PDS Biotech Announces Updated Results from VERSATILE-002 Phase 2 Clinical Trial Presented at ESMO 2024

Rhea-AI Summary

PDS Biotechnology (Nasdaq: PDSB) announced updated results from the VERSATILE-002 Phase 2 clinical trial evaluating Versamune® HPV in combination with KEYTRUDA® for first-line treatment of HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Key findings include:

- Median Overall Survival of 30 months
- Objective Response Rate of 36% (19/53 patients)
- Disease Control Rate of 77% (41/53 patients)
- 21% of patients (11/53) experienced 90-100% tumor shrinkage
- 9% of patients (5/53) had a complete response

The combination therapy showed promising tolerability and efficacy compared to published data for pembrolizumab alone. PDS Biotech plans to initiate the VERSATILE-003 Phase 3 clinical trial this year to further evaluate the combination therapy.

Positive

• Median Overall Survival of 30 months, significantly higher than published data for pembrolizumab (12-18 months)
• Objective Response Rate of 36%, higher than published data for pembrolizumab (19-25%)
• High Disease Control Rate of 77%
• 21% of patients experienced deep tumor responses with 90-100% shrinkage
• 9% of patients achieved complete response
• Versamune® HPV granted Fast Track designation by FDA
• VERSATILE-003 Phase 3 clinical trial planned to begin this year

Negative

• Treatment-related adverse events of Grade ≥3 observed in 9 patients

Insights

Medical Research Analyst

The updated results from the VERSATILE-002 Phase 2 trial show promising outcomes for Versamune® HPV combined with KEYTRUDA® in treating HPV16-positive recurrent/metastatic head and neck cancer. The median Overall Survival of 30 months is significantly higher than the 12-18 months typically seen with KEYTRUDA® alone. The Objective Response Rate of 36% and Disease Control Rate of 77% also outperform historical data for KEYTRUDA® monotherapy.

Notably, 21% of patients experienced 90-100% tumor shrinkage, indicating deep and meaningful responses. The tolerability profile appears manageable, with only 9 patients experiencing Grade ≥3 treatment-related adverse events. These results suggest that Versamune® HPV may enhance the efficacy of immunotherapy without substantially increasing toxicity, potentially offering a new first-line treatment option for this patient population.

Oncology Doctor

The VERSATILE-002 trial results are clinically significant. The 30-month median Overall Survival is a substantial improvement over current standards, potentially extending life expectancy for patients with this aggressive cancer. The 36% Objective Response Rate and 77% Disease Control Rate indicate robust anti-tumor activity.

Of particular interest is the 21% of patients achieving 90-100% tumor shrinkage, suggesting the potential for long-term disease control or even functional cures in some cases. The 9% complete response rate is also noteworthy. These deep responses are important in head and neck cancer, where tumor burden significantly impacts quality of life. The planned Phase 3 VERSATILE-003 trial will be critical in confirming these promising results and potentially changing the standard of care for HPV16-positive HNSCC.

Financial Analyst

The updated VERSATILE-002 trial results present a strong case for PDS Biotech's Versamune® HPV technology. The significantly improved survival and response rates compared to current standards could position the company for substantial market share in the HPV16-positive HNSCC space, a growing subset of head and neck cancers.

The planned Phase 3 VERSATILE-003 trial, if successful, could lead to FDA approval and commercialization. With Fast Track designation already granted, the regulatory pathway may be accelerated. Investors should note that the global HNSCC market is projected to reach $4.5 billion by 2027, presenting a significant opportunity. However, it's important to consider that Phase 3 trials are costly and time-consuming, potentially impacting PDS Biotech's cash position. The company's ability to fund the upcoming trial and potential commercialization will be key factors to watch.

Median Overall Survival remains at 30 months; Objective Response Rate of 36% and Disease Control Rate of 77%

11/53 (21%) of patients experienced 90-100% tumor shrinkage

VERSATILE-003 Phase 3 clinical trial planned to begin this year

PRINCETON, N.J., Sept. 16, 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 updated data from the VERSATILE-002 trial evaluating Versamune^® HPV (formerly PDS0101) in combination with KEYTRUDA^® (pembrolizumab) as a first-line (1L) treatment for patients with HPV16-positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The data were presented during a poster session on September 14 at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.

As of the latest data cut of the VERSATILE-002 single-arm, Phase 2 trial on May 17, 2024, Versamune^® HPV plus pembrolizumab continued to be well tolerated in this 1L R/M HPV16-positive HNSCC population. Enrollment in the trial (n=53) is complete, 10 patients remain on study treatment and 27 patients (including the 10 on treatment) continue to be followed for survival. Median patient follow-up is 16 months. The data demonstrated the following:

• Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months; Published mOS for pembrolizumab is 12-18 months^1,2
• Objective Response Rate (ORR) of 36% (19/53); Published ORR for pembrolizumab is 19-25%^1,2
• Disease Control Rate (DCR) is 77% (41/53)
• 21% (11/53) of patients had deep tumor responses and shrinkage of 90-100%
• 9% (5/53) of patients had a complete response
• Treatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1)

“The updated response data we presented at ESMO show the strong clinical activity and durability of Versamune^® HPV plus pembrolizumab,” said Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial. “Continued evaluation shows the promise of this combination in improving survival for patients with HPV16-positive HNSCC.”

A global, randomized, controlled Phase 3 clinical trial, VERSATILE-003, that will evaluate Versamune^® HPV plus pembrolizumab vs. pembrolizumab monotherapy as 1L treatment in patients with HPV16-positive R/M HNSCC with CPS ≥1 is planned to start this year.

“We’re encouraged to see that as the data from our VERSATILE-002 clinical trial have matured, responses continue to improve, suggesting durability of the Versamune^® HPV induced anti-tumor immune response,” said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “The encouraging patient survival and clinical responses coupled with promising tolerability as seen in the VERSATILE-002 trial underscore our belief in the potential of the combination to be the first HPV-targeted immunotherapy for HNSCC, and a significant advancement in the treatment of the growing population of patients with HPV16-positive HNSCC. We are working toward initiating the VERSATILE-003 Phase 3 study this year.”

Versamune^® HPV has been granted Fast Track designation by the FDA.

1. Harrington K. et al. J Clin Oncol. 2022 ascopubs.org/journal/jco on October 11, 2022: DOI https://doi.org/10.1200/JCO.21.02508
2. Licitra L. et al. 2024, International Journal of Radiation Oncology Volume 118, Issue 5e2-e3April 01

No head-to-head studies have been performed comparing Versamune^® HPV with other treatments

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune^® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

For more information, please visit www.pdsbiotech.com.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, Versamune^® HPV (formerly PDS0101), PDS0203 and other Versamune^® and Infectimune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, Versamune^® HPV, PDS0203 and other Versamune^® and Infectimune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune^® and Infectimune^® are registered trademarks of PDS Biotechnology Corporation.

Keytruda^® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

FAQ

What are the key results of PDS Biotech's VERSATILE-002 Phase 2 trial for PDSB stock?

The VERSATILE-002 Phase 2 trial showed a Median Overall Survival of 30 months, an Objective Response Rate of 36%, and a Disease Control Rate of 77% for Versamune® HPV in combination with KEYTRUDA® in treating HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma.

When is PDS Biotech (PDSB) planning to start the VERSATILE-003 Phase 3 trial?

PDS Biotech plans to initiate the VERSATILE-003 Phase 3 clinical trial later in 2024 to further evaluate Versamune® HPV plus pembrolizumab combination therapy.

What is the significance of the Fast Track designation for Versamune® HPV (PDSB)?

The Fast Track designation granted by the FDA for Versamune® HPV may expedite the development and review process, potentially bringing the therapy to market faster for PDS Biotech (PDSB).

How does the efficacy of PDS Biotech's Versamune® HPV compare to pembrolizumab alone for HNSCC?

Versamune® HPV in combination with pembrolizumab showed higher efficacy compared to published data for pembrolizumab alone, with a Median Overall Survival of 30 months vs. 12-18 months and an Objective Response Rate of 36% vs. 19-25%.