Ambrx issued the following announcement on Jan. 4.
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 receptor growth-promoting protein found on the surface of some cancer cells. About 20% of breast cancers overexpress the HER2/neu gene, which causes these cancers to grow more aggressively. Unmet medical needs remain today in HER2-positive metastatic breast cancer. Many tumors progressed after currently approved HER2-targeted regimens.
About Ambrx
Ambrx Inc. is a clinical stage biopharmaceutical company using an expanded genetic code to create Precision Biologics, this includes next generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as novel cytokines to modulate the immune system and long-acting therapeutic peptides for metabolic and cardiovascular disease, all designed to have improved pharmacologic properties and novel biological activity. Leveraging the Ambrx proprietary technology platforms, Ambrx has collaborations with Bristol Myers Squibb, Astellas, BeiGene, Sino Biopharma, Elanco and NovoCodex, with drug products generated using Ambrx technology in different stages of clinical trials. Ambrx is advancing a robust portfolio of clinical and preclinical programs optimized for efficacy, safety and ease of use in multiple therapeutic areas. For additional information, visit www.ambrx.com.
About Fast Track Designation
Fast Track Designation is designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions that have the potential to address unmet medical needs. The designation enables early and frequent communication with the FDA and is intended to accelerate drug approval and patient access to novel treatment options.
