FDA Grants Fast Track Designation to Novel CAR T-Cell Therapy for Thyroid Cancers


The FDA has granted a fast track designation to the autologous chimeric antigen receptor (CAR) T-cell agent, AIC100, for the treatment of patients with anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer, according to a press release by AffyImmune Therapeutics, Inc.

“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," remarked Eric von Hofe, president and chief operating officer of AffyImmune, in the press release. "It highlights the unmet need in treating refractory solid tumors and points to the potential of AIC100 to address that need. "

The agent is currently under investigation in the phase 1 study of patients with relapsed and/or refractory advanced thyroid cancer and ATC. The study is assessing the incidence of overall grade 3 to 5 adverse events (AEs) and the incidence of CAR T-related AEs as the coprimary end points. As secondary end points, the study is evaluating the number of AIC100 cells present after infusion by polymerase chain reaction, measuring the CAR T cell subsets by flow cytometry in peripheral blood, comparing tumor biopsies collected prior to initiation of AIC100 therapy and at the end of treatment or after disease progression, measuring cytokine levels in plasma samples, as well as CAR T antibodies in peripheral blood post-infusion.

Approximately 24 patients will be enrolled in the study. The investigators plan to stagger enrollment to allow for all patients to be followed for 30 days prior to treatment with AIC100. Once on the study, patients will undergo leukapheresis for collection of autologous lymphocytes. The autologous T cells will be discharged and expanded in-vitro to generate the AIC100 product. The investigational agent, AIC100, will be infused at 4 different dose levels following lymphodepleting therapy. In cohort 1, patients will receive 1 x 10e6 CAR T cells, and the amount of CAR T cells administered is increased by 1 for each of the other 3 cohorts.

Patients are eligible for inclusion in the study if they have measurable disease, an ECOG performance status of 0 to 2, a life expectancy of greater than 8 weeks, and adequate hepatic, renal, bone marrow, and coagulation function. Only patients with either ATC including those with a BRAF mutation and DTC are eligible for the study.

Individuals who present with active systemic infections that are not controlled, central nervous system disorder, another malignancy within 2 years, active autoimmune disease, and other serious illness are not eligible for inclusion in the study. In terms of prior treatment, patients cannot have received a prior investigational gene therapy or chimeric antigen receptor therapy.

With a fast track designation form the FDA, the development of AIC100 will be expedited to address an unmet medical in the thyroid cancer field. The designation will allow the developer more frequent interaction with the FDA to discuss data that may later lead to an FDA approval. AIC100 was previously granted orphan drug designation.

"We look forward to a close relationship with the FDA to expedite development and future approvals," said on Hofe, in a statement.


AffyImmune Therapeutics' AIC100 granted fast track designation for treating thyroid cancer. News release. AffyImmune Therapeutics, Inc. May 17, 2021. Accessed May 19, 2021. https://bit.ly/3oue1a5

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