Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, has announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its RET inhibitor A400/EP0031 in the US. The drug is being developed in collaboration with Ellipses Pharma.
A400 is a next-generation selective RET inhibitor (SRI) designed to target a broad spectrum of RET gene fusions and mutations, potentially overcoming resistance to first-generation SRIs. In March 2021, Kelun-Biotech entered into a licensing agreement with Ellipses Pharma, granting the UK oncology specialist exclusive rights to A400 in the US and select European countries, while retaining rights in Greater China, South Korea, Singapore, and Malaysia. The drug was cleared for a Phase I/II study in the US in June 2022 and received orphan drug designation (ODD) from the FDA in November 2023 for RET fusion-positive solid tumors. A400 was awarded fast-track designation (FTD) status by the FDA in April 2024 for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC). Phase I/II trial results indicated that A400 demonstrated promising anti-tumor efficacy in patients with advanced RET+ solid tumors, with objective response rates (ORR) of 80.8% and 69.7% for first-line and above second-line advanced RET+NSCLC, respectively. Disease control rates (DCR) in both scenarios exceeded 96%.
Ellipses Pharma is set to present the results of the Phase I dosage escalation and expansion study in patients with advanced RET variant NSCLC and other tumors who have not previously used SRIs or received treatment at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.- Flcube.com
