PDS Biotech Reveals Final Topline Survival Results from VERSATILE-002 Phase 2 Study in Head and Neck Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Aug 25 2025
0mins
Source: Newsfilter
Clinical Trial Results: The VERSATILE-002 Phase 2 trial reported a median overall survival (mOS) of 39.3 months for patients with HPV16-positive head and neck cancer treated with PDS0101 and pembrolizumab, significantly higher than the standard care mOS of 17.9 months.
Patient Demographics: The trial included 53 patients, and the durable survival benefits were consistent across various demographics and clinical characteristics, indicating the effectiveness of the treatment regardless of age or prior treatments.
Company's Positioning: PDS Biotechnology aims to lead in treating HPV16-positive head and neck cancers, addressing a significant unmet medical need, and emphasizes that their combination therapy is well tolerated by patients.
Future Plans: The company plans to publish full data from the trial later this year and continues to develop PDS0101 alongside other therapies in multiple ongoing clinical trials.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy PDSB?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on PDSB
Wall Street analysts forecast PDSB stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for PDSB is 9.00 USD with a low forecast of 3.00 USD and a high forecast of 15.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.872
Low
3.00
Averages
9.00
High
15.00
Current: 0.872
Low
3.00
Averages
9.00
High
15.00
About PDSB
PDS Biotechnology Corporation is a clinical-stage immunotherapy company. The Company is developing a pipeline of targeted cancer immunotherapies based on its Versamune T cell-activator and Versamune in combination with its interleukin 12 (IL-12) fused antibody drug conjugate (ADC), PDS01ADC, a tumor targeting immunocytokine. PDS0101 is its lead Versamune based immunotherapy. PDS0101 combines Versamune with a mixture of short proteins (peptides) derived from the cancer-causing HPV16 viral protein. Versamune is a proprietary lipid nanoparticle and T cell activating platform. PDS0301 is an investigational tumor-targeting antibody conjugate of Interleukin 12 (IL-12) that enhances the proliferation, potency, infiltration, and longevity of T cells in the tumor microenvironment. Its Versamune immunotherapies and Versamune in combination with PDS01ADC, are utilized for treatments in oncology, and Infectimune is utilized for preventive vaccines against infectious agents.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Oncolytics Biotech Advances Pelareorep for Anal Cancer with 29% Response Rate
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in anal cancer during the GOBLET Cohort 4, significantly exceeding the historical benchmark of 10%, indicating its crucial clinical value in a setting with no FDA-approved treatment options.
- Duration of Response: Among 14 evaluable patients, the median duration of response for pelareorep reached approximately 17 months, far surpassing the standard treatment's 9.5 months, showcasing the drug's durable efficacy in heavily pretreated patients and addressing a critical unmet medical need.
- FDA Accelerated Approval Plans: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss advancing pelareorep into a registration-directed clinical study, paving the way for potential accelerated approval if the data is validated.
- Strategic Investment and Expert Support: The company expanded its Scientific Advisory Board by adding three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, further strengthening its strategic positioning in the gastrointestinal oncology field.
Continue Reading
Oncolytics Biotech Advances Pelareorep for Anal Cancer with 29% Response Rate
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in anal cancer patients during the GOBLET Cohort 4 study, significantly surpassing the historical benchmark of 10%, indicating the therapy's substantial potential in a patient population with no FDA-approved options.
- Duration of Response: The study also revealed a median duration of response of approximately 17 months, far exceeding the standard treatment's 9.5 months, suggesting that pelareorep offers durable efficacy in heavily pretreated patients, addressing a critical unmet medical need.
- FDA Accelerated Approval Plans: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss advancing pelareorep into a registration-directed clinical study, paving the way for accelerated approval if the observed data can be replicated.
- Strategic Investment and Expansion: The company is enhancing its strategic positioning in gastrointestinal oncology by expanding its Scientific Advisory Board, further solidifying its market presence in anal cancer and other indications.
Continue Reading