- ARX788 demonstrated robust anti-tumor
activity, with disease control rate of 100% in the 29 patients
treated at 1.5 mg/kg Q3W –
- ARX788 demonstrated treatment effect among
patients who previously failed a median of seven anti-HER2
targeting therapies –
- Conducted a poster presentation of the ARX788
clinical study ACE-Breast-03 during an ongoing trial poster session
at SABCS -
Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage
biopharmaceutical company using an expanded genetic code technology
platform to discover and develop Engineered Precision Biologics
(EPBs), today announced that NovoCodex Pharmaceuticals Ltd.
(NovoCodex), Ambrx’s partner in China, presented positive safety
and efficacy data from its ongoing ACE-Breast-01 Phase 1 clinical
study of ARX788 at the San Antonio Breast Cancer Symposium
(SABCS).
ACE-Breast-01 is a Phase 1 clinical study of ARX788 in
HER2-positive metastatic breast cancer patients whose disease is
resistant/refractory to HER2 targeted agents including trastuzumab,
ADCs (antibody drug conjugates), TKIs (tyrosine kinase inhibitors)
and bispecific antibodies. The updated data, presented during a
spotlight poster session (PD8-04), demonstrates ARX788’s robust
anti-tumor activity.
Study Highlights
- ARX788 at 1.5 mg/kg Q3W demonstrated robust treatment effect as
illustrated by objective response rate (ORR) in 29 patients in all
prior anti-HER2 treatments groups:
Prior Anti-HER2
Therapy
Confirmed ORR
Trastuzumab containing
regimens*
19/29 (66%)
HER2 ADC regimens (T-DM1,
DX126-262, A166, BAT8001, HS630)**
4/5 (80%)
HER2 TKI regimens (lapatinib,
pyrotinib, neratinib, AST-1306, Hemay-022)
15/23 (65%)
Both HER2 ADC and HER2 TKI
regimens
3/4 (75%)
Bispecific antibody containing
regimens (KN026 and M802)
3/4 (75%)
Table represents subsets of a total of 29 evaluable patients in
the 1.5 mg/kg Q3W cohort, treatment groups are not mutually
exclusive
* All patients at 1.5 mg/kg Q3W received prior
trastuzumab-containing regimens
** One patient who received prior pertuzumab also achieved
confirmed partial response (PR)
- The disease control rate among evaluable patients in the 1.5
mg/kg cohort was 100% (29/29)
- ARX788 demonstrated low systemic toxicity and was generally
well tolerated with most adverse events being grade 1 or 2
- No dose limiting toxicity or drug-related deaths occurred
“As the ACE-Breast-01 data for ARX788 continues to develop, we
are encouraged by the ADC’s anti-tumor activity and safety profile.
ARX788’s ability to continually deliver anti-cancer activity in
patients with prior anti-HER2 therapies including ADCs, TKIs and
bispecifics, truly highlights the potential of our drug candidate,”
said Feng Tian, Ph.D., Chairman of the Board, President and CEO of
Ambrx. “I look forward to working with NovoCodex to realize the
full potential of ARX788.”
The Phase 1 clinical study being conducted by our partner,
NovoCodex, is a dose escalation study designed to evaluate the
safety and anti-tumor activity of ARX788 administered every three
weeks in heavily pretreated patients with HER2-positive metastatic
breast cancer. The 29 evaluable patients in the 1.5 mg/kg Q3W dose
cohort who participated in the study were heavily pretreated with,
and had failed, a median of seven prior lines of therapy (median of
six for the 69 patients in all cohorts) in the advanced disease
setting.
Additionally, Ambrx presented a poster on ACE-Breast-03 in a
SABCS ongoing trial poster session (OT1-02-02). The poster details
ARX788 in its ongoing global ACE-Breast-03 Phase 2 clinical study
in patients with HER2-positive metastatic breast cancer whose
disease is resistant or refractory to T-DM1, and/or T-DXd, and/or
tucatinib-containing regimens. The study is currently enrolling up
to 200 patients and will assess the efficacy, safety and
pharmacokinetics of ARX788, with confirmed objective response rate
as the primary endpoint.
Dr. Tian continued, “Ambrx’s proprietary EuCODE technology
enables ARX788 to maximize the delivery efficiency of the
therapeutic’s cytotoxic payload AS269 into HER2-expressing tumor
cells. I am looking forward to our on-going global ACE-Breast-03
phase 2 study designed for patients with HER2-positive metastatic
breast cancer whose disease is resistant or refractory to T-DM1,
T-DXd, and tucatinib-containing regimens.”
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.
Source: Ambrx, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20211209005334/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
Ambrx Biopharma (NYSE:AMAM)
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