News Releases

• Data show unprecedented CAR T patient response in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers
• Of the two patients evaluable for efficacy assessment at day 42 treated with an intermediate dose of CAR T cells, both experienced tumor reductions, with one achieving a partial response with 42 percent reduction in target tumor lesion
• No dose limiting toxicities reported; two patients had transient grade 1 cytokine release syndrome
  

NATICK, Mass., May 25, 2023 /PRNewswire/ -- AffyImmune Therapeutics, Inc., a clinical stage biotechnology company finding safe, effective ways to use CAR T cells against solid cancers, today announced 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) Annual Meeting in Chicago, Illinois, on June 5, 2023.

"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

About AffyImmune Therapeutics, Inc.
AffyImmune is realizing the potential of cancer immunotherapy by extending the anti-cancer activity of CAR T cell therapy to solid tumors. AffyImmune's Tune & Track platform finely tunes the affinity of CAR T cells to reduce toxicity and increase CAR T cell longevity while allowing in vivo monitoring through a proprietary tracking system. The company was founded in 2016 and is enrolling patients in its Phase 1 trial to treat advanced thyroid cancers.

Contact Information:
Matt Britz
AffyImmune Therapeutics, Inc.
508-654-3600 x2
mbritz@affyimmune.com

SOURCE AffyImmune Therapeutics