Cullinan Oncology to sell Cullinan Pearl to Taiho Pharmaceutical for $275m

American biopharma company Cullinan Oncology has agreed to sell its subsidiary Cullinan Pearl to Taiho Pharmaceutical, a Japanese specialty pharma company, for $275 million.

Cullinan Oncology has also reached an agreement with Taiho Pharmaceutical to co-develop and co-commercialize CLN-081/TAS6417, the lead program of Cullinan Oncology. Cullinan Pearl holds worldwide rights to CLN-081/TAS6417 outside of Japan.

CLN-081 is an orally available, differentiated, irreversible inhibitor of epidermal growth factor receptor (EGFR). It specifically targets cells that express EGFR exon 20 insertion mutations while sparing cells that express wild-type EGFR.

It is presently in phase 1/2a development for the treatment of non-small-cell lung carcinoma (NSCLC) in patients with an exon 20 insertion mutation.

Nadim Ahmed — CEO of Cullinan Oncology said: “Taiho is an ideal partner with whom to advance CLN-081/TAS6417 into later stage development and commercialization, given their deep understanding of the molecule and strategic focus on targeted therapies, existing stake in Cullinan Pearl, and strong oncology-focused commercial capabilities in the U.S.

“Importantly, the structure of the agreement provides the opportunity to efficiently establish our own commercial infrastructure, which will also be leveraged for our future programs.”

Under the terms of the deal, Taiho Pharmaceutical will pay an additional sum of up to $130 million to Cullinan Oncology related to EGFR exon20 non-small cell lung cancer (NSCLC) regulatory milestones.

Cullinan Oncology will retain the option of co-commercializing CLN-081/TAS6417 in the US along with Taiho Pharmaceutical through Taiho Oncology, the Japanese firm’s US subsidiary.

Taiho Pharmaceutical will be commercializing CLN-081/TAS6417 in regions outside the US and China. The two firms will contribute equally to the clinical development of CLN-081/TAS6417 in the future in the US, with each sharing profits from potential US sales on an equal basis.

Masayuki Kobayashi — President and Representative Director of Taiho Pharmaceutical said: “We are pleased to bring CLN-081/TAS6417 back into our pipeline and move it towards commercialization with Cullinan Oncology.

“Cullinan Oncology has carried CLN-081/TAS6417 from pre-IND to planned pivotal study in approximately three years. Meanwhile the Food and Drug Administration (FDA) has granted Breakthrough Designation status for this novel molecule.

“Utilizing Cullinan Oncology’s unique business model through this strategic collaboration, we aim to hasten and maximize the development of CLN-081/TAS6417. Together with Cullinan Oncology, the Taiho group will work to expeditiously deliver this agent to patients as soon as possible.”

The acquisition, which is subject to customary conditions such as expiration or termination of the waiting period under US antitrust laws, is likely to be wrapped up in Q2 2022.

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