AVM Biotechnology has announced it has landed a third Phase I Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). The grant will evaluate the ability of the company’s small molecule, AVM0703 (in combination with the standard chemotherapy regimen R-CHOP) to reduce R-CHOP cycles in an aggressive, immune-resistant murine B cell Non-Hodgkin’s Lymphoma (NHL) model.
AVM0703 is currently the subject of an adaptive design expansion cohort clinical trial treating imminently terminal “no-option” NHL patients (NCT04329728). In the trial, which is nearing completion of the safety portion, patients reportedly have experienced mild to moderate side effects.
Although median survival has not been reached, patients have shown a durable response to at least 11 months in multiple forms of NHL. After a single, one-hour outpatient infusion, AVM0703 induces and mobilizes endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like cells; the treatment currently is the only therapeutic known to mobilize these unique immune cells.
While R-CHOP typically administered in six repeat cycles can elicit high response rates in NHL, relapse rates are high and long-term toxicities problematic. This includes secondary cancers caused by the treatment itself, as well as substantial neuro- and cardiac toxicities.
An approach that increases complete response rates and lowers relapse rates without significant toxicities continues to be an unmet need for NHL. AVM0703 in combination with NHL standard of care such as R-CHOP could reduce relapse rates and even potentially limit the total number of chemotherapy cycles required for complete response, significantly impacting patients’ short- and long-term quality of life.
The company previously received two other SBIR Phase 1 grants from the NCI and National Institute of Diabetes and Digestive Kidney (NIDDK) as well as two Phase 2 grants from the same agencies. The previous NCI grants support the existing clinical trial as well as research utilizing AVM0703 as a preconditioning agent prior to chemotherapy. This brings AVM’s total nondilutive government funding to $4.4 million validating the potential of AVM0703 in both cancer and Type 1 Diabetes.
AVM Biotechnology, a clinical-stage company, is developing AVM0703 as a treatment for NHL, solid tumors, and autoimmune disorders. The research funded by this grant will help to further elucidate the use of AVM0703 in combination with chemotherapy while the company is concurrently investigating AVM0703 as a monotherapy in relapsed/refractory “no-option” NHL. Previous preclinical research as well as patient outcomes in an FDA-approved Compassionate Use Program indicate AVM0703 has the potential to become an important treatment modality for NHL patients solidifying AVM’s influence in the immunotherapy space.