Laekna Secures Approval for LAE120 in Advanced Solid Tumours Treatment
Tuesday, March 04, 2025
Laekna has received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application of LAE120, a novel USP1 inhibitor, for the treatment of advanced solid tumours.
LAE120 is an allosteric and highly potent USP1 inhibitor with demonstrated monotherapy effectiveness and combination potential with PARP inhibitors in cancers with homologous recombination deficiency (HRD).
Its unique chemical structure distinguishes it from other known USP1 inhibitors, potentially leading to a different conformational change in USP1. LAE120 has shown strong tumour inhibition in various xenograft models, including MDA-MB-436 and K562, both as a standalone treatment and in combination with PARP inhibitors.
LAE118 is a novel allosteric inhibitor designed to selectively target various PI3Kα mutants. Preclinical studies suggest that it offers superior anti-cancer efficacy and tolerability compared to existing PI3Kα inhibitors.
The company is also progressing with other drug candidates. In the fourth quarter of 2024, Laekna advanced LAE118, a mutant-selective PI3Kα inhibitor, into an IND-enabling study. PI3Kα mutations are common in several cancers, including breast, colorectal, lung, and endometrial cancers.
However, first-generation PI3Kα inhibitors target both wild-type and mutant forms equally, raising concerns about tolerability and efficacy.
Laekna continues to expand its drug development pipeline and is actively pursuing strategic partnerships to enhance global clinical development and commercialisation.
In November 2024, the company entered into a collaboration agreement with Eli Lilly to support the clinical development of LAE102 for obesity treatment.
Laekna aims to collaborate with leading pharmaceutical companies to accelerate the progress of its drug candidates and bring new treatments to patients worldwide.
Source: laekna.com
