NCI-led Phase 2 clinical trial of this reported combination was initiated in June 2020
FLORHAM PARK, N.J., June 22, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (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 the publication of data generated by the National Cancer Institute (NCI) based on preclinical studies of PDS Biotech’s lead clinical program, PDS0101, in combination with two other investigational anti-cancer agents. The article “Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine” by Rumfield et al. was published in the Journal for ImmunoTherapy of Cancer, and provides strong rationale for clinical evaluation of this three-component treatment combination in a recently initiated NCI-led Phase 2 clinical trial.
The results of the NCI’s preclinical study indicated that PDS0101 generated both human papillomavirus (HPV)-specific T-cells and an associated antitumor response when used as a monotherapy. When PDS0101 was combined with two other development-stage anti-cancer agents, Bintrafusp alfa (M7824) and NHS-IL12, the data suggest the agents worked synergistically to provide enhanced tumor regression and T-cell response as compared to the agents alone.
Dr. Frank Bedu-Addo, PDS Biotech’s Chief Executive Officer, commented, "The results of this preclinical study highlight the potential of PDS0101, Bintrafusp alfa (M7824) and NHS-IL12 when administered in combination, to improve treatment outcomes in patients with advanced HPV-associated cancers such as anal, cervical, head and neck and vulvar cancers. We look forward to progressing development of this triple therapeutic combination in the upcoming Phase 2 study in patients with HPV-associated cancers.”
The studies detailed in the Journal for ImmunoTherapy of Cancer were conducted under an existing Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI. The CRADA includes collaborative development work on both PDS0101 and a second development stage compound, PDS0103.
The full publication can be accessed here.
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. 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 engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. 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 and Co., PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer. In separate partnership with the National Cancer Institute (NCI), and The University of Texas MD Anderson Cancer Center, PDS Biotech is conducting additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer respectively.
Forward Looking Statements
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