PDS Biotechnology Corp. (PDSB:NASDAQ) and collaborator National Cancer Institute (NCI) will continue evaluating PDS0101-based triple combination therapy for advanced human papillomavirus (HPV)-positive cancers but only in checkpoint inhibitor refractory patients after having identified them as the optimal prospective treatment population, reported H.C. Wainwright & Co. analyst Dr. Joseph Pantginis in a September 21, 2022 research note.
H.C. Wainwright & Co. has a Buy rating and a $15 per share price target on PDS Biotechnology, the current share price of which, in comparison, is about $3.19.
In this patient group, the NCI-led, Phase 2 clinical trial will evaluate PDS' lead drug candidate PDS0101, an HPV16 targeted, T-cell activating immunotherapy, together with the immune-modulating agents, M9241 and bintrafusp alfa, as a third-line treatment for anal, penile, cervical, vaginal, vulvar, and head and neck cancers.
"The company intends to focus on the development of the triple combination therapy specifically for this patient group given the extreme unmet need coupled with the signals of efficacy observed in the checkpoint inhibitor refractory Phase 2 trial arm," noted Pantginis.
Data for this cohort showed PDS0101 plus M9241 plus bintrafusp alfa therapy, resulting in a 77% survival rate at a median follow-up period of 12 months patients. This represents "a significant improvement," Pantginis noted, given the median survival period for this group historically is three to four months. The treatment also was shown to have a manageable safety profile.
PDS and the NCI are to meet with the U.S. Food and Drug Administration before year-end to discuss the registration path forward.
Pantginis reiterated that along with this triple combination Phase 2 study, PDS0101 is being evaluated in three additional, independent Phase 2 trials as a treatment for various early-stage and advanced solid tumors.
"PDS0101 represents a potentially significant value driver for the company due to the unmet met need in HPV-driven malignancy and its differentiated immune activating properties, and we believe that PDS is well positioned for the clinical and regulatory advancement of PDS0101," wrote Pantginis.
One of the studies about which there is news is VERSATILE-002, assessing PDS0101 in combination with Keytruda (pembrolizumab) in recurrent or metastatic HPV16-positive head and neck cancer, Pantginis indicated. Partners PDS and Merck were recently given the approval to proceed to full enrollment of the study arm, given the Phase 2 preliminary objective response endpoint was met.
Also, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom just approved a Phase 2 PDS0101 plus pembrolizumab clinical trial to take place in Europe. Enrollment for it should commence this quarter.
"The acceptance of the clinical trial application by the MHRA marks an important step for the development of the immunotherapy candidate, helps accelerate enrollment into the VERSATILE-002 study, and provides global visibility of the company's pipeline and ongoing programs," Pantginis commented.
Finally, the analyst reported PDS completed a debt financing agreement for a total of $35 million ($35M), which will fund the advancement of PDS0101 into Q2/25. PDS will get $25M in the first payment tranche and has the option to subsequently receive $10M more.
H.C. Wainwright & Co. has a Buy rating and a $15 per share price target on PDS Biotechnology, the current share price of which, in comparison, is about $3.19.
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Disclosures For H.C.Wainwright & Co., PDS Biotechnology Corp., September 21, 2022
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Joseph Pantginis, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of PDS Biotechnology Corporation (including, without limitation, any option, right, warrant, future, long or short position). As of August 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of PDS Biotechnology Corporation. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from PDS Biotechnology Corporation for non-investment banking services in the previous 12 months.
The Firm or its affiliates did not receive compensation from PDS Biotechnology Corporation for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in PDS Biotechnology Corporation as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited.
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