Elevab Therapeutics, a U.S. subsidiary of HLB, is accelerating its efforts to expand the indications of its targeted cancer therapy, Lira-Pugratinib, beyond cholangiocarcinoma. On June 19, Elevab announced the initiation of patient dosing in a global Phase 2 trial aimed at broadening the drug's application across various cancer types. Lira-Pugratinib is currently under review by the U.S. Food and Drug Administration (FDA) for approval specifically for cholangiocarcinoma.
HLB explained that Elevab has begun patient enrollment and dosing at the Samsung Medical Center in South Korea, as well as at the Moffitt Cancer Center in the United States, marking the official launch of its global clinical trials.
The cancer treatment is designed for patients with specific genetic mutations, regardless of the cancer type. This Phase 2 trial will evaluate the efficacy and safety of Lira-Pugratinib in patients with unresectable, locally advanced, or metastatic solid tumors who have confirmed FGFR2 fusions or rearrangements. The trial will be conducted across five countries: the United States, South Korea, the United Kingdom, Spain, and France, with the primary endpoint being the objective response rate (ORR).
In previous global Phase 1/2 trials, Lira-Pugratinib demonstrated significant anti-cancer activity in a cohort of 42 patients with FGFR2 fusions or rearrangements across 13 different solid tumor types. Elevab plans to conduct an interim analysis after collecting data from at least five patients across a minimum of seven cancer types based on an integrated dataset.
Additionally, Lira-Pugratinib has received orphan drug and breakthrough therapy designations from the FDA for its cholangiocarcinoma indication. The priority review is currently underway, with a final decision expected by September 27. Given its strong clinical data compared to competing drugs, HLB aims to expedite the approval and commercialization process.
Kim Dong-geun, CEO of Elevab Therapeutics, stated, "We will accelerate the progress of our global clinical trials to ensure the successful implementation of our strategy to expand indications across various cancer types."
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.