AffyImmune Confirms Full Response in Anaplastic Thyroid Cancer Patient

AffyImmune Therapeutics, a biotechnology company in the clinical stage, has announced promising early results from a Phase 1 trial of its CAR T-cell therapy, AIC100, aimed at targeting ICAM-1 for patients with advanced thyroid cancer. In a groundbreaking achievement, one patient with anaplastic thyroid cancer (ATC), the most aggressive form of thyroid cancer, achieved a metabolic complete response (mCR) after a single intravenous dose of AIC100. This marks the first recorded instance of a complete response in any solid tumor cancer type following a single dose of autologous CAR T cells.

Matt Britz, CEO of AffyImmune, expressed enthusiasm over this milestone, highlighting the potential of CAR T-cell therapy in treating solid tumors. He emphasized the critical need for effective treatments for differentiated thyroid cancer (ADTC) and ATC, both of which have poor survival rates and limited treatment options. Britz believes that AIC100 could potentially overcome the current limitations of CAR T therapies and pave the way for new treatment paradigms for solid tumor cancers.

The Phase 1 study involved ten patients, six with ATC and four with poorly differentiated thyroid cancer (PDTC), who were administered AIC100 at three different dose levels. No dose-limiting toxicities were reported, and the maximum tolerated dose was not reached. Among the patients, 60% developed mild to moderate cytokine release syndrome (CRS), but no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) or other severe adverse events were noted.

For patients evaluated at dose levels 2 (100 million CAR T cells) and 3 (500 million CAR T cells), the overall response rate (ORR) was 33%. This included one patient at dose level 2 who achieved a durable partial response (PR) and another at dose level 3 who attained a sustained mCR, allowing them to discontinue all chemotherapy. The disease control rate (DCR) for these patients was 67%.

Dr. Samer A. Srour, the lead investigator of the trial and Assistant Professor at The University of Texas MD Anderson Cancer Center, recognized the significance of these findings. He noted that the safety profile and promising antitumor activity observed in this Phase 1 study provide a robust foundation for further development of AIC100. Dr. Srour indicated plans to evaluate higher dose levels and explore the potential application of AIC100 to other ICAM-1-positive cancers.

The promising data will be presented at the ASCO 2024 Annual Meeting in a poster session focusing on head and neck cancers. Dr. Srour will present the detailed findings on June 2, 2024, at the McCormick Place Convention Center in Chicago, IL.

AffyImmune Therapeutics is dedicated to developing innovative therapies for cancers with high unmet medical needs. Their proprietary technology, which combines ICAM-1 targeting with affinity-tuned LFA-1 binding, aims to address critical challenges in CAR T therapy, such as toxicity, antigen loss, and T-cell exhaustion. Their lead candidate, AIC100, is currently in a Phase 1 trial for advanced thyroid cancers and shows potential for broader applications in other ICAM-1-positive cancers.

AffyImmune is based in Natick, Massachusetts, and continues to focus on advancing its pipeline of therapies designed to transform the treatment landscape for advanced solid cancers.