PDS Biotech's PDS0101 and Keytruda Combination Therapy to Enter Phase 3 Trial for HPV16-Positive Cancers

Key Insights

• PDS Biotechnology is set to initiate the VERSATILE-003 Phase 3 trial in Q1 2025, evaluating the combination of PDS0101 and Keytruda.
• The trial will focus on patients with HPV16-positive head and neck squamous cell carcinoma (HNSCC).
• The analysts believe Merck's Keytruda success in KEYNOTE-689 study is unlikely to affect the Versamune double combination since KEYNOTE-689 enrolled very few HIV16+ patients.

PDS Biotechnology is advancing its combination therapy, PDS0101 and Keytruda (pembrolizumab), into a Phase 3 registrational trial, named VERSATILE-003, for the treatment of HPV16-positive cancers. The trial is expected to commence in the first quarter of 2025.

The VERSATILE-003 trial will evaluate the efficacy and safety of PDS0101 in combination with Merck’s Keytruda in patients with head and neck squamous cell carcinoma (HNSCC) who are positive for the human papillomavirus 16 (HPV16).

Analyst Perspective

Alliance Global Partners has adjusted its price target for PDS Biotechnology to $4.50, down from $7, while reaffirming a Buy rating on the company's stock. This decision follows PDS Biotechnology's announcement of its Q3 results and details regarding the design and initiation of the VERSATILE-003 trial.

The firm suggests that recent developments with Merck’s Keytruda in the HNSCC space, specifically its success in the KEYNOTE-689 study, are unlikely to impact the Versamune double combination. This is because the KEYNOTE-689 study included a limited number of HPV16-positive patients.