Recent Funding:
Avid Bioservices (SoCal) to be Acquired for $1.1 Billion by Private Equity Firms
Avid Bioservices, a California-based biologics CDMO, is set to be acquired by GHO Capital Partners and Ampersand Capital Partners for $1.1 billion. The deal, which offers a 13.8% premium on Avid’s current stock price, comes after a challenging year for the company with a decrease in early-stage customer demand. Despite setbacks, Avid’s recent earnings showed signs of recovery. The acquisition is expected to close by Q1 2025.
Recent Layoffs:
23andMe (SF) Shutters Cancer Drug Research Programs, Lays Off 40% of Staff
23andMe is closing its therapeutic division and laying off 40% of its workforce to focus on consumer genetics and telehealth. This shift follows a steep drop in stock value and an ongoing effort to go private. The company is seeking buyers for its antibody drugs in early-stage trials targeting cancer and inflammation. These moves aim to cut costs and refocus resources on 23andMe’s core services.
Sana Biotechnology is halting its SC291 CAR-T program for cancer, shifting focus to autoimmune applications, particularly B-cell-mediated diseases. It’s also ending work on its CNS program, seeking partners for the pipeline. To extend cash through 2026, Sana will prioritize type 1 diabetes treatments and a separate CD22-directed CAR-T in blood cancers, with clinical data expected over the next 12-18 months. This restructuring may lead to additional layoffs as the company works to streamline operations and reduce costs.
Viracta Therapeutics, facing financial constraints, announced a second round of layoffs this year, reducing its workforce by 42% and slimming its board of directors from 10 seats to 6. These changes aim to redirect resources toward the company’s lead lymphoma treatment program for relapsed/refractory Epstein-Barr virus (EBV)-positive peripheral T-cell lymphoma (PTCL). The company’s main focus, a combination therapy of the HDAC inhibitor nanatinostat and antiviral valganciclovir (nana-val), showed promising Phase 2 results in PTCL patients, including a 60% overall response rate in certain second-line cases.
Earlier this year, Viracta had already laid off 23% of its staff and halted nana-val development for solid tumors to prioritize lymphoma. With about $30 million in cash as of June, the company expects funding to last until March 2025, with an NDA submission goal for the nana-val PTCL program in 2026.
M&A, Deals, Partnerships:
Kalaris Therapeutics, a retinal disease-focused biopharma founded by Samsara BioCapital, has merged with AlloVir in an all-stock transaction. This merger aims to fund the advancement of Kalaris’ TH103, an anti-VEGF treatment developed by VEGF pioneer Dr. Napoleone Ferrara, currently in Phase 1 trials for age-related macular degeneration. The combined company will operate as Kalaris Therapeutics with $100 million in expected cash, anticipated to support operations through Q4 2026.
FDA Approvals:
FDA Clears Novavax to Resume Testing of COVID-19 and Influenza Combination Vaccine
The FDA has lifted its hold on Novavax’s Phase 3 trial for a combination COVID-19 and influenza vaccine, as well as on trials for standalone flu vaccines. This pause began after a serious adverse event, initially reported as motor neuropathy, occurred in a Phase 2 trial. After further review, the event was reclassified as ALS—a condition deemed unrelated to Novavax’s vaccine. The FDA’s concerns have now been “satisfactorily” addressed, allowing Novavax to move forward with testing. Novavax is aiming to expand its offerings with this combination shot, though the company has faced challenges in uptake and share value compared to earlier mRNA COVID vaccines from Pfizer and Moderna.
FDA Approves Autolus’ New CAR-T Therapy Aucatzyl for B-cell Precursor Acute Lymphoblastic Leukemia
The FDA has approved Aucatzyl, a CAR-T cell therapy developed by Autolus Therapeutics, for treating B-cell precursor acute lymphoblastic leukemia that progresses after prior treatments. Competing with Gilead’s Tecartus, Aucatzyl is priced at $525,000, reflecting its unique design, which aims to increase active cell count post-infusion and reduce side effects, potentially providing a safer profile without a required risk mitigation plan.
Autolus’ approach could make Aucatzyl a preferred option by reducing severe immune responses and operational burden on treatment centers. Clinical trial data showed a 63% remission rate with a low incidence (3%) of severe cytokine release syndrome. The company has 30 U.S. treatment centers ready to deliver Aucatzyl, with plans to expand coverage further by late 2025.
Other Interesting News:
Acadia Pharmaceuticals (SD) Sells Priority Review Voucher for $150M
Acadia Pharmaceuticals has sold a priority review voucher for $150 million to an undisclosed buyer, marking a higher-than-average sale price for these FDA vouchers, which allow expedited reviews of new drug applications. Acadia received the voucher in March 2023 alongside FDA approval for Daybue, its treatment for Rett syndrome, a rare pediatric disease. The sale will net Acadia $100 million after sharing proceeds with Neuren Pharmaceuticals, the company from which it licensed Daybue in 2018.
Analysts note that high values may reflect the FDA’s upcoming termination of the rare pediatric disease voucher program, increasing voucher demand. Acadia plans to allocate the funds to support commercial efforts, pursue business development, and advance rare disease and central nervous system research.
Rapt Therapeutics (SF) Ends Zelnecirnon Program Amid Clinical Holds
Rapt Therapeutics announced it is discontinuing development of zelnecirnon, an immunology drug candidate, after clinical holds and regulatory discussions indicated no viable path forward. The FDA initially halted two Phase 2 trials in February due to liver failure in a patient with atopic dermatitis, which led to a liver transplant. After unblinding both studies, Rapt found no further instances of liver toxicity but decided to halt the program based on FDA guidance.
CEO Brian Wong stated the company plans to focus on next-generation CCR4 compounds with improved safety profiles and anticipates selecting a new candidate in early 2025. Rapt is also actively exploring in-licensing opportunities to broaden its pipeline.
Rapt’s stock dropped significantly following the news, down 42% to $1.66. In addition to zelnecirnon’s discontinuation, the company is progressing its oncology candidate, tivumecirnon, in mid-stage trials, including combination studies with Merck’s Keytruda. To preserve capital, Rapt previously announced layoffs of approximately 40% of its workforce.
