Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alumis, Entero, Eterna, Ernexa, Immunogenx, Kaken, Relmada, Regor, SOLVE FSHD, Transcripta, Trigone, Twostep.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Axsome, Cassava, CNS, Genelux, Kezar, Mural, Nanoscope, Newsoara, Oncotelic, Traws.
The first disease modifying therapies for Alzheimer’s may have limited utility in some senses, but they will be a force for change, providing momentum and altering the way governments as payers, and health systems as carers, think about the disease.
Acrivon Therapeutics Inc. provided updated phase II data for checkpoint kinase candidate ACR-368, highlighting promising response rates for biomarker-positive patients with endometrial cancer and raising the possibility of an accelerated pathway in the second-line setting.
Wave Life Sciences Ltd. plans to file with the U.S. FDA for accelerated approval of WVE-N531, an exon skipping oligonucleotide for boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping, a decision based on favorable data from the phase II Forward-53 study. The analysis was conducted after 48 weeks of treatment with 10 mg/kg of the drug dosed every two weeks. Forward-53 achieved all trial goals, turning up sustained exon skipping, muscle concentrations, and dystrophin restoration through 48 weeks and a 61-day tissue half-life that supports giving the DMD therapy once a month.
Ushering in a new class of antibiotics, the U.S. FDA approved GSK plc’s gepotidacin for use in uncomplicated urinary tract infections. Branded Blujepa, the oral triazaacenaphthylene bacterial topoisomerase inhibitor is indicated for treating female adults and adolescents, 12 and older.
Astrazeneca plc is investing heavily in China, signing two R&D deals, worth up to about $8 billion in up-front payments and milestones combined, with Chinese companies Harbour Biomed Ltd. and Syneron Bio, establishing a joint venture with Shenzhen Kangtai Biological Products Co. (Biokangtai) for vaccines, and creating a new R&D center in Beijing through another $2.5 billion investment.
Chinese pharmaceutical companies are making significant inroads into the global oncology market, particularly with the development and approval of immune checkpoint inhibitors. These treatments, which have shown strong efficacy in various cancer indications, are not only transforming the oncology landscape in China but are also gaining traction in high-value international markets, including the U.S.
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