PDS has a clinical trial collaboration agreement with Merck to evaluate the combination of PDS’s PDS0101 with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in a Phase 2 clinical trial. This trial will evaluate the safety and efficacy of the PDS0101-KEYTRUDA®combination in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection after failure with platinum-based chemotherapy.
NATIONAL CANCER INSTITUTE
PDS has a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), an Institute of the U.S. National Institutes of Health. Under CRADA03039, PDS and NCI are co-developing several immunotherapies in upcoming Phase 2 clinical trials over the 2018–2020 period, utilizing combinations of Versamune® with NCI- and PDS-sourced tumor-related proteins or their fragments recognized by the immune system (antigens) in prostate, breast, and HPV-related cancers.
The currently confirmed CRADA03039-sponsored clinical trials include:
- PDS0101: Phase 2b clinical trial in pre-anal (Anal Intraepithelial Neoplasia, or AIN2/3) and pre-cervical (Cervical Intraepithelial Neoplasia, or CIN2/3) patients who are also HIV-positive.
- PDS0102: Phase 2b clinical trial in late-stage prostate cancer (D0) patients at risk of biochemical recurrence without radiographically measurable disease.
MERCK CIE/EMD MILLIPORE
Schaffhausen, Switzerland: A division of EMD-Millipore, Merck Cie, has developed a proprietary process to manufacture the patented structurally-specific lipid used in Versamune®. Merck Cie has granted PDS Biotechnology an exclusive worldwide commercial license to utilize the chiral lipid in immunotherapies and vaccines. Merck Cie provides the lipid manufactured under cGMP conditions for use in PDS Biotechnology’s products.