Post by David Oxley
CEO, Vaccinogen Inc. | Leading FDA SPA & Fast Track OncoVAX® registration-enabling immunotherapy program for Stage II colon cancer | Cross-Border Licensing, Pre-IPO Fundraising, NASDAQ / NYSE Readiness
Colorectal Cancer Awareness Month: The Immune System Already Solved Cancer Targeting. Vaccinogen Is Scaling the Solution. We honor those affected by colorectal cancer by redoubling our commitment to turning the post-surgical curative window into a reality with our registration-enabling pivotal trial evaluating OncoVAX® in Stage II colon cancer. This pivotal trial operates under an FDA Special Protocol Assessment (SPA) and Fast Track designation, with an integrated DSMB-guided interim framework designed to support a potential accelerated BLA pathway and a potential first approval as early as 2030. OncoVAX® has already delivered a 52% relative reduction in recurrence or death (ITT) and 60% with full dosing, with durable benefit lasting >15 years in responders and zero systemic toxicity. Our second platform OncaVERT™ — captures the immune “observation window” to deliver fully human targeting backbones that supercharge existing ADCs, bispecifics, and PD-1/PD-L1 franchises. The post-surgery curative window is real. The gap in MSS Stage II is clear. Patients are counting on us. What do you think? Is harnessing the patient’s own immune system the next leap for oncology portfolios?