,000 shares in the company.

The stock was adding 1.44% to $38.01 in premarket trading.

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Offerings

Vaxcyte, Inc. PCVX priced its underwritten public offering of common stock and pre-funded warrants. Vaxcyte is selling 2.5 million shares of common stock and pre-funded warrants to purchase 2.5 million shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $20 per share, and the pre-funded warrants are being sold at a public offering price of $19.999 per underlying share.

The aggregate gross proceeds to Vaxcyte from this offering are expected to be approximately $100 million.

The stock was slipping 8.05% to $20.23 in premarket trading.

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