On October 29, 2020 AffyImmune Therapeutics reported enrollment of the first patient in its Phase I clinical study evaluating AIC100, the company’s novel affinity-tuned CAR-T cell product, in patients with advanced, refractory thyroid cancer (Press release, AffyImmune Therapeutics, OCT 29, 2020, View Source [SID1234569444]). The trial is designed to test safety, biological activity and real-time assessment of CAR T cell localization in patients.
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The study, entitled: ‘Phase I study of AIC100 in relapsed and/or refractory advanced thyroid cancer and anaplastic thyroid cancer’ is being conducted at Weill Cornell Medicine. Unlike most CAR-T cell products, AIC100 was designed to specifically target tumor cells overexpressing the target (ICAM-1) while avoiding normal cells expressing lower levels. This was accomplished by lowering the affinity of the targeting portion of the chimeric antigen receptor (CAR) of AIC100 through directed evolution to levels more comparable to physiological levels governing T cell interactions with their targets. Prior studies in animal models clearly showed that that these lower affinity CAR T cells not only spared normal cells but also persisted longer having greater anti-tumor activity in animal models.
Eric von Hofe, President of AffyImmune Therapeutics, stated: "After overcoming a few COVID-19 related delays we are excited to announce the enrollment of our first patient in the AIC100 trial, this marks another important step for us. Affinity tuning clearly provides a number of advantages over the traditional approach of designing CAR-T cells." He continued, "the resulting CAR-T cells are able to discriminate based on target expression, persist longer for better tumor cell killing and open the door to targeting antigens previously avoided for fear to on-target off-tumor toxicity. We are gratified in being able to bring this novel CAR-T product to the clinic for refractory thyroid cancers, which are notoriously aggressive with no good treatment options."