Galapagos and Adaptimmune Sign Clinical Collaboration for TCR T-Cell Therapy Uza-cel Licensing in Cancer

Adaptimmune and Galapagos have entered into a clinical collaboration to evaluate uza-cel, a next-generation MAGE-A4 TCR T-cell therapy, in patients with head and neck cancer. This trial will assess the safety and efficacy of uza-cel, produced using Galapagos' decentralized manufacturing platform. Previous testing in a centralized setting has shown promising partial responses in four out of five patients. Initial in vitro results using Galapagos' platform also indicate potential for further clinical development.

Adaptimmune will receive an initial amount of $100 million, consisting of $70 million upfront and $30 million for research and development funding. Additionally, they could earn up to $100 million in option exercise fees, up to $465 million in development and sales milestone payments, and tiered royalties on net sales. Galapagos has the option to exclusively license uza-cel for global development and commercialization in head and neck cancer, and potentially other solid tumors.

The announcement, made public on May 30, 2024, revealed that Galapagos and Adaptimmune will combine efforts to develop and potentially commercialize uza-cel. This collaboration leverages Galapagos' decentralized cell therapy manufacturing platform, which could deliver fresh, fit cells in a vein-to-vein time of seven days, crucial for patients needing rapid treatment.

Uza-cel is targeted at the MAGE-A4 cancer antigen found in multiple solid tumors. The therapy co-expresses the CD8α co-receptor, which could enhance the immune response against tumors. The Adaptimmune-conducted Phase 1 SURPASS trial has shown promising results, particularly in head and neck cancer, with an 80% overall response rate. Preliminary in vitro testing of uza-cel produced on Galapagos' platform has also shown encouraging results, suggesting improved efficacy and durability compared to centralized production.

Dr. Paul Stoffels, CEO and Chairman of Galapagos, expressed excitement about the partnership with Adaptimmune. He highlighted that this collaboration aligns with Galapagos' aim to advance novel cell therapies and expand their oncology portfolio. Adrian Rawcliffe, CEO of Adaptimmune, noted the compelling early results from the Phase 1 SURPASS trial, emphasizing the potential of combining uza-cel with Galapagos' manufacturing platform to enhance treatment for late-stage cancers.

According to the agreement, Adaptimmune will receive $70 million upfront and $15 million in R&D funding initially, with an additional $15 million contingent on the proof-of-concept trial's progress. Adaptimmune will oversee the clinical proof-of-concept trial in head and neck cancer and provide the vector for uza-cel production. Galapagos will handle the delivery of the fresh uza-cel product for the trial using their innovative manufacturing platform.

Adaptimmune retains the rights to develop, manufacture, and commercialize uza-cel for platinum-resistant ovarian cancer, currently under investigation in the SURPASS-3 trial. After the proof-of-concept trial, Galapagos can exclusively license uza-cel globally for a maximum of $100 million, depending on the indications. Adaptimmune may also receive up to $465 million in various milestone payments and tiered royalties on net sales.

Galapagos' decentralized manufacturing platform is designed to produce fresh, fit cells within a seven-day timeframe, enhancing physician control and patient experience. The platform includes the xCellit™ workflow management software, Lonza’s Cocoon® automated manufacturing system, and a unique quality control strategy. This collaboration aims to provide a faster, potentially transformative treatment for patients with significant unmet medical needs in head and neck cancer and other solid tumors.