Breaking Barriers in Immunotherapy
Frank Bedu-Addo, President and CEO of PDS Biotechnology, joined the Bio Breakthroughs podcast to unpack how his company is reshaping the cancer treatment landscape. The challenge? Conventional therapies like CAR T have limitations—high cost, logistics, immune toxicity, and limited impact on solid tumors. Even cancer vaccines have struggled to activate potent killer T cells needed to eliminate tumors. PDS Biotechnology addresses these limitations head-on.
The Power of Lipid Nanoparticles
At the core of PDS Biotechnology’s innovation is its Versamune® platform—a lipid nanoparticle-based delivery system that enhances immune uptake and access to lymph nodes. As Bedu-Addo explains, this elegant yet powerful system not only delivers antigens but also activates pathways to train killer T cells—achieving what most cancer vaccines have failed to do for decades.
Clinical Validation in Phase 2 Trials
PDS0101, their lead immunotherapy candidate, has demonstrated remarkable results across three Phase 2 trials. In HPV16-positive head and neck cancer, patients receiving PDS0101 achieved a median overall survival of 30 months, more than double that of standard-of-care therapies. Additional trials at MD Anderson (cervical cancer) and the NCI (HPV16-positive cancers) showed consistent, strong survival outcomes.
Expanding the Platform
With a successful Phase 3 trial underway in HPV16-positive head and neck cancer, PDS is also exploring new horizons. The company recently announced IND approval to target MUC1-positive cancers—such as colorectal, non-small cell lung, ovarian, and breast—broadening the platform’s reach. Its ADC program (IL-12 antibody-drug conjugate) in colorectal and prostate cancers also advances rapidly, with promising Phase 1 data already achieved.
What’s Ahead
PDS Biotechnology is set for a dynamic second half of 2025. Expect updates from multiple trials—including final Phase 2 data, Phase 3 recruitment progress, and early-stage results from ADC trials. Their strategic partnerships with MD Anderson and the NCI ensure scientific rigor while enabling the company to remain laser-focused on their lead program.
