Ambrx Granted Orphan Drug Designation for ARX788 for the Treatment of Gastric Cancer

SAN DIEGO, Calif., March 17, 2021 – Ambrx, a clinical stage biopharmaceutical company using an expanded genetic code to create Engineered Precision Biologics, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for ARX788 for the treatment of patients with HER2-positive gastric cancer, including cancer at the gastroesophageal junction. The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan drug designation for ARX788 for gastric cancer provides Ambrx with certain benefits, including an exemption to FDA prescription drug user fees and tax credits for qualified clinical trials. Orphan drug designation also confers eligibility for seven years of market exclusivity to an orphan drug post-approval, subject to receiving marketing approval from the FDA. “The ongoing Phase 1 ACE-Gastric-01 trial has shown promising anti-tumor activity in HER2-positive advanced gastric patients who have been previously treated with trastuzumab and chemotherapy in the metastatic setting,” said Feng Tian, Ph.D., President and CEO of Ambrx. “Receiving orphan drug designation from the FDA is an important milestone in our ongoing efforts to develop ARX788 for a wide range of HER2-positive cancers. We are proud to be targeting a rare disease that is currently severely underserved by advancing ARX788 into additional clinical trials.” The company anticipates the release of additional Phase 1 data from the ACE-Gastric-01 trial by the end of 2021 and initiation of ACE-Gastric-02, a global Phase 3 trial for HER2-positive gastric cancer, in the second half of 2021. ACE-Gastric-02 is currently planned...

Ambrx Appoints Audit Executive Chris Nolet to Board of Directors

SAN DIEGO, Calif., February 23, 2021 – Ambrx, a clinical stage biopharmaceutical company using an expanded genetic code to create Engineered Precision Biologics, today announced the appointment of Chris Nolet to the company’s Board of Directors. Mr. Nolet brings extensive experience as a long-time audit partner and business advisor in the life sciences industry, and has assumed the role of Chair of Ambrx’s Audit Committee. “We are delighted that Chris will be joining our Board of Directors given his deep expertise, knowledge base and industry network,” said Feng Tian, Ph.D., President and CEO of Ambrx. “His experience in helping transition clinical stage companies into commercially integrated pharmaceutical companies should prove invaluable to Ambrx. As Chair of the Audit Committee, he will provide the accounting and financial oversight to support Ambrx through the next stages of the company’s growth. I am confident that Chris will prove to be an indispensable board member and look forward to benefiting from his counsel in the years ahead.” “I am very pleased to join Ambrx’s Board at such a pivotal time in the company’s history, and to help the development of Ambrx’ Engineered Precision Biologics, which could dramatically improve the treatment outcomes for a variety of cancer patients,” said Mr. Nolet. “Ambrx recently completed a $200 million private financing round that included some of the world’s leading healthcare investors. In addition, Ambrx’s lead development candidate, ARX788, has generated promising clinical data, and received Fast Track Designation from the FDA as a potential monotherapy for the treatment of metastatic HER2-positive breast cancer patients.” Mr. Nolet currently serves on the Boards of Viela Bio (NASDAQ: VIE),...

FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer

SAN DIEGO, Jan. 4, 2021 /PRNewswire/ — Ambrx announced that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the metastatic setting. “This is an important milestone for ARX788 that underscores the strong unmet medical need to develop new and effective treatment options for breast cancer patients whose tumors progressed on currently approved HER2 directed regimens,” said Joy Yan, MD, PhD, Ambrx Chief Medical Officer. “It’s our mission to drive science forward to help bring innovative therapeutic options to cancer patients and we look forward to working closely with the FDA to optimize and expedite the development of ARX788.” This designation was granted based on the phase 1 studies that assessed the safety, tolerability, pharmacokinetic (PK), and preliminary efficacy of ARX788. About ARX788 ARX788 is a homogeneous and highly stable antibody drug conjugate (ADC) targeting the HER2 receptor. ARX788 is a Precision Biologic ADC that consists of two cytotoxic payloads site-specifically conjugated to a Herceptin® (trastuzumab) based antibody. ARX788 was designed for maximum performance in the preclinical setting by optimizing the number, position and chemical bonds that conjugate the cytotoxic AS269 payload to the antibody. AS269 is a proprietary tubulin inhibitor specifically designed to form a highly stable covalent bond with our synthetic amino acids, a fundamental step in the creation of a Precision ADC. Ambrx licensed the China rights of ARX788 to its partner NovoCodex. About HER2-positive Metastatic Breast Cancer Human epidermal growth factor receptor 2 (HER2) is a tyrosine kinase...

Ambrx Presents Phase 1 Trial Data Update and Phase 2/3 Clinical Trial in Progress for Lead Program ARX788 at the 2020 San Antonio Breast Cancer Symposium

• 74% ORR in the Phase 1 HER2-positive Breast Cancer Trial in China and 67% ORR in the Phase 1 HER2 Expressing Pan-tumor Trial in US/AU • Multiple Global Phase 2/3 Trials to Begin Early 2021 SAN DIEGO, December 10, 2020 – Ambrx Inc., a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code, provided a clinical update on their lead program ARX788, a homogeneous and highly stable, site-specific antibody drug conjugate (ADC) targeting HER2 positive cancers. “As presented at the 2020 San Antonio Breast Cancer Symposium, ARX788 Phase 1 studies demonstrated promising antitumor activity in heavily pre-treated cancer patients at the recommended Phase 2 dose,” said Joy Yan, MD, PhD, Ambrx Chief Medical Officer. • ORR of 74% (14/19) and DCR of 100% in the 1.5 mg/kg cohort of the Phase 1 HER2-positive breast cancer trial in China • ORR of 67% (2/3) and DCR of 100% in the 1.5 mg/kg cohort of Phase 1 HER2-positive pan tumor trial in U.S. and Australia • mDOR or mPFS at the 1.5 mg/kg dose have not been reached. • ARX788 was well-tolerated, with most adverse events being mild or moderate, and were manageable. Patients who failed prior Kadcyla® (T-DM1) or Enhertu® (DS-8201a) achieved clinical responses, as assessed by RECIST v1.1 in the ACE-Pan Tumor-01 (ARX788-1711) trial, which enrolled patients with HER2 expressing cancers including breast cancer, gastric/gastroesophageal junction adenocarcinoma, non-small cell lung cancer, bladder, colorectal, biliary track, and salivary gland cancers in US and Australia. “The randomized controlled Phase 2/3 HER2-positive breast cancer pivotal trial in China has treated 22 subjects as of December 5th, 2020...

Ambrx Closes $200 million in Crossover Financing with Leading Healthcare Investors to Advance its Clinical and Preclinical Pipeline of Precision Biologics

SAN DIEGO, November 9, 2020 – Ambrx Inc., a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code announced today the successful closing of an oversubscribed US$200 million crossover financing round. New investors include Fidelity Management & Research Company LLC, funds and accounts managed by BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. BofA Securities acted as the sole placement agent for the offering. “This financing represents our most significant capital raise to date and includes several leading global and US based healthcare funds. Since mid-2018, our new management team, set on a new long term vision, has committed to building company fundamentals and transforming Ambrx from a technology developer to a full-fledged biopharmaceutical company,” said Dr. Feng Tian, CEO and Chairman of Ambrx. “The conclusion of this financing and the strong data emerging from our ongoing clinical programs, as well as our deep preclinical pipeline of proprietary drug candidates, positions the company for rapid growth.” Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long acting therapeutic peptides for metabolic and cardiovascular disease. The company’s innovation engine continues to expand the clinical and preclinical pipeline by discovering new and valuable programs that take full advantage of the Ambrx technologies....

Ambrx and Sino Biopharma Announce Collaboration to Develop Two Next-Generation Biologics

Sino Biopharma receives exclusive rights to develop and commercialize two Ambrx enabled drug products in China Ambrx receives upfront payment plus undisclosed milestone payments and royalties. SAN DIEGO, USA and BEIJING, China, January 12, 2020 – Ambrx Inc., a clinical-stage biopharmaceutical company focused on the development of next generation biologics using an expanded genetic code and Sino Biopharmaceutical Limited (1177.HK), a leading Chinese pharmaceutical company with a large number of medical products covering multiple therapeutic areas, announced a joint collaboration to develop two products enabled by Ambrx’s unique non-natural amino acid incorporation technology platforms. Under the agreement, Ambrx received an upfront payment to create two innovative drug candidates, with Sino Biopharma then leading IND enabling activities for both China and the US. The parties will jointly develop the programs to world-class standards with Sino Biopharma commercializing the products within the greater China area and Ambrx commercializing the products rest-of-world. Ambrx is eligible to receive additional milestone payments for development, regulatory, and sales-based events, as well as tiered royalties on future sales. “We are delighted to join forces with Ambrx, a leader in precision engineered biologics and breakthrough protein therapeutics, to develop two next generation cancer drugs” commented Stephen Hsin Tse, Executive Director of Sino Biopharma. “This collaboration helps fulfill our strong commitment to develop and commercialize innovative biological drugs for the China market.” The collaboration combines Ambrx’s clinically validated ReCODE™ and EuCODE™ platforms with Sino Biopharma’s strong resources and commitment to bring nextgeneration biologic drugs to market. “Sino Biopharma is a large, unique and fast-growing powerhouse in the Chinese pharmaceutical industry, combining strong drug development expertise with substantial commercial...