Cullinan Oncology & Taiho Pharmaceutical Complete Agreement for Strategic Collaboration to Jointly Develop & Commercialize CLN-081/TAS6417

Cullinan Oncology, Inc. recently announced the completion of its agreement with Taiho Pharmaceutical Co., Ltd. (Taiho) signed in May 2022. Per the terms of the agreement, the companies will collaborate on the US development of CLN-081/TAS6417, a next-generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer (NSCLC).

Taiho has also completed its acquisition of Cullinan Oncology’s subsidiary, Cullinan Pearl Corp. (Cullinan Pearl) which has worldwide rights outside of Japan to CLN-081/TAS6417. Taiho has provided an upfront payment to Cullinan Oncology of $275 million with the potential for an additional $130 million tied to EGFR exon20 NSCLC regulatory milestones.

In addition, the two companies have agreed to co-develop and co-commercialize CLN-081/TAS6417. Cullinan Oncology retains the option to co-commercialize CLN-081/TAS6417 in the United States together with Taiho through its US subsidiary, Taiho Oncology, Inc. Taiho and Cullinan Oncology will equally contribute to the future clinical development of CLN-081/TAS6417 in the US, with each receiving 50% of the profits from potential US sales.

CLN-081/ TAS6417 is an orally available small molecule being developed in collaboration with Taiho Pharmaceutical Co., Ltd. CLN-081/TAS6417 is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer (NSCLC). CLN-081/TAS6417 is being investigated in a Phase 1/2a dose escalation and expansion trial evaluating oral, twice-daily administration of various doses in patients with NSCLC harboring EGFRex20ins mutations who have had at least one prior treatment with platinum-based chemotherapy or another approved standard therapy. CLN-081/TAS6417 has received Breakthrough Therapy Designation from the FDA.

Cullinan Oncology, Inc. is a biopharmaceutical company dedicated to creating new standards of care for patients with cancer. We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners. Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications. Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization. As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.

Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer. For more information, visit www.cullinanoncology.com.