Enterome Announces First Patient Dosed in a Phase 1/2 Trial with Second OncoMimics™ Vaccine, EO2463, in Non-Hodgkin Lymphoma
Enterome SA, a clinical stage biopharmaceutical company developing novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health, announces that the first patient was dosed in a Phase 1/2 clinical trial (‘SIDNEY’) with EO2463, its second OncoMimicsTM vaccine for the treatment of indolent non-Hodgkin lymphomas (iNHL). Initial clinical data from the trial are expected in 2022.
EO2463 is an innovative, off-the-shelf microbiome-peptide based cancer vaccine that combines four microbiome-peptides of B lymphocyte-specific lineage markers. EO2463 is designed to trigger the immune system into recognizing B cells as bacterial (i.e. non-self) and eliciting a targeted cell-killing response. The clinical rationale behind targeting these specific lineage cell markers is to induce the full depletion of malignant B lymphocytes that cause NHL.
The SIDNEY trial (EONHL1-20; NCT04669171) is a multicenter, open-label, Phase 1/2 study assessing the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination with standard-of-care lenalidomide and/or rituximab in patients with follicular and marginal zone lymphoma. A total of 60 patients are expected to be enrolled in Europe and the US.
This is the third clinical trial investigating OncoMimicsTM cancer vaccine candidates in solid and liquid malignancies to be launched by Enterome in the last 12 months.
Professor Pier Luigi Zinzani, MD, PhD, from the University of Bologna (Italy), is SIDNEY’s Global Coordinating Investigator. Prof. Zinzani is a renowned hematologist with extensive clinical research and drug development experience in the field of NHL, Hodgkin’s disease and chronic lymphocytic leukemia.
Prof. Zinzani, said: “Targeting B-cell specific antigens with a therapeutic non-self, off-the-shelf, vaccine is a very interesting approach to treating NHL. We are excited to begin clinical studies to investigate whether EO2463 can impact not only relapsed disease in combination with established standard-of-care options, but also very early stages of iNHL when used as monotherapy. We look forward to seeing the immunological and clinical impact of the vaccine and providing updates on the progress of this study.”
Dr. Jan Fagerberg, Chief Medical Officer of Enterome, said: “EO2463 is Enterome’s second microbiome-peptide based cancer vaccine generated from our unique drug discovery platform. This clinical trial is another significant step in our strategy to deliver proof of concept data for our OncoMimicsTM vaccines, which we believe can target both solid and liquid malignancies. We are delighted to initiate this trial and believe that the data we expect to generate from clinical trials with EO2401 and EO2463 will position Enterome as a clear leader of next-generation cancer vaccines.”