PDS Biotech Announces Efficacy & Safety Data from VERSATILE-002 Phase 2 Clinical Trial in Recurrent or Metastatic Head & Neck Cancer

PDS Biotechnology Corporation recently announced a poster presentation of preliminary data from its ongoing Phase 2 VERSATILE-002 clinical trial at the American Society of Clinical Oncology (ASCO) Annual Meeting that took place June 3-7, 2022, in Chicago and online.

VERSATILE-002 is a single-arm Phase 2 study evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune technology, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab). The combination is being evaluated in checkpoint inhibitor (CPI) -naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). The data presented at ASCO detailed preliminary safety and efficacy data for CPI-naïve patients at a prespecified interim analysis point.

In the VERSATILE-002 clinical trial, patients are being treated with KEYTRUDA 200 mg by IV infusion every three weeks, plus subcutaneous injection of PDS0101 for the first 4 treatment cycles (Cycles 1-4) and again on Cycle 12; KEYTRUDA treatment continues for up to 35 cycles, or until disease progression or demonstrated intolerance to therapy.

Highlights of the abstract from 19 patients (safety) with available imaging data for 17 of the 19 (efficacy) in the VERSATILE-002 clinical trial include:

• Response rates thus far** (tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients which compares favorably to the published results of approximately 19% for approved checkpoint inhibitors used as monotherapy for recurrent or metastatic head and neck cancer, with 2 of the 7 having complete responses (CR)
• Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%
• Clinical efficacy (ORR* + SD) was seen in 13/17 (76.5%) patients
• Progressive/ongoing disease was reported in 4/17 (23.5%) patients
• Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of KEYTRUDA® (range 1-18)
• There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)
• No patients required dose interruption or reduction on the combination treatment
• No patients discontinued the combination treatment
• At 9 months of follow up (median not yet achieved):
• Progression free survival (PFS) rate was 55.2%
• Overall survival (OS) rate was 87.2%

“While preliminary, we are excited to see the enhanced clinical responses and tolerability of PDS0101 in combination with KEYTRUDA in the CPI-naive arm of the VERSATILE-002 trial,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “We believe PDS0101’s ability to generate tumor-attacking killer T-cells without increasing toxicity based on these preliminary results speaks to the specificity of the Versamune-based immunotherapies and the potential of these drug candidates to work in combination with a broad range of anti-cancer therapies. These data continue to strengthen our confidence that PDS0101 in combination with KEYTRUDA could potentially improve patient outcomes.”

“The clinical activity seen with PDS0101 in combination with KEYTRUDA thus far, in addition to the favorable safety profile continues to show promise in this difficult-to-treat patient population,” stated Dr. Jared Weiss, MD, Lead Principal Investigator at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center. “While the patient pool is small, the responses we are seeing in these patients based on the preliminary results are significant, leading to shrinking of tumors, and extending overall survival.”

The abstract for this poster is now available online on the ASCO conference website: https://am.asco.org/; data in this press release have been updated since the abstract submission.

*Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867
Burtness B et al., Pembrplizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (keynote 048): a randomized, open label phase 3 study; Lancet 2019;394(10212):1915-1928
https://www.opdivo.com/head-and-neck-cancer
https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
**The study is on-going and includes confirmed and unconfirmed responses.

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the company’s proprietary Versamune and Infectimune T-cell activating technology platforms. We believe our Versamune-based products are demonstrating the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells including long-lasting memory T-cell responses. PDS Biotech has developed multiple therapies, based on combinations of Versamune and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company continues to advance its pipeline of candidates to address a wide range of cancers, including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers. For more information, visit www.pdsbiotech.com.