Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adicet, Alteogen, Defence, Mirium, Outlook, Sellas.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aerovate, Boehringer, Emergent, Indivior, J&J, Just-Evotec, Kinetic, Pari, Sandoz, Scisparc, Spexis, Tuhura.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Cellprothera, Hillevax, Ideaya, Sirnaomics.
Ideaya Biosciences Inc. appears to be in the lead to develop a treatment for tumors with deletions in both copies of methylthioadenosine phosphorylase (MTAP). Despite the large market with an estimated annual incidence rate in the U.S. of approximately 75,000 patients, there are no FDA approved therapies for MTAP-deleted solid tumors.
Hillevax Inc. is turning its attention to preventing moderate or severe acute gastroenteritis events (AGEs) in adults with norovirus after the phase IIb NEST-IN1 trial testing virus-like particle-based vaccine HIL-214 in infants missed its primary and secondary endpoints, news that sent shares of the company (NASDAQ:HLVX) plummeting 88% to close July 8 at $1.64, a significant drop from the IPO price of $17 two years ago.
Myricx Bio Ltd. has closed the largest series A for a European biotech this year, raising £90 million (US$115.4 million), to take forward antibody-drug conjugates based on novel payload chemistry.
As developers in the oft-troubled TIGIT class forge onward, Roche Holding AG’s Genentech unit provided an unfavorable update July 5 on the phase II/III Skyscraper-06 study testing anti-TIGIT candidate tiragolumab plus Tecentriq (atezolizumab) and chemotherapy vs. Keytruda (pembrolizumab, Merck & Co. Inc.) and chemo as first-line treatment for non-squamous non-small-cell lung cancer (NSCLC).
In the third-largest acquisition announced this year, pharma giant Eli Lilly and Co. is buying oral integrin therapies developer Morphic Holding Inc. for $3.2 billion. Morphic stock (NASDAQ:MORF) got a tremendous boost from the acquisition, with shares closing 75% upward at $55.74 each on July 8, the day the deal was announced.
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