FDA grants fast track designation to CAR T-cell therapy for thyroid cancer
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The FDA granted fast track designation to AIC100, a chimeric antigen receptor T-cell therapy, for the treatment of anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer, according to the agent’s manufacturer.
AIC100 (AffyImmune Therapeutics) is an autologous, gene-edited, affinity-tuned CAR T-cell therapy that targets the protein intracellular adhesion molecule 1 (ICAM-1) on the surface of cancer cells.
The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
The agency previously granted orphan drug designation to AIC100 for advanced thyroid cancer, according to the manufacturer’s website.
“We are pleased to have received fast track designation for our first-in-human CAR T-cell product currently being tested in patients with refractory thyroid cancer,” Eric von Hofe, PhD, president and chief operating officer of AffyImmune, said in a company issued press release. “It highlights the unmet need in treating refractory solid tumors and points to the potential of AIC100 to address that need.”
AffyImmune began enrollment in a phase 1 study of AIC100 in October.
The trial is designed to evaluate the safety and antitumor activity of AIC100 for patients with relapsed or refractory advanced thyroid cancer and anaplastic thyroid cancer. The study also will evaluate the biological activity and provide a real-time assessment of CAR T-cell localization among patients who receive the lower-affinity CAR T-cell therapy designed to target tumor cells that overexpress ICAM-1 and avoid normal cells that express lower levels of the protein.
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