PDS Biotechnology Corp. (PDSB:NASDAQ) announced expanded interim data from the Phase 2 trial of its lead asset PDS0101 in human papillomavirus (HPV16)-associated cancers, which show "clinical signs of durable efficacy and safety in an extremely challenging patient population with very few available treatment options and no approved standard of care," reported H.C. Wainwright & Co. analyst Dr. Joseph Pantginis in an October 11 research note.
Patients in the study, conducted by the National Cancer Institute, have recurrent or metastatic HPV-positive anal, cervical, head and neck, vaginal, or vulvar cancer and have failed prior therapy.
H.C. Wainwright & Co. has a Buy rating and a $15 price target on PDS, the stock of which is currently trading at about $4.02 per share.
The trial is evaluating triple combination therapy of PDS0101 plus immunomodulating agents, bintrafusp alfa and M9241, in these patients.
"We remind investors that targeting these cancers remains a crucial unmet medical need," Pantginis wrote.
Highlights of New Results
The expanded interim data show that at a median follow-up period of 16 months, 19 out of 29, or 66% of checkpoint inhibitor-refractory patients were still alive.
In terms of safety, 24 out of 50, or 48% of, patients experienced Grade 3 adverse events, 2 out of 50, or 4% of patients experienced Grade 4 ones, and no patients experienced Grade 5 events.
These results are consistent with those previously announced at this year's American Society of Clinical Oncology meeting.
Data for the checkpoint inhibitor-naïve group "also remain encouraging," Pantginis wrote. Six out of 8, or 75% of, these patients were still alive at a median of 25 months of follow-up. Three out of eight, or 38% of, patients had a complete response.
"The company intends to fully focus on the development of the triple combination therapy specifically in checkpoint inhibitor-refractory patients," wrote Pantginis.
Moving the Program Forward
To continue advancing its PDS0101 clinical program reported Pantginis, PDS completed a $35 million debt financing agreement with Horizon Technology Finance to help fund it. Also, PDS has an upcoming meeting with the U.S. Food and Drug Administration to discuss how to best proceed toward potential approval.
H.C. Wainwright & Co. has a Buy rating and a $15 price target on PDS, the stock of which is currently trading at about $4.02 per share.
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Disclosures For H.C.Wainwright & Co., PDS Biotechnology Corp., October 11, 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 September 30, 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. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.
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