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Adaptimmune, Galapagos Partner to Develop TCR Therapy Uza-Cel

NEW YORK – Adaptimmune Therapeutics and Belgian biotech Galapagos on Thursday announced a clinical collaboration with an option for Galapagos to license Adaptimmune's next-generation T-cell receptor (TCR) therapy uzatresgene autoleucel (uza-cel).

Under the agreement, Adaptimmune will receive an upfront exclusivity payment of $70 million, plus $15 million in research and development funding at signing. The firm will receive another $15 million payment after it begins dosing patients in the planned proof-of-concept study. Adaptimmune will be responsible for the trial and the supply of the vector for the manufacturing of uza-cel, while Galapagos will use its decentralized cell manufacturing platform to engineer uza-cel and deliver it to patients.

Once the proof-of-concept trial is complete, Galapagos will have the exclusive option to license uza-cel for a maximum of $100 million, depending on the number of indications. If the option is exercised, Adaptimmune is eligible to receive development, regulatory, and sales milestone payments of up $465 million and tiered royalties on net sales in the mid-single to low-double-digit range.

Galapagos will have the option to license uza-cel in solid tumor indications, but Adaptimmune will retain the right to develop, manufacture, and commercialize uza-cel for platinum-resistant ovarian cancer.

Uza-cel is a MAGE-A4-directed autologous TCR T-cell therapy currently being studied in a Phase II trial in patients with recurrent ovarian cancer and in a Phase I trial in solid tumors, including endometrial, esophageal, esophagogastric junction, gastric, head and neck, melanoma, non-small cell lung, ovarian, and urothelial cancer expressing MAGE-A4.

Adaptimmune recently ended a collaboration and license agreement with Genentech for two discovery-stage allogenic T-cell therapies. In February, the firm submitted an application to the US Food and Drug Administration seeking approval for its engineered T-cell therapy afamitresgene autoleucel (afami-cel) as treatment for patients with synovial sarcoma.