HLB Therapeutics Granted Waiver from European Pediatric Investigation Plan for NK Cell Therapy

On June 2, HLB Therapeutics announced that its U.S. subsidiary, Regentree, has been granted a waiver from submitting a Pediatric Investigation Plan (PIP) for its NK cell therapy (RGN-259) by the Pediatric Committee under the European Medicines Agency (EMA).

PIP is one of the regulatory requirements of the EMA that must be submitted when applying for new drug marketing authorization in Europe, in order to demonstrate safety and efficacy in pediatric populations. If certain criteria are met, a waiver application can be submitted to obtain exemption from the PIP requirement.

Preparing a PIP requires the development of a protocol for pediatric clinical trials, and after submission, it typically takes several months for the EMA to review and approve it.

Regentree is currently conducting a final review of the data in a frozen state after completing patient enrollment for the European clinical trial (SEER-3) of its NK cell therapy. The company plans to proceed with the data lock process soon and announce the top-line results.

HLB Therapeutics CEO Ahn Kihong stated, "It appears that exemption from the PIP, which usually requires significant time and cost for European new drug marketing authorization, is possible. We will engage in out-licensing negotiations with global big pharma companies after increasing the value of RGN-259 through an indication expansion strategy for limbal stem cell deficiency."