Quantum Leap Healthcare Collaborative™ (Quantum Leap) and 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 selection of Ambrx’s antibody drug conjugate (ADC) ARX788 for a
new investigational treatment arm in the I-SPY 2.2 TRIAL for the
treatment of HER2-positive breast cancer in the neoadjuvant
setting. Sponsored by Quantum Leap, the I-SPY 2.2 TRIAL is a
continuation of the I-SPY 2 TRIAL that seeks to create personalized
treatments by adapting therapies for each patient to optimize the
clinical outcome.
“We are particularly excited about this collaboration,” stated
Dr. Laura J. Esserman, MD, MBA, Director of the Breast Care Center
at the UCSF Helen Diller Family Comprehensive Cancer Center, and
Principal Investigator of I-SPY Family of Trials. “We hope this
will usher in an era of more targeted, effective and less toxic
therapies for people with HER2-positive breast cancers, leveraging
decades of investment in science and drug development, and
delivering better treatment to patients when they need it most.
This is the right drug, for the right patient at the right
time.”
I-SPY 2.2 is an adaptive Phase 2 clinical trial that evaluates
emerging targeted agents, allowing those agents to either be
combined with less toxic chemotherapeutic regimens or to replace
cytotoxic chemotherapy entirely. ARX788 will be evaluated as a
monotherapy, and in combination with the PD-1 targeting checkpoint
inhibitor cemiplimab, in HER2-positive early-stage breast cancer in
the neoadjuvant setting. Ambrx anticipates the ARX788 arms to begin
enrolling patients in May 2022.
Quantum Leap, sponsor of the I-SPY 2.2 TRIAL, leads a
pre-competitive consortium that includes the U.S. Food & Drug
Administration (FDA), industry, patient advocates, philanthropic
sponsors, and clinicians from more than 16 major U.S. cancer
research centers.
“I am thrilled that Quantum Leap has selected Ambrx’s antibody
drug conjugate, ARX788, to be evaluated in the I-SPY 2.2 TRIAL,”
said Feng Tian, Ph.D., Chairman of the Board, President, and CEO of
Ambrx. “We are encouraged by the favorable anti-tumor activity and
safety profile of ARX788 for the treatment of early-stage breast
cancer. It may provide a less toxic treatment option for patients
through the precision conjugation of cytotoxic payloads targeting
HER2 receptors. I look forward to collaborating with Quantum Leap
and exploring the potential of our antibody drug conjugate in
enabling effective chemo-free therapeutic treatments to
patients.”
ARX788 is an anti-HER2 antibody drug conjugate (ADC) that is
being studied broadly in breast cancer, gastric/GEJ cancer and
other solid tumors. ARX788 is a homogeneous and highly stable ADC
that maximizes potential anti-tumor activity by optimizing the
number and position of its payloads and the chemical bonds that
conjugate the payloads to the antibody. The United States Food and
Drug Administration (FDA) has granted ARX788 the Fast Track
Designation for the treatment of HER2-positive metastatic breast
cancer.
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 more information, please
visit www.ambrx.com.
About the I-SPY TRIALs
The I-SPY 2 TRIAL (Investigation of Serial studies to Predict
Your Therapeutic Response with Imaging And moLecular analysis) was
designed to rapidly screen promising experimental treatments and
identify those most effective in specific patient subgroups based
on molecular characteristics (biomarker signatures). The trial is a
unique collaborative effort by a consortium that includes the Food
and Drug Administration (FDA), industry, patient advocates,
philanthropic sponsors, and clinicians from more than 20 major U.S.
cancer research centers. Under the terms of the collaboration
agreement, Quantum Leap Healthcare Collaborative is the trial
sponsor and manages all study operations. For more information,
visit www.ispytrials.org.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative is a 501(c)(3) charitable
organization established in 2005 as a collaboration between medical
researchers at University of California, San Francisco and Silicon
Valley entrepreneurs. Our mission is to integrate high-impact
research with clinical processes and systems technology, resulting
in improved data management and information systems, greater access
to clinical trial matching and sponsorship, and greater benefit to
providers, patients and researchers. Our goal is to improve and
save lives. Quantum Leap provides operational, financial, and
regulatory oversight to the I-SPY Trials. For more information,
visit www.QuantumLeapHealth.org.
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 ARX788, clinical development and strategic plans for ARX788, and
the timing of program updates and milestones related to ARX788.
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 trials 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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Ambrx Biopharma Inc., Contacts: INVESTORS Laurence
Watts, Managing Director Gilmartin Group, LLC. 619-916-7620
ir@ambrx.com
MEDIA media@ambrx.com
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