AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced today important findings which indicate a mechanism of action for its ROOT OF CANCER technology. Serum biomarker analyses and in vitro cellular modeling performed with cancer patient samples collected in a randomized Phase 2 clinical trial demonstrated a statistically significant association between long-term survival and activation of a specific subset of lymphocytes.
AIVITA’s findings point to a category of T lymphocytes called Th17 cells common in tissue surrounding tumors, which can transform from passive tolerating T cells into cytotoxic, tumor-fighting cells. Linear regression analyses were performed on serum samples collected after 3 weekly subcutaneous injections of a vaccine specifically targeting tumor-initiating cells, otherwise known as cancer stem cells. The findings indicate that the patient’s endogenous Th17 cells undergo a cytotoxic transformation in response to AIVITA’s ROOT of CANCER treatment.
“Our data suggest that Th17 cells in untreated cancer patients have an antigen repertoire that is incomplete or below a sufficient signal-strength threshold to be effective,” said Dr. Gabriel Nistor, AIVITA’s Chief Science Officer. “It is clear that AIVITA’s cancer stem cell vaccine elevates an appropriate antigenic signal in all immune responding cells, and particularly induces a cytotoxic transformation of the Th17 subpopulation.”
“Previous immunotherapy approaches have proven that dendritic cells can deliver a payload, but they chose the wrong payload,” said Dr. Hans S. Keirstead, AIVITA’s Chief Executive Officer. “These mechanistic data confirm that our treatment causes the patient to mount a vigorous immune attack against the very seed of cancer, the cancer stem cell. And now, within a few weeks, we can predict survival of those 72% of treated patients that survive.”
AIVITA is extending and confirming its mechanism of action data in three active clinical studies of its platform ROOT of CANCER therapy, in patients with ovarian cancer, glioblastoma or melanoma.