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PDS Biotech Announces Interim Data
PDS Biotech Announces Interim Data.
About this update from Emv Capital Plc
[{"type":"text","content":"\n\nReach: For immediate release\nNetScientific plc\n(\"NetScientific\" or the \"Company\")\nPDS Biotech Announces Interim Data\nDemonstrates 12-Month Survival Rate of 87% with PDS0101 in Combination with KEYTRUDA® (pembrolizumab) for Head and Neck Cancer Patients\nNetScientific Plc (AIM: NSCI), the investment and commercialisation group with an international portfolio of innovative life science, sustainability and technology companies, reports that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, has announced promising interim data.\nThe interim data relates to the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with unresectable, recurrent, or metastatic human papillomavirus (HPV)16-positive head and neck cancer.\nThe results will be featured in a poster presentation and in a head and neck cancer expert panel discussion at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held from 2 - 6 June in Chicago.\nThe presentation, titled \"Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC)\" (Abstract #6012), concluded that the combination was well tolerated, and the results justify a global confirmatory randomized, controlled study, VERSATILE-003, which PDS Biotech is planning to initiate this year. The study's 48 ICI naïve participants, 94% of whom were male with a median age of 62.5, received at least one cycle of the combination arm, 56.3% received four doses, and 22.9% received five doses.\nIn measuring the efficacy of PDS0101 in combination with KEYTRUDA®, the abstract highlights the following interim data:\n· Estimated 12-month overall survival rate was 87.1%. Published results are 36-50% with approved ICIs used alone*.\n· Median progression-free survival was 10.4 months (95% CI 4.2, 15.3). Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels*.\n· A disease control rate (disease stabi...