2022-10-05 | NDAQ:PDSB | Press release
Abstracts highlight data from Phase 2 clinical trials – PDS0101-CRT combination study in cervical cancer and PDS0101-based triple combination study in HPV16-expressing cancers
FLORHAM PARK, NJ, Oct. 05, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Company (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious diseases, today announced that two abstracts reporting results from clinical development studies of PDS0101 have been accepted for presentation at the 37th Annual Meeting of the Society for Cancer Immunotherapy (SITC 2022) which will be held from November 8 to 12, 2022 in Boston.
PDS0101 is PDS Biotech’s lead candidate under development for the treatment of HPV-expressing cancers. Abstracts Accepted for Presentation at SITC 2022 Highlight Research from the Ongoing IMMUNOCERV Phase 2 Clinical Trial of PDS0101 in Combination with Standard Chemoradiotherapy (CRT) for the Treatment of Locally Advanced Cervical Cancers and the phase 2 clinical trial involving the triple combination therapy in advanced cancers expressing HPV16. The IMMUNOCERV clinical trial is led by researchers at the University of Texas MD Anderson Cancer Center. The PDS0101 triple combination clinical trial is being conducted by the National Cancer Institute (NCI) Cancer Research Center.
“We are delighted that the abstracts highlighting the therapeutic potential of PDS0101 in locally advanced cervical cancer and advanced refractory HPV16-expressing cancers have been accepted for presentation at SITC 2022,” said Dr. Frank Bedu-Addo, President and CEO of PDS Biotech. “The fact that this research has been accepted for presentation at SITC, one of the leading conferences in oncology, highlights the quality of the clinical research performed with PDS0101 and the potential of our Versamune® technology in the development of immunotherapies for address a variety of cancer indications that remain underserved by current treatment options.”
Abstract number: 674
Title of abstract: IMMUNOCERV, an ongoing phase II trial combining PDS0101, an HPV-specific T-cell immunotherapy, with chemotherapy and radiation therapy for the treatment of locally advanced cervical cancers
Speaker: Dr. Ann Klopp, University of Texas MD Anderson Cancer Center
Date of the session: Friday November 11
Abstract number: 695
Title of abstract: Immune correlates associated with clinical benefit in patients with checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapies
Speaker: Dr Meg Goswami, National Cancer Institute
Date of the session: Thursday, November 10
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies against cancer and infectious diseases based on our proprietary Versamune® technology and Infectimune™ T-cell activation technology platforms. We believe that our Versamune® target has the potential to overcome the limitations of current immunotherapy by inducing large amounts of polyfunctional, high-quality tumor-specific CD4+ helper and CD8+ T cells. To date, our leading Versamune® clinical candidate, PDS0101, has demonstrated the potential to shrink tumors and stabilize disease in combination with approved and experimental therapies in patients with a wide range of HPV-expressing cancers in several Phase 2 clinical trials. Our Infectimune™-based vaccines have also demonstrated the potential to induce not only robust and long-lasting neutralizing antibody responses, but also potent T-cell responses, including T-cell responses long-term memory T in preclinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About PDS0101
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with antigens targeted in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a phase 2 study in the first-line treatment of recurrent or metastatic ENT cancer, as well as in the second-line treatment of recurrent or metastatic ENT cancer. metastatic disease in patients with failed prior checkpoint inhibitor therapy. A National Cancer Institute-supported Phase 2 clinical study of PDS0101 in triple therapy is also underway in checkpoint inhibitor-refractory patients with multiple advanced HPV-associated cancers. A third Phase 2 clinical trial in the first-line treatment of locally advanced cervical cancer is being conducted by the University of Texas MD Anderson Cancer Center. A final Phase 2 clinical trial of PDS0101 monotherapy in the first-line treatment of newly diagnosed patients with HPV16+ head and neck cancer is underway at the Mayo Clinic.
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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) regarding PDS Biotechnology Corporation ( the “Company”) and other matters. These statements may discuss objectives, intentions and expectations regarding future plans, trends, events, results of operations or financial condition, or otherwise, based on the 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 on or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intention,” “forecast,” “direction,” “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions which 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 variety 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 anticipated cash flow 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 the raising of such additional capital may restrict the company’s operations or require the company to waive its rights to the company’s products technologies or product candidates; the Company’s limited operating history in the Company’s current industry, which makes it difficult to assess the Company’s prospects, the Company’s business plan or the likelihood of successful implementation of this business plan by the Company; the timing for the Company or its partners to initiate planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates; the future success of these trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaborative studies regarding 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 planned clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, rate of recruitment and completion trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material change in our currently projected expenditures), futility analyses, conference presentations and data reported in an abstract, and receipt of any interim or preliminary results (including, without limitation, preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any statements by the Company regarding its understanding of the mechanisms of action of product candidates and the interpretation of preclinical and early clinical results from its clinical development programs and any collaborative studies; and other factors, including legislative, regulatory, political and economic developments that are not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations resulting from or related to COVID-19 . The foregoing discussion of important factors that could cause actual events to differ from expectations should not be construed as complete and should be read in conjunction with the statements that are included herein and elsewhere, including the risk factors included in the company’s annual and periodic reports. filed with the SEC. 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 statement, whether as a result of new information, future events or otherwise.
Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
Investor contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
E-mail: drandolph@pdsbiotech.com
rich rooster
CG Capital
Phone: +1 (404) 736-3838
E-mail: pdsb@cg.capital
Media Contact:
Bill Borden/Dave Schemelia
Tiberend Strategic AdvisorsInc.
Telephone: +1 (732) 910-1620/+1 (609) 468-9325
E-mail: bborden@tiberend.com /dschemelia@tiberend.com
