Drug hope for lung fibrosis

Dr Michael Foley of AdAlta Limited talks new therapeutics and the Australian biotech industry

By Dr Giselle Roberts

LIMS-embedded biotech, AdAlta Limited, is riding the crest of a discovery wave. When I met Chief Scientific Officer, Dr Michael Foley, he and researcher Dr Kate Griffiths were in the midst of putting the final touches to their Scientific Reports paper. The ground-breaking research, in collaboration with the Alfred Hospital and Cedars-Sinai Institute in the United States, shows that AdAlta’s candidate drug, AD-114, has the potential to bring idiopathic pulmonary fibrosis (IPF) “to a grinding halt,” as Foley proudly explained.

It is big news for the Australian biotech, which now plans to take its innovative class of protein therapeutics to clinical trial.

Understanding IPF

GR: OK, let’s start at the very beginning. What is fibrosis?

MF: Fibrosis is a result of inflammation or damage to vital organs in the body. Collagen buildup occurs causing scarring of the lungs, liver, skin, eyes, heart or kidneys. It is present in 45% of all diseases and leads to irreparable damage and eventual organ failure. A liver or kidney infection, for example, can lead to fibrosis, and macular degeneration can eventually lead to scarring of the retina and blindness.

GR: And AdAlta are working on idiopathic pulmonary fibrosis, or IPF.

MF: IPF is a specific type of lung fibrosis. It is characterized by a decline in lung function, and many patients also complain about a persistent, dry cough. There’s no cure, and most patients live only three to five years after diagnosis.

GR: How prevalent is it?

MF: IPF is relatively rare, but still affects over 135,000 people in the United States, with about 48,000 new cases being diagnosed annually. In the US 40,000 people die each year from IPF, the same mortality rate as breast cancer. The disease affects about 100,000 people in Europe and 5,000 people in Australia.

GR: What treatment options are currently available?

MF: There are two therapeutic drugs on the market. They slow down disease progression, but don’t stop it, and they have serious side effects including sensitivity to sunlight and nausea.

Clinical pathways

GR: OK, so AdAlta has used its technology platform to generate a new class of protein therapeutics known as i-bodies – and your fibrosis drug candidate is one of them. What are they?

MF: An i-body is a human protein that combines the advantages of small molecules (for stability) and antibodies (with a high affinity and specificity for treating certain illnesses) into one powerful treatment. We have developed this technology platform from scratch based on information gained from a unique class of antibodies only found in sharks.

GR: And the i-body for IPF is unique in what way?

MF: Our candidate drug, AD-114, blocks a particular protein that is believed to play a critical role in the recruitment of fibrotic cells to the lungs. It shows strong therapeutic promise in preclinical studies, not only for IPF, but for other types of fibrosis like that caused by macular degeneration in the eye.

GR: That success has certainly translated into investor confidence for AdAlta. Raising $10 million in your initial public offering in 2016 must certainly help to pave the way for clinical trials.

MF: Yes, that was the main reason behind AdAlta’s ASX bid, and we hope to get to Phase I clinical trials by the end of the year. It’s ambitious, but we think that we can do it. We want to take this as far as we can, see our drug candidate work in IPF patients, and ultimately find out if it makes a difference to their quality of life or life expectancy.

GR: It’s an incredible feat for a relatively small Australian biotech company. How do you do it?

MF: AdAlta has a really committed management team and an exceptional scientific advisory board. We are constantly reviewing our strategy and mapping the best way forward. We draw on areas of expertise and we collaborate with scientific leaders in the field. Small companies need to be nimble and clever in terms of who they partner with. We don’t have hundreds of people working for us, so we have to be selective in what we do and what we give to others. I’ve always found ‘logistics’ and ‘strategy’ to be boring words, but it’s what we do every day.

Biotech boon

GR: AdAlta was established in 2007, and you have been in the trenches from the very beginning. How does it feel to be a scientist working in industry?

MF: When I went into biotech I thought, “This is going to be completely different.” But, in reality, good science is the foundation of the biotech industry, and I have always found that very refreshing. At the end of the day, you have to come up with the data. You also have to build strong collaborations, build trust among your investors, be aware of what you are good at, and do it well. First and foremost, you have to build a good scientific team.

GR: Because good science is what it is all about.

MF: Deep down, I love the science and being involved with a great group of people who are trying to take something through to the clinic. Very few scientists get to do that. I’m still as enthusiastic as the day I started. You have to be in this business, because it is not without its frustrations. Even now, I still go home and look at sequences or gels and wonder, “What is going on here, and what else can we do?” Sometimes I think, “This is great,” and sometimes I think, “Hang on, this might be too good to be true!” I try not to find the things I want, but, instead, discover the things that are there. That’s how the important discoveries are made.

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