AdAlta Investor Briefing 2021

This video series covers AdAlta’s 2021 Investor Briefing.

At the briefing, CEO Tim Oldham, VP Clinical Product Development Claudia Gregorio-King and Prof Glen Westall, a leading respiratory and lung fibrosis specialist, discussed the Company’s strategic progress and top-line results from Part A of the Phase I clinical trial of AD-214.


Highlight
Tim Oldham, CEO and Managing Director

AdAlta Investor Briefing March 10, 2021

Adalta (ASX:1AD) Chief Executive Officer & Managing Director, Dr Tim Oldham, talked about the positive progress from AdAlta’s AD-214 Part A of the Phase I trial and how the results.


Investor Update: Tim Oldham, CEO and Managing Director.

Investor Briefing March 10, 2021

 

Adalta (ASX:1AD) Chief Executive Officer & Managing Director, Dr Tim Oldham, talked about the positive progress from AdAlta’s AD-214 Part A of the Phase I trial and how the results have led to expanded opportunities for the company, the initial clinical validation i-body platform and how it has now also strengthened AdAlta’s asset creation options. Dr Oldham also discussed the significant milestones achieved since March 2020.


AD-214 Phase I HV SAD top-line results
Claudia Gregorio-King, Vice President, Clinical Product Development

AdAlta Investor Briefing March 10, 2021

AdAlta (ASX:1AD) Vice President, Clinical Product Development Claudia Gregorio-King, gave a detailed explanation of the preliminary healthy volunteer single dose results. In the discussion, Claudia explained AD-214’s excellent safety profile, how AD-214 engages the CXCR4 receptor, and how the results showed that receptor occupancy was sustained at high levels for an extended period of time.


Context: importance for IPF
Professor Glen Westall, Leading respiratory and lung fibrosis specialist

AdAlta Investor Briefing March 10, 2021

Leading respiratory and lung fibrosis specialist, Professor Glen Westall, spoke about the global environment for lung fibrosis, the limitations of available treatments and the significance of AdAlta’s recent initial clinical results and AD-214 development approach.


Looking ahead
Tim Oldham, CEO and Managing Director

AdAlta Investor Briefing March 10, 2021

AdAlta’s (ASX:1AD) CEO and Managing Director Tom Oldham discussed AdAlta’s long- and short-term strategic goals, reaffirming benefits of the redesigned Phase I program for AD-214. Dr Oldham also explained how clinical and commercial validation of i-body platform is unlocking new possibilities for pipeline expansion, allowing AdAlta to become a multi-asset company.


Full presentation pack

Looking back on Pulmonary Fibrosis Awareness Month 2020

 

As September draws to a close, we’d like to look back on Pulmonary Fibrosis Awareness Month.

While the world has changed immensely in 2020, the need to develop a better treatment for pulmonary fibrosis remains as acute as ever.

In commemoration of the month, we’d like to share this 2017 blog post with Specialist Respiratory and Transplant Physician, Dr Glen Westall.

In the post, Dr Westall discusses Idiopathic Pulmonary Fibrosis (IPF) and his first-hand experience with the disease.

Associate Professor Glen Westall – Specialist Respiratory and Transplant Physician

Associate Professor Glen Westall has worked in the field of lung fibrosis for more than 15 years, published over 70 original research manuscripts and co-authored 8 book chapters in the field of lung fibrosis and lung transplantation.

Yet despite his extensive knowledge about the disease, Idiopathic Pulmonary Fibrosis (IPF) can still surprise him.

“Medical text books suggest that most diseases behave similarly, however the human experience tells us otherwise,” said Assoc. Prof Westall.

“Some patients with IPF can be stable for decades, whilst others often have a very aggressive disease that deteriorates rapidly.”

A highly regarded specialist based at The Alfred, Assoc. Prof. Westall’s interest in lung fibrosis was sparked more than 15 years ago when he worked in London as a registrar in the Royal Brompton Hospital’s Lung Fibrosis service under two giants in the field, Prof Ron du Bois and Prof Athol Wells.

“Back then, we had no treatments for IPF, we were heavily involved with clinical trials, recognising that without treatment, IPF was a progressive and typically fatal condition.

“We are entering an exciting era for lung fibrosis. We now have two antifibrotic agents, Nintedanib and Perfenidone that are available in Australia. More importantly, there are a large number of phase 1 and phase 2 studies running or in the pipeline evaluating new antifibrotic agents”

“Whilst we are making progress, there remains much work that still needs to be done in understanding IPF, both at a patient and a scientific level.”

AdAlta to present on 29 July at IRD Invest

AdAlta Limited (ASX: 1AD) is pleased to announce that Dr Tim Oldham will present at the IRD Invest virtual investor conference on Wednesday, 29 July 2020 at – 11:30 am AEST. Dr Time Oldham will provide an update on the recent developments and future plans at AdAlta.

The event is free to attend and investors are invited to register, ahead of time via the following link:

https://www.irdepartment.com.au/site/irdinvest

Once the registration form is completed, investors will receive a confirmation email with detail on how to access the briefing.

Moving AD-214 into the clinic: AdAlta’s coming of age moment

AdAlta recently achieved a transformational milestone, with ethics approval of our phase I human trial for lead candidate AD-214 marking our successful transition to a clinical stage biotechnology company.

The approval is the first independent review of our complete pre-clinical development package and confirms that we have completed all the necessary safety and efficacy testing to support progressing the development of AD-214 into human clinical studies, a milestone that the AdAlta team has been working towards for many years.

Our CEO Dr Tim Oldham says that ethics approval is a “coming of age moment”, and notes the milestone is important for three reasons.

“It validates the quality of the work we have done to date on AD-214, it proves that we can develop a drug all the way from discovery through to clinical stage, and this study will help validate our entire platform,” he says.

“I’m incredibly proud of this achievement and incredibly grateful to everyone who has been involved on our journey so far and to those who will be involved in our study as we work towards improving outcomes for those patients suffering the debilitating effects of ILD and IPF.”

For more information on the significance of ethics approval, watch the video interview with Dr Oldham here.

Our announcement on ethics approval was also featured in online financial news outlet, The Sentiment. You can read the article here.

About the phase I study of AD-214

The first subject in the phase I study is expected to receive AD-214 in the second half of July and top-line safety results from the healthy volunteers are expected to be available at the beginning of CY2021.

Subject to satisfactory completion of Part A of the trial, initiation of Parts B and C of the trial in patients with Interstitial Lung Disease (ILD), including patients with Idiopathic Pulmonary Fibrosis (IPF), is expected early in 2021. The primary end point of the trial is safety and tolerability of AD-214. The trial is not designed to show evidence of efficacy against ILD or IPF.

CEO, Dr Tim Oldham interviewed by Pitt Street Research

Our CEO, Dr Tim Oldham was recently interviewed by Stuart Roberts of Pitt Street Research about AdAlta’s growth strategy and upcoming Phase 1 clinical trials of lead candidate, AD-214 which are due to commence in mid-2020.

In the interview, Dr Oldham speaks about how AdAlta is “the first company to use the CXCR4 axis to attack fibrosis” and how AdAlta is targeting a larger market than IPF with multiple disease indications for AD-214.

To view the interview, click here.

 

 

 

 

 

 

 

 

CEO Dr Tim Oldham speaks about i-body development in Insights Care

AdAlta CEO Dr Tim Oldham was recently profiled by online healthcare magazine, Insights Care.

Tim spoke about the development of the i-body platform, AdAlta’s recent achievements and the Company’s mission to develop multiple i-body based drugs against challenging to access drug targets to address substantial unmet medical needs.

To read the article, click here.

Article by CSO Mick Foley on next-generation antibody like therapeutics published in EBR

An article by our Chief Scientific Officer Mick Foley reviewing the emergence of next-generation antibody like therapeutics including I-bodies was published in the latest issue of European Biopharmaceutical Review (EBR).

To read the article, click here.

For the contents of the current issue of EBR, click here.

 

Disclaimer:
This article is taken from European Biopharmaceutical Review April 2020, pages 32-35. © Samedan Ltd

Investor Briefing March 2020

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

Welcome announcement

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.


Staging growth

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.

Full presentation pack