FLORHAM PARK, N.J., May 31, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy firm growing a rising pipeline of molecularly focused most cancers immunotherapies and infectious illness vaccines based mostly on the Company’s proprietary Versamune® and Infectimune™ T-cell activating applied sciences, introduced the acceptance of its Clinical Trial Application (CTA) from the Medicines and Healthcare merchandise Regulatory Agency (MHRA) in the United Kingdom (UK) to permit expansion of its VERSATILE-002 study of PDS0101 together with Merck’s anti-PD-1 remedy KEYTRUDA® (pembrolizumab) to the UK. The MHRA is amongst a number of regulatory companies that PDS Biotech is looking for approval from to increase the trial into varied websites exterior of the United States. PDS Biotech anticipates that enrollment in the UK may start throughout the third quarter of 2022.
“The acceptance of this CTA marks another important regulatory milestone for PDS Biotech. Initiation of our global expansion is a key advancement to expedite enrollment into the VERSATILE-002 clinical study,” said Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “Additionally, this expansion allows PDS to expose global regulators to our novel molecularly targeted immunotherapies.”
Chris Curtis, Chief Executive Officer of the UK-based charity group, The Swallows, said, “The reported preliminary safety data of PDS0101 in combination with pembrolizumab is highly encouraging, and we are pleased that European patients will be able to enroll in this promising clinical study of an HPV-targeted immunotherapy with standard of care, pembrolizumab.”
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy firm growing a rising pipeline of molecularly focused most cancers and infectious illness immunotherapies based mostly on the Company’s proprietary Versamune® and Infectimune™ T-cell activating know-how platforms. Our Versamune®-based merchandise have demonstrated the potential to beat the limitations of present immunotherapy by inducing in vivo, massive portions of high-quality, extremely potent polyfunctional tumor particular CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed a number of therapies, based mostly on combos of Versamune® and disease-specific antigens, designed to coach the immune system to higher acknowledge diseased cells and successfully assault and destroy them. The Company’s pipeline merchandise tackle varied cancers together with HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Our Infectimune™ -based vaccines have demonstrated the potential to induce not solely sturdy and sturdy neutralizing antibody responses, but in addition highly effective T-cell responses together with long-lasting reminiscence T-cell responses. To be taught extra, please go to www.pdsbiotech.com or observe us on Twitter at @PDSBiotech.
Forward Looking Statements
This communication comprises forward-looking statements (together with inside the that means 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 different issues. These statements might talk about objectives, intentions and expectations as to future plans, tendencies, occasions, results of operations or monetary situation, or in any other case, based mostly on present beliefs of the Company’s administration, in addition to assumptions made by, and data at the moment obtainable to, administration. Forward-looking statements usually embody statements which might be predictive in nature and rely on or seek advice from future occasions or circumstances, and embody phrases akin to “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and different comparable expressions amongst others. Forward-looking statements are based mostly on present beliefs and assumptions which might be topic to dangers and uncertainties and are usually not ensures of future efficiency. Actual results may differ materially from these contained in any forward-looking assertion consequently of varied elements, together with, with out limitation: the Company’s capacity to guard its mental property rights; the Company’s anticipated capital necessities, together with the Company’s anticipated money runway and the Company’s present expectations concerning its plans for future fairness financings; the Company’s dependence on further financing to fund its operations and full the improvement and commercialization of its product candidates, and the dangers that elevating such further capital might prohibit the Company’s operations or require the Company to relinquish rights to the Company’s applied sciences or product candidates; the Company’s restricted working historical past in the Company’s present line of enterprise, which makes it tough to judge the Company’s prospects, the Company’s marketing strategy or the probability of the Company’s profitable implementation of such marketing strategy; the timing for the Company or its companions to provoke the deliberate clinical trials for PDS0101, PDS0203 and different Versamune® and Infectimune™-based product candidates; the future success of such trials; the profitable implementation of the Company’s analysis and improvement applications and collaborations, together with any collaboration research regarding PDS0101, PDS0203 and different Versamune® and Infectimune™-based product candidates and the Company’s interpretation of the results and findings of such applications and collaborations and whether or not such results are enough to help the future success of the Company’s product candidates; the success, timing and price of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s present product candidates, together with statements concerning the timing of initiation, tempo of enrollment and completion of the trials (together with the Company’s capacity to totally fund its disclosed clinical trials, which assumes no materials adjustments to our at the moment projected bills), futility analyses, shows at conferences and information reported in an summary, and receipt of interim results (together with, with out limitation, any preclinical results or information), which aren’t essentially indicative of the ultimate results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of motion and interpretation of preclinical and early clinical results from its clinical improvement applications and any collaboration research; and different elements, together with legislative, regulatory, political and financial developments not inside the Company’s management, together with unexpected circumstances or different disruptions to regular enterprise operations arising from or associated to COVID-19. The foregoing overview of essential elements that would trigger precise occasions to vary from expectations shouldn’t be construed as exhaustive and needs to be learn along with statements which might be included herein and elsewhere, together with the danger elements included in the Company’s annual and periodic reviews filed with the SEC. The forward-looking statements are made solely as of the date of this press launch and, besides as required by relevant regulation, the Company undertakes no obligation to revise or replace any forward-looking assertion, or to make another forward-looking statements, whether or not consequently of new data, future occasions or in any other case.
Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]
