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Taiho Pharmaceutical Acquires Cullinan Pearl, Regaining Rights to EGFR Inhibitor

NEW YORK – Taiho Pharmaceutical on Tuesday said it will acquire Cullinan Oncology subsidiary Cullinan Pearl for $275 million upfront, and the companies will jointly develop and commercialize an irreversible EGFR inhibitor targeting EGFR exon 20 insertion mutations.

Under the terms of the deal, Cullinan is eligible to receive an additional $130 million in regulatory milestones for the EGFR inhibitor, dubbed CLN-081 by Cullinan and TAS6417 by Taiho.

Taiho, based in Tokyo, discovered this EGFR inhibitor, but in 2019 granted Cullinan Pearl a global license to develop and commercialize the drug outside of Japan. In acquiring Cullinan Pearl, a company Taiho and Cullinan Oncology set up together, Taiho regains the rights to commercialize the EGFR inhibitor in ex-Japan markets.

In the deal, Cullinan has the option to co-commercialize the therapy in the US with Taiho's US subsidiary Taiho Oncology. Taiho will sell the EGFR inhibitor in countries outside of the US and China.

Taiho and Cullinan Oncology will share the cost of developing the drug in the US and split the profits from sales in the country. Factoring in the upfront payment from Taiho and reduced development costs because of this deal, Cullinan Oncology said that its cash runway now extends through 2026.

"The structure of the agreement provides the opportunity to efficiently establish our own commercial infrastructure, which will also be leveraged for our future programs," Cullinan CEO Nadim Ahmed said in a statement.

CLN-081/TAS6417 is currently undergoing a Phase I/IIa study in previously treated, recurrent or metastatic non-small cell lung cancer patients harboring EGFR exon 20 insertion mutations. Interim data on a small number of patients were encouraging enough that the US Food and Drug Administration granted CLN-081/TAS6417 breakthrough therapy designation in January.

In December 2020, Cullinan out-licensed this EGFR inhibitor to Zai Lab for development, manufacturing, and commercialization in greater China in a deal worth up to $231 million.