Companies partner on TCR T-cell therapy for head & neck cancer

T cell receptor

Adaptimmune Therapeutics and Galapagos have entered into a clinical collaboration agreement to develop Adaptimmune’s TCR T-cell therapy for head and neck cancer and other potential solid tumours.

Under the terms of the agreement, Adaptimmune will receive an upfront exclusivity payment of $70 million, plus $15 million in R&D funding at signing. A further $15 million in R&D funding will follow subject to the start of dosing in a proof-of-concept trial.

Adaptimmune will be responsible for the clinical proof-of-concept trial in head and neck cancer and the supply of the vector for the manufacturing of uza-cel.

Galapagos will provide fresh uza-cel product for the head and neck cancer trial using its decentralised cell therapy manufacturing platform.

Following completion of the trial, Galapagos will have the option to license global rights to uza-cel for a maximum of $100 million, depending on the number of indications in relation to which the option is exercised.

In addition, Adaptimmune is eligible to receive development, regulatory and sales milestone payments of up $465 million, unless the agreement is terminated, and tiered royalties on net sales in the mid-single to low-double digit range.

Adaptimmune will retain the right to develop, manufacture, and commercialise uza-cel for platinum-resistant ovarian cancer (currently being developed in the SURPASS-3 trial).

Compelling early results in solid tumours

Uza-cel is a clinical-stage engineered TCR T-cell therapy developed by Adaptimmune, targeting the MAGE-A4 cancer antigen expressed in various solid tumours. It is engineered to express the CD8α co-receptor alongside the engineered TCR that targets MAGE-A4.

The Adaptimmune sponsored Phase I SURPASS trial with centrally manufactured uza-cel has shown encouraging results in head and neck cancer with an overall response rate of 80%.

Initial in vitro results suggest that uza-cel, produced on Galapagos’ decentralised manufacturing platform, yields early phenotype T-cells that could improve efficacy and durability compared to uza-cel centrally manufactured on Adaptimmune’s platform.

Galapagos’ decentralised manufacturing platform also offers the potential for the delivery of fresh, fit cells with a vein-to-vein time of seven days in a patient population in which rapid access to treatment is vital.

Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer, said: “Data with uza-cel from our Phase I SURPASS trial has demonstrated compelling early results in ovarian, bladder, and head and neck cancers. In head and neck cancer, we have seen reductions in target lesions across all five patients treated to date, and there have been four confirmed partial responses. Combining uza-cel with Galapagos’ unique decentralised manufacturing platform has the potential to deliver an even more effective TCR T-cell therapy for people with critical late-stage cancers.”

Dr Paul Stoffels, Galapagos’ Chief Executive Officer and Chairman, added: “For patients with head and neck cancer, an area with significant unmet medical needs, this collaboration offers the promise for faster access to a potentially transformative treatment.”

Diana Spencer, Senior Digital Content Editor, DDW

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