PDS Biotech Announces Oral Presentation of PDS0101 Data by the National Cancer Institute at 2021 American Society of Clinical Oncology Annual Meeting

Rhea-AI Summary

PDS Biotechnology Corporation (PDSB) announced that efficacy and safety data from the NCI's Phase 2 study of PDS0101 for advanced HPV-associated cancers has been accepted for oral presentation at the ASCO 2021 Annual Meeting, scheduled for June 4-8. The trial demonstrated preliminary efficacy with a response from 3 of the first 8 patients, leading to expanded enrollment. The study focuses on a combination of PDS0101, M9241, and bintrafusp alfa. Dr. Lauren V. Wood expressed optimism regarding the study's potential in immunotherapy.

Positive

• Initial efficacy data from the Phase 2 clinical study of PDS0101 was accepted for presentation at ASCO.
• The trial showed preliminary efficacy with 3 of the first 8 patients responding, prompting expanded enrollment.

Negative

• None.

FLORHAM PARK, N.J., April 29, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced that initial efficacy and safety data from the National Cancer Institute’s (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment (NCT04287868) has been accepted for oral presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting taking place June 4-8.

The accepted abstract summarizes initial findings from the ongoing trial, which studies PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional “trap” fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. Earlier this year, it was announced that the trial had achieved its preliminary efficacy threshold of an objective response in 3 or more of the first 8 patients as measured by RECIST 1.1. The trial subsequently expanded enrollment to both checkpoint inhibitor naïve patients and patients who have failed prior therapy with checkpoint inhibitors. “We are encouraged by the data and look forward to the presentation of initial findings from the study,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “ASCO provides an important opportunity to share the potential of both PDS0101 and the Versamune® platform with the research and medical community.”

Abstract Number: 2501
Abstract Title: Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.

Presenting Author: Julius Strauss, MD, National Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Date: June 7, 2021
Time: 3:00 PM-6:00 PM EDT

The abstract will be available on Wednesday, May 19 at 5:00 PM EDT on ASCO.org.

For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:  1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website:  https://trials.cancer.gov.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in multiple indications. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. 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 targeted antigens in HPV-expressing cancers.  In partnership with Merck and Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

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 PDS0101, PDS0203 and other Versamune® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® based products 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 our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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.

FAQ

What is the significance of the Phase 2 study for PDS0101 by PDS Biotechnology?

The Phase 2 study of PDS0101 shows promising initial efficacy data for treating advanced HPV-associated cancers, which is critical for the company's pipeline.

When will the results from the PDS0101 study be presented?

The results from the PDS0101 study will be presented during the ASCO 2021 Annual Meeting from June 4-8, with the specific session on June 7.

What are the expectations for PDS0101 according to PDS Biotechnology’s CMO?

Dr. Lauren V. Wood expressed encouragement about the initial data from the PDS0101 study and sees it as an opportunity to share its potential.

What is the target group for the clinical study of PDS0101?

The target group for the clinical study includes patients with advanced HPV-associated cancers who have experienced progression or recurrence after treatment.