Ambrx Biopharma Inc. Announces First Patient Dosed in its Global Phase 2 ACE-Breast-03 Clinical Study of ARX788 for the Treatment of HER2-Positive Metastatic Breast Cancer
04 Novembro 2021 - 09:00AM
Business Wire
Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage
biopharmaceutical company using an expanded genetic code technology
platform to create Engineered Precision Biologics, today announced
the first patient has been dosed in its global ACE-Breast-03 Phase
2 clinical study of ARX788 in patients with HER2-positive
metastatic breast cancer.
ARX788 is an anti-HER2 antibody drug conjugate (ADC) that is
being studied broadly in breast cancer, gastric/GEJ cancer and
other solid tumors. The FDA has granted ARX788 Fast-Track
Designation for the treatment of HER2-positive metastatic breast
cancer in December 2020.
“Dosing the first patient in this Phase 2 study of ARX788 in
patients with HER2-positive metastatic breast cancer marks an
important milestone for Ambrx,” said Feng Tian, Ph.D., Chairman of
the Board, President, and CEO of Ambrx. “We have made excellent
progress with our clinical development pipeline over the last few
months, highlighted by our positive data of ARX788 for
HER2-positive gastric cancer, as well as the dosing of the first
patient in a Phase 1 trial of ARX517 for PSMA expressing tumors.
Our growing clinical programs, coupled with an influx of capital
from our IPO in June 2021, leaves Ambrx well-positioned to
potentially attain several near-term clinical and corporate
milestones.”
The global ACE-Breast-03 Phase 2 clinical study is a multicenter
study to evaluate the efficacy and safety of ARX788 in
HER2-positive, metastatic breast cancer patients whose disease is
resistant or refractory to T-DM1, and/or T-DXd, and/or
tucatinib-containing regimens. The primary outcome measure of the
study will be the objective response rate.
About Ambrx Biopharma Inc. (Ambrx)
Ambrx is a clinical stage biopharmaceutical company using an
expanded genetic code technology platform to discover and develop
Engineered Precision Biologics. These include next generation
antibody drug conjugates (ADCs), bispecifics, targeted
immuno-oncology therapies, novel cytokines to modulate the immune
system, and long-acting therapeutic peptides for metabolic and
cardiovascular disease. Ambrx is advancing a robust portfolio of
clinical and preclinical programs designed to optimize efficacy,
safety and ease of use, in multiple therapeutic areas, including
its lead product candidate ARX788. In addition, Ambrx has clinical
collaborations with multiple partners, for drug candidates
generated using Ambrx technology. For additional information,
please visit www.ambrx.com.
Forward-Looking Statements
This press release includes certain “forward-looking statements”
intended to qualify for the “safe harbor” from liability
established by the Private Securities Litigation Reform Act of
1995, as amended. Forward-looking statements may be identified by
the words “anticipate,” believe,” “estimate,” “expect,” “intend,”
“plan,” “project,” “may,” “will,” “could,” “should,” “seek,”
“potential” and similar expressions, and include, without
limitation, express or implied statements regarding Ambrx’s beliefs
and expectations regarding the advancement and potential benefits
of its product candidates, clinical development and strategic
plans, the timing of future events, and anticipated upcoming
milestones. Forward-looking statements are based on Ambrx’s current
expectations and are subject to inherent uncertainties, risks and
assumptions that are difficult to predict. Factors that could cause
actual results to differ include, but are not limited to, those
risks and uncertainties associated with: the impact of the COVID-19
pandemic on Ambrx’s business, operations, strategy, goals and
anticipated milestones; Ambrx’s ability to execute on its strategy
including with respect to the timing of its R&D efforts,
initiation of clinical studies and other anticipated milestones;
risks associated with development of novel therapeutics, including
potential delays in clinical trials and regulatory submissions and
the fact that future clinical trial results may not be consistent
with preliminary results or results from prior preclinical studies
or clinical trials; Ambrx’s ability to fund operations as
anticipated; and the additional risks and uncertainties set forth
more fully under the caption “Risk Factors” in Ambrx’s registration
statement on Form F-1 filed with the United States Securities and
Exchange Commission (SEC) on June 14, 2021, and elsewhere in
Ambrx’s filings and reports with the SEC. Forward-looking
statements contained in this announcement are made as of this date,
and Ambrx undertakes no duty to publicly update or revise any
forward looking statements, whether as a result of new information,
future events or otherwise, except as may be required under
applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20211104005452/en/
INVESTORS Laurence Watts Managing Director Gilmartin Group, LLC.
619-916-7620 ir@ambrx.com
MEDIA Ian Stone Managing Director Canale Communications (619)
849-5388 media@ambrx.com
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