PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technologies, announced the acceptance of its Clinical Trial Application (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) to allow expansion of its VERSATILE-002 study of PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) to the UK. The MHRA is among several regulatory agencies that PDS Biotech is seeking approval from to expand the trial into various sites outside of the United States. PDS Biotech anticipates that enrollment in the UK could begin during the third quarter of 2022.
“The acceptance of this CTA marks another important regulatory milestone for PDS Biotech. Initiation of our global expansion is a key advancement to expedite enrollment into the VERSATILE-002 clinical study,” stated Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “Additionally, this expansion allows PDS to expose global regulators to our novel molecularly targeted immunotherapies.”
https://finance.yahoo.com/news/pds-biotech-announces-expansion-versatile-120000822.html
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