FRANCE — EverImmune, a clinical-stage biotech company specializing in the development of live biotherapeutics in microbiota oncology, reports that the first patient has been treated in Phase I clinical trial (EV 2101) evaluating Oncobax AK in lung and kidney cancer patients.

The purpose of the trial is to evaluate the toxicity and efficacy of Oncobax AK when used in combination with immunotherapy.

EverImmune is a spinoff from French Cancer Institute, Gustave Roussy,C and the biotech is looking to harness gut microbiota for the development of a theragnostic approach to restoring the response of immune checkpoint inhibitors (ICIs).

EverImmune plans to enroll 60 patients — 19 with non-small cell lung cancer (NSCLC) and 41 with renal cell carcinoma (RCC) — in phase I and IIa trials being conducted at four centers in France and Belgium.

Phase I results are expected at the end of the first half of 2023. EV 2101 clinical trials are using a screening test to select patients with Akkermansia deficiency and resistant to immunotherapy.

Patients are given a daily dose of Oncobax AK to see if the drug candidate can reverse this resistance.

Currently, up to 70% of patients with NSCLC and 60% with RCC do not respond to immunotherapy, while up to 50% of patients are Akkermansia deficient.

Oncobax AK is used as an oral adjuvant to anticancer immunotherapies. It is designed to safely boost the immune system and restore sensitivity to immunotherapies in primary resistance settings.

Over the past 10 years, research has highlighted the importance of gut microbiota in determining the efficacy of antitumor immunotherapy in both preclinical tumor models and cancer patients.

The gut microbiota has been linked to cancer and has been shown to influence anticancer drug efficacy.

Resistance to chemo drugs or immune checkpoint inhibitors (ICIs) is linked to altered gut microbiota, whereas supplementation with specific bacterial species restores responses to anticancer drugs.

EverImmune said it has harnessed the gut microbiota and developed a unique approach that combines diagnostic and therapeutic technologies to restore cancer patients’ response to immune checkpoint inhibitors (ICIs).

This approach focuses on Akkermansia, a commensal bacterium that EverImmune has identified as modulating the efficacy of antitumor immunotherapy in patients with lung or kidney cancer.

According to InsightAce Analytic’s newest research, the Global Live Biotherapeutic Product (LBP) Market is worth US$ 355.9 million in 2021 and is predicted to reach US$ 2.6 billion in 2030, with a promising CAGR of 25.2% between 2022 and 2030.

Over the forecast period, market growth is anticipated to be driven by expanding research and development efforts as well as a growing pipeline of microbiome-targeting therapies that are anticipated to treat a wide range of serious diseases.

EverImmune has also other bacteria in its pipeline under development for use in the treatment of different types of cancer such as breast and colon cancers.

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