A video series covering the 2020 Investor Briefing, where senior leaders from AdAlta reviewed the three significant recent achievements for a lead product candidate, AD-214, and AdAlta’s strategic program.
CEO Update Investor Briefing March 2020
AdAlta Chief Executive Officer & Managing Director, Dr Tim Oldham, discusses AdAlta’s recent milestones, vision and strategic plans.
Individual Speaker Presentations
AdAlta Chair, Paul MacLeman introduces the 2020 Investor Briefing and reviews three significant recent achievements for lead product candidate, AD-214.
Vision and strategic goals
AdAlta CEO, Tim Oldham summarises the AdAlta vision and strategic plan, presents a case study illustrating what is required to realise the plan, and describes the key strategic priorities and metrics that will drive success. AdAlta’s purpose is to use its i-body platform to develop novel protein therapeutics against drug targets that have proven difficult to drug with traditional antibodies. In order to maximise the number of drugs developed from the i-body platform, AdAlta will develop an internal pipeline of drugs targeting GPCRs in fibrosis, inflammation, and oncology and enter co-development partnerships for drugs against other difficult targets and in other therapeutic areas. Near term priorities are: progress AD-214 into clinical trials and expand indications; develop an internal pipeline of 5 product candidates targeting GPCRs; develop an external pipeline through 3-5 co-development partnerships, and continue to invest in improving the i-body platform and AD-214 product.’
AD-214: pre-clinical update and PET tracer
AdAlta CSO, Mick Foley describes the significance of three significant recent achievements: winning a $1m competitive grant to develop a radio-labeled version of AD-214 to enable PET imaging in patients, significantly improving the value of our Phase I program; demonstrating efficacy of AD-214 in the gold standard animal model of Idiopathic Pulmonary Fibrosis (IPF), enabling progress into Phase I trials; and demonstrating that AD-214 binds to its target, CXCR4, for longer than the circulating half-life in blood plasma, going confidence that a weekly or longer dosing schedule may be possible and confirming the Phase I dosing schedule. Professor Foley also describes the work AdAlta is doing to extend indications for AD-214 beyond IPF.
AD-214: Phase 1 clinical strategy
AdAlta’s Vice-President Clinical Product Development, Claudia Gregorio-King discusses the two-part Phase I program for AD-214 incorporating an initial healthy volunteer cohort and then rapidly moving to patients with fibrotic interstitial lung disease (ILD) including IPF. Dr Gregorio-King also reviews potential Phase II trial size and scope.
Pipeline and partnership expansion
AdAlta CEO, Tim Oldham describes AdAlta’s sweet spot for internal projects (drugs acting on GPCRs implicated in fibrosis, inflammation or oncology where the GPCR has been validated as a disease target and previous attempts to drug the target have been unsuccessful); the describes the processes for selecting these projects, securing co-development partnerships on other targets and out-licensing internal projects such as AD-214.
Continuous i-body platform and AD-214 product improvement
AdAlta COO, Dallas Hartman, outlines strategies for continuous improvement of the i-body platform (to extend intellectual property and improve discovery efficiency and manufacturability of discovered i-bodies); and for continuous improvement of AD-214 processes and formulations to maximise the number of indications and dose levels for which the drug can be used.
AdAlta CEO, Tim Oldham brings the strategic themes together into a roadmap for R&D and financing for the next three years. The roadmap comprises a near term focus on maximising data generated as AD-214 moves into the clinic for the healthy volunteer part of the Phase I program, catalysing growth options; an expansion of these options during the second part of the AD-214 program through investments in i-body2.0, new indication proof of concept and initial discovery on new targets; and acceleration of growth as major investments in the internal pipeline are made and partnering efforts come to fruition.