NCI CRADA Target Announced

  • NCI CRADA Target Announced

    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).

    About Versamune®

    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.

    Contact Details:

    PDS Biotechnology Corp.
    Frank Bedu-Addo, Ph.D., CEO
    Michael King, M.B.A., CFO
    Phone: +1-732-640-0145
    Email: execinfo@pdsbiotech.com

    PDS-Biotech

    Comments are closed.