Cullinan Oncology and Taiho Reunite to Co-Develop NSCLC Drug
On Thursday, Cullinan Oncology and Taiho Pharmaceutical announced that Taiho was acquiring Cullinan Pearl and will co-develop and co-commercialize a non-small cell lung cancer (NSCLC) drug. Under the terms of the deal, Taiho is making an upfront payment to Cullinan Oncology for $275 million, with an additional $130 million in regulatory milestones.
In 2019, Taiho licensed the drug to Cullinan Pearl. Cullinan Pearl was formed by Taiho and its subsidiaries and Cullinan Oncology. That global license, except for Japan, was for the development and commercialization of CLN-081/TAS6417, an orally available tyrosine kinase inhibitor designed to target activating mutations in EGFR.
Cullinan Oncology will co-develop the drug and keep the option to co-commercialize it in the U.S. with Taiho through the U.S. subsidiary, Taiho Oncology. Taiho will commercialize it outside the U.S. and China.
Taiho and Cullinan Oncology will divide clinical development in the U.S. evenly, with a 50/50 split on profits from potential U.S. sales.
“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. “Cullinan Oncology has carried CLN-081/TAS6417 from pre-IND to planned pivotal study in approximately three years. Meanwhile, the (U.S.) Food and Drug Administration has granted Breakthrough Designation status for this novel molecule.”
Kobayashi added, “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.”
In October 2021, Nadim Ahmed was appointed president and chief executive officer of Cullinan Oncology, as well as appointed to the board. Prior to joining Cullinan Oncology, Ahmed was president, Hematology at Bristol Myers Squibb and at Celgene, where he was president, Global Hematology & Oncology via its acquisition by BMS.
Ahmed said Thursday, “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. 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.”
Ahmed went on to note, “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.”
At a clinical and regulatory update for CLN-081 on March 28, Cullinan Oncology noted that of 39 patients who were response evaluable in its Phase I/II trial in NSCLC patients whose tumors harbored EGFR exon 20 insertion mutations, 16 achieved a confirmed partial response for a 41% confirmed response rate. No patients demonstrated Grade 3 or greater treatment-related diarrhea or rash. The promising response durability observed in an initial Phase I patient cohort with an estimated median response duration of more than 15 months and median progression free survival of 12 months appeared to continue.
At the time, Ahmed said, “CLN-081 continues to show a differentiated clinical profile relative to EGFR exon 20 agents, including a high response rate, promising response durability, and favorable safety and tolerability, which provides a potential opportunity to improve the standard of care for patients with EGFR exon 20 mutant NSCLC.”