Adaptimmune and Galapagos Ink Deal for uza-cel TCR T-cell Therapy in Head & Neck Cancer and Future Tumors

Adaptimmune and Galapagos have announced a collaboration to conduct a clinical proof-of-concept trial for uza-cel, a next-generation MAGE-A4 TCR T-cell therapy, specifically targeting head & neck cancer. Uza-cel has demonstrated positive outcomes in a Phase 1 trial with partial responses in four out of five patients when produced using Adaptimmune’s centralized manufacturing platform. Initial testing on Galapagos’ decentralized platform also shows promise, paving the way for further clinical development.

Adaptimmune is set to receive initial payments totaling $100 million, broken down into a $70 million upfront fee and $30 million for research and development (R&D). The agreement includes potential additional payments up to $100 million for option exercise fees, and further milestone payments up to $465 million, along with tiered royalties on net sales. Galapagos has been granted the option to exclusively license uza-cel for global development and commercialization in head & neck cancer, and possibly other solid tumor types in the future.

Uza-cel, developed by Adaptimmune, targets the MAGE-A4 cancer antigen present in various solid tumors. The therapy employs a next-generation T-cell receptor (TCR) engineered to express the CD8α co-receptor alongside the TCR, which potentially enhances the immune response against solid tumors. The Phase 1 SURPASS trial, conducted by Adaptimmune, has shown promising results with an 80% response rate in head & neck cancer, including confirmed partial responses in four out of five patients. Preliminary in vitro results suggest that uza-cel produced on Galapagos' decentralized platform generates early phenotype T-cells, which may improve efficacy and durability compared to the centralized manufacturing method.

The decentralized platform from Galapagos offers the potential benefit of delivering fresh, fit cells within a seven-day vein-to-vein time, which is crucial for patients needing rapid treatment. This platform could enhance physician control and improve the overall patient experience.

Adrian Rawcliffe, CEO of Adaptimmune, highlighted the synergy between uza-cel and Galapagos’ decentralized platform, expressing optimism that this collaboration could deliver more effective treatments for patients with advanced-stage cancers. Dr. Paul Stoffels, CEO and Chairman of Galapagos, echoed this sentiment, emphasizing the strategic alignment with their goal of advancing novel cell therapies and addressing significant unmet medical needs in oncology.

Under the terms of the collaboration, Adaptimmune will retain the right to develop and commercialize uza-cel for platinum-resistant ovarian cancer, which is currently being tested in the SURPASS-3 trial. The proof-of-concept trial for head & neck cancer will be managed by Adaptimmune, which will also supply the necessary vector for manufacturing uza-cel. Galapagos will handle the delivery of the fresh cell product for this trial using its decentralized manufacturing platform.

Upon successful completion of the proof-of-concept trial, Galapagos may exercise an exclusive option to license global rights to uza-cel, with payments contingent on the number of indications the option covers. Adaptimmune is eligible for additional development, regulatory, and sales milestone payments, and royalties on net sales.

The agreement underscores the commitment of both companies to innovate in the field of oncology, leveraging their respective strengths to potentially offer new, effective treatments for patients with critical cancer conditions.