Valo Therapeutics Announces Clinical Trial Application Submission for German Phase I Oncology Clinical Trial of PeptiCRAd-1 with Pembrolizumab
Helsinki, Finland, 13th July 2021:
Valo Therapeutics Limited (Valo Tx), the developer of novel, adaptable immunotherapy platforms for cancer and infectious diseases, today announced it has submitted a clinical trial application (CTA) to the German Regulatory Agency, The Paul Ehrlich Institute (PEI) for a Phase I, first-in-human trial of PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus 1) in three tumor types.
The trial, to take place in Germany, will be an open-label, non-randomized, multi-centre study to evaluate the safety and immune activity of PeptiCRAd-1, a tumor-specific peptide-coated conditionally replicating adenovirus (VALO-D102) expressing immuno-stimulatory molecules CD40L and OX40L, in combination with an immune checkpoint inhibitor (CPI), pembrolizumab, in 15 patients with melanoma, triple negative breast cancer or non-small cell lung cancer. The company plans to start the trial in Q4 2021, with completion of 12 patients due by end of 2022. Trial endpoints include safety of PeptiCRAd-1 alone and in combination with pembrolizumab, and will explore local and systemic immune activation, and immune responses against the immunogenic peptides derived from NY-ESO-1 and MAGE-A3, as well as clinical responses to PeptiCRAd-1 + CPI. Patients will undergo intensive immune monitoring to identify biomarker-related outcomes, among other signals of clinical benefit.
Paul Higham, CEO of Valo Tx, commented, “This Phase I first-in-human immuno-oncology trial in Germany is another significant milestone as we further validate our PeptiCRAd platform to develop antigen-coated oncolytic viruses as therapeutic vaccines. Based on strong in vivo data we expect to see a synergistic improvement in tumor control when checkpoint inhibitors are combined with our tumor-antigen coated oncolytic adenovirus. This first program focuses on well-known, highly prevalent targets present on the three tumor types to be included. In the future, we expect our platform will be a powerful system to deliver advanced individualized or ‘patient-specific’ cancer treatments.”
The Coordinating Investigator for the trial, Prof. Dr med. Elke Jäger, from the Hospital Nordwest Frankfurt am Main’s Department of Oncology and Haematology, one of Germany’s top oncology treatment centres with a wealth of immuno-oncology experience, said; “Thanks to our institution’s status as an academic hospital, the medical facility that I work in gives patients the opportunity to participate in innovative clinical trials at both national and international levels. I’m delighted to be in the position to work with Valo Therapeutics to lead its first-in-human trial of its novel immuno-therapy approach to oncology, targeting several solid tumor indications all with high unmet medical need.”
PeptiCRAd is an innovative way of combining the best features of two clinically proven cancer immunotherapy approaches: oncolytic adenoviruses and peptide vaccines. PeptiCRAd uses immunogenic oncolytic viruses as active carriers of tumor-specific peptides to direct the immune system to specifically target and kill cancer cells.
About Valo Tx
Valo Therapeutics (Helsinki) is an immunotherapy company that is developing antigen-coated oncolytic viruses and vaccine vectors as therapeutic vaccines against cancer and infectious disease. The Valo Tx lead platform, PeptiCRAd (Peptide-coated Conditionally Replicating Adenovirus), was developed out of the laboratory of Professor Vincenzo Cerullo at the University of Helsinki. It turns oncolytic adenoviruses into targeted tissue specific cancer vaccines without the need to generate and manufacture multiple genetically modified viruses. The company is also developing PeptiENV and PeptiVAX, among other neoantigen strategies, in collaboration with Professor Cerullo. PeptiENV is expected to improve the therapeutic response to oncolytic enveloped viruses in the treatment of multiple forms of cancer, while PeptiVAX is a program to develop a novel, adaptable anti-infectives vaccination platform. A film explaining the PeptiCRAd technology can be found here.
Scius Communications (for Valo)