Ambrx Biopharma Inc. Announces Submission of IND Application for ARX305 with the U.S. FDA
15 Februar 2022 - 2:00PM
Business Wire
- ARX305 is being developed as an anti-CD70
antibody drug conjugate for treatment of a broad range of solid and
hematologic tumors -
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
it received a “Study May Proceed” letter from the U.S. Food and
Drug Administration (FDA) related to an Investigational New Drug
(IND) application for ARX305, an antibody drug conjugate (ADC)
designed to target CD70 to treat a broad range of solid and
hematologic tumors such as renal cell carcinoma. ARX305 is the
third ADC developed by Ambrx on its proprietary Engineered
Precision Biologics platform that has received IND clearance.
The clinical study cleared by the FDA, ARX305-01, is a first in
human, Phase 1, multicenter, open-label, dose-escalation, and
dose-expansion study to evaluate the safety, pharmacokinetics and
preliminary anti-tumor activity of ARX305 in adults with clear cell
renal cell carcinoma who are resistant or refractory to prior
standard therapies.
ARX305 is an anti-CD70 ADC designed to target cancer cells
displaying CD70, a protein expressed on a broad range of tumors
including renal cell carcinoma, nasopharyngeal cancers, multiple
myeloma, non-Hodgkin’s lymphoma and acute myeloid leukemia. Ambrx
previously licensed the rights to develop and commercialize ARX305
in China to NovoCodex Pharmaceuticals Ltd. (NovoCodex).
“I am pleased with the milestones that we have reached on the
development of antibody drug conjugates, marked by the filing and
clearance of the IND application for ARX305, our third ADC program
to reach this stage of development,” said Feng Tian, Ph.D.,
Chairman of the Board, President, and CEO of Ambrx. “As we continue
to explore potential indications for Ambrx’s proprietary ADC
technology, the progression of ARX305 towards clinical trials
targeting patients with various CD70 expressing tumors reinforces
our confidence in the broad application of our platform.”
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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220215005390/en/
INVESTORS Laurence Watts Managing Director Gilmartin Group, LLC.
619-916-7620 ir@ambrx.com
MEDIA media@ambrx.com
Ambrx Biopharma (NYSE:AMAM)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Ambrx Biopharma (NYSE:AMAM)
Historical Stock Chart
Von Apr 2023 bis Apr 2024