OncoVax® is a groundbreaking immunotherapy that treats and prevents disease progression in advanced Stage 2 colon cancer patients. The next crucial step is completing the FDA-approved Phase IIIB clinical trial, which will use an optimized and bioequivalent manufacturing process already validated in clinical settings.
Vaccinogen is actively seeking investment to fund this pivotal Phase IIIB trial, which can be completed in just 3 to 4 years from its start. With key regulatory advantages—such as a Special Protocol Assessment (SPA) and Fast Track designation—along with an initial evaluation 12 months post-enrollment of the last patient, we believe FDA approval is highly achievable within this timeline.
To execute the Phase IIIB trial, Vaccinogen has partnered with a consortium of leading companies for both manufacturing (CDMO) and clinical trial management (CRO). This global network allows for a seamless, turn-key trial launch once funding is secured, with no need for additional staffing or facility investment—either for the trial or eventual commercialization. Based on previous clinical results and the number of patients to be treated (550), the risk of trial failure is minimal to negligible.
Vaccinogen is also excited about the broader potential of OncoVax®. Beyond the Phase IIIB trial, we are exploring its use in combination with standard treatments for more advanced stages of adenocarcinomas, starting with Stage III colon cancer. Additionally, our work on Human Monoclonal Antibodies (HuMab) could unlock a new wave of adenocarcinoma vaccines for prevention, with OncoVax®-treated patients providing a key platform for this breakthrough. The neoepitopes identified through HuMabs could hold the key to revolutionizing cancer vaccines.
OncoVax® has the potential to transform cancer care by saving millions of lives worldwide, initially focusing on colon cancer and possibly extending to other adenocarcinomas. This patented technology, secured through 2039, has already demonstrated safety and efficacy in a Phase IIIA trial for minimal residual disease in colon cancer.
To find out more about Vaccinogen and OncoVax® please contact us at the link below.
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