Taiho Pharmaceutical and Cullinan Oncology have announced an agreement through which Taiho will acquire Cullinan Pearl and co-develop and co-commercialize Cullinan Oncology’s lead program, CLN-081/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 U.S. 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 $275 million and up to an additional $130 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-commercialize CLN-081/TAS6417 in the United States together with Taiho Pharmaceutical
through its U.S. subsidiary, Taiho Oncology.
Taiho will commercialize CLN-081/TAS6417 in territories outside U.S. and China. Taiho and Cullinan Oncology will equally contribute to the future clinical development of CLN-081/TAS6417 in the U.S., with each receiving 50% of the profits from potential U.S. sales.
As a result of the upfront cash payment and reduction in development and pre-commercialization costs, Cullinan Oncology anticipates its cash runway to extend through 2026 based on current operating plans. This guidance does not include the potential regulatory milestone cash payments or future U.S. profit share post-launch.
It is estimated that approximately 85% of all newly diagnosed patients with lung cancer, or
approximately 1.9 million people worldwide have NSCLC. Among those patients with NSCLC, approximately 2% or 38,000 patients have exon 20 insertions. In the U.S., approximately 16% of NSCLC cases harbor EGFR mutations, with insertions at exon 20 accounting for 12% of those mutations. Patients with EGFR exon 20 insertions are known to have poorer outcomes than those with more common EGFR mutations, such as exon 19 deletion. CLN-081/TAS6417 is currently in Phase I/IIa development for treatment of patients with NSCLC having an exon 20 insertion mutation.
“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.
“Cullinan Oncology has carried CLN081/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.”
“We are excited to embark on this collaboration with Taiho. 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.,” said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology.
“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. The transaction payments, reduced development expense, and potential ongoing revenue stream upon future commercialization will help us to devote greater resources to advance our robust pipeline of assets across a wide range of modalities, each with the potential to be the first or best in their class, to deliver on our promise to bring new therapeutic solutions to patients with cancer.”