- Follows initiation of Phase 1a/1b study in the U.S.
- Company plans to include clinical centers in China to broaden geographic representation and
accelerate patient enrollment into the Phase 1a/1b study
SAN
DIEGO and SHANGHAI,
May 6,
2024 /PRNewswire/ -- Adcentrx Therapeutics
("Adcentrx"), a biotechnology company revolutionizing Antibody-Drug
Conjugate (ADC) therapeutics for cancer and other life-threatening
diseases, announced today that China National Medical Products
Administration (NMPA) has cleared Adcentrx's Investigational New
Drug (IND) application for ADRX-0706 which enables the company
to include China-based clinical
centers in the ongoing Phase 1a/1b
study for the treatment of select advanced solid tumors.
ADRX-0706 is an ADC comprised of a novel fully human IgG1
antibody targeting human Nectin-4 linked to a proprietary
tubulin inhibitor payload, AP052, through Adcentrx's innovative
i-Conjugation™ technology using a cleavable linker and stable
conjugation chemistry. This novel platform technology enables
a highly stable ADC with a drug-antibody ratio of eight (DAR 8)
with a substantially expanded therapeutic window as demonstrated in
preclinical studies. Nectin-4 is a validated target for ADCs with
high expression in multiple solid tumors and limited expression in
normal tissues. It plays a crucial role in tumor progression and
has been associated with poor prognosis and resistance to
conventional therapies.
"NMPA's clearance of the ADRX-0706 IND is an important milestone
for Adcentrx," said Hui Li, Ph.D.,
Founder and Chief Executive Officer of Adcentrx. "We now have the
ability to recruit patients in both the U.S. and China to generate valuable data in different
patient populations, and the data will enable us to further explore
ADRX-0706 in treating patients with high unmet needs across
multiple tumor types."
The first-in-human Phase 1a/b clinical trial of ADRX-0706 is an
open-label, multicenter dose escalation and dose expansion study.
The study is enrolling patients with select advanced solid tumors.
The primary objectives of the study are to characterize the safety
and tolerability and to determine the optimal dose of ADRX-0706.
The company expects an initial data readout in mid-2024.
About ADRX-0706
ADRX-0706 is a fully proprietary ADC
product candidate discovered by Adcentrx. The antibody component
targets Nectin-4, a cell surface adhesion protein over-expressed in
multiple human cancers and associated with poor disease prognosis.
ADRX-0706 has a favorable pharmacokinetic and safety profile in
preclinical models and has demonstrated significant efficacy across
a variety of tumor indications in vitro and in vivo. ADRX-0706 is
currently being evaluated in a Phase 1a/b clinical trial.
For more information about the ADRX-0706 Phase 1a/b clinical
trial, please refer to the Study ID NCT06036121 on
ClinicalTrials.gov.
About Adcentrx Therapeutics
Adcentrx is a
biotechnology company focused on accelerating breakthroughs in
protein conjugate therapeutic development for cancer and other
life-threatening diseases. Adcentrx has pioneered the development
of i-Conjugation™, an ADC technology platform addressing key
components of protein conjugate design to solve challenges
typically seen in ADCs. In addition to ADRX-0706, Adcentrx is
developing a robust pipeline of ADCs with first-in-class
potential.
For more information about Adcentrx and its innovative ADC
technologies, please visit https://adcentrx.com.
Contact Information:
Investor Relations
ir@adcentrx.com
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SOURCE Adcentrx Therapeutics