In its drive to rewrite the rules of the tumor microenvironment so it can capture of the holy grail of successfully battling solid tumors by using T cells, Affini-T Therapeutics Inc. has completed an oversubscribed $175 million. The focus is to develop 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. Read More
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. Read More
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 in various solid tumors and paired with Xtandi in metastatic prostate cancer. Read More
The U.S. biosimilar review process seems to be hitting its stride, with the FDA approving, in the first cycle, 67%, or 14, of the 21 biosimilar applications filed and acted upon in the first four years of BsUFA II. Read More
Researchers at the University of Queensland have found a genetic link between endometriosis and ovarian cancer subtypes, enabling them to identify potential drug targets for therapy and increasing the understanding of both diseases. Read More
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated. Read More
New hires and promotions in the biopharma industry, including: Anaptysbio, Aravive, Capsida, Evommune, Hookipa, Longboard, Mozart, Neuraxpharm, Ocugen, Phathom, Veraxa, Vita, Voyager. Read More
Biopharmas raising money in public or private financings, including: Applied Genetic Technologies, Awakn Life Sciences, Bioaegis, Edesa, ITM Isotope Technologies Munich, Itolerance, Statera. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeterna Zentaris, Athira, Atom, Biogen, Cortexyme, Eisai, Evommune, Immunogen, Pulmatrix, Tonix, Turning Point, Uniqure, Vallon. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Aerium, Chimeron, Curative, Moderna. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aura, Biomarin, BMS, Kye, Neurosense, Oryzon, Provention, Travere. Read More
