- Feb 01 2018
NCI CRADA Target Announced
PDS Biotechnology Announces First PDS0101 Target Indication Under PDS-National Cancer Institute Collaborative Research and Development Agreement (CRADA)
North Brunswick, NJ—PDS Biotechnology Corporation, a clinical-stage immuno-oncology company pioneering the development of novel multifunctional immunotherapeutic products, today announced a progression of its CRADA with the National Cancer Institute.
The lead program under the CRADA collaboration is being developed to address a significant unmet medical need – HPV cancer in HIV-positive individuals. Despite significant activity in the field of immunotherapy for HPV-related cancer, there is an urgent need for effective immunotherapeutics to treat HIV-infected patients with HPV-related cancers.
PDS and the NCI are planning to initiate a Phase 2b clinical trial in this patient population starting in the second half of 2018. The clinical trial will recruit both HPV16-positive and HIV-positive subjects with high-grade anal intraepithelial neoplasia (anal pre-cancer).
Versamune® is a novel clinical stage, synthetic lipid-based immunotherapy platform. The Versamune®-based products which are administered by sub-cutaneous injection, have been demonstrated to facilitate superior anti-tumor efficacy due to the platform’s multi-functional mechanism of action. The platform provides potent activation of the type I interferon genes. The mechanism of action also involves effective presentation of the tumor antigens via the MHC Class I pathway. Both mechanisms together promote strong in-vivo induction of polyfunctional tumor-targeting CD8+ T-cells. This result, as well as excellent safety were confirmed in a Phase 1/2a human clinical trial. The Versamune® approach also inhibits immune-suppressive regulatory T-cells within the tumors, further facilitating the anti-tumor efficacy of the products. The Versamune® platform is now being applied to the development of multiple Phase 2b clinical-stage cancer products, including both early and late-stage cancer indications, as well as combinations with other successful immuno-oncology approaches such as checkpoint inhibitors.
About PDS Biotechnology
PDS Biotechnology is a private biopharmaceutical company with a growing pipeline of simpler, safer, and more effective clinical-stage immunotherapies to treat various early-stage and late-stage cancers. PDS is progressing a pipeline of immuno-oncology products to treat various cancers including, head and neck cancer, cervical cancer, prostate cancer, breast cancer etc. into phase 2 human clinical trials. This pipeline progression is based on successful demonstration of safety, and strong induction of antigen-specific CD8+ T-cell responses in a recently completed phase 1/2a human clinical trial.