NEW YORK – EverImmune on Tuesday said it has secured €3.46 million ($3.4 million) in financing from Bpifrance to support a Phase I/II trial of its live biotherapeutic product Oncobax AK in patients with non-small cell lung cancer or renal cell carcinoma who are deficient in the gut bacterium Akkermansia muciniphila.
The financing is a mix of subsidies and repayable loans awarded under Bpifrance's "innovations in biotherapies and bioproduction" call for projects, which is part of the French government's 2030 Acceleration Strategy to promote technology transfer in biotherapeutic development from early stage to clinical research.
Abnormal gut microbiome composition has been associated with poor response to immune checkpoint inhibitor therapy. In preclinical studies, researchers explored oral supplementation with A. muciniphila strain p2261 in a mouse model of microbiome-related immunotherapy resistance, finding that efficacy of PD-1 blockade was restored via recruitment of T lymphocytes into the tumor beds.
In the ongoing clinical trial, which was launched in February, researchers will use a companion diagnostic test to select 71 NSCLC and RCC patients deficient in A. muciniphila and resistant to immunotherapy. The patients will receive a daily oral dose of Oncobax AK, a microbiome therapeutic comprising encapsulated lyophilized A. muciniphila p2261. The main outcome measure of the trial is improved objective response rate and, secondarily, progression-free survival.
In addition to Oncobax AK, Villejuif, France-based EverImmune is developing other microbiome therapeutics in different cancer types including breast and colon.