Taiho Pharmaceutical has signed an agreement under which the company will acquire Cullinan Oncology subsidiary Cullinan Pearl in a deal valued at $405 million.
The agreement also includes a strategic partnership to jointly develop and commercialize Cullinan Oncology’s flagship program, CLN-081/TAS6417.
Cullinan Pearl was created by Taiho, its subsidiaries and Cullinan Oncology. It also holds worldwide rights to CLN-081/TAS6417, excluding Japan.
An irreversible, differentiated, orally available epidermal growth factor receptor (EGFR) inhibitor, CLN-081/TAS6417 acts on cells expressing EGFR exon 20 insertion mutations without affecting cells expressing wild-type EGFR.
It is a clinical candidate for the treatment of EGFR exon 20 non-small cell lung cancer (NSCLC).
Pursuant to the agreement, Cullinan Oncology is entitled to receive $275 million in upfront cash payment upon Taiho’s acquisition of Cullinan Pearl.
Taiho will also make additional payments of up to $130 million to Cullinan Oncology, to achieve regulatory milestones for non-small cell lung cancer (NSCLC) exon 20 EGFR.
Under the agreement, Taiho and Cullinan Oncology will carry out the development of CLN-081/TAS6417 while Cullinan Oncology will hold an option to co-market the therapy in the United States with Taiho Oncology.
In addition, in territories outside of the United States and China, Taiho will cover the commercialization of CLN-081/TAS6417.
The companies will also fund future clinical development of CLN-081/TAS6417 in the United States and will also share profits from potential product sales in the region.
Cullinan Oncology and Taiho intend to begin a pivotal clinical trial of the therapy in the second half of this year.
President and Representative Director of Taiho Pharmaceutical, Masayuki Kobayashi, said, “Cullinan Oncology has moved CLN-081/TAS6417 from pre-IND to the planned pivotal study in approximately three years.
“Utilizing Cullinan Oncology’s unique business model through this strategic collaboration, we aim to accelerate and maximize the development of CLN-081/TAS6417.”
Subject to necessary closing conditions, the agreement is expected to close in the second quarter of this year.
In November 2020, Taiho signed an exclusive license agreement for Lung Therapeutics’ single-chain recombinant human urokinase plasminogen activator, LTI-01, in Japan.
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