MedPath

Adaptimmune's Journey to Pioneering TCR-T Therapy for Cancer Treatment

Adaptimmune, a biotech company founded in 2008, has made significant strides in developing T-cell receptor (TCR)-T therapies for cancer. Despite challenges and rocky collaborations with pharmaceutical giants like GSK and Astellas, Adaptimmune achieved a major breakthrough with the FDA approval of its first engineered TCR-T therapy, afami-cel, for treating metastatic or unresectable synovial sarcoma. This approval marks several firsts in the field of cell therapy, offering new hope for patients with rare solid tumors.

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.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Afami-cel Approval and Its Potential Influence on the Adoption of TCR Therapies

The approval of afamitresgene autoleucel (afami-cel) as the first T-cell receptor (TCR) therapy is seen as a pivotal milestone that could accelerate the development and acceptance of TCR-based treatments. This approval establishes a regulatory precedent, validates the therapeutic approach, and provides real-world evidence of safety and efficacy in treating solid tumors.

Adaptimmune's Lete-cel Receives FDA Breakthrough Therapy Designation for MRCLS

The FDA granted Breakthrough Therapy Designation to Adaptimmune's lete-cel for myxoid/round cell liposarcoma (MRCLS) treatment.
The designation is for patients who have undergone anthracycline-based chemotherapy and meet specific genetic criteria.

uniQure Receives FDA Nod for Accelerated Approval Pathway for Huntington's Disease Gene Therapy

uniQure secured FDA agreement to pursue accelerated approval for its Huntington's disease gene therapy, potentially expediting treatment availability.
The FDA's decision reflects a more flexible approach to genetic medicines for severe rare diseases under Peter Marks.

Adaptimmune's Lete-cel Shows Promise in Advanced Sarcomas, BLA Submission Planned

Adaptimmune's Lete-cel, a TCR-T cell therapy, demonstrated a 42% response rate in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma.
The median duration of response was 12.2 months, with manageable side effects like cytopenias and cytokine release syndrome.

FDA Roundup: TCR T-Cell Therapy Approved, CAR-T REMS Modified, and Clinical Holds Lifted

The FDA granted accelerated approval to Adaptimmune's afami-cel (Tecelra) for unresectable or metastatic synovial sarcoma in patients who have received prior chemotherapy.
Risk Evaluation and Mitigation Strategies (REMS) for autologous CAR-T immunotherapies were modified by the FDA to reduce the burden on healthcare systems.

FDA Approves Afami-Cel (Tecelra) for Advanced Synovial Sarcoma with MAGE-A4 Expression

The FDA granted accelerated approval to afami-cel (Tecelra) for unresectable or metastatic synovial sarcoma in adults after prior chemotherapy.
Approval is based on the SPEARHEAD-1 trial, showing a 43% overall response rate and a 4.5% complete response rate in treated patients.

FDA Approves Lifileucel (Amtagvi): First TIL Therapy for Melanoma

The FDA has granted accelerated approval to lifileucel (Amtagvi) for advanced melanoma after prior therapies, marking the first tumor-infiltrating lymphocyte (TIL) therapy approval.
Lifileucel is a personalized immunotherapy that uses a patient's own T cells extracted from their tumor to target and destroy cancer cells.

Adaptimmune Announces U.S. FDA Acceptance of Biologics License Application for Afami-cel

Adaptimmune Therapeutics plc has announced the U.S. FDA's acceptance for priority review of its Biologics License Application for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma, marking a significant step towards offering a new treatment option for this condition.

FDA Grants Breakthrough Therapy Designation for Affinity Enhanced T-Cell Therapy in Synovial Sarcoma

The FDA has granted Breakthrough Therapy designation to Adaptimmune Therapeutics plc for its affinity enhanced T-cell therapy targeting NY-ESO in synovial sarcoma, highlighting the therapy's potential in treating this form of cancer. The designation is based on promising results from a phase I/II trial, showing significant response rates among patients.

FDA Grants Breakthrough Therapy Designation to Adaptimmune's T-Cell Therapy for Synovial Sarcoma

The FDA granted Breakthrough Therapy designation to Adaptimmune's affinity-enhanced T-cell therapy targeting NY-ESO for synovial sarcoma, expediting its development.
The designation was based on Phase I/II trial results showing a 60% response rate in patients receiving the target dose of engineered T-cells.

Reference News

[1]
Adaptimmune: The long road to developing the first TCR-T ...
labiotech.eu · Sep 3, 2024

Adaptimmune, founded in 2008, has grown into a global biotech leader in TCR-T therapies for cancer. Despite challenges, ...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy