AMAM Ambrx Biopharma Inc. American Depositary Shares (each representing seven)
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
ARX788 (ACE-Breast-02)
HER2-positive metastatic breast cancer
|
Phase 2
Phase 2
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
ARX788 (ACE-Gastric-02)
Gastric cancer
|
Phase 2/3
Phase 2/3
|
Phase 1 data reported an ORR of 44.4% (12/27), SAE occurred in 6.7% (2/30) and drug-related grade 3 and above adverse events (AEs) comprised only 10% (3/30), noted October 4, 2021. Phase 2/3 trial dosing commenced in August 2021.
|
|
ARX517 (APEX-01)
PSMA Expressing Tumors
|
Phase 1
Phase 1
|
Phase 1 commencement of dosing announced August 3, 2021.
|
|
ARX788 (ACE-Breast-03)
Breast cancer
|
Phase 2
Phase 2
|
Phase 2 trial to commence 2H 2022.
|
Latest News
-
View Full Article Hide Full Article
- 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211004005345/en/
-
View Full Article Hide Full Article
- Discussion to focus on engineered cytokines and their role in immune-oncology -
Ambrx (NYSE:AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced that Feng Tian, Ph.D., President and Chief Executive Officer of Ambrx, will participate in a virtual panel discussion at the H.C. Wainwright 23rd Annual Global Investment Conference, taking place September 13-15, 2021. The discussion will be led by Michael King, Managing Director and Senior Biotechnology Analyst at H.C. Wainwright.
Discussion Topic: Engineered Cytokines: The Next Big Wave in Immuno-Oncology.
Date and Time: Tuesday, September 14, 2021, at 1:30 pm EDT, 10:30 am PDT.Individuals interested in listening to the panel discussion may do so using the webcast link under "Latest Events" in the Investors section of the company's website at: www.ambrx.com.
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 additional information, please visit www.ambrx.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210909006086/en/
-
View Full Article Hide Full Article
Ambrx (NYSE:AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced the first patient has been dosed in a Phase 1, multicenter, open-label, dose-escalation, and dose expansion study to evaluate the safety, pharmacokinetics (PK), and anti-tumor activity of ARX517 in subjects with prostate specific membrane antigen (PSMA) expressing tumors found in prostate, pancreatic, lung and ovarian cancers.
ARX517 is an anti-PSMA antibody drug conjugate (ADC) that demonstrated activity in both enzalutamide sensitive and resistant preclinical models for prostate cancer while demonstrating favorable PK and toxicity profiles in IND-enabling GLP toxicity studies.
"I am excited to announce that we dosed our first patient in our Phase 1 trial, and thus have taken the first steps in evaluating the potential clinical benefit of ARX517 in cancer patients with tumors overexpressing PSMA," said Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx. "ARX517 is the second ADC in our internal pipeline to enter the clinic, which I believe speaks to the broad applicability and productivity of our technology platform. I look forward to updating you on the progression of this trial."
The Phase 1 trial will be a multi-center, open-label, dose escalation and dose expansion study. This trial, referred to as APEX-01, is designed to assess the safety, tolerability and PK profile, as well as the anti-tumor activity, of ARX517 as a monotherapy. The trial will enroll up to 76 patients with advanced solid tumors whose diseases have failed prior standard therapies.
About PSMA, prostate cancer and other solid tumors
PSMA has been found highly expressed in prostate cancer, particularly in metastatic castration-resistant prostate cancer (mCRPC). Additionally, PSMA has been found in a variety of other solid tumors. Prostate cancer represents a significant unmet need and sizable market opportunity. There were 1.3 million new cases of prostate cancer with five-year survival rates of approximately 27% and 359,000 associated deaths worldwide in 2018. For men, prostate cancer is the second most frequent cancer and the fifth leading cause of cancer death. The global market for prostate cancer therapies was estimated to be $9.3 billion in 2018 and is forecast to grow to $12.8 billion by 2028. While non-ADC therapies are available to treat mCRPC, there is no approved therapy specifically targeting PSMA to treat prostate cancer.
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 Bristol Myers Squibb, BeiGene, Sino Biopharma, Elanco and NovoCodex, for drug candidates generated using Ambrx technology. For additional information, please visit www.ambrx.com.
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the potential benefits of ARX517; the expected scope, endpoints and timing of the APEX-01 clinical trial; projected growth in the market for prostate cancer; and other statements that are not historical facts. These forward-looking statements are based on Ambrx's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to clinical trials, including the fact that prior results may not predict future clinical trial outcomes; impacts of the COVID-19 pandemic and actions taken to slow its spread, including potential delays in clinical trials; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Ambrx operates and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Ambrx's filings and reports with the Securities and Exchange Commission. Ambrx undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210803005135/en/
-
View Full Article Hide Full Article
Ambrx (NYSE:AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced the appointment of Sonja Nelson to Chief Financial Officer.
"I am delighted to welcome Sonja to Ambrx as we expand our executive team, in light of our ongoing expansion," said Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx. "Sonja brings a breadth of experience in financial operations, planning and strategy from within the biotechnology industry. Her arrival at Ambrx solidifies the company's management team, and I look forward to leaning on her experience as we transition into the next stages of our company's development."
"I would like to thank Dr. Tian and the Ambrx team for welcoming me to the company. I'm excited to be joining Ambrx and impressed by the strength of the company's development pipeline, and the underlying technology behind it," said Ms. Nelson. "I look forward to leveraging my experience in the public biotech sector to help provide Ambrx with the financial optionality it needs to further its development pipeline."
Ms. Nelson is an experienced financial executive, who joins Ambrx with 10 years of executive experience within the biotechnology industry. Most recently, she served as Chief Financial Officer at NantKwest, now ImmunityBio (NASDAQ:IBRX). Prior to NantKwest, Ms. Nelson was Vice President, Corporate Controller for AltheaDx. Previously, Ms. Nelson served as Corporate Controller at Cadence Pharmaceuticals (NASDAQ:CADX, which was acquired by Mallinckrodt plc))). Ms. Nelson also served as Director, General Accounting at Cricket Communications, Inc. (acquired by AT&T) between 2008 and 2012. She started her career at KPMG and holds a bachelor's degree in business administration with specialization in taxation and auditing from the University of Applied Sciences in Pforzheim, Germany. She is a Certified Public Accountant.
About Ambrx
Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create 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 collaborations with Bristol Myers Squibb, BeiGene, Sino Biopharma, and NovoCodex, for drug candidates generated using Ambrx technology. For additional information, please visit www.ambrx.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Ambrx's plans, the future development and potential of Ambrx's product candidates, and expected contributions of Ms. Nelson. The words "anticipate," "estimate," "expect," "intend," "may," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks associated with preclinical and clinical development, whether Ambrx will be able to access sufficient funding to execute its business plan, the fact that future clinical results may be inconsistent with prior results, and other factors discussed in the "Risk Factors" section of Ambrx's registration statement on Form F-1 filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ambrx specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210630005273/en/
-
View Full Article Hide Full Article
Ambrx, a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop Engineered Precision Biologics (EPBs), today announced the pricing of its initial public offering of 7,000,000 American depositary shares (ADSs), each representing seven ordinary shares, at a public offering price of $18.00 per ADS. The total gross proceeds to Ambrx from the offering are expected to be $126.0 million before deducting underwriting discounts and commissions and estimated offering expenses. In addition, Ambrx has granted the underwriters a 30-day option to purchase up to an additional 1,050,000 ADSs at the initial public offering price, less underwriting discounts and commissions. All of the ADSs are being offered by Ambrx. The shares are expected to begin trading on the New York Stock Exchange on June 18, 2021 under the ticker symbol "AMAM". The offering is expected to close on June 22, 2021, subject to the satisfaction of customary closing conditions.
Goldman Sachs & Co. LLC, BofA Securities and Cowen are acting as joint book-running managers for the offering.
A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on June 17, 2021. The offering is being made only by means of a written prospectus. A copy of the final prospectus relating to the offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, or by telephone at (800) 294-1322, or by email at dg.prospectus_requests@bofa.com; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com.
This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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 Bristol Myers Squibb, Astellas, BeiGene, Sino Biopharma, Elanco and NovoCodex, for drug candidates generated using Ambrx technology.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "estimate," "expect," "intend," "may," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the preliminary prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ambrx specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210617005926/en/