Initial results, safety data from clinical trial shared during international medical conference
As an institution dedicated to pioneering medical advancements and championing clinical research, Providence Saint John’s Health Center was one of three hospitals nationwide – and the only hospital on the West Coast – to enroll patients in an early phase clinical trial examining the safety and efficacy of a novel cell therapy to treat patients with severe COVID-19 associated respiratory failure.
The therapy, called agenT-797, relies on unmodified invariant natural killer T (iNKT) cells, which occur naturally in the blood stream and spark immune responses to target damage of inflamed tissue. The proprietary treatment, which was developed by the trial’s sponsor MiNK Therapeutics, Inc., uses amplified cells from healthy donors and infuses them into critically ill patients. Once in the body, the cells can decrease inflammation and protect vital tissues, including in the lungs.
While in an early stage of clinical development, the novel therapy is a promising treatment option for adults with severe COVID-19 respiratory failure who require mechanical ventilation or lung bypass through venovenous Extracorporeal Membrane Oxygenation (VV-ECMO). Even with the most advanced care, the mortality rate in these patients can exceed 70%, so new therapies are needed to treat critically ill patients.
“The goal of the current study was to demonstrate that we could give these cells safely, without causing allergic reactions or something called cytokine release syndrome, which can occur with other cell therapies used mainly in cancer treatment,” said Terese Hammond, M.D., associate medical director of Providence Saint John’s ICU, who led the clinical trial at the health center. “So far, the treatment has been promising and has been well tolerated, even among patients who are on VV-ECMO, which makes this study even more unique.”
Over the past year, Providence Saint John’s has successfully enrolled five patients in the clinical trial. Results from Phase 1 and 2 of the clinical trial were positive, with an overall survival rate of 77% among patients intubated or mechanically ventilated, which is higher than the national average of approximately 40%.
“The data from the study of iNKTs in patients with COVID-19 respiratory failure are compelling and show a much higher survival rate than we have seen in our community-based cohort of older, intubated patients,” Dr. Hammond said. “We are in the early stages of bringing cell and other precision therapies to critically ill patients, much the same way that oncologists brought these treatments to their patients years prior. It is an exciting avenue to pursue. “
Dr. Hammond shared additional results from the clinical trial on Thursday, Nov. 10, during a presentation at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting in Boston.
MiNK also hosted an R&D Day on Nov. 10, where Dr. Hammond and other medical leaders showcased recent developments in MiNK’s clinical and next-generation programs. An archived version of the R&D webinar is now available on the MiNK website, minktherapeutics.com.