PDS Biotech Announces Release of Interim Data for PDS0101 in NCI-Led Phase 2 Clinical Study in Oral Presentation at ASCO 2021 Annual Meeting
PDS Biotech Announces Release of Interim Data for PDS0101 in NCI-Led Phase 2 Clinical Study in Oral Presentation at ASCO 2021 Annual Meeting
Tumor reduction was observed in 83% (5 of 6) of HPV16-positive relapsed or refractory checkpoint inhibitor naïve advanced cancer patients and 58% (7 of 12) of HPV16-positive relapsed or refractory advanced cancer patients who have also failed checkpoint inhibitor therapy
FLORHAM PARK, N.J., June 08, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced the presentation of interim data from the Phase 2 trial led by the National Cancer Institute (NCI), of the National Institutes of Health (NIH), at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting.
The Phase 2 trial (NCT04287868) studies PDS0101 (Versamune®-HPV16) in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional “trap” fusion protein targeting TGF-? and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. PDS0101 is an immunotherapy candidate designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by activating the immune system to produce in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive. Analyses of immune responses and other immune correlates are ongoing.
Highlights from the presentation include the following:
- Data from a total of 25 patients with data available as of the time of presentation submission:
- Update on the data previously reported for the original fourteen (14) HPV16-positive patients who were in the subject of the abstract published on May 19th.
- An additional seven (7) HPV16-negative patients (patients whose cancer was NOT caused by HPV16 infection) who were not discussed in the abstract.
- An additional four (4) HPV16-positive patients who are checkpoint inhibitor refractory whose data became available after the abstract submission.
- 100% (25/25) of patients enrolled had failed chemotherapy treatment.
- 96% (24/25) of patients enrolled had failed both chemotherapy and radiation treatment.
- 56% (14/25) of patients enrolled had failed checkpoint inhibitor therapy (checkpoint inhibitor refractory).
- Most types of HPV-related cancers (anal, cervical, head and neck, vaginal and vulvar cancers) were represented among the study subjects.
- The following update was provided on the initial six (6) HPV16-positive patients who had NOT been treated with checkpoint inhibitors (checkpoint inhibitor naïve):
- 83% (5/6) of the patients demonstrated an objective response (tumor reduction >30%). The reported objective response rate with current standard of care checkpoint inhibitor treatment is 12-24%.
- 100% (6/6) are still alive at 8 months – the historic average (median) survival or life span for this patient population is 7-11 months.
- 80% (4/5) of patients who had an objective response still have an ongoing response at 8 months.
- One (1) patient had a complete response (no evidence of disease).
- No new patients had been added to this group by the time of submission.
- The following information was provided on the twelve (12) HPV16-positive patients who have also failed treatment with checkpoint inhibitors after failing chemotherapy and radiation treatment (checkpoint inhibitor refractory):
- Four patients had recently been added since the abstract. Tumor reduction was observed in 58% (7/12), with an overall objective response rate of 42% (5/12) already achieved; the objective response rate of the current standard of care is 5-12%
- One patient in this group had achieved a complete response by the time of reporting
- 80% (4/5) of patients who had an objective response have an ongoing response at 8 months
- 83% (10/12) of patients are still alive at 8 months; historic average (median) survival or life span for this patient population is only 3-4 months
- PDS0101 is designed to treat patients whose cancer is caused by infection with HPV16. Seven (7) patients had cancer that was not caused by HPV16 (HPV16-negative patients). In this group
- 0% (0/7) experienced tumor reduction.
- 80% (4/5) checkpoint inhibitor naïve patients are still alive at 8 months.
- 0% (0/2) checkpoint inhibitor refractory patients are still alive at 8 months.
The NCI Center for Cancer Research’s Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial. Bintrafusp alfa is being jointly developed by Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA, Darmstadt, Germany.
The trial is evaluating the treatment combination in both checkpoint inhibitor naïve and refractory patients with advanced HPV-associated cancers that have progressed or returned after treatment. The vast majority of these cancers are caused by HPV16 infection. Objective response is measured by radiographic tumor responses according to RECIST 1.1. These reported data provide additional insights following the preclinical studies published by the NCI examining the potentially complementary mechanisms of action of the three immunotherapies, understood to involve potent in-vivo HPV16-specific killer and helper T-cell induction with effective T-cell tumor infiltration (PDS0101), blocking of immune checkpoints as well as targeting of TGF-? (Bintrafusp alfa). The preclinical results suggested superior tumor regression.
“The achievement of a 67% tumor reduction among all HPV16-positive cancer patients including both CPI naïve and CPI refractory patients continues to strengthen the evidence supporting continuing clinical investigation of novel Versamune® platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer in which we believe results in a strong synergy with bintrafusp alfa and NHS-IL12. The data provide early evidence of notable clinical activity, and we saw effective tumor regression in these patients,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “The interim data demonstrating that this response was limited only to patients with HVP16-positive cancer, and also the fact that all responding patients who have stayed on treatment continue to show ongoing responses after a median duration of 8 months solidifies our belief that PDS0101’s ability to generate a robust, targeted T-cell response may have the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV16-associated cancers who have limited treatment options.”
There are more than 630,000 cases of HPV-associated malignancies including cervical, oropharyngeal and anal cancer worldwide annually. HPV-16 is responsible for most of these cases. About 15-20% of HPV-associated malignancies respond to PD-(L)1 inhibitors. However, for the overwhelming majority of patients who progress on these immunotherapies there is no effective standard of care therapy.
The company is hosting a conference call today at 8:00 am ET to discuss the data presented at ASCO. Registration for the conference call is now open and a live webcast of the event will be available online in the investor relations section of the company's website at https://pdsbiotech.com/investors/news-center/events. A replay will be available on the company website for 90 days following the webcast.
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 developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products may overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple investigational 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. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens 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 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 NCI and The University of Texas MD Anderson Cancer Center, respectively. The current product targets HPV16-positive cancers, and upon successful proof of concept will be broadened to address cancers caused by other oncogenic HPV-types.
Forward Looking Statements
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