Affini-T Therapeutics Inc. has completed an oversubscribed $175 million financing to develop its multiple oncogene driver programs for treating solid tumors such as those with mutated KRAS variants into the clinic, pursue complementary technology licenses to strengthen its cell therapy platform and to optimize its discovery engine. The company has research laboratories in Seattle, and its headquarters and manufacturing is in Boston. The financing was co-led by Vida Ventures and Leaps by Bayer. Additional investors included the Humboldt Fund, The Parker Institute for Cancer Immunotherapy, Catalio Capital Management, Agent Capital, Alexandria Venture Investments, Erasca Ventures and the Fred Hutchinson Cancer Research Center.
Spotlight raises $36.5M to advance non-viral gene editing tech, lead I-O program
Spotlight Therapeutics Inc., a company developing cell-targeted in vivo CRISPR gene editing biologics, has raised $36.5 million in series B financing to support advancement of its first-in-class immuno-oncology program and further applications of its in-house technology platform. The financing round was co-led by new investors GordonMD Global Investments and Epiq Capital Group, with participation from Magnetic Ventures, as well as existing investors GV, Emerson Collective, and others.
Phase Ib efforts fail with GR antagonist in cancer, Oric stops development
Oric Pharmaceuticals Inc. is quitting development of ORIC-101 after interim analyses of two phase Ib studies concluded that the clinical activity does not justify going forward with the compound. The company was testing ORIC-101, a glucocorticoid receptor antagonist, combined with Abraxane (nab-paclitaxel, Bristol Myers Squibb Co.) in various solid tumors and paired with Xtandi (enzalutamide, Astellas Pharma Inc./Pfizer Inc.) in metastatic prostate cancer. Oric has turned its energies to several other phase I-stage oncology monotherapies. Shares (NASDAQ:ORIC) were trading midday at $4.55, down $2.13, or almost 32%. Also reporting setbacks were Aligos Therapeutics Inc., which ended development of ALG-020572 for chronic hepatitis B virus infection because of safety concerns in a phase I trial, and Neurana Pharmaceuticals Inc. with tolperisone, which failed in a phase III pain study.
Inspections, IRs fly in the ointment of US biosimilar program
The U.S. biosimilar review process seems to be hitting its stride, with the FDA approving, in the first cycle, 67% of the 21 biosimilar applications filed and acted upon in the first four years of BsUFA II. That compares with a 39% first-cycle approval rate under the first BsUFA program. But there’s a need for improvement, especially when it comes to facility inspections and information requests (IRs), according to a final assessment of the BsUFA II program that was presented today. The independent assessment also pointed to a trend showing that companies with biosimilars already on the U.S. market may have an edge when it comes to getting subsequent biosimilars approved.
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Adamis, Aerium, AGTC, Allovir, Argenx, Ascentage, Atrogi, Awakn Life Sciences, Bioaegis, Bracco Imaging, Bristol Myers Squibb, Cali, Calliditas, Cansinobio, Chimeron, Curative, Edesa, Evommune, ITM Isotope Technologies, Itolerance, Kalvista, Lung, Marinus, Merck, Moderna, Nanomerics, Neurana, Neurosense, Obseva, Oragenics, Orphazyme, Palisade, Pfizer, Pharmacyte, Pharvaris, Philochem, Plus, Ribon, Statera, Takeda, Terns, Transcenta, Vertex, Viridian, Visus, Windtree, Zai Lab, Zentalis