On May 25, 2023 AffyImmune Therapeutics, Inc., a clinical stage biotechnology company finding safe, effective ways to use CAR T cells against solid cancers, reported positive safety and early efficacy results from a Phase 1 study of affinity tuned and trackable AIC100 CAR T cells in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers, which will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois, on June 5, 2023 (Press release, AffyImmune Therapeutics, MAY 25, 2023, View Source [SID1234632109]).
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"We are very encouraged by the early data, as it marks a groundbreaking CAR T patient response in aggressive and difficult to treat anaplastic thyroid cancers," said Matt Britz, Chief Operating Officer at AffyImmune. "This is an important clinical milestone for AffyImmune as we continue to develop AIC100 in the clinic and explore additional solid tumor indications with high unmet need."
The current Phase 1 study is exploring three dose levels (DL) of AIC100 CAR T cells, which are developed using AffyImmune’s proprietary Tune & Track CAR T cell platform. To date, AIC100 CAR T cells demonstrated excellent safety and encouraging efficacy in anaplastic (ATC) and poorly differentiated (PDTC) thyroid cancers.
As of May 1, 2023, seven patients (4 ATC; 3 PDTC) were infused with AIC100: three patients (2 ATC, 1 PDTC) in DL1 and four patients (2 ATC, 2 PDTC) in DL2. Early results from the Phase 1 study include:
No DLTs were reported; two patients had transient grade 1 CRS.
For the four patients infused in DL2, two patients were evaluable for efficacy assessment at day 42. Both had tumor reductions. One ATC patient achieved partial response (PR) with 42 percent reduction in target tumor lesion and a second PDTC patient had stable disease (SD).
"The objective partial response in DL2 for a patient with metastatic ATC who failed multiple lines of therapy is unprecedented and very encouraging," said Samer Ali Srour, MB ChB, MS, assistant professor of Stem Cell Transplantation & Cellular Therapy at The University of Texas MD Anderson Cancer Center. "AIC100 demonstrated an excellent safety profile with no DLTs in patients with ATC and PDTC, and the antitumor activity is promising, especially these responses were observed at the low dose levels 1 and 2."
Details of the poster presentation:
Abstract Title: Safety and early efficacy results of phase 1 study of affinity tuned and trackable AIC100 CAR T cells in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers
Session Title: Head and Neck Cancer
Date and Time: Monday, June 5, 1:15 PM-4:15 PM CDT
Location: McCormick Place Convention Center, Exhibit Hall A, Poster Board 87
Presenter: Samer Ali Srour, MBChB, MS, Assistant Professor, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX