Ambrx and Wyeth signed a worldwide alliance that aims to discover, develop, and commercialize protein drug candidates against three targets in multiple disease areas. Ambrx will receive up-front payments and research funding as well as development and regulatory milestones and tiered royalties.
Ambrx’s core patented technologies, ReCODE™ and EuCODE™, have been developed to enable the site-selective substitution of novel (i.e. unnatural) Ambrx amino acids at any site within a protein to which the precise coupling of polyethylene glycol (PEG) can be effected. Ambrx says that by analyzing a number of site-specific protein variants, it can rapidly select molecules with the best overall profiles for further evaluation as drug candidates. The company’s technologies can also be used more broadly to site-specifically couple a diverse array of molecules to a protein, creating a range of novel protein-based products.
Ambrx is developing a pipeline of candidates for growth deficiency, multiple sclerosis, type II diabetes, obesity, and oncology. The company says it aims to have four to five clinical-stage programs by early 2010, including a number of wholly owned programs.
Lead product, ARX201, is a long-acting human growth hormone, currently in Phase II trials. It is being developed in partnership with Merck Serono. In February the companies expanded their collaboration to include the development and commercialization of ARX424, Ambrx’ preclinical product f or the treatment of multiple sclerosis.
Another preclinical candidate, FGF21, is a novel protein with biological properties similar to fibroblast growth factor 21, according to Ambrx. It is being developed in partnership with Merck & Co. for type 2 diabetes and related metabolic disorders.
Ambrx also has a drug discovery alliance with Eli Lilly in multiple therapeutic areas including metabolic diseases and central nervous system disorders.
Ambrx’s lead unpartnered program is a long-acting interferon-beta. The company claims the molecule has demonstrated enhanced in vivo potency (> twofold) and pharmacokinetics (19-fold increased exposure) when compared with currently marketed interferon beta products.