Accutar Biotechnology Presents Phase 1 Data of AC699 Monotherapy in Patients with ER+ / HER2- Breast Cancer at ASCO 2024
2024年6月1日 - 9:00PM
ビジネスワイヤ(英語)
– Differentiated Mechanism of Action of a
Chimeric Degrader as Compared to Fulvestrant and Novel SERDs –
– Treatment with AC699 Monotherapy Resulted in
21% ORR for All Evaluable Patients, and 50% for Those Who Had an
ESR1 Mutation –
– Favorable Safety and Tolerability Profile at
All Doses with No DLTs or ≥ Grade 3 Adverse Events Related to AC699
–
Accutar Biotechnology, Inc., a biotechnology company focusing on
artificial intelligence (AI)-enabled drug discovery, announced data
from an ongoing Phase 1 study of AC699 monotherapy in patients with
ER-positive / HER2-negative locally advanced or metastatic breast
cancer. The data will be presented in a poster discussion session
at the American Society of Clinical Oncology (ASCO) Annual Meeting
in Chicago, IL on June 1, 2024.
AC699 is a potent and selective orally bioavailable, chimeric
degrader of estrogen receptor (ER) α, and offers a potential new
breast cancer treatment option based on a differentiated mechanism
of action as compared to fulvestrant and novel SERDs with deeper
ERα degradation as demonstrated in preclinical studies. AC699 is
currently being evaluated in an ongoing Phase 1 clinical study as a
single agent for the treatment of ER-positive / HER2-negative
locally advanced or metastatic breast cancer (NCT05654532). The
primary objectives are to evaluate the safety and tolerability of
AC699. Secondary and exploratory objectives include
pharmacokinetics, preliminary efficacy and pharmacodynamic
evaluation. The study uses a 3+3 dose-escalation design, with
once-daily oral dosing of AC699 at 100, 200, 300, 400, and 600
mg.
Phase 1 Study Results:
- As of April 8, 2024, 29 participants were enrolled and treated
with AC699 at doses ranging from 100-400 mg. The participants had a
median of 5 (range 2-10) prior lines of therapy, including 3 (range
1-8) prior lines in the metastatic setting
- The objective response rate was 21% (4/19) and increased to 50%
(4/8) for those who had an ESR1 mutation
- There were no > Grade 3
drug-related adverse events (AEs), no dose limiting toxicities, no
discontinuations and no dose reductions due to AEs
- AEs related to AC699 occurred in 38% of participants and
included nausea (14%), hot flush (14%), and fatigue (10%)
- The maximum tolerated dose had not been reached yet
Details of the poster presentation at ASCO
2024 are as follows:
- Date/Time: June 1, 2024, 9:00 AM – 12:00 PM CDT
- Abstract Number: 3074
- Title: Preliminary results from a phase 1 study of AC699, an
orally bioavailable chimeric estrogen receptor degrader, in
patients with advanced or metastatic breast cancer.
- Session: Developmental Therapeutics—Molecularly Targeted Agents
and Tumor Biology
- Abstracts and full session details can be accessed through the
ASCO meeting planner: Link
"We are extremely pleased with the groundbreaking safety and
efficacy that AC699 has demonstrated thus far in Phase 1, with
early evidence of its best-in-class potential, especially for
patients with ESR1 mutations,” said Jie Fan, Ph.D., Chief Executive
Officer of Accutar Biotechnology, Inc. "We look forward to
completing the dose escalation portion of the study and starting
the Phase 2 study soon. We believe that the oral dosing of AC699
and its differentiated mechanism of action, as compared to
fulvestrant and novel SERDs, can potentially provide a new safe and
effective treatment option for this patient population.”
About AC699 and the Phase 1 Study (AC699-001)
AC699 is an investigational orally bioavailable, chimeric
degrader of estrogen receptor (ER) α. In preclinical studies, AC699
has demonstrated potent and selective protein degradation of ERα
wildtype and mutants with favorable pharmacological properties, as
well as promising anti-tumor activities in ER-positive animal tumor
models.
The purpose of the Phase 1 multi-center, open-label study is to
assess the safety, tolerability, pharmacokinetics, and preliminary
anti-tumor activity of AC699 treatment in patients with ER-positive
/ HER2-negative locally advanced or metastatic breast cancer
(NCT05654532). Additional information on this clinical trial can be
found on www.clinicaltrials.gov.
About Accutar Biotechnology, Inc.
Accutar is a clinical stage biotech company focused on
AI-enabled drug discovery, and its application to the discovery and
development of clinically differentiated medicines.
Be transformative. For patients.
To learn more about Accutar, please visit us at
www.accutarbio.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240601126229/en/
Jiaqi Ren Media@accutarbio.com