AffyImmune Announces Confirmed Complete Response in Patient with Anaplastic Thyroid Cancer
23 Mayo 2024 - 4:00PM
Business Wire
- 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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Media: Kimberly Ha KKH Advisors
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