PDSB - PDS Biotech gains 20% after Phase 2 data for lead asset in head and neck cancer

2023-05-26 06:53:18 ET

PDS Biotechnology ( NASDAQ: PDSB ) added ~20% pre-market Friday after announcing interim Phase 2 data for its lead candidate PDS0101 in combination with Merck's ( NYSE: MRK ) anti-PD-1 therapy, Keytruda in certain patients with human papillomavirus (HPV)16-positive head and neck cancer.

Highlights of the readout indicate an 87.1% 12-month overall survival (OS) rate and a 10.4-month median progression-free survival (PFS) for the drug combo in 48 adults cancer patients who had not received an Immune Checkpoint Inhibitor (ICI) previously.

The open-label trial named VERSATILE-002 was designed to evaluate PDS0101 and Keytruda in adults with HPV16-positive unresectable, recurrent, or metastatic HNSCC.

VERSATILE-002 further indicates a disease control rate of 70.6% and an objective response rate of 41% (for both confirmed and unconfirmed responses). The trial has not reached the median overall survival yet, and 8% of subjects have experienced Grade 3 treatment-related adverse events.

Data will be part of a presentation at next month's American Society of Clinical Oncology (ASCO) Annual Meeting for 2023.

PDS Biotechnology ( PDSB ) said that data support a global clinical study called VERSATILE-003 which it plans to start this year.

More on PDS Biotech

• PDS Biotechnology slips 14% following German Merck licensing deal
• PDS Biotechnology: Late-Stage Biotech With Enormous Potential

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