Recent Funding:
Genentech Vet Launches ADC Startup Synthetic Design Lab with $20M Seed
Ex-Genentech leader Daniel Chen and Exelixis’ Ramesh Baliga are developing more potent, safer antibody-drug conjugates, backed by Playground Global and Godfrey Capital. Startup aims for first clinical trial next year, leveraging protein engineering and biophysics to target hard-to-hit cancers beyond HER2.
Recent Layoffs:
Tempest Therapeutics (SF) Lays Off 80% of Staff Amid Strategic Review
Tempest is laying off 21 of 26 employees by April 30 to preserve cash while seeking a merger or partnership after failing to fund a Phase 3 trial of its liver cancer drug, amezalpat. The company ended 2023 with $30.3M and also received FDA orphan drug designation for TPST-1495 in familial adenomatous polyposis.
Caribou Biosciences (SF) Cuts 32% of Staff and Refocuses Pipeline on Cancer Cell Therapies
Caribou is ending its lupus and leukemia programs to focus on advancing two CRISPR-engineered off-the-shelf cancer cell therapies, CB-010 (lymphoma) and CB-011 (multiple myeloma), with updated trial results expected later this year. The restructuring extends the company’s cash runway through late 2027, but comes amid ongoing challenges in matching the efficacy of personalized CAR-T therapies.
Other Interesting News:
Halozyme claims Merck used its drug delivery technology without permission to develop a subcutaneous version of Keytruda, seeking damages and injunctive relief. FDA approval for subcutaneous Keytruda could happen by September 23, intensifying the dispute.
Gilead Sciences (SF) Reports Q1 Revenue Miss Amid Oncology Weakness, HIV Franchise Remains Strong
Gilead reported $6.7 billion in Q1 revenue, with oncology sales falling 4% mainly due to weaker Trodelvy and cell therapy performance, while HIV drugs like Biktarvy and Descovy grew. Lenacapavir (Sunlenca) could significantly boost future revenue pending an FDA decision by June 19 to expand its use for HIV prevention.
ALX Oncology (SF) Ends Head & Neck Cancer Development After Dual Phase 2 Failures
Evorpacept, combined with Merck’s Keytruda, failed to meet primary endpoints in two Phase 2 trials (Aspen-03 and Aspen-04) for head and neck cancer. Despite setbacks, ALX will continue evorpacept trials in breast and colorectal cancer. Follows March layoffs of 30% of staff and a broader pivot to focus cash on evorpacept after prior gastric cancer trial disappointment.
FDA Chief Marty Makary Pushes Faster Drug Approvals, Defends Cuts and Vaccine Reassessment
Promotes a “plausible mechanism” pathway for faster rare disease drug approvals; supports reassessing Covid vaccines for children. Claims layoffs didn’t impact reviewers, despite reports; no immediate action planned on abortion pill mifepristone.