PDS Biotech Announces Expanded Preliminary Data from the Phase 2 Trial of Triple Combination PDS0101 Targeting Advanced HPV-Positive Cancers

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PDS Biotechnology Corporation

66% of HPV 16-positive checkpoint inhibitor-refractory patients are alive after a median follow-up of 16 months

FLORHAM PARK, NJ Oct. 11, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious diseases, today announced expanded interim data evaluating the Phase 2 clinical trial of PDS0101-based triple therapy in advanced human papillomavirus (HPV)-positive cancer. This Phase 2 study is being conducted at the Center for Cancer Research (CCR) at the National Cancer Institute (NCI), part of the National Institutes of Health. Preliminary efficacy data from 37 HPV16-positive evaluable patients, including 29 patients in the checkpoint inhibitor (CPI)-refractory arm, are consistent with the results presented at ASCO 2022 and confirm the selection of CPI-refractory patients as the initial patient population for the ongoing clinical treatment development of the triple combination.

The NCI-led phase 2 clinical trial (NCT04287868) is evaluating PDS0101 in combination with two investigational immunomodulators – M9241, a tumor-targeted IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/TGF -β) – in recurrent or metastatic HPV-positive cancers in patients who have failed previous therapy. The triple combination is being studied in CPI-naïve and refractory patients with HPV-positive advanced anal, cervical, head and neck, vaginal and vulvar cancer. Both M9241 and bintrafusp alfa are owned by Merck KGaA, Darmstadt, Germany.

The highlights of the extended preliminary data are as follows:

  • survival data: 66% (19/29) of the HPV 16-positive CPI-refractory patients in the cohort were alive at a median follow-up of 16 months. Historically, this group has had a median overall survival of only 3-4 months. I

  • Security profile: Grade 3 treatment-emergent adverse events (AEs) occurred in 48% (24/50) of patients and Grade 4 AEs in 4% (2/50) of patients. There were no grade 5 treatment-related AEs

The results for HPV-16-positive checkpoint inhibitor-naïve patients also continue to appear encouraging: 75% (6/8) of CPI-naïve patients were alive after a median follow-up of 25 months. 38% (3/8) of responders had a complete response.

“The expanded preliminary data investigating PDS0101-based triple therapy in advanced HPV-positive cancer appear to continue to demonstrate clinical evidence of efficacy, durability and safety in an extremely challenging patient population with very few available treatment options,” said Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “Importantly, these results reinforce the decision to evaluate this novel combination for the treatment of CPI-refractory patients who do not have an approved standard of care and support the development of a combination therapy to address the significant unmet need.”

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious diseases based on our proprietary Versamune® and Infectimune™ T-cell activating technology platforms. We believe in our purposeful Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large numbers of high-quality, potent polyfunctional tumor-specific CD4+ helper and CD8+ killer T cells. To date our lead Versamune® The clinical candidate PDS0101 has demonstrated in multiple phase 2 clinical trials the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad spectrum of HPV-positive cancers. Our Infectimune™-based vaccines have also shown in previous pre-clinical studies the potential to induce not only robust and durable neutralizing antibody responses, but also potent T-cell responses, including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the benefits of Versamune® Platform with targeted antigens in HPV-positive cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a phase 2 study for the first-line treatment of recurrent or metastatic head and neck cancer and also for the second-line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A Phase 2 clinical trial is also being conducted in partnership with the National Cancer Institute (NCI) in second- and third-line treatment of several advanced HPV-positive cancers. A third phase 2 clinical trial in first-line treatment of locally advanced cervical cancer is being conducted with the University of Texas MD Anderson Cancer Center.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Forward-Looking Statements

This release 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) with respect to PDS Biotechnology Corporation (the “Companies “) and other matters. These statements may discuss goals, intentions and expectations regarding 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 and information currently available, management. Forward-looking statements generally include statements that are forward-looking in nature and depend on or relate to future events or conditions and contain words such as “may”, “will”, “should”, “would”, “expects”, “anticipates” . ”, “plan”, “likely”, “believe”, “estimate”, “forecast”, “intend”, “forecast”, “guidance”, “outlook” and other similar expressions. 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 statements due to a number of factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the company’s anticipated capital requirements, including the company’s expected cash position and the company’s current expectations regarding its plans for future equity financing; the Company’s dependence on additional financing to fund its operations and to complete the development and commercialization of its product candidates and the risks that raising such additional capital could limit the Company’s operations or force the Company to acquire rights to the technologies or product candidates of the give up company; 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 a business plan; the timing for the Company or its partners to initiate planned clinical trials for PDS0101, PDS0203 and other Versamune® and product candidates based on Infectimune™; the future success of such studies; the successful implementation of the Company’s research and development programs and collaborations, including all collaboration studies related to 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 recruitment and completion of the trials (including the Company’s ability to to fully fund its disclosed clinical trial (which does not require material changes to our current projected expenditures), futility analysis, conference presentations and data reported in an abstract, and receipt of interim or preliminary results (including, but not limited to pre-clinical results or data) that are not necessarily indicative of the definitive results of the Company’s ongoing clinical trials; all statements by the Company regarding its understanding of the mechanisms of action of product candidates and the interpretation of pre-clinical and early clinical results from its clinical development programs and collaborative studies; and other factors, including legal, regulatory, political and economic developments beyond the Company’s control, including unforeseen circumstances or other disruptions to normal business operations, arising out of or related to COVID-19. The foregoing summary 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 contained herein and elsewhere, including the risk factors contained in The Company’s annual and interim reports filed with us include the S. The forward-looking statements are made only as of the date of this press release and, except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements or to endorse any other forward-looking statements whether as a result of new information, future events or any other reason.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor contacts:
Deanne Randolph
PDS Biotech
Telephone: +1 (908) 517-3613
[email protected]

Rich Cockrell
CG capital
Telephone: +1 (404) 736-3838
[email protected]

media
Dave Schemelia
Tiberend Strategic Advisors, Inc.
Telephone: +1 (609) 468-9325
[email protected]

Bill Borden
Strategic Advisors of Tiberend
Telephone: +1 732-910-1620
[email protected]

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I bouquet J, et al. J Immunother Cancer 2020;8:e001395. doi:10.1136/jitc-2020-001395

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