Adaptimmune's Evolution and Breakthrough in TCR-T Therapy
Founded in 2008 in Oxfordshire, England, Adaptimmune has grown from a small laboratory to a globally recognized biotech company. Specializing in T-cell receptor (TCR)-T therapies, Adaptimmune aims to harness the body's T cells to target and destroy cancer cells. The company's journey has been marked by significant milestones, including the development of its first TCR-T therapy, lete-cel, which targets the NY-ESO-1 cancer antigen expressed in various tumors.
Collaborations and Challenges
Adaptimmune's collaboration with GSK in 2015 was a pivotal moment, leading to the development of lete-cel. However, the partnership faced setbacks, culminating in GSK returning the rights to the NY-ESO program to Adaptimmune in 2023, along with a preclinical TCR-T therapy program called PRAME. Adaptimmune's journey also includes a partnership with Astellas, which was terminated in 2023, and a significant deal with Roche's Genentech that was exited in the same year. Despite these challenges, Adaptimmune secured a $665 million deal with Galapagos for its preclinical candidate uza-cel, a MAGE-A4 TCR T therapy for ovarian cancer.
FDA Approval of Afami-cel (Tecelra)
Adaptimmune's perseverance paid off with the FDA's accelerated approval of afami-cel, marketed as Tecelra, for the treatment of metastatic or unresectable synovial sarcoma. This approval is historic, marking the first engineered cell therapy for a solid tumor and the first new treatment for this type of sarcoma in over a decade. Afami-cel demonstrated a 43% overall response rate in clinical trials, with some patients experiencing the disappearance of their cancer.
Future Prospects
With the Galapagos deal providing financial support, Adaptimmune is set to launch Tecelra, priced at $727,000 per dose, making it the most expensive cellular medicine for cancer in the U.S. The company plans to make Tecelra available at authorized treatment centers, aiming for 30 centers within two years. Despite investor skepticism, Adaptimmune remains optimistic about the potential of its TCR-T therapies, estimating peak yearly sales of $400 million in the U.S. for afami-cel and lete-cel combined. The company also anticipates expanding the use of these therapies to other cancer indications in the future.