Japan-based Taiho Pharmaceutical Co., Ltd. and US-based Cullinan Oncology, Inc. (Nasdaq: CGEM) announced on Thursday an agreement through which Taiho will acquire Cullinan Pearl Corp. and co-develop and co-commercialise Cullinan Oncology's lead program, CLN-081/TAS6417 (development code in Cullinan Oncology: CLN-081, development code in Taiho: TAS6417), an orally available, differentiated, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild-type EGFR.
Subject to customary closing conditions, including expiration or termination of the waiting period under US antitrust laws, the acquisition is expected to close in the second quarter of 2022. Under the agreement, Taiho will acquire Cullinan Oncology's subsidiary, Cullinan Pearl, which has worldwide rights outside of Japan to CLN-081/TAS6417, for an upfront payment to Cullinan Oncology of USD275 million and up to an additional USD130 million tied to EGFR exon20 non-small cell lung cancer (NSCLC) regulatory milestones.
Cullinan Oncology will co-develop CLN-081/TAS6417 and will retain the option to co-commercialise CLN-081/TAS6417 in the US together with Taiho Pharmaceutical through its US subsidiary, Taiho Oncology, Inc. Taiho will commercialise CLN-081/TAS6417 in territories outside US and China. Taiho and Cullinan Oncology will equally contribute to the future clinical development of CLN-081/TAS6417 in the US, with each receiving 50% of the profits from potential US sales. As a result of the upfront cash payment and reduction in development and pre-commercialisation costs, Cullinan Oncology anticipates its cash runway to extend to 2026 based on current operating plans.
'We are pleased to bring CLN-081/TAS6417 back into our pipeline and move it towards commercialization with Cullinan Oncology,' said Masayuki Kobayashi, President and Representative Director of Taiho Pharmaceutical Co., Ltd.
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