PDS Biotech VERSATILE-002 Phase 2 Clinical Trial Meets Primary Study Endpoints in First Line Recurrent/Metastatic HPV16-Positive Head and Neck Cancer

Rhea-AI Summary

PDS Biotech's VERSATILE-002 Phase 2 clinical trial for first-line recurrent/metastatic HPV16-positive head and neck cancer met primary study endpoints with a 30-month median overall survival, impressive response rates, and a planned Phase 3 trial in 2024. The trial evaluated the combination of Versamune® HPV + KEYTRUDA® (pembrolizumab) and showed promising results. The Company also announced a two-part registrational trial focusing on a triple combination therapy.

Positive

• 30-month median overall survival (OS) in first-line recurrent/metastatic HNSCC patients.

• Impressive overall response rates (ORR) of 34% (CPS≥1) and 48% (CPS≥20).

• Progression-free survival (PFS) of 6.3 months (CPS≥1) and 14.1 months (CPS≥20).

• Durable response seen in patients with CPS≥1.

Negative

• None.

Insights

Medical Research Analyst

The data presented by PDS Biotech regarding their VERSATILE-002 Phase 2 Clinical Trial in HPV16-positive HNSCC patients shows a noteworthy median overall survival rate of 30 months, which starkly contrasts the published results for other immune checkpoint inhibitors ranging from 7-18 months. Such a significant extension in survival signifies a potential paradigm shift in first-line treatments for this cancer subtype. It's also of interest to note the stratification based on Combined Positive Score (CPS), with higher ORR in patients with higher CPS, indicating a possible correlation between CPS and the efficacy of the treatment. The progression-free survival data of 6.3 to 14.1 months further emphasizes the treatment's capacity for durable control of the disease. The Company's strategic move to integrate their novel ADC, alongside Versamune® and pembrolizumab, hints at a synergistic approach which, if successful, could redefine standard care practices. Considering these factors, this development could potentially lead to increased investor confidence in the company's clinical capabilities and their pipeline's potential value.

Oncology Doctor

As a clinician, the update on PDS Biotech's clinical trial results is quite promising, showing a remarkable improvement in overall survival rates for patients with HPV16-positive head and neck cancer. This is particularly important because the survival rates significantly exceed the current benchmarks set by existing treatments, suggesting that Versamune® in combination with pembrolizumab could offer a meaningful advancement in therapy. Head and neck cancers, especially those associated with HPV16, represent a difficult-to-treat patient population and advancements like these can have profound impacts on patient care. Through their dose optimization and randomized trials, PDS Biotech appears to be methodically building towards a robust Phase 3 trial, potentially improving outcomes for patients with recurrent/metastatic HNSCC.

Biotech Market Analyst

The positive results from PDS Biotech's Phase 2 clinical trial may be a catalyst for the company's stock performance in the near term, as they exceed published benchmarks for similar treatments. The potential for a strong candidate to advance into Phase 3 trials with solid data can be a significant driver of value and interest from both partners and investors in the biotech market. PDS Biotech's strategic focus on a combination therapy approach also taps into a growing trend in oncology treatments, where multi-modal regimes are increasingly common. Pending the successful outcome of their two-part registrational trial, PDS Biotech could capture a sizeable share of the market for HPV-related cancers, subject to FDA approval and market adoption.

30 month median overall survival (OS); median OS independent of patient CPS score

ORR 34% (CPS≥1); 48% (CPS≥20)

Phase 3 registrational trial planned to initiate in 2024

PRINCETON, N.J., May 09, 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, hosted a Key Opinion Leader event on May 8, 2024 during which prominent experts in head and neck squamous cell cancer (“HNSCC”) discussed positive, updated VERSATILE-002 data and the unmet need in HPV16-positive HNSCC. A replay of the event can be found here.

• The VERSATILE-002 trial is evaluating Versamune^® HPV + KEYTRUDA^® (pembrolizumab) in patients with HPV16-positive HNSCC.
• Median overall survival (“mOS”) is 30 months (n=53) in first line recurrent metastatic HNSCC; Published results for immune checkpoint inhibitors are 7-18 months.
• The immune checkpoint inhibitor (ICI) naïve cohort (n=53) met its primary endpoint of best overall response (BOR).
  • BOR by investigator assessment is 34% (Combined Positive Score (CPS) ≥1; n=18/53); 48% (CPS≥20; n=10/21); Published results for ICIs are <20% (CPS>1) and <25% (CPS≥20).
  • Progression free survival (“PFS”) is 6.3 months (CPS≥1); 14.1 months (CPS≥20); Published results for immune checkpoint inhibitors 2-3 months.
  • VERSATILE-002 data to date indicate a durable response in first line recurrent and / or metastatic HNSCC patients with CPS≥1.
  • The combination of Versamune^® HPV + pembrolizumab was well tolerated.
• The Company announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune^® HPV + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent/metastatic HNSCC.
  • PDS01ADC is the Company’s novel, investigational tumor-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune^® HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.
  • Part one of the clinical trial will focus on dose optimization with a data readout based on safety and objective response rate.
  • The randomized second part of the trial will include an interim data readout with OS as its primary endpoint.
    

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 head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of IL-12 fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune^® HPV in regimen with a standard-of-care immune checkpoint inhibitor. We believe that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.

We believe that with a novel investigational “inside-outside” mechanism, the PDS01ADC and Versamune^® HPV immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. We believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility.

Our Infectimune^® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. 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, 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, PDS0101, 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