The FDA granted fast track designation to the chimeric antigen receptor T-cell therapy AIC100 as treatment for patients with anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer, according to the company responsible for this cellular therapy, AffyImmune Therapeutics, Inc.1
The designation allows for the rapid development and review of drug candidates with the potential to serve an unmet medical need. It also means the company will have better access to the FDA with more frequent interactions regarding the development process, earlier approval, and patient access.
“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, President and COO of AffyImmune, said in a press release. “It highlights the unmet need in treating refractory solid tumors and points to the potential of AIC100 to address that need. We look forward to a close relationship with the FDA to expedite development and future approvals.”
The cellular therapy is currently being examined in a phase 1 trial (NCT04420754) of 24 participants with either relapsed/refractory poorly differentiated thyroid cancer or anaplastic thyroid cancer. Patients are treated in 1 of 4 cohorts by dose levels of 1 × 10-6, 1 × 10-7, 1 × 10-8, or 5 × 10-8 CAR-positive T-cells. Treatment is planned as a single-dose infusion, but additional administrations may be necessary in the case of partial response or stable disease within 30 days, investigator decision, the absence of dose-limiting toxicities, or available cell doses already manufactured.
The primary end point of the trial is the overall incidence of grade 3 or greater adverse effects (AEs) and the incidence of CAR T-cell therapy–related AEs, such as cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, hemophagocytic lymphohistiocytosis or macrophage activation syndrome, and tumor lysis syndrome. Secondary outcome measures include detection, expansion, and persistence of AIC100 after infusion, analysis of CAR T-cell subsets in peripheral blood by flow cytometry, assessment and analysis of CAR T-cell infiltrate by tumor biopsy at treatment completion or progression, cytokine levels in plasma samples, and CAR T antibodies in peripheral blood.
Eligible patients will have anaplastic thyroid cancer that is either BRAF wild type or BRAF mutant after BRAF inhibitor failure or poorly differentiated thyroid cancer that has failed surgery, radioactive iodine, chemotherapy, radiation therapy and/or targeted therapies with measurable disease, and ECOG performance status of 2 or lower, and a life expectancy of 8 weeks or more. Adequate hepatic, kidney, bone marrow, and coagulation function and no lingering toxicities from prior anticancer therapy are also required.
AIC100 is 1 of several CAR T-cell therapies being developed by AffyImmune Therapeutics, Inc. to treat solid tumors. It is an affinity-tuned ICAM-1 targeted, third-generation, CAR T-cell product. In addition to indications in thyroid cancer, the therapy is also being explored in patients with gastric cancer and triple-negative breast cancer.2
1. AffyImmune Therapeutics’ AIC100 Granted Fast Track Designation for Treating Thyroid Cancer. News release. AffyImmune Therapeutics, Inc. May 17, 2021. Accessed May 24, 2021. https://prn.to/3fL5paW
2. AffyImmune Is Developing a Leading Pipeline of Affinity-Tuned CAR T-cell Therapies to Treat Solid Tumors. AffyImmune Therapeutics, Inc. Accessed May 24, 2021. https://bit.ly/3wwbrDa
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