Gritstone Bio Files for Bankruptcy Despite Securing Government Vaccine Contract
How does a company that was awarded a government contract of over $400 million go bankrupt just one year later?
Gritstone Bio Inc., a vaccine developer that once touted its ability to make a next-generation COVID shot, filed for Chapter 11 bankruptcy in Delaware last week.
The company was sued in June over allegations that it misled investors about its ability to launch a large vaccine trial following study delays. The stock has slumped more than 90% this year.
As I had previously written, Gritstone is best known for its work in cancer vaccines, with its lead program, dubbed GRANITE, in phase 2/3 trials for metastatic, microsatellite-stable colorectal cancer.
However, its phase 2 colorectal cancer vaccine data fell short of the success needed to reverse its fortunes.
Gritstone reported a 21% relative risk reduction of progression or death in the investigational drug arm. The hazard ratio (HR) of 0.79 favored the GRANITE combination but the top end of the 95% confidence interval was 1.50, a result that would mean the control group performed much better than the cancer vaccine.
Investigators randomized 104 patients with metastatic microsatellite stable colorectal cancer to take one of two front-line therapies. All patients received induction and maintenance chemotherapy. Around half of the subjects also received Gritstone’s personalized neoantigen cancer vaccine, Bristol Myers Squibb’s Yervoy and Roche’s Tecentriq during the maintenance phase.
The primary endpoint looked at changes in circulating tumor DNA (ctDNA). On that measure, Gritstone’s drug combination was numerically worse than chemotherapy alone, with the molecular responses in the vaccine and control arms coming in at 30% and 41.7%, respectively. Gritstone attributed the result to its misunderstanding of how ctDNA would change after treatment.
Gritstone CEO Andrew Allen, M.D., Ph.D., said in the company’s release that the biotech is “excited” by GRANITE’s potential, but the data need “more time to mature.”
Any guess as to what that might mean? Maybe they intend to change the endpoints to try and massage the data into giving them the answer they wanted.
Gritstone CEO Andrew Allen, M.D., Ph.D., said in a statement. “CtDNA levels in both arms decreased on chemotherapy for longer than we anticipated, generating similar short-term molecular response rates across arms and rendering our protocol measure of ctDNA change uninformative.”
Allen latched on to progression-free survival (PFS) data to contend that the results are “highly encouraging.” PFS data are more mature in the subgroup, leading Allen to call the result “a striking signal,” but, again, the confidence intervals are wide enough that the vaccine may be less effective than the control.
What does this mean for the samRNA COVID genetic vaccine candidate?
On September 27 Gritstone bio (GRTS.O) secured a $433 million contract awarded by the Biomedical Advanced Research and Development Authority (BARDA) to conduct a mid-stage study of its self-amplifying mRNA (samRNA) COVID-19 genetic vaccine candidate.
Gritstone was set to conduct a 10,000-person U.S.-based phase 2 study for its self-amplifying mRNA (samRNA) vaccine candidate. The study was expected to get off the ground in the first quarter. Gritstone expected to receive up to $10 million from the contract by the first quarter upon hitting certain goals related to the study’s preparation.
Gritstone was expected to launch the trial during the fall in order to “allow use of fully GMP-grade raw materials."
However, Gritstone Bio laid off 40% of employees in February after delaying the start of a phase 2 trial testing its COVID vaccine, which in turn pushed back the receipt of federal funds.
With money already expected to run out by year-end, Gritstone plans to present an agreement to the court as early as next week. It also intends to keep operating as usual and plans to keep advancing its clinical development programs during the financial restructuring process, the company said in a statement.
Given what we know about the damage caused by mRNA injections, let’s hope for everyone’s sake that the self-amplifying mRNA candidate does not move forward.
Who are the major shareholders?
Thinking they could use cfDNA as their endpoint was a terrible mistake. That’s putting an unknown on top of an unknown. It sounds like to me whoever was designing the study thought it would be cool to measure cfDNA out of inexperience and now they will never know if it actually had an impact on cancer or not. The only reason there is a gold rush on mRNA approaches was because of covid and that road they took…but for how much of a failure that has been for ID I don’t see how that will ever translate well over to immuneoncology. They could have measured residual disease in a more straightforward way…and how about actually characterizing peripheral T and B cells to see if there were actually receptors and antibodies being made against the cancer antigens…