Transcription of The Stock Network Interview with Arovella Therapeutics (ASX:ALA), CEO and Managing Director Dr Michael Baker
Lel Smits: Arovella Therapeutics is a biotechnology company developing invariant natural killer T-cell therapies for the treatment of blood cancers and solid tumors. In January this year Arovella achieved a major regulatory milestone with the US FDA acceptance of its investigational new drug for lead program ALA101, validating its preclinical data manufacturing process and clinical development plan and clearing the path for a first in-human phase one trial. The investigational new drug acceptance also establishes a regulatory framework for Arovella’s broader CAR-INKT platform, supporting the advancement of additional programs including ALA105 for gastric cancer.
Ahead of Wholesale Investors Emergence 2026 conference, I’m joined by CEO and Managing Director Dr Michael Baker to discuss the significance of this milestone and what comes next as Arovella enters the clinic. Michael, welcome to the Stock Network.
Dr Michael Baker: Thank you for having me.
Lel Smits: Now the FDA has accepted Arovella’s investigational new drug for ALA101, allowing the company to begin its first in-human phase one trial. What does this investigational new drug acceptance mean for Arovella at the company level and also why is it such an important inflection point as you move from preclinical development into the clinic?
Dr Michael Baker: Excellent question and it is a huge milestone. So it’s a major operational and regulatory achievement for the company and I have to say the team did a fantastic job putting all of the information together and responding to the FDA’s responses and what it does is it validates our preclinical manufacturing and clinical development plans from one of the world’s major regulatory bodies, the Food and Drug Administration in the US, the FDA.
So why that’s important for us as a company is what that means now is we’re in a position where we are able to start advancing and accelerating our plans to take ALA101 into phase one clinical studies for patients with CD19 positive lymphoma and leukemia. So essentially this is a really big catalyst that starts making very clear the transition from Arovella being a preclinical stage company into a clinical stage company.
Lel Smits: Excellent and alongside ALA101, Arovella is advancing a broader CAR-INKT platform including solid tumor programs such as ALA105. How does the successful IND for ALA101 help de-risk and accelerate the development of the wider pipeline and also what do you think investors should be watching over the next 12 months?
Dr Michael Baker: Yeah that’s a really important point actually and making that very clear. The IND for ALA101 is really important but what it does really is a huge step forward for each of our programs that will come behind that product because what it means is we now have the framework for the IND submission and when we think about what Arovella is developing in terms of the cell therapy, the bulk of that is manufacturing that goes into these products. For our next program ALA105 which we’re developing for gastric cancer and pancreatic cancer, so much of that manufacturing process stays the same.
We change one major raw material called the lentiviral vector so when it comes to preparing all the information required for the IND submission for that we expect much of those sections will already be written because a lot of them will stay the same. So in short what we expect out of that is a much faster and more cost-effective way to take our future programs into clinical trials which is terrific. So over the next 12 months we’ve got quite a busy year ahead as you can imagine.
Main goal is naturally is to get ALA101 into clinic as quickly as we can and there’s a series of steps that we need to take in order to do that. Getting clinical trial sites on board and activated, a human research ethics committee submission followed by enrolling sorry screening enrolling and dosing the first patient and then we are expecting some more solid tumor data for our other program ALA105 but also some more commercial activity as we look to bring new technologies into the company.
Lel Smits: Well Michael congratulations again on this massive milestone for the company and look forward to hearing more from Arovella Therapeutics as the year goes on.
Dr Michael Baker: Thank you, much appreciated.