On February 17, 2023 CanVirex reported that it has moved forward in the development of its lead candidate Mevacil for the treatment of cancer (Press release, CanVirex, FEB 17, 2023, View Source;utm_medium=rss&utm_campaign=moving-forward-in-the-development-of-canvirexs-lead-candidate-mevacil-for-the-treatment-of-cancer [SID1234627397]).
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CanVirex is in preparation of a 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.
IL-12 is one of the most potent inducers of anti-tumor immunity through various direct and indirect effects on immune cells. However, based in its potency, IL-12 can induce unspecific immune reactions after systemic administration which can cause severe toxicities. By using an IL-12-armed oncolytic measles virus, IL-12 production is restricted to the tumor site. In addition, virus-induced cancer cell death releases tumor antigens and danger signals which alert the immune system. Consequently, the immune stimulatory IL-12 is provided in an environment that has already been stimulated to induce an anti-tumor immune response. Thus, IL-12 activity is directed to develop its full potential towards the induction of an anti-tumor immune response.
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, a biopharmaceutical company that develops and manufactures vaccines and biologics for human and animal health. 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 and we are excited to announce that the tech transfer run and a confirmation run under cGMP-like conditions were successful. We are looking forward to reaching our next milestones with IDT, which include the implementation of an engineering run and generation of Clinical Trial Material (CTM).