Q+A: How this biotech CEO keeps the faith in a cancer cure
11m 58s
Imugene, a biotech company, reported encouraging half-year results despite ongoing losses and a significant drop in share price. Its lead therapy, Aesacell, has demonstrated high response rates in advanced lymphoma patients, with some achieving cancer-free status for nearly two years. The FDA has provided positive feedback on the company's strategy, which focuses on niche, rare cancers to accelerate approval through smaller, more efficient trials. Currently in Phase 1B trials, Imugene aims to advance quickly to later-stage studies or partnerships. Financially, the company is cutting costs and may seek acquisition by a larger pharmaceutical firm to fund further development. CEO Leslie Chong highlights the experienced team's history of successfully bringing drugs to market as a key strength, alongside Aesacell's potential in late-stage and earlier-line cancer treatments.
Welcome to Fear in Greed Q&A, where we ask and answer questions about business, investing, economics, politics and more. I'm Sean Aelma. Biotech company Imigene reported its half-year results yesterday. It's still lost making, but sharply cutting costs and seeing what appears to be genuinely encouraging clinical results. It's lead cancer therapy Aesacell, issuing strong response rates in difficult lymphoma cases with some patients cancer-free for nearly two years. The FDA has given positive feedback on the company's strategy, but at the same time, the company's share prices down around 80% over the last year. Leslie Chong is the CEO and managing director of Imigene. Leslie, welcome to Fear in Greed. Thanks so much for having me. I've got to ask upfront, the business you're in, how do you keep the faith because it is such a long process? That's a wonderful question. So look, I've been in the industry of cancer drug development. I dare say, for almost 30 years, 28 years to be exact, I started quite young, as you can imagine. It has been a lifelong dream to be able to have a drug that actually leads to that C word, which is a positive word of cure. I'm very happy and proud that I've been a part of that for most of my adult life now. Imigene, what are your best prospects or best prospects right now? I think it's Aesacell. Hands down. Aesacell is showing that those results that really gets you through to the marketing process. So you mentioned earlier, how do you keep the faith? You have to know how a drug works, and then you have to really cuddle it and nurture it so that the drug becomes beneficial to patients one day when it's marketed. Okay. So Aesacell, what is it? It's telling us what it does in plain English. So in plain English, we borrow A, not borrow, we get healthy donor T cells. We engineer those, genetically modify those. And so they're frozen, then shipped to our 10 unique sites in the US and five unique sites here in Australia. And then when a patient fails off of a lot of different therapies that exist and they initially work and then they fail, they can actually get our drug. And what we have seen so far is we've got 83% response rates in this very late advanced stage, diffuse large B cell lymphoma. And we've also seen 82% response rate in a, it's called another car T naive. It's another product, but it works differently because it's highly personalized and it gets the T cells from the patients themselves. So if they haven't received those because they're not approved for certain kinds of lymphoma, we have another cohort of patients that's also weeping benefit as well. You're doing very well here, Lyslick, so I'm following you so far, which is saying something in your space. What phase are you up to in terms of trials? So in these kind of therapies that are called chimeric antigen receptor T cell. So remember, it's a car T. And so in these therapeutics, they've actually gotten approvals quite early. So you run a phase one to show that it's safe, but within these car T therapies, they've shown that there's a huge amount of response rate 50% or greater and in blood cancers. Now that has been quite rare in previous therapeutics. So the FDA has been quite expeditious about marketing these and allowing patients to be able to receive these. So most of the time, car T's only had to do a phase one and then a phase two or so two phase of trials to get them approved, which is amazing. And so where's Isis cell up to? So we're at that really great spot where we're at phase one B. So bar progress phase one. And then we're also we've already gone to the FDA to get our strategy approved or a check mark by the FDA for a registration on study, which is the next phase. And it could be a phase two and it could be or it could be a phase three, but either or a combination of both, but one other study in order to get it approved. Okay. And so when will that what's the timeline you're hoping for on this? So I I given what we have seen with our current patient population, sooner the better, but as you know, the regulatory process is very long, laborious. I'm keeping the faith as you said, Sean, we're also looking at other options of increasing our patient pool by going into a niche indications of blood cancers. And we're seeing great results there. And the beauty of those is that the FDA really likes niche and rare kinds of cancers because they get to be the hero to approve those. And they allow for companies like ours and others to only have a small number of patients in order to get approval. So we are enrolling those patients in our phase one B study so that we go back to the FDA and say, Hey, look at these results. You've already okayed our bigger study that to market. We think that we have a real opportunity to make some big changes in this rare cancer type with this number of patients. And so we are hoping for a smaller much of the efficient. And it's what's what we call our fast to market strategy straight up. Okay. You're still running a business, Leslie. So that's kind of the medical side of it, but you're running a business and you have been cutting costs. You still you know, you raise money. You spend that money. You don't get to return necessarily for for years. How do you do that? Like, I mean, it's not just you that have to get the faith. It's your staff. It's your investors. It's everyone. That's right. So we are listed on the ASX. We do a capital raise, extend out the shares and folks can come in on the ride. And then the market also buys shares to own a percentage of the company, etc. So that's how sort of the market works. But what we hope one day and largely what happens to small biotech companies like ours is that they get bought out by big pharmaceutical company. So that's sort of the business that we're in. Where big pharmaceutical companies that have big pockets and big development strategies and resources to be able to run a larger phase two, three study so that they can market it. And then we get royalties, etc. But it's when they come in to partner with you is when things really get explosive. So it's not I mean, you are listed. So it's not private equity, but like a private equity strategy, a small private equity firm comes in, takes an interest in the company and then sells to a large private equity firm. It's not that dissimilar to that. Do do you have to get bought by a larger farmer company or can you ultimately do it on your own? You can certainly market the product yourself. It's a laborious row, but this is one of the reasons why we are coupling our opportunity and really strengthening our strategy for a marketable product. Because you can imagine for the first cohort that we have the what's called the diffuse large B cell lymphoma that have relapsed after a standard of care. That product is already pretty much checkmarked and we have a row to market. That study happens to be quite large with a number of patients. We think certainly we can win in that space. However, I think the best way to do this is to have a rare population and the FDA is being very kind to rare and niche indications. And so we can market the product or get get well underway before before big farmer takes great interest in a company like ours. Okay. If I'm an investor and we are not an investment podcast or anyone listing that is thinking about Immune gene going find some financial advice. We are not saying good or bad in any way whatsoever. But if I'm an investor, what is it that I should be attracted to Immune gene, particularly given your share price performance over the past 12 months? Biotech has had it pretty rough lately. Immune gene is no exception. However, Imaging has dedicated
clinical developers who have done this before. So between all of myself and my CMO, John Bayon and Ursula McCurray, we have something like 14 drugs that we've actually shepard through the development and have marketed. So we're a proven team one, two, we have a product that obviously is working in really late stage. So the thing you know about cancer is that every time you fell off of a therapy, it just gets harder and harder. And the tumor cancer just gets unfortunately slept, you know, really clever in finding an escape route. The fact that our patients have third line have felled off of mirrors of different therapies and some patients have six lines of therapy. And we're seeing a response rate complete, complete clearance of their cancer. Some with partial response, which means more than 50% of their cancer are gone. We know that this is working in a certain population, especially in late stage. So you can imagine if we bring it up a little bit closer to the earlier lines, it could possibly work better, especially in that rare niche population. We also have another strategy of combining with the blockbuster medication. And so this not only improves our registration pathway, but our commercialization. So we've got lots of clever things that we're doing with Acer cell and I could think of three things that I just mentioned now as a roadmap to either getting partnered or marketing our drugs ourselves. It's a really good luck with it all. Thank you for talking to Fear and Grade. Thank you for having me. I was Leslie Chong, CEO and managing director of Immune Gene. I'm Sean Alma and this is Fear and Grade, pure and day.
Podcast Summary
Key Points:
Imugene's lead cancer therapy, Aesacell, shows strong clinical results, including high response rates in advanced lymphoma cases, with some patients cancer-free for nearly two years.
The company is pursuing a fast-to-market strategy by targeting niche, rare cancers, which may expedite FDA approval and reduce the required patient pool for trials.
Despite promising clinical progress, Imugene faces financial challenges, with its share price down about 80% over the past year, and is cutting costs while exploring partnerships or buyouts by larger pharmaceutical companies.
The experienced leadership team has a track record of successfully developing and marketing multiple drugs, adding credibility to the company's prospects.
Summary:
Imugene, a biotech company, reported encouraging half-year results despite ongoing losses and a significant drop in share price. Its lead therapy, Aesacell, has demonstrated high response rates in advanced lymphoma patients, with some achieving cancer-free status for nearly two years. The FDA has provided positive feedback on the company's strategy, which focuses on niche, rare cancers to accelerate approval through smaller, more efficient trials.
Currently in Phase 1B trials, Imugene aims to advance quickly to later-stage studies or partnerships. Financially, the company is cutting costs and may seek acquisition by a larger pharmaceutical firm to fund further development. CEO Leslie Chong highlights the experienced team's history of successfully bringing drugs to market as a key strength, alongside Aesacell's potential in late-stage and earlier-line cancer treatments.
FAQs
Imigene's most promising therapy is Aesacell, which has shown strong response rates in difficult lymphoma cases, with some patients cancer-free for nearly two years.
Aesacell is a chimeric antigen receptor T-cell (CAR-T) therapy that involves genetically modifying healthy donor T-cells, freezing them, and shipping them to treatment sites for patients who have failed other therapies, showing high response rates in advanced lymphomas.
Aesacell is currently in phase 1B trials, and Imigene has engaged with the FDA to plan the next registration study, which could be phase 2, phase 3, or a combination.
Imigene is focusing on niche or rare blood cancer indications, which the FDA favors for faster approval with smaller patient cohorts, as part of a 'fast to market' strategy.
Imigene aims to either market its products independently or, more commonly, be acquired by a larger pharmaceutical company with resources for advanced trials and commercialization, potentially earning royalties.
Investors may be attracted by Imigene's experienced team with a history of developing marketed drugs, promising clinical results in late-stage patients, and strategies like combination therapies to enhance commercialization.
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