Basel (Switzerland) and Dessau-Rosslau (Germany), Rockville, MD (USA), March 6th, 2023 – IDT Biologika, a leading Contract Development and Manufacturing Organization (CDMO) specialized in vaccines, gene and immune therapy and oncolytic viruses, and CanVirex, a biotechnology company that is developing an immuno-viro-therapeutic platform, have moved forward in the treatment of cancer.
Both companies collaborate to enter the clinical phase I/IIa trial to assess safety and tolerability of Mevacil in patients with advanced-stage solid cancers.
Mevacil is a proprietary, oncolytic measles virus that encodes the genetic information for the cytokine interleukin 12 (IL-12) on its viral genome. Thus, during viral replication, cancer cells not only amplify the oncolytic agent, but also produce therapeutic IL-12 themselves.
In a preclinical study, Mevacil induced complete tumor remissions (CR) in 90% of mice suffering from murine colorectal adenocarcinomas, a CR rate which has not been achieved by other immunotherapies in this study, including immune checkpoint inhibition. More strikingly, when tumors were re-implanted into previously cured mice, tumors were completely rejected by the murine immune system. Thus, Mevacil treatment induced a protective, systemic anti-tumor immunity. Based on these promising preclinical results, Mevacil has the potential to outperform current immunotherapies, especially in patients who are resistant to immune checkpoint inhibition.
A major challenge in the development of oncolytic measles virus-based therapeutics is the manufacturing of the measles vector at high yields under current Good Manufacturing Practice (cGMP).
To overcome this challenge, CanVirex has partnered with IDT Biologika. Prior to entering the clinical phase, drug candidates needs to be manufactured under cGMP conditions to comply with regulatory requirements, a task requiring state-of-the-art manufacturing infrastructure, expertise and industrial scale capabilities. Consequently, a technology transfer of CanVirex’s cGMP manufacturing technology has been initiated to IDT Biologika. Both, tech transfer run and a confirmation run under cGMP-like conditions were successful.
The next milestones include the implementation of an engineering run and generation of Clinical Trial Material.
Prof. Dr. Dr. Guy Ungerechts, Founder, CMO & CSO at CanVirex: “CanVirex’s measles virus constructs have the potential to directly kill cancer cells, stimulate antitumor immune responses, and favorably change the tumor microenvironment. Our platform technology has inherent competitive advantages, including a favorable safety profile due to the measles vaccine-derived backbone, significant tumor specificity, and induction of long-lived immune memory. Moreover, our versatile measles virus platform can be armed with either immunomodulating transgenes like cytokines, e.g., interleukin 12, immune checkpoint inhibitors, BiTEs, tumor-associated antigens and proprietary peptide libraries for innovative cancer therapies, or with payloads encoding pathogen-specific antigens for vaccine development. With our proprietary manufacturing know-how, we are confident to achieve high and commercially viable yields at cGMP quality. The expertise of IDT Biologika in the production of viral vectors makes them the ideal CDMO partner to fulfil our needs for clinical trial material, generated from a robust manufacturing process.”
Dr. Heidi Trusheim, Senior Director, Process Development at IDT Biologika: “Oncolytic viruses are important for many therapies and a great source of hope for patients. In a joint project with CanVirex, we are working on an anti-cancer therapeutic. We support our customer from process development on the way to enter the clinical phase I/IIa trial and contribute our experience in the development and production of oncolytic viruses and apply our state-of-the-art production infrastructure and expertise.”