The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space.
VANCOUVER, British Columbia – Yiviva Inc., a pharmaceutical company focused on developing botanical drugs, has moved its lead candidate further into an international phase IIb trial for liver cancer and closer to an application through the FDA’s little-used botanicals pathway and a similar pathway in China. The company’s lead candidate, YIV-906, is intended for use in immunotherapy, chemotherapy and radiation therapy.
Anixa Biosciences Inc. and the Moffitt Cancer Center now have details the FDA said it needs regarding their CAR T therapy development program. The collaborators said the information can be provided to the FDA in about 30 days. The agency then has 30 days to respond.
With the advent of targeted therapies, cancer drugs have made strides in safety as well as efficacy. Still, because of the life threatening nature of the illness, safety is less of a focus in cancer drugs than other therapy types.
CEO David Epstein said Black Diamond Therapeutics Inc. was “delighted” with phase I data testing BDTX-189 in advanced solid tumors harboring EGFR or HER2 alterations, but Wall Street seemed less so. Shares (NASDAQ:BDTX) closed at $13.93, down $8.30, or 37%.
DUBLIN – Numab Therapeutics AG has moved closer to the front rank of European antibody developers by raising CHF100 million (US$111 million) in a series C financing round to accelerate the development of NM21-1480, a trispecific antibody that acts both as a PD-L1 inhibitor and 4-1BB (CD137) agonist. It also contains a human serum albumin recognition group, to extend its circulatory half-life.
BEIJING, China and SANTANDER, Spain – Antengene Corp. and Calithera Biosciences Inc. entered a worldwide exclusive license agreement to develop and market the CD73 inhibitor CB-708 (ATG-037), as part of a push to use the small-molecule inhibitor to grab significant market share in Asia Pacific and global markets.
Building on a deal first struck in 2019, artificial intelligence (AI) specialist Exscientia Ltd. has agreed to take responsibility for a multitarget drug discovery collaboration with Bristol Myers Squibb Co. that could be worth more than $1.2 billion in all. The expanded collaboration, first established with BMS-acquired Celgene Corp., includes $50 million in up-front funding, up to $125 million in near to mid-term potential milestones, plus additional clinical, regulatory and commercial payments. It remains focused on small-molecule drug candidates in areas including oncology and immunology.
Interius Biotherapeutics Inc., which just closed on an oversubscribed $76 million series A financing, is fixed on simplifying CAR T-cell creation by making the process less cumbersome, less expensive and time consuming, and all done in vivo.
The anti-TIGIT bispecific antibody AGEN-1777’s preclinical status didn’t stand in the way of Bristol Myers Squibb Co.’s whopper deal with Agenus Inc., which is collecting $200 million up front and as much as $1.36 billion in potential milestone payments in trade for development and commercial rights to the Fc-enhanced compound.
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