On June 14, 2022 AVM Biotechnology, a clinical stage company advancing AVM0703 in the treatment of Non-Hodgkin’s Lymphoma (NHL)/Leukemia, reported that it has been awarded a Phase II Small Business Innovative Research (SBIR) grant (Press release, AVM Biotechnology, JUN 14, 2022, View Source [SID1234615975]). This $2 million National Cancer Institute (NCI) grant will assist in the continuation of the company’s existing clinical trial (AVM0703 for Treatment of Leukemia or Lymphoma, NCT04329728).

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This Phase II grant has been awarded for continued support of the adaptive-design, expansion cohort clinical trial of AVM0703 for "no-option," Relapsed/Refractory (R/R) NHL/Leukemia patients. The study is currently enrolling at City of Hope, UCLA, Norton Cancer Institute, and the University of Texas Southwestern. Additional sites are being brought on-line.

AVM0703:

is a small molecule which triggers the production and release of endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like cells (AVM-NKT).
induces AVM-NKT cells rapidly in the blood following a single dose.
is currently the subject of an adaptive design expansion cohort clinical trial with the dose escalation phase nearing completion and the efficacy phase projected to commence soon.
In the ongoing dose escalation phase, which included 11 highly refractory patients who had been heavily pretreated averaging 5.3 prior lines of therapy with 6 of 11 having failed hematopoietic stem cell transplantation (HSCT) or CAR-T, results included:

100% clinical response at 18 mg/kg target Ph II dose, with durable partial response/stable disease ongoing out to greater than 9 months in 1 patient.
Of 10 evaluable patients from the dose-escalation; 4 experienced partial response and 2 other patients subsequently reached complete remission.
An additional 20% achieved stable disease or significant clinical response including durable vision restoration in 1 patient.
One heavily pretreated patient with T-cell lymphoma who did not meet inclusion/exclusion criteria received AVM0703 under an FDA-approved Compassionate Use Program. That patient has experienced a very good partial response.

The drug has been well-tolerated with no reported Dose Limiting Toxicities (DLTs) or grades 4 or 5 adverse events. AVM0703 also potentiates chemotherapy and CAR-T response in pre-clinical models.

NHL is the 7th most common cancer in the US with over half of the 77,240 diagnosed annually over the age of 65. Even with treatment, disease recurs or relapses in approximately 50% of these patients and many become refractory to additional treatment. Patients can undergo many lines of various therapies including chemotherapy, radiation, CAR-T and HSCT which can be associated with significant toxicities and poor outcomes with many relapsing and requiring additional treatment. Based on its strong safety profile and clinical response, AVM0703 presents an appealing alternative to these therapies.

"AVM0703 represents an exciting new treatment option for NHL patients who have failed other therapies or who do not qualify for further chemotherapy, radiation, or cell therapies, including CAR-T. In addition to improvement in disease status, several patients treated with AVM0703 in the dose-escalation phase of the study have qualified for other treatments they had formerly been excluded from accessing," said Joe Luminiello, CEO.

AVM Biotechnology previously received a Phase I NCI grant from the National Institutes of Health (NIH) to study the use of AVM0703 as a preconditioning agent to allow safe and efficient delivery of therapeutic immune cells for cancer treatment. The company has requested breakthrough therapy designation and plans for accelerated approval for commercial launch in mid 2024.