On May 12, 2022 Cullinan Oncology, Inc. (Cullinan Oncology) (Nasdaq: CGEM) and Taiho Pharmaceutical Co., Ltd. (Taiho) reported an agreement through which Taiho will acquire Cullinan Pearl Corp. (Cullinan Pearl) and co-develop and co-commercialize 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 (Press release, Cullinan Oncology, MAY 12, 2022, View Source [SID1234614263]). 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.

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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, Inc. 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%1 of all newly diagnosed patients with lung cancer, or approximately 1.9 million people worldwide have NSCLC. Among those patients with NSCLC, approximately 2%2-3 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%(4) 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 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."

"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."

Cullinan Oncology Conference Call Information

Cullinan Oncology will host a conference call today, May 12, at 8 a.m. EDT during which company executives will provide an overview of the collaboration. Investors and the general public are invited to listen to a live webcast of the call. A link to join the call and to find related materials will be available at: View Source

About CLN-081/TAS6417

CLN-081/TAS6417 is an orally available tyrosine kinase inhibitor designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. CLN-081/TAS6417 is a clinical candidate for NSCLC driven by EGFR exon 20 insertion mutations and is expected to be a novel therapeutic option for patients with highly unmet medical needs. In 2019, Taiho granted Cullinan Pearl, a company that Taiho and its subsidiaries and Cullinan Oncology had established together, an exclusive global license, excluding Japan, for the development and commercialization of CLN-081/TAS6417. Following this agreement, Cullinan Pearl rapidly advanced CLN-081/TAS6417, opening an Investigational New Drug application and initiating a global Phase I/IIa study in NSCLC patients harboring EGFR exon 20 mutations, which is currently ongoing. Cullinan Oncology announced that the FDA granted Breakthrough Therapy Designation for CLN-081/TAS6417 in early 2022. Cullinan Oncology and Taiho expect to initiate a pivotal study in the second half of 2022.