Following a day of deals that collectively bring a potential $3.75 billion into three biopharma companies – namely Ascidian Therapeutics, Belharra Therapeutics and Mabcare Therapeutics – researchers will be busy discovering new therapies for neurological and immunological diseases, and advancing globally a candidate for solid tumors. Ascidian joined with Roche Holding AG to discover and develop RNA exon editing neurology therapeutics for up to $1.84 billion, while Mabcare licensed rights to cancer drug MTX-13 to Day One Biopharmaceuticals for up to $1.2 billion. Likewise, Belharra partnered in an immunology small-molecule deal worth $700 million with Sanofi SA.

Merck’s pneumococcal vaccine, Capvaxive, wins US FDA approval

Becoming the first pneumococcal conjugate vaccine specifically designed for adults 18 and older, Merck & Co. Inc.’s 21-valent candidate, Capvaxive (V-116), gained U.S. FDA approval on its June 17 PDUFA date. The Rahway, N.J.-based company expects to take significant market share based on positive phase III findings from the Stride-3 trial. Analysts have estimated the product could reach $2 billion in annual global sales. Capvaxive is indicated for the prevention of invasive disease caused by Streptococcus pneumoniae as well as to prevent pneumococcal pneumonia in adults. The indication for preventing pneumonia caused by 21 S. pneumoniae serotypes is approved under accelerated approval based on immune responses measured by opsonophagocytic activity. Final approval is subject to a confirmatory trial.

Two deaths prompt partial clinical holds on three Zentalis studies

The deaths of two cancer patients treated with the small molecule azenosertib has prompted the U.S. FDA to place a partial clinical hold on a phase I study and two phase II studies from Zentalis Pharmaceuticals Inc. The deaths are presumed by Zentalis to be from sepsis. Both patients were in the phase II Denali study of platinum-resistant ovarian cancer. The other two azenosertib studies affected by the partial clinical hold are the phase I ZN-c3-001 dose-escalation study of solid tumors and the phase II Teton study of uterine serous carcinoma. Azenosertib, Zentalis’ lead candidate, is a WEE1 kinase inhibitor for treating advanced solid tumors and hematologic malignancies. The company’s stock (NASDAQ:ZNTL) had wilted 36% at midday to $5.40 per share. A year ago, the shares were going for $28.52 each.

Imbiologics nets $20M up front for Navigator autoimmune drug 

South Korea’s Imbiologics Inc. scored a potential $940 million (₩1.3 trillion) technology transfer deal with U.S. biotech Navigator Medicines Inc. for its bispecific antibody drug candidate, IMB-101 (Oxtima), to treat autoimmune diseases. Under the deal terms, Suwon-si, Gyeonggi-do-based Imbiologics will gain $20 million up front and potential development and commercialization milestone payments, along with royalties based on net sales. In turn, Navigator Medicines, described as a portfolio firm of RA Capital Management, will gain global rights, excluding Asia but including Japan, for the asset. IMB-101 is a novel bispecific antibody targeting the OX40 ligand and TNF-alpha.

Marea launches with $190M to tackle cardiometabolic diseases

Marea Therapeutics came out of stealth mode today after raising $190 million through its series A and B financings. The newco already has one drug in phase II development thanks to an in-licensing deal with Novartis AG. That lead program, MAR-001, is a monoclonal antibody targeting ANGPTL4 that’s designed to lower remnant cholesterol and improve adipose tissue and metabolic function, which will hopefully reduce cardiovascular events.

Madrigal is the NASH/MASH master … of the moment

For the time being, Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) stands alone as the only U.S. FDA-approved treatment for treating nonalcoholic steatohepatitis (NASH). But new and positive data from multiple companies shows Madrigal may soon have company.

Ternarx out of stealth to develop targeted protein degraders  

Fledgling biotech Ternarx has emerged from stealth mode and is the first of its kind in Australia to develop targeted protein degrader technology to destroy disease-causing proteins that cannot be targeted by conventional drugs. The Melbourne-based company will initially develop targeted protein degraders against currently undrugged transcription factors in cancers with significant unmet need, starting with neuroblastoma and prostate cancer.

Also in the news

Aerovate, Agios, Amarna, Arvinas, Assembly, Astrazeneca, Biomarin, Biontech, Biotest, Carsgen, Cytomx, Electra, Enlivex, Enterprise, Evaxion, Freeline, Galapagos, Grifols, GSK, Hutchmed, Innate Pharma, Iteos, J&J, Keros, Kira, Kriya, Longeveron, Medilink, Mirum, Mustang Bio, Nurix, Regeneron, Roche, Salarius, Scilex, Seaport, Shuttle, Spur, Spybiotech, Sumitomo, Swanbio, Takeda