EverImmune, a clinical-stage biotechnology company specialized in the development of live biotherapeutic products in the field of microbiota oncology, announced that a first patient has been treated in its phase I clinical trial (EV 2101) evaluating Oncobax® AK in lung and kidney cancer patients.
The aim of the trial is to assess the toxicity and efficacy of Oncobax AK when administered alongside an immunotherapy treatment. EverImmune plans to recruit a total of 60 patients – 19 with Non-Small Cell Lung Cancer (NSCLC) and 41 with Renal Cell Cancer (RCC) – across the phases I and IIa of the trial, which is taking place at four sites in France and Belgium. The phase I results are expected at the end of the first half of 2023.
Over the past ten years, research has highlighted the importance of the gut microbiota in determining the efficacy of anticancer immunotherapies in both preclinical tumor models and cancer patients.
EverImmune has harnessed the gut microbiota and developed a unique approach, combining diagnostic and therapeutic technologies, which seeks to restore cancer patients’ response to immune checkpoint inhibitors (ICIs). This approach focuses on Akkermansia (AK), a commensal bacterium that everImmune has identified as modulating the efficacy of anticancer immunotherapies in patients with lung or kidney cancer.
“It’s major news for the field of targeted oncobiotics that the first patient has now joined this clinical trial. The challenge is to select patients who are deficient in Akkermansia, so that we can look to reverse this bacterial deficiency and improve their immunotherapy outcomes,” said Dr. Philippe Barthélémy, medical oncologist and investigator for the trial at the Institut de Cancérologie Strasbourg Europe (ICANS) in Strasbourg, France.
The EV 2101 clinical trial uses a screening test to select patients who are deficient in Akkermansia and resistant to immunotherapy treatment. The patients are given a daily dose of Oncobax AK to see if the drug candidate can reverse this resistance. Currently, up to 70% of NSCLC patients and 60% of those with RCC do not respond to immunotherapy, while up to 50% of patients are deficient in Akkermansia.
“We’re proud to start phase I of our EV 2101 clinical trial and look forward to seeing the results later this year. Our next goal is to launch phase IIa of the trial during 2023, which will give us further insights into the efficacy 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, that will be a real step forward for science and for patients,” said Jean-Luc Marsat, president of everImmune.