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 and NovoCodex form Second Collaboration to Develop and Commercialize Ambrx’s Antibody Drug Conjugates

SAN DIEGO and SHANGHAI, October 22, 2019 /PRNewswire/ — Ambrx and NovoCodex Biopharmaceuticals Ltd., (NovoCodex), a majority owned company of Zhejiang Medicine Co Ltd., today announced that they have formed a second collaboration to develop and commercialize Ambrx’s internally developed site-specific antibody drug conjugates (ADCs). Under the agreement, Ambrx and NovoCodex will join forces to continue the development of ARX305, an Ambrx enabled ADC for the treatment of CD70 positive cancers. Under the terms of the agreement, NovoCodex is responsible for developing and commercializing ARX305 in China while Ambrx is responsible for developing and commercializing ARX305 outside of China. NovoCodex will fund global development activities to the end of Phase 1 clinical trials and pay Ambrx an undisclosed upfront payment, development milestones, and a double digit royalty on product sales in China. NovoCodex is also eligible to share in undisclosed portion of ARX305 product sales outside of China. “We are excited to initiate our second collaboration with NovoCodex following our successful collaboration with ARX788, which is currently in Phase 1 clinical trials for HER2 positive breast and gastric cancers. ARX305 is a natural extension to the first collaboration with the inclusion of another Ambrx enabled ADC that is intended to treat CD70 positive cancers such as Renal Cell Carcinoma and Multiple Myeloma. Further, we continue to align ourselves with China’s leading pharmaceutical companies” said Feng Tian, Ph.D., Chief Executive Officer of Ambrx. “ARX305, which is expected to start Phase 1 clinical trials in early 2021, allows Ambrx to expand its ADC pipeline into multiple cancer types while gaining access to the China market through our partnership with NovoCodex.” Chunbo...