PDS Biotechnology Granted FDA Fast Track Designation for Lead Candidate PDS0101

NetScientific plc (AIM: NSCI), the international life sciences and sustainability technology investment and commercialisation Group, announces that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), has been granted Fast Track designation for PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of recurrent or metastatic HPV16-positive head and neck cancer by the U.S. Food and Drug Administration (FDA).

PDS0101, in combination with KEYTRUDA®, is being studied in the VERSATILE-002 Phase 2, open-label, multicenter trial for the treatment of recurrent or metastatic HPV16-positive head and neck cancer (known as MSD outside the US and Canada).

The FDA’s Fast Track designation program is designed to aid in the development and to expedite the review of drug candidate applications that could potentially treat serious or life-threatening conditions. In order to receive Fast Track designation, a product must also demonstrate the potential to address an unmet medical need. Treatments granted this designation are given the opportunity to have more frequent meetings and interactions with the FDA throughout the entire drug development and review process, with the goal of moving promising new drugs more rapidly through the process. It also provides the opportunity to submit sections of a New Drug Application (NDA) on a rolling basis, where the FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission. In addition, Fast Track designated products are eligible for Priority Review at the time of NDA or Biologics License Application submission.

PDS Biotech’s lead candidate, PDS0101, is a T cell HPV-specific immunotherapy delivered subcutaneously that has shown the potential to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells within patients by activating multiple immune pathways. These HPV-specific T cells have been shown to target tumors such as anal, cervical, head and neck, penile, vaginal, vulvar that are caused by HPV16 infection. The incidence of head and neck cancer cases has been increasing steadily over the last 10-15 years and over 90% of HPV-positive head and neck cancers are caused by HPV16.1 In addition to the Phase 2 VERSATILE-002 trial, PDS Biotech is also conducting three additional Phase 2 studies in advanced HPV-associated cancers, locally advanced cervical cancer, and early-stage pre-metastatic HPV-associated oropharyngeal cancer with the National Cancer Institute (NCI), The University of Texas MD Anderson Cancer Center, and Mayo Clinic, respectively.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

1Exploring Roles of HPV16 variants in head and neck squamous cell carcinoma: current challenges and opportunities, Daniela Cochicho, Rui Gil da Costa, Ana Felix, Virology Journal, November 2021

Dr. Ilian Iliev, CEO of NetScientific, commented:

“The FDA fast track designation of PDS0101 provides recognition that the drug fills an unmet need in a serious condition, with the purpose to get a drug to patients faster. The Board therefore considers this a significant milestone and value inflection point for PDS.”


NetScientific holds 4.72% of PDS on an undiluted basis.


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