Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
09 Dezember 2021 - 03:11PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
December 9, 2021
(Commission File No. 001-40505)
Ambrx Biopharma Inc.
(Translation of registrant’s name into
English)
Cayman Islands
(Jurisdiction of incorporation or
organization)
10975 Torrey Pines Road
La Jolla, California 92037
(Address of registrant’s principal executive
office)
Indicate by check mark whether the registrant files or will file
annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form
40-F ☐
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted
by Regulation S-T Rule
101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted
by Regulation S-T Rule
101(b)(7): ☐
On December 9, 2021, Ambrx Biopharma Inc. (Ambrx) 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.
| |
• |
|
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:
|
|
|
|
|
|
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Prior Anti-HER2 Therapy
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Confirmed ORR |
|
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Trastuzumab containing regimens*
|
|
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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)
|
|
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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
|
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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereto duly authorized.
|
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| Ambrx Biopharma Inc. |
|
|
| By: |
|
/s/ Feng Tian
|
| Name: |
|
Feng Tian, Ph.D. |
| Title: |
|
Chief Executive Officer |
Date: December 9, 2021
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