ADC Company Ambrx Partners with China’s Hisun Pharmaceutical; Plans IPOBy
The biopharmaceutical company Ambrx Inc. and Zhejiang Hisun Pharmaceutical Company Ltd. have formed a collaboration for the development and commercialization of bispecifics for the treatment of cancer based on Ambrx technology. Hisun will have commercial rights to the products in China while Ambrx will retain commercial rights outside of China and will be entitled to receive royalties on sales of the products in China. Hisun will manufacture the product to cGMP standards for clinical and commercial supplies on a global basis.
Ambrx Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing optimized protein therapeutics known as bio-conjugates. The company is developing ARX201, a long-acting growth hormone that has successfully completed Phase IIb clinical trials. Ambrx has entered into antibody-drug conjugate (ADC) collaborations with Merck, Astellas, Bristol-Myers Squibb, and Zhejiang Medicine as well as collaborations to discover and develop products incorporating Ambrx technology with Bristol-Myers Squibb, Eli Lilly, and other undisclosed companies.
Its drug candidates include ADCs, bi- and multi-specific drug conjugates, and long-acting therapeutic proteins. Its most advanced ADC program is ARX788, an ADC for cancers expressing human epidermal growth factor 2, or HER2, for which the company intends to begin clinical trials in early 2015. Its most advanced long-acting proteins are ARX201, a once-weekly human growth hormone, or hGH, has successfully completed a Phase IIb clinical trial, and ARX328, a long-acting leptin for lipodystrophy and weight management, for which the company intends to submit an investigational new drug application to FDA in mid-2014. Its most advanced collaboration product candidate in human health is ARX618, a long-acting Fibroblast Growth Factor 21 for Type 2 diabetes, which its collaborator Bristol-Myers Squibb, has advanced through Phase I clinical trials and expects to begin Phase II clinical trials for in the second half of 2014, according to Ambrx.
The company’s technology creates proteins in both bacterial and mammalian cell systems to create bio-conjugates in the system most appropriate for a given product candidate. Its bacterial platform, ReCODE, has generated its most mature programs, including several collaboration programs and several internal programs focused on long-acting therapeutic proteins. It applies its mammalian platform, EuCODE, to generate the majority of its ADC product candidates.
In early May 2014, Ambrx filed a Form S-1 with the US Securities and Exchange Commission for an initial public offering.