EverImmune, a clinical-stage biotechnology company specializing in the development of live biotherapeutics in the area of ​​microbiota oncology, announces that the first patient has been treated in its Phase I clinical trial (EV 2101) evaluating Oncobax AK in lungs and kidneys cancer the patients.

The purpose of the trial is to assess the toxicity and efficacy of Oncobax AK when given in combination with immunotherapy treatment. EverImmune plans to enroll 60 patients – 19 with non-small cell lung cancer (NSCLC) and 41 with kidney cancer (RCC) – in Phases I and IIa of the trial, which is taking place in four sites in France and Belgium. Phase I results are expected at the end of the first half of 2023.

“It is great news for the field of targeted oncobiotics that the first patient has joined this clinical trial. The challenge is to select patients deficient in Akkermansia, in order to be able to reverse this bacterial deficiency and improve the results of their immunotherapy,” said Philippe Barthélémy, medical oncologist and trial investigator at the Institut de Cancérologie Strasbourg Europe ( ICANS). in Strasbourg, France.

Akkermansia deficiency

The EV 2101 clinical trial uses a screening test to select patients deficient in Akkermansia and resistant to immunotherapy treatments. 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% of those with RCC fail to respond to immunotherapy, while up to 50% of patients are Akkermansia deficient.

“We are proud to begin Phase I of our EV 2101 clinical trial and look forward to seeing results later this year. Our next goal is to initiate the Phase IIa trial in 2023, which will allow us to better understand the effectiveness of Oncobax AK. If we can show that the human body is able to use bacteria to fight pathologies as complex as lung or kidney cancer, it will be a real breakthrough for science and for patients,” said Jean-Luc. Marsat, president of everImmune.

Use of gut microbiota in oncology

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

EverImmune said it has harnessed the gut microbiota and developed a unique approach, combining diagnostic and therapeutic technologies, which aims to restore cancer patients’ response to immune checkpoint inhibitors (ICI).

This approach focuses on Akkermansia, a commensal bacterium identified by everImmune as modulating the efficacy of cancer immunotherapies in patients with lung or kidney cancer.