HaemaLogiX earlier this week announced it has received TGA approval to commence a Phase 1 clinical trial of its KMCAR™ CAR-T cell therapy targeting multiple myeloma, marking a key milestone for the privately held biotech as it moves closer to a potential market listing.
Executive director and chief scientific officer Dr Rosanne Dunn said the approval enables the company to initiate its first-in-human study using its proprietary CAR-T platform, which modifies a patient’s own T cells to recognise and destroy myeloma cells. She highlighted that the therapy targets a highly specific marker found only on myeloma cells, which may support an improved safety profile compared to existing treatments.
Dunn noted that current therapies often affect normal immune cells, leading to severe complications. She stated that a significant proportion of patients die from infections rather than the cancer itself, describing these as “non-relapse deaths” linked to immune suppression caused by treatment.
The Phase 1 trial is expected to begin treating patients within months, subject to ethics approval, and will be conducted at the Peter MacCallum Cancer Centre. The company anticipates a steady stream of news flow through patient updates and interim data readouts.
In parallel, HaemaLogiX is advancing its monoclonal antibody therapy, KappaMab, into a Phase 2b trial. Dunn said the program has already demonstrated both safety and efficacy, with results published in 2023. She added that the study is designed with the potential to transition directly into a Phase 3 pivotal trial, positioning it closer to commercialisation.
Key Highlights
- HaemaLogiX received TGA approval for a Phase 1 trial of KMCAR™ CAR-T therapy
- Therapy modifies patient T cells to specifically target myeloma cells
- Unique targeting avoids damage to normal immune cells, supporting better safety profile
- Current treatments often cause fatal infections due to immune suppression
- Trial to be conducted at Peter MacCallum Cancer Centre
- Patient treatment expected to begin within months (pending ethics approval)
- Second program, KappaMab, advancing to Phase 2b trial
- KappaMab has already shown safety and efficacy (published 2023)
- Potential pathway for KappaMab to move into Phase 3 pivotal study
- CAR-T therapy offers potential for long-lasting treatment with fewer clinic visits
- Focus on improving quality of life and reducing treatment-related complications
- IPO/listing expected in the near term (months)
Proactive: Welcome back to Proactive Investors. I'm your host, Kerry Stevenson. Today I’m joined by Dr Rosanne Dunn, Executive Director and Chief Scientific Officer of HaemaLogiX. Great to see you. You’re not listed yet, but that’s imminent. You’ve received the green light for a first-in-human trial of your KMCAR™ T-cell therapy for multiple myeloma. Why is this such a milestone for HaemaLogiX?
Dr Rosanne Dunn: This is the first clinical trial using our CAR-T cell platform. It’s a cell therapy where the patient’s own T cells are modified to directly recognise and kill myeloma cells. One of the unique aspects is the specificity — myeloma cells have a distinct target that our therapy recognises, and it’s not found on normal immune cells. That specificity gives us a strong safety profile.
Proactive: Is anyone else achieving similar results?
Dr Rosanne Dunn: No. Most current treatments also target normal immune cells, effectively destroying the patient’s immune system. This leads to infections, and nearly half of patients die from what are called non-relapse deaths — not from the cancer itself, but from infections caused by treatment.
Proactive: You’ve received TGA approval for a Phase 1 trial. What milestones and news flow can investors expect as you move toward listing?
Dr Rosanne Dunn: The KMCAR™ trial is a Phase 1 study. With TGA approval secured, we now need ethics approval, after which we expect to begin treating patients within the next few months at the Peter MacCallum Cancer Centre. We’ll provide ongoing updates as patients are treated.
We also have a second program, KappaMab, entering a Phase 2b trial. This is our fourth clinical trial overall. We’ve already demonstrated safety and efficacy, with data published in 2023. Both programs will generate ongoing data through interim analyses.
Proactive: Which program excites you more?
Dr Rosanne Dunn: KappaMab is particularly exciting because, based on success, it could roll directly into a Phase 3 pivotal study. We’ve already shown it works and is safe, bringing it closer to market than the CAR-T therapy.
That said, CAR-T therapies are highly attractive for patients. They involve reinfusing modified cells that can persist and continue targeting cancer, potentially reducing the need for repeated treatments.
Proactive: And in terms of patient outcomes?
Dr Rosanne Dunn: Because of the specificity of our therapies, we expect improved quality of life. Our monoclonal antibody has already shown it does not cause the infections seen with other treatments. We hope to see similar benefits with the CAR-T approach.
Proactive: You’re not listed yet, but it’s coming soon. Are we talking months or years?
Dr Rosanne Dunn: Months.
Proactive: Final thoughts — why should people pay attention to HaemaLogiX right now?
Dr Rosanne Dunn: Multiple myeloma is still considered incurable. Existing treatments extend life but come with significant side effects. Our goal is to improve both clinical outcomes and quality of life for patients with this disease.