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AdAlta: A New Paradigm of Therapeutic Antibodies

Dr. Tim Oldham | AdAlta

Bacteria, viruses and disease are an ever-present threat in our lives. However, due to our complex immune system we are able to potentially fight off illnesses through disease-fighting molecules called antibodies.

AdAlta Limited (ASX:1AD) is an ASX-listed biotechnology company that is using its powerful technology platform to generate a promising new class of single domain antibody protein therapeutics that have the potential to treat some of today’s most challenging medical conditions.

It has pioneered a technology that mimics the shape and stability of a crucial antigen-binding domain, discovered initially in sharks and then developed as a human protein. The result is a range of unique compounds, or i-bodies, that are capable of uniquely interacting with previously challenging to access targets such as G-protein coupled receptors (GPCRs) that are implicated in many serious diseases.

The further advantage of i-bodies is their ability to bind with high affinity and specificity to a drug target, like a traditional monoclonal antibody, reducing the off-target side effects commonly associated with small molecule drugs.

AdAlta was established 12 years ago with three pieces of IP from an academic collaboration known as the Cooperative Research Centre for Diagnostics, made up of multiple academic institutes and commercial parties in the field of developing novel diagnostic tests and technologies. The Company listed on the Australian Securities Exchange in 2016.

It is developing its lead i-body drug candidate – AD-214 – for treatment of a range of fibrotic diseases, the first of which is Idiopathic Pulmonary Fibrosis (IPF), a type of fibrosis of the lung. AdAlta is currently preparing for its Phase I clinical studies for AD-214, with the clinical program expected to commence in mid-2020.

In an interview with Insights Success, Dr. Tim Oldham, the CEO of AdAlta shares his perspectives and opinions about the company, its vision and mission, and AdAlta’s major accomplishments and upcoming milestones.

Below are the highlights of the interview:

IS: What are the pioneering healthcare solutions your company is developing?

AdAlta’s i-body platform has unique capabilities for drug development. We are focused on challenging to access drug targets where traditional small molecule and antibody technologies have not been able to deliver optimal therapeutic outcomes. Our lead internal program is a case in point.  AD-214 is being developed to improve outcomes for fibrotic disease, including IPF.

A GPCR known as CXCR4 is known to be involved in fibrosis. However, it is also involved in regulation of blood stem and immune cells which should not be activated chronically (any IPF treatment would be chronic (continuous) therapy). The only approved drug targeting CXCR4 is used for stem cell mobilisation.

It also happens to be anti-fibrotic but is toxic when used chronically. AdAlta’s innovation has been to discover an i-body that can block CXCR4’s fibrotic signalling, but not affect stem cell mobilisation, making it a potential first-in-class drug for IPF and fibrotic diseases. We aim to progress AD-214 into clinical trials in mid-2020.

IS: What are the major threats and challenges your company faces? What has been your strategy to overcome these?

Drug development, particularly biological drug development, has very high rewards when it is successful, but is a risky and expensive process. Financing such programs is always a challenge and we’ve been very fortunate to attract some high-profile, patient investors in our company to date.

Our scale is also a challenge – today we are critically dependent on success of a single product, AD-214, and diversifying the pipeline to reduce risks is a key goal (though this increases cash requirements in the near term).

Addressing these challenges requires a very clear strategy for the pipeline, patient investors aligned with the strategy, great execution, and biology that delivers the hoped-for outcome. We can control all but the last and this, then, is the focus of the leadership team.

Unfortunately, biology does not always behave as expected or hoped for. For example, AdAlta changed the format of its lead i-body just prior to moving it into clinical trials and this required repeating significant manufacturing and pre-clinical work. Whilst that affected our original clinical program timeline, we made the decision to transition as AD-214 retains the unique therapeutic benefits of AD-114 but delivers enhanced activity and manufacturability. AD-214 is also expected to be more attractive to patients and potential pharma partners.

IS: Can you elaborate on your company’s major accomplishments? Please mention any awards or accolades you have received so far, if any.

In the past year, AdAlta has successfully completed a Good Laboratory Practice (GLP) non-human primate toxicology study to evaluate the safety and toxicology of AD-214, an essential pre-requisite to initial human studies.

We successfully completed AD-214 cell-line and manufacturing process development and completed manufacturing of clinical (GMP grade) AD-214 bulk drug substance. And we were awarded a Biotechnology Translational Bridge (BTB) program grant from the Australian Medical Research Futures Fund (MRFF) to develop a radiolabeled PET imaging agent version of AD-214. It will significantly enhance the information we can obtain about AD-214 through initial human studies.

On the partnership front, we entered a partnership with GE Healthcare to develop pre-clinical targets for diagnostic imaging and received our first ever partnering revenue. We also entered  collaboration with UK-based research organisation, Excellerate Biosciences, to identify i-bodies with unique efficacy, safety and duration and determine which ones are best-in-class for binding to certain drug targets, specifically certain G protein-coupled receptors (GPCRs).

AdAlta was named as a finalist in the Australian Technologies Competition in 2018 and last year, was named as a Company to Watch in the ANZLF Trans-Tasman Innovation and Growth Awards.

IS: What is your perspective on the status of the Asian healthcare industry?.

Asia’s healthcare industry is at an exciting stage. Ten years ago, it was regarded as a second- or third-tier market where local players were largely copiers of western drugs. The markets have now matured significantly, both in quality of access to healthcare (so that Asia and China in particular are now high on everyone’s partnering list) and local innovation. We have also seen Japanese pharma increasingly globalise.

IS: What it the outlook for your company over the next few years? What are some of the expected milestones?

AdAlta’s mission is to develop multiple i-body based drugs against challenging to access drug targets from its platform to address substantial unmet needs. It will use its ‘coming of age’ as a clinical-stage biotech company to accelerate and expand the level of activity on its two revenue streams: development of carefully selected internal product candidates into clinical proof of concept prior to licensing to big pharma (more AD-214’s); and developing more partnerships where we co-develop drugs from our platform against targets brought to us by partners (more GE-like deals).

IS: What would your advice be for budding medical science enthusiasts and health-tech entrepreneurs?

Biotech and health technology are not for the faint hearted. You need persistence, resilience and access to great mentors and advisers. Above all, it is really important to start with the end in mind: ‘What product will customers (usually governments or insurers) pay for?’ I see too many elegant technical discoveries that are not being developed into a useful product because there has not been a consideration of what partners and customers will actually pay for.

About the Leader

Dr. Tim Oldham became CEO of AdAlta in October 2019 following a more than 20-year career developing strategy and building growth businesses in pharma companies and biotechs in Europe and Asia. He sees an opportunity to leverage the “coming of age” moment for any platform company that is getting its first product into clinical trials to accelerate the growth of the company and significantly expand its pipeline. This requires continued focus on delivering lead product candidate AD-214 into clinical trials in mid-2020; development of target selection processes to make smart choices about new products to add to the pipeline; and expanding the product pipeline through internal and partner programs. This of course requires additional funding – linking the new, expanded vision for AdAlta with an achievable operating strategy and a financing strategy that continues to build value for existing and new shareholders is a key objective for Dr Oldham and his team.



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