Monday, 26 February 2024

Valo Therapeutics Begins First Patient Dosing of PeptiCRAd-1, Advancing Immuno-oncology Innovation

Germany based trial of 15 patients with melanoma, triple negative breast cancer or non-small cell lung cancer

Valo Therapeutics Oy (ValoTx), the developer of novel, adaptable immunotherapies for cancer, announces that the first patient has been treated in its Phase I trial of PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus) in three tumor types.

PeptiCRAd-1 combines the power of a tumor-specific adenovirus (expressing immune-stimulatory molecules CD40L and OX40L) with immunogenic tumor peptides derived from NY-ESO-1 and MAGE-A3 proteins thereby generating tumor-specific, cytotoxic T-cells that will attack and kill cancer cells. The trial is designed to evaluate the safety, immune activity, and tumor response of PeptiCRAd-1 alone and then in combination with the immune checkpoint inhibitor (CPI), pembrolizumab in 15 patients with either melanoma, triple-negative breast cancer or non-small cell lung cancer. The trial will explore local and systemic immune activation, and immune responses against the tumor-specific NY-ESO-1 and MAGE-A3 peptides, as well as clinical responses. It includes intensive immuno-monitoring of tumor and blood samples from patients to confirm the mechanism of action of PeptiCRAd-1 and to identify biomarker-related outcomes, among other signals of clinical benefit.

Paul Higham, CEO of ValoTx, commented, “I’m delighted we have commenced clinical development with the first patient treated in our Phase I trial of PeptiCRAd-1. Our thanks go to Prof. Dr med. Elke Jäger and her team at the hospital Krankenhaus Nordwest in Frankfurt and Prof. Guy Ungerechts and his team at the National Center for Tumor diseases (NCT) in Heidelberg, for all their excellent preparatory work to reach this major milestone. Based on strong in vivo data generated by our research team, we expect to see both a potent tumor-directed immune response and changes in the tumor microenvironment that will facilitate tumor control. This first PeptiCRAd program uses well-known, tumor-specific targets (NY-ESO-1 and MAGE-A3) that are highly prevalent on the three tumor types to be included. In the future, the inherent adaptability and flexibility of our platform will allow us to deliver advanced individualized or ‘patient-specific’ cancer treatments.”

The Coordinating Investigator for the trial, Prof. Dr med. Elke Jäger, from the hospital Krankenhaus Nordwest in Frankfurt am Main’s Department of Oncology and Hematology, one of Germany’s top oncology treatment centers with a wealth of immuno-oncology experience, said: “We are very excited to be involved in this study. This is a truly innovative immuno-therapy approach which has shown great promise in the pre-clinical setting. We hope to be able to translate this to positive clinical outcomes for patients.”

Published on : 23rd May, 2023