On May 18, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported the completion of enrollment in the immune checkpoint inhibitor naïve group (ICI naïve) of its VERSATILE-002 Phase 2 trial for the treatment of recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer (Press release, PDS Biotechnology, MAY 18, 2023, View Source [SID1234631853]).

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VERSATILE-002 (NCT04260126) is a Phase 2, open-label, multicenter trial of the efficacy and safety of PDS0101 administered in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in adults with HPV16-positive, unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). VERSATILE-002 is investigating two patient populations with HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with an ICI, also known as the ICI naïve cohort, and is PD-L1 positive. The second group of patients has failed treatments, including ICI therapy (ICI refractory). In December 2022, PDS Biotech announced the completion of enrollment in the first stage of the ICI refractory group.

PDS Biotech recently announced that updated data from the ICI naïve group will be the subject of a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The abstract was also selected as one of the featured posters to be reviewed by an expert panel in the Head and Neck Cancer discussion session. The data will build upon previously announced preliminary efficacy data reported at ASCO (Free ASCO Whitepaper) 2022 from 17 ICI naïve VERSATILE-002 patients, which demonstrated an objective response rate of 41% (confirmed and unconfirmed responses), clinical benefit rate of 77%, and an overall survival rate of 87% at nine months.

"Completing enrollment in the ICI naïve arm is an important milestone in the VERSATILE-002 Phase 2 trial and the ongoing development of PDS0101 in combination with KEYTRUDA as a potential treatment for recurrent and/or metastatic HPV16-positive head and neck cancer," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "HPV-driven HNSCC is a growing problem, and there is a large unmet medical need to develop an HPV-targeted immunotherapy. Preliminary data reported at ASCO (Free ASCO Whitepaper) 2022 and highlighted at our October 2022 Head and Neck Cancer KOL Roundtable suggest that PDS0101 in combination with KEYTRUDA may lead to improved outcomes in ICI naïve, recurrent or metastatic HNSCC patients. We now look forward to reporting updated data from the VERSATILE-002 trial at ASCO (Free ASCO Whitepaper) 2023 as the next step towards a planned global confirmatory randomized, controlled trial investigating the combination of PDS0101 and KEYTRUDA in this same patient population."

90% of HPV-associated head and neck cancers in the U.S. are reported to be caused by HPV16, as reported in a study published in the Journal of Clinical Medicine (J Clin Med 2018 Sep;7(9):241). The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the combination of PDS0101 and KEYTRUDA for the treatment of HPV16-positive HNSCC.

About PDS0101

PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002

VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

Preliminary efficacy and safety data were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for ICI naïve patients (PR link). Preliminary data from the first 19 patients demonstrated that 77% of the patients with available imaging (17 of 19) had either disease stabilization or tumor shrinkage. Additionally, the overall survival rate of these patients at 9 months was 87%.