Gritstone Bio Inc. has had a tough year and new interim phase II data of Granite haven’t helped. The company called the progression-free survival results “encouraging” in the ongoing phase II/III trial of its personalized neoantigen-targeting immunotherapy for treating front-line microsatellite stable colorectal cancer.
Phase II/III results from Gritstone Bio Inc. with Granite, a personalized neoantigen cancer vaccine for colorectal cancer, turned up the opposite of what some investors expected, and the company’s shares (NASDAQ:GRTS) ended April 2 at $1.20, down $1.15, or 49%.
Despite what appears to be a recovering public financing market for the biopharma industry, with about $20 billion raised so far through follow-on offerings in the first two months of 2024, emerging companies remain in that precarious position between dwindling cash and their next milestone inflection points.
As investors await phase II/III data from Gritstone Bio Inc.’s closely watched trial with Granite, an individualized neoantigen vaccine for microsatellite-stable colorectal cancer, Wall Street was busy handicapping odds for firm’s new approach, given the struggles by personalized methods generally.
Despite big wins in precision oncology – such as last year’s accelerated FDA nod for Amgen Inc.’s Lumakras (sotorasib) in KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer – industry has barely scratched the surface of the field’s potential. Part of the problem is on the scientific front. Only about a third of patients are currently eligible for targeted therapy, since the majority of patients “do not have a known therapeutic vulnerability for which we have a drug match,” Keith Flaherty, director of clinical research at Massachusetts General Hospital, said during a Feb. 14 session at the BIO CEO & Investor Conference. “And that’s a big problem.”
The HHS Advisory Committee on Immunization Practices that had mixed opinions in June on the necessity of boosters will have a chance to consider new data when it meets again Aug. 24. Since that June adcom, COVID-19 infection rates have risen steadily and the FDA allowed for a third dose of the mRNA vaccines in certain adults with compromised immune systems.
Contrary to the broader markets, BioWorld’s Cancer Index is down by 22% this year, losing more than 7% throughout the month of July, despite oncology driving several high-money deals and accounting for 38%, the lion’s share, of financings. Both the Nasdaq Biotech Index and the Dow Jones Industrial Average are tracking similarly for the year, and are up by 13.2% and 15.2%, respectively, as of Aug. 10.
The pace at which companies are integrating the sophisticated tools of artificial intelligence (AI) and machine learning (ML) into their drug discovery and development programs continues to accelerate.
