Galapagos Licenses Adaptimmune T-cell Therapy

Belgian biotech company Galapagos has announced a new clinical collaboration with Adaptimmune, focusing on the licensing of Adaptimmune’s TCR T-cell therapy candidate, uza-cel, primarily for head and neck cancer, with potential for future application in other solid tumors. This agreement ensures Adaptimmune receives an initial $70 million along with $30 million for research and development, with the possibility of further payments up to $665 million and tiered royalties on net sales. Galapagos holds the option to globally develop and commercialize uza-cel for various solid tumor indications.

Preliminary phase 1 trials for uza-cel in head and neck cancer have shown encouraging outcomes, with four out of five patients exhibiting partial responses. Additionally, initial in vitro studies using Galapagos’ platform have supported continued clinical development of uza-cel.

Uza-cel is an advanced TCR T-cell therapy targeting the MAGE-A4 cancer antigen, and its safety and efficacy will be further evaluated in a proof-of-concept trial utilizing Galapagos’ decentralized manufacturing platform.

Galapagos has been aiming to secure a partnership of this nature. Earlier this year, when announcing its 2023 financial results, the company revealed its intention to curtail cash burn in 2024, advance its CAR-T studies, and explore additional opportunities in immunology and oncology. This announcement followed pipeline reductions and about 100 layoffs aimed at streamlining operations and focusing on innovation.

In 2022, Galapagos initiated a new organizational strategy called "Forward, Faster," which emphasizes patient-centric research in immunology and oncology. This strategy includes investments in existing drug modalities like CAR-T and enhancing business development efforts, leading to the elimination of 200 positions across European sites.

On a similar note, Adaptimmune faced changes earlier this year when its potential $3 billion strategic collaboration with Genentech, which began in 2021, was terminated. The UK-based biotech had initially entered into an agreement with Genentech in September 2021 to develop and commercialize allogenic cell therapies for multiple oncology indications. Adaptimmune received an upfront payment of $150 million and was promised another $150 million over five years, along with potential research, regulatory, and commercial milestone payments exceeding $3 billion, plus royalties.

As stated in Adaptimmune’s SEC filing, Genentech notified the company that the agreement would terminate within 180 days. Up to that point, Adaptimmune had received $150 million upfront and $35 million in milestone payments. Although no specific reason was given for the termination, Adaptimmune stressed its focus on launching its lead candidate, afami-cel, later this year pending FDA approval. The autologous T-cell therapy candidate is set for a PDUFA date of August 4 for advanced synovial sarcoma.

In summary, Galapagos and Adaptimmune’s collaboration on uza-cel represents a significant effort to push forward innovative cancer therapies, focusing initially on head and neck cancer. This partnership aligns with Galapagos’ strategic goals to enhance its portfolio in oncology and immunology while navigating financial efficiencies and organizational restructuring. Adaptimmune, despite the setback with Genentech, remains committed to advancing its pipeline with a keen focus on afami-cel's impending FDA review.