Biotech Daily: Cancer Causing Impurities In Merck's Diabetic Drug, Vir Bio-GSK Shun FDA Submission Plans For COVID-19 Treatment, Aethlon's Monkeypox Trial

Zinger Key Points
  • Vir Biotech is shifting strategy from rapidly developing pandemic medicines to a focus on long-term control.
  • NTTP belongs to the nitrosamine class of compounds, some of which are classified as cancer causing substances.
Biotech Daily: Cancer Causing Impurities In Merck's Diabetic Drug, Vir Bio-GSK Shun FDA Submission Plans For COVID-19 Treatment, Aethlon's Monkeypox Trial

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

Stocks In Focus

Vir Biotech Shuns FDA Submission Plans For GSK-Partnered COVID-19 Treatment

In its Q2 earnings releaseVir Biotechnology Inc VIR and its partner GSK plc GSK said that they do not plan to file a marketing application for sotrovimab for COVID-19 at this time.

The company also said it does not intend to pursue the U.S.-based Phase 3 COMET-STAR prophylaxis trial, citing evolving COVID-19 landscape and FDA discussions.

Discussions with the FDA remain ongoing regarding the appropriate path forward for sotrovimab in the U.S.

Aethlon Medical To Start Lab Studies For Hemopurifier For Monkeypox

Aethlon Medical Inc AEMD said it is commissioning a new in vitro binding experiment to confirm that the Hemopurifier effectively captures the current strain of the monkeypox virus.

In 2008, the company conducted an in vitro study demonstrating that the Hemopurifier effectively bound and removed the monkeypox virus.

The study indicated that the Hemopurifier removed 44% of the monkeypox virus in the first hour of testing, 82% after six hours, and 98% after 20 hours.

SAB Biotherapeutics Shifts Focus On Infection Candidate As DoD Contract Closes

SAB Biotherapeutics SABS will discontinue its work with the U.S. Department of Defense (DoD) under a prototype research and development agreement.

The conclusion will allow the company to focus on its core priorities and expand its current pipeline.

FDA Temporarily Allows Higher Impurity Levels In Merck's Diabetes Drug

The FDA recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck & Co Inc's MRK type 2 diabetes drug Januvia/Janumet (sitagliptin).

The agency said that to avoid a shortage and to help ensure patients have access to an adequate supply, the FDA said it would not object to the temporary distribution of sitagliptin containing the impurity above the acceptable intake limit.

Evotec, Alpine Expand Pact For Commercial Process Development Of Autoimmune Disease Candidate

Evotec SE's EVO subsidiary, Just - Evotec Biologics Inc, has expanded a multi-year partnership with Alpine Immune Sciences Inc ALPN for ALPN-303 for systemic lupus erythematosus and other B cell-mediated inflammatory and autoimmune diseases. 

Just - Evotec Biologics will leverage its data-driven technology platform to develop a commercial manufacturing process for ALPN-303. 

2seventy bio Shares Jump On Positive Data From Bristol Myers-Partnered Cancer Immunotherapy

Bristol Myers Squibb Co BMY and 2seventy bio Inc TSVT have announced topline results from KarMMa-3 Phase 3 trial of Abecma (idecabtagene vicleucel) for multiple myeloma.

The interim analysis demonstrated a statistically significant improvement in progression-free survival. 

Treatment with Abecma also showed an improvement in the key secondary endpoint of overall response rate compared to standard regimens. 

Centessa Culls Early-Stage Asset For Inherited Disorder

Centessa Pharmaceuticals plc CNTA has decided to discontinue the development of ZF874 following a recent report of an adverse event involving elevated liver enzymes (AST/ALT) in a PiMZ subject dosed with 5 mg/kg in the Phase 1 study. 

Based on the results observed, the company concluded that ZF874 was unlikely to achieve the desired target product profile.

Gemini Therapeutics Announces Reverse Merger Pact With Hematology-Focused Company

Gemini Therapeutics Inc GMTX and privately held Disc Medicine Inc have entered into a merger agreement in an all-stock transaction

The combined company will focus on advancing Disc's pipeline of hematology programs, including multiple patient studies for its clinical-stage programs bitopertin and DISC-0974. 

The combined company will operate under the Disc Medicine moniker, trade on the Nasdaq Global Market under the 'IRON' ticker, and be led by Disc Medicine's CEO, John Quisel.

Caladrius's Merger Partner Inks Trial Pact With Roche

Caladrius Biosciences Inc's CLBS merger partner, Cend Therapeutics Inc has announced a trial collaboration with Roche Holdings AG RHHBY.

Under the terms of the agreement, Roche will be responsible for the operational management of the trial, while Cend and Roche share equally in the costs of the CEND-1 treatment arms in the study.

VYNE Therapeutics Shares Disappointing Data From Atopic Dermatitis Trial

VYNE Therapeutics Inc VYNE has announced results from the Phase 2a segment of Phase 1b/2a trial evaluating FMX114 for mild-to-moderate atopic dermatitis.

The study did not meet its primary endpoint based on the absolute and percent change relative to baseline in the Atopic Dermatitis Severity Index.

Aridis' Inhaled Pan-Coronavirus Antibody Cocktail Shows Encouraging Preclinical Action

Aridis Pharmaceuticals Inc's ARDS inhaled treatment of its fully human monoclonal antibody cocktail AR-701 resulted in no detectable SARS-CoV-2 virus in the lungs of infected non-human primates.

The candidate also protected their lungs from disease. 

AR-701 was effective in non-human primates as a prophylactic or therapeutic treatment regimen.

Offering

Verona Pharma plc VRNA announced an underwritten public offering of 10 million American Depositary Shares.

Mirum Pharmaceuticals Inc MIRM priced its previously announced underwritten public offering of 3.5 million shares at $23/share, with gross proceeds of $80 million.

Karuna Therapeutics Inc KRTX priced an upsized, underwritten public offering of 3.5 million shares at $215/share, for approximately $750 million gross proceeds.

On The Radar

Earnings

Adamis Pharmaceuticals Corp ADMP: After market close.

Ascendis Pharma A/S ASND: After market close.

Eyenovia Inc EYEN: After market close.

DiaMedica Therapeutics Inc DMAC: After market close.

TRACON Pharmaceuticals Inc TCON: After market close.

BioCardia Inc BCDA: After market close.

Cyclacel Pharmaceuticals Inc CYCC: After market close.

Posted In: COVID-19 CoronavirusBiotechEarningsNewsPenny StocksHealth CareFinancingOfferingsContractsSmall CapFDAMoversTrading IdeasGeneral