MELBOURNE Australia, 1 July 2021: AdAlta Limited (ASX:1AD), the clinical stage biotechnology company developing novel therapeutic products from its i-body platform is pleased to announce that it has accepted a clinical resupply proposal with KBI Biopharma Inc, USA (KBI Biopharma) to ensure supply of bulk AD-214 drug substance for future clinical trials.
Global contract manufacturing capacity for biological drugs such as AD-214 is increasingly constrained due in part to the demands of COVID-19 vaccine production on both production capacity and raw material supply chains, resulting in extended production lead times.
Dr Tim Oldham, AdAlta’s Chief Executive Officer, said: “Securing production capacity for future clinical supplies of AD-214 now provides increased timeline certainty for AdAlta and our potential partners. The full results of our current clinical programs, indication prioritisation initiatives and partnering efforts will shape future clinical trials. This resupply ensures that we can minimise the time required to progress AD-214 into those future clinical trials.”
The clinical resupply services will be delivered under AdAlta’s contract development and manufacturing Master Services Agreement with KBI Biopharma that was announced on 5 June 2018. Manufacturing is scheduled to supply material for clinical use in early 2023. The cost of resupply is paid as each manufacturing activity is completed. Final cost depends on the eventual batch size and optional ancilliary services selected by AdAlta but is in line with AdAlta’s expectations and the costs of previous batches.
KBI Biopharma has previously manufactured the AD-214 drug substance being used in AdAlta’s current Phase I clinical program and AdAlta has sufficient AD-214 drug product on hand to complete the Phase I/Ib clinical trial program described in the Company’s 10 March 2021 update.
KBI Biopharma, a JSR Life Sciences Company, is an award-winning biopharmaceutical contract services organization providing fully integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of our 300+ client partners, KBI Biopharma have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, KBI Biopharma deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. KBI Biopharma have locations in Durham and Research Triangle Park (NC), Boulder and Louisville (CO), The Woodlands (TX), and Leuven, Belgium. More information is available at www.kbibiopharma.com
AdAlta Limited is a clinical stage drug development company headquartered in Melbourne, Australia. The Company is using its proprietary i-body technology platform to solve challenging drug targeting problems and generate a promising new class of single domain antibody protein therapeutics with the potential to treat some of today’s most challenging medical conditions. The i-body technology mimics the shape and stability of a unique and versatile antigen-binding domain that was discovered initially in sharks and then developed as a human protein. The result is a range of unique proteins capable of interacting with high selectivity, specificity and affinity with previously difficult to access targets such as G-protein coupled receptors (GPCRs) that are implicated in many serious diseases. i-bodies are the first fully human single domain antibody scaffold and the first based on the shark motif to reach clinical trials.
AdAlta is conducting Phase I clinical studies for its lead i-body candidate, AD-214. AD-214 is being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other human fibrotic diseases, for which current therapies are sub-optimal and there is a high unmet medical need.
The Company is also entering collaborative partnerships to advance the development of its i-body platform. It has an agreement with GE Healthcare to co-develop i-bodies as diagnostic imaging agents against Granzyme B, a biomarker of response to immunooncology drugs, a program now in preclinical development.
AdAlta’s strategy is to maximise the products developed using its next generation i-body platform by internally discovering and developing selected i-body enabled product candidates against GPCRs implicated in fibrosis, inflammation and cancer and partnering with other biopharmaceutical companies to develop product candidates against other classes of receptor, in other indications, and in other product formats.