- The first complete response from a single intravenous (IV) dose of autologous CAR T in a patient with solid tumors

- Unprecedented safety and early efficacy data to be presented with complete response in poster session at ASCO 2024 Annual Meeting

AffyImmune Therapeutics, a clinical-stage biotechnology company committed to developing novel, first-in-class CAR T cell therapies, today announced early results from a Phase 1 study evaluating the safety and efficacy of AIC100, an ICAM-1 targeting and affinity-tuned LFA-1 binder chimeric antigen receptor (CAR) T-cell therapy, in patients with advanced thyroid cancer. Notably, a metabolic complete response (mCR) was achieved in one patient with anaplastic thyroid cancer (ATC), the most aggressive form of the disease.

“We are excited to be the first to demonstrate the potential of autologous CAR T to induce a complete response in a patient with a solid tumor cancer. The confirmed mCR in the AIC100 Phase 1 study is the first known complete response following a single IV dose of autologous CAR T cells observed in any solid tumor cancer type,” said Matt Britz, CEO, AffyImmune.

“This Phase 1 study addresses the urgent unmet medical need for effective treatments for patients with advanced differentiated thyroid cancer (ADTC) and ATC which has a median survival rate of less than six months. These are aggressive forms of thyroid cancer that currently have limited treatment options and poor patient outcomes. We believe AIC100 has the potential to overcome current barriers to CAR T, and ultimately establish a new paradigm for patients with solid tumor cancers,” Britz added.

As of the data cutoff date, 10 patients (6 ATC; 4 PDTC) were infused with AIC100 at 3 dose levels (DLs). No dose-limiting toxicities were observed across all dose levels, and the maximum tolerated dose was not reached. 60% (n=6) of patients developed grade 1/2 cytokine release syndrome (CRS), with no incidence of immune effector cell-associated neurotoxicity syndrome (ICANS) or other serious adverse events related to AIC100.

For evaluable patients in DL2 (100 million CAR T cells) and DL3 (500 million CAR T cells) (n=6), the ORR was 33%, with one patient at DL2 achieving a durable partial response (PR) and another patient at DL3 achieving an ongoing durable mCR allowing the patient to be off all chemotherapy. DCR was 67%.

“These findings represent a significant milestone in the development of AIC100 as a potential treatment option for patients with advanced thyroid cancers. The safety profile and promising antitumor activity observed in this Phase 1 study provide a strong foundation to advance this candidate further in development,” said Dr. Samer A. Srour, the trial’s Lead Investigator and Assistant Professor at The University of Texas MD Anderson Cancer Center. “We look forward to improve on these results and to further evaluate the safety and efficacy of AIC100 at higher dose levels and to potentially expand its application to other ICAM-1-positive cancers.”

Presentation Details:

Title: Safety and Efficacy of AIC100 Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients with Advanced Thyroid Cancers: results from the phase 1 study

Presenter: Dr. Samer Ali Srour, The University of Texas MD Anderson Cancer Center

Session Type: Poster Session– Head and Neck Cancer

Abstract Number: 6112

Date and Time: June 2, 2024: 9:00 AM - 12:00 PM CDT

Location: McCormick Place Convention Center, Chicago, IL

AffyImmune will also be hosting an event during ASCO 2024:

Event: Navigating Advanced Thyroid Cancer: Unmet Needs and Innovations

Date and Time: Monday, June 3, 2024 / 6:00 – 7:00 PM

Location: Hyatt Regency McCormick Place, Chicago, IL

RSVP: https://affyimmune.com/registration-for-navigating-advanced-thyroid-cancer-unmet-needs-and-innovations/

For more information about the Phase 1 study, visit www.clinicaltrials.gov (NCT04420754).

About AffyImmune Therapeutics

AffyImmune is a clinical-stage biopharmaceutical company committed to developing a first-in-class, ICAM-1 targeting and affinity-tuned LFA-1 binder CAR T therapy to transform the lives of patients with advanced solid cancers. The Company’s proprietary technology utilizing ICAM-1/LFA-1 interaction can potentially address the critical CAR T challenges such as toxicity, antigen loss, T-cell trafficking and exhaustion, while also allowing in vivo tracking of the CAR T cells. Its lead candidate, AIC100, is currently in a Phase 1 study to treat patients with advanced thyroid cancers including advanced differentiated thyroid cancer (ADTC) and anaplastic thyroid cancer (ATC). AffyImmune is developing a focused pipeline in ICAM-1-positive cancers with high unmet medical need. AffyImmune is based in Natick, MA. For more information, visit www.affyimmune.com.

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