PDS Biotech Announces Clinical Strategy Update and Reports Full Year 2023 Financial Results

Unique mechanism of action of the combination of PDS01ADC and Versamune® results in 3-year survival of 75% and 75% overall response rate in advanced head and neck cancer trial

As a result, Company to focus late-stage clinical strategy on triple combination of PDS01ADC, PDS0101 (Versamune® HPV) and KEYTRUDA® in advanced head and neck cancer

Strong safety profile of IL-12 fused antibody drug conjugate (PDS01ADC) demonstrated to date with data generated in >300 cancer patients; Versamune® HPV tested in >110 HNSCC patients

Successful recent meeting with FDA provided clear guidance on trial design and regulatory pathway for pivotal randomized trial of triple combination in recurrent metastatic HPV-positive HNSCC

Company to host conference call and webcast today at 8:00 AM ET

PRINCETON, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced an update to its clinical development strategy and reported its financial results for the year ended December 31, 2023.

“We have obtained compelling data from several Phase 2 trials in the fourth quarter of 2023, including long-term survival data from the National Cancer Institute (NCI)-led triple combination trial of PDS01ADC in combination with Versamune® HPV (PDS0101) and an investigational immune checkpoint inhibitor (ICI), as well as our VERSATILE-002 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We now have a better understanding of how our drug platform technology works in advanced cancer, and we have therefore made the strategic, data-driven decision to add our novel, investigational IL-12 fused antibody drug conjugate, PDS01ADC, to the promising combination of Versamune® HPV and KEYTRUDA® to advance the triple combination as our top clinical development priority.”

“By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV+ head and neck squamous cell cancer (HNSCC), we strongly believe this approach may rapidly establish our proprietary combination of PDS01ADC and Versamune® HPV as a transformative oncology treatment. The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. It may also significantly increase the rates of durable tumor shrinkage or overall responses,” said Dr. Bedu-Addo. “We are grateful to the patients and physicians who participated in the clinical trials which have helped inform our understanding of how the drug therapies may be used most effectively to safely address advanced cancer, and our decision to prioritize the triple combination.”

With the recent long-term survival Phase 2 data from the NCI-led triple combination trial, together with favorable safety and extended survival results seen in both ICI naïve and resistant patients in our VERSATILE-002 trial, PDS Biotech has decided to prioritize the triple combination in place of the VERSATILE-003 trial. This decision enables PDS Biotech to focus its resources on the drug regimen it believes has the highest potential to benefit patients with HNSCC and to drive shareholder value.

“We have had several discussions with key opinion leaders in HNSCC regarding the use of the triple combination in HNSCC. A clear unmet need is seen in HPV+ HNSCC with few agents being studied in this population due to the difficulty in treating advanced HNSCC,” said Kirk V. Shepard, M.D., Chief Medical Officer of PDS Biotech. “These discussions with expert HNSCC oncologists have guided our decision to prioritize the triple combination in our efforts to address the growing incidence of advanced HPV+ HNSCC.”

“Despite good outcomes in many patients with HPV-related HNSCC, approximately 20% of patients will develop recurrent, incurable disease, often in young individuals in the prime of their lives. HPV-related HNSCC that progresses after standard first-line chemotherapy is a devastating, hard-to-treat cancer with no HPV-related treatment currently approved. The NCI clinical trial data show significant promise in the use of PDS01ADC in combination with Versamune® HPV,” said Katharine A. Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center and Principal Investigator of PDS Biotech’s upcoming triple combination trial. “A controlled randomized clinical trial that builds upon the current data is warranted, and I am intrigued by the potential of this unique combination to treat HNSCC.”

Clinical Strategy Update

Triple Combination Clinical Trial (PDS01ADC, Versamune® HPV and KEYTRUDA®)

• Company in discussions with the U.S. Food and Drug Administration (FDA) on the design of potentially pivotal clinical trial to treat HPV+ HNSCC, with the trial expected to start in 2024.
• Previously announced data from Phase 2 NCI-led triple combination clinical trial for the treatment of recurrent/metastatic ICI naïve and ICI resistant HPV16-positive cancers including head and neck, anal, cervical, vaginal and vulvar cancers support rationale:
  • ICI naïve group: 75% of patients remain alive at 36 months. The median overall survival (OS) was not reached. Published results show a 36-month survival rate of approximately 20% with ICIs. An overall response rate (ORR) of 75% and complete response of 38% were seen in patients treated with the triple combination. Published ORR of