PDS Biotechnology Corporation has received FDA clearance for its Investigational New Drug (IND) application to evaluate a combination therapy for MUC1-positive metastatic colorectal cancer (mCRC). The therapy combines Versamune® MUC1, a novel MUC1-targeted immunotherapy candidate, with PDS01ADC, an IL-12 fused antibody drug conjugate. This Phase 1/2 trial will be conducted in collaboration with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA).
This IND clearance is a significant step forward in addressing the unmet need for effective treatments for mCRC, particularly Proficient Mismatch Repair/Microsatellite Stable mCRC, which represents 95% of mCRC cases and exhibits resistance to current immunotherapies. The combination of Versamune® MUC1 and PDS01ADC holds promise in stimulating robust and sustained anti-tumor T-cell responses within the tumor microenvironment, potentially offering a new therapeutic avenue for patients who have exhausted existing treatment options. The collaboration with the NCI further validates the potential of this approach.
The trial will focus on patients with unresectable, metastatic colorectal cancer who have failed prior treatments. This IND clearance represents an expansion of the Versamune® platform, which has primarily been investigated in HPV-related cancers. Additionally, a recently issued U.S. Patent (#12,201,685) covers the methods of using the combination of Versamune® and cytokines to enhance anti-tumor immune responses.
This IND clearance sets the stage for clinical investigation of a potentially groundbreaking combination therapy in a challenging cancer type. Positive trial results could lead to a new treatment paradigm for mCRC and further solidify the versatility and potential of the Versamune® platform in targeting various solid tumors. This advancement may also spur further research and development in the field of targeted immunotherapies for hard-to-treat cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
