AdAlta gets commercial-ready after pre-clinical safety studies show promising results

AdAlta (ASX: 1AD), the Australian biotechnology company pioneering new ‘i-body’ antibody technology, is gearing up to commercialise its lead drug program, AD-114, and enter the clinic following three successful pre-clinical safety studies.

Pre-clinical safety studies have shown AD-114, being developed to treat idiopathic pulmonary fibrosis (IPF) to be well-tolerated, with no mortalities or adverse effects.

AdAlta’s Managing Director and CEO, Sam Cobb commented: “We were very pleased with the way that AD-114 performed in our third non-human primate study. No off-target effects were observed – an encouraging sign that we may have a better therapy to offer IPF patients who currently have to live with the many unwanted side effects of the only two treatments currently on the market.

“A fourth toxicology study is expected to be completed in the first half of 2018.  That will complete the package of preclinical information required before AD-114 can move into human trials.  The final non-human primate study and clinical data will be required for the package of data that potential pharma partners will want to see.”

The i-body AD-114 differs from existing treatment options and others currently in clinical development as it binds to the chemokine receptor CXCR4. The target CXCR4 is expressed at low levels or absent in healthy tissue and is increased and at high levels in tissue affected by a number of disease states, including fibrosis. AD-114 is the only anti-CXCR4 drug candidate being developed for the treatment of fibrosis.

This month, AdAlta announced that it had been granted a key Australian patent to protect the use of AD-114 for the treatment of a number of diseases, including fibrosis. AdAlta has a portfolio of international and local patents protecting both its i-body platform and AD-114.

AdAlta also announced this month that it had signed a commercial agreement with German-based XL-protein GmbH, granting exclusive rights to apply PASylation® technology to extend the half-life of AD-114 in the human body. PASylated AD-114 will enable less frequent administration of AD-114 in the clinic, making it ideal for treating chronic conditions such as IPF.

AD-114 has been described by world-leading lung disease researcher Professor Cory Hogaboam from Cedars Sinai Medical Centre in the USA, as “hitting the sweet spot” and providing “a compelling case” for treating IPF. Earlier this year, AD-114 was spotlighted as a novel therapeutic approach to treating IPF at the inaugural global IPF Summit, where AdAlta presented alongside top researchers and drug developers from around the world.

AD-114 has been granted orphan drug status by the US FDA, and if approved, would be a first-in-class treatment. ‘Orphan’ drugs are those developed to treat a rare medical condition, and they are usually granted accelerated development and regulatory timelines.

“We’ve achieved so many significant milestones this year in the development of our lead i-body AD-114 and the platform provides further opportunity,” Sam Cobb said. “With a library of over 20 billion i-bodies, we have an opportunity to identify a therapeutic pipeline of drugs.”