AdAlta (ASX:1AD), a Melbourne-based biotechnology company working to advance its lead i-body candidate toward clinical development, has announced new agreements related to the development of its lead therapeutic program, AD-214.
The company announced Selexis SA has been appointed for cell line development. KBI Biopharma has been appointed for process development, analytical development, formulation development, and clinical manufacturing services.
The appointments follow an announcement in April AdAlta would take forward an improved version of its lead therapeutic program for the treatment of Idiopathic Pulmonary Disease (IPF).
The company said the new version, AD-214, is expected to deliver significantly improved half-life (duration of time the drug remains in the body), enhanced activity, and be applicable across a broader range of fibrotic disease areas making it more attractive to patients and potential pharmaceutical partners.
AD-214 is an Fc-fusion protein that contains two i-body molecules that bind with high affinity to the human target CXCR4.
"At the back end of AD-214 is the Fc fragment, or tail region, of a traditional monoclonal antibody that will extend the drug’s half-life," said the company. "As AD-214 is made using Fc-fusion technology, it requires an alternate manufacturing process to the original drug, AD-114."
“Selexis and KBI Biopharma have extensive experience and expertise in the development of manufacturing processes for marketed and late clinical stage biological compounds,” said AdAlta chief operating officer Dallas Hartman.
“We evaluated 12 proposals as part of the manufacturing tender process and liked the fact that Selexis and KBI have a strong track record of working together in an integrated manner to develop Fc-fusion protein-based drugs. We’re excited to get started with the manufacturing process and ensure AD-214 makes swift progress to the clinic.”
“Now that we have signed manufacturing contracts, Selexis will immediately start cell line development and we expect to have materials for the four-week non-human primate toxicology study in the second half of 2019 and be in the clinic in the first quarter of 2020,” said AdAlta CEO Sam Cobb.