AdAlta, a biotech that develops protein-based therapeutics, has retained FujiFilm Diosynth Biotechnologies to manufacture AD-114, AdAlta’s lead drug molecule for the treatment of idiopathic pulmonary fibrosis (IPF).
AdAlta is using its proprietary technology platform to create i-bodies, a new class of protein therapeutics that are the human equivalent of the antigen-binding domain of shark antibodies. According to a company press release, i-bodies combine the advantages of monoclonal antibodies (high target specificity and affinity) with the stability features of small molecules, and include the long binding loop that is particular to shark antibodies and enables the i-body to recognize and bind to a diverse range of therapeutically-relevant drug targets, including such difficult but important targets as G-protein coupled receptors (GPCRs) and ion channels.
FujiFilm, under the agreement, will oversee the process of development, formulation, and manufacture of AD-114 using its proprietary aPVEway advanced protein platform, a technology developed to produce proteins in bacteria, which has been proven its effectiveness in over 90 biologics.
“We are looking forward to applying our versatile pAVEway expression system with such an innovative company as AdAlta with its unique i-body platform, and helping the company bring its novel biologic treatment, AD-114, to patients in need,” Steve Bagshaw, FujiFilm’s chief executive officer, said in the release.
Initial molecules produced at FujiFilm’s facilities in the U.K. will be used in animal and toxicology studies.
AdAlta is primarily focused on the treatment of fibrotic diseases. AD-114 is the company’s leading i-body candidate for the treatment of IPF and other human fibrotic diseases that currently have sub-optimal treatments.
According to the company, AD-114 has key advantages for IPF treatment, including:
- Specificity for diseased human tissue — with effects shown on IPF tissue without off-target impact on normal lung tissue
- Higher efficacy than previously approved IPF drugs — According to the company, AD-114 showed greater in vitro efficacy compared to Ofev (nintedanib) and Esbriet (pirfenidone), two FDA-approved IPF treatments
- Anti-inflammatory effects — research in multiple animal models has shown that AD-114 has both anti-fibrotic and anti-inflammatory effects.
“The execution of this contract is an important step forward in the manufacture of our lead candidate. We have been impressed with the work already completed by the team at FujiFilm and expect to proceed rapidly with manufacturing of preclinical material for animal and clinical studies,” said Sam Cobb, AdAlta’s chief executive officer.