Ambrx Announces Positive Data on ARX788 for the Treatment of HER2+ Gastric Cancer Presented at CSCO
04 Oktober 2021 - 2:00PM
Business Wire
- ARX788 demonstrated an ORR of 44.4% in
ongoing ACE-Gastric-01 Phase 1 clinical study in China -
- Ambrx and NovoCodex recently dosed the first
patient in the ACE-Gastic-02 global Phase 2/3 study -
Ambrx (NYSE: AMAM), a clinical stage biopharmaceutical company
using an expanded genetic code technology platform to create
Engineered Precision Biologics, today announced that NovoCodex
Pharmaceuticals Ltd. (NovoCodex), Ambrx’s partner in China,
presented positive interim data from the ACE-Gastric-01 Phase 1
clinical study of ARX788 for the treatment of HER2+ metastatic
gastric / gastroesophageal junction (GEJ) cancer at The Chinese
Society of Clinical Oncology (CSCO). The newly presented data
suggests that ARX788 at a 1.7 mg/kg dose has a tolerable safety
profile. The data presented here adds to and updates trial data
that Ambrx presented at the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting in June 2021. Ambrx received Orphan
Drug designation from the FDA for the treatment of gastric cancer,
including cancer at the GEJ, in early 2021.
Updated ACE-Gastric-01 Phase 1 Interim Data
Highlights
(Data as of June 30, 2021)
- 7 patients dosed at 1.7 mg/kg every three weeks.
- Demonstrated overall response rate (ORR) of 44.4%
(12/27) in the response-evaluable patients across all three
cohorts (1.3 mg/kg, 1.5 mg/kg, 1.7 mg/kg every three weeks).
- Low drug-related severe adverse events (SAE) occurred in
6.7% (2/30) of all treated patients across all three cohorts
(1.3 mg/kg, 1.5 mg/kg, 1.7 mg/kg every three weeks). Drug-related
grade 3 and above adverse events (AEs) comprised only 10% (3/30).
- As expected, the most common AEs observed were ocular-related
and dose-dependent.
- Median overall survival (mOS) of 10.7 months across all
three cohorts (1.3 mg/kg, 1.5 mg/kg, 1.7 mg/kg every three weeks)
and mOS for the 1.7 mg/kg cohort has not been reached.
- Enrollment in ACE-Gastric-01 is completed with ongoing
follow-up.
1.3 mg/kg
1.5 mg/kg
1.7 mg/kg
All
Response-evaluable
patients
n=7
n=13
n=7
n=27
ORR
42.9%
46.2%
42.9%
44.4%
DCR
57.1%
46.2%
85.7%
59.3%
mPFS (months)
3.6
2.4
4.1
4.1
mOS (months)
10.1
10.7
Not reached
10.7
Source: NovoCodex, CSCO 2021
presentation.
“We are thrilled with the progress from the NovoCodex sponsored
study of our lead clinical asset, ARX788, and look forward to
continuing our collaboration as we explore the capabilities of our
antibody drug conjugate in treating HER2 positive cancers and solid
tumors,” said Feng Tian, Ph.D., Chairman of the Board, President
and CEO of Ambrx. “We are encouraged by the continued positive data
from the ACE-Gastric-01 study and we look forward to enrolling more
patients in our ongoing global co-sponsored ACE-Gastric-02 Phase
2/3 trial.”
ACE-Gastric-01 is a Phase 1 clinical study of ARX788 for the
treatment of HER2+ metastatic gastric/GEJ cancer that is being
conducted in China by Ambrx’s partner, NovoCodex. The ongoing
clinical study recently completed enrollment of 30 patients and is
designed to be a dose escalation and expansion study with patients
receiving treatment doses of 1.3 mg/kg, 1.5 mg/kg, or 1.7 mg/kg
every 3 weeks. Ambrx previously presented data from two Phase 1
studies of ARX788 at ASCO where patients received a dose of ARX788
up to 1.5 mg/kg every three weeks or every four weeks.
In August 2021, NovoCodex also announced the dosing of the first
patient in the Ambrx and NovoCodex co-sponsored global Phase 2/3
trial of ARX788 in HER2+ gastric cancer. ACE-Gastric-02 is a
multicenter, randomized, controlled clinical trial to evaluate the
efficacy and safety of ARX788 in patients with HER2+ advanced
gastric or gastroesophageal junction adenocarcinoma.
About 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, the company 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211004005345/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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