Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) recently highlighted encouraging new clinical data for its allogeneic CAR-T therapy Azer-Cel, while also confirming the company will present the program at the upcoming American Society of Clinical Oncology (ASCO) conference.
Managing director Dr Leslie Chong said the company’s latest results continued to demonstrate strong responses in heavily pre-treated blood cancer patients, including individuals who had previously exhausted multiple lines of therapy.
Azer-Cel is an off-the-shelf CAR-T therapy using healthy donor T cells rather than relying on a patient’s own cells. Chong explained this approach aimed to address limitations associated with traditional autologous CAR-T therapies, including lengthy manufacturing times and the inability of some patients to generate viable T cells.
The company previously reported an 81% response rate in diffuse large B-cell lymphoma patients who had failed prior autologous CAR-T therapies. New preliminary data from a second cohort involving CAR-T naïve patients appeared to maintain response rates above 80%.
Chong said some indications including marginal zone lymphoma, Waldenström’s macroglobulinemia and follicular lymphoma had shown “100% hit” response rates in early-stage data.
The ASCO presentation represents a potentially significant milestone for Imugene, given the conference’s reputation as one of the world’s leading oncology events. Chong noted only a small proportion of submitted abstracts are selected for oral presentation.
Beyond the clinical results, Imugene has also advanced regulatory discussions with the US Food and Drug Administration. Chong said the company had already received positive feedback regarding its manufacturing processes, which could help de-risk future registration pathways.
The company is also evaluating multiple commercialisation strategies, including combination studies involving established therapies in large oncology markets. Chong described these markets as being worth billions of dollars annually and confirmed Imugene was already in discussions with pharmaceutical companies.
Potential catalysts for investors include further patient data updates, ASCO exposure, progress with FDA engagement and the expansion of clinical programs across additional blood cancer indications.
Chong said Azer-Cel was delivering “meaningful responses” in patients who had failed several prior therapies, while also highlighting patient stories demonstrating extended quality time with family and friends following treatment.
Imugene currently operates 10 clinical trial sites in the United States and five in Australia as it continues to expand development of the therapy.
Interview highlights
- Imugene discussed progress with its allogeneic CAR-T therapy Azer-Cel.
- Azer-Cel is designed as an off-the-shelf CAR-T treatment using healthy donor T cells.
- The therapy can be delivered rapidly compared with traditional autologous CAR-T treatments.
- Clinical data in diffuse large B-cell lymphoma showed an 81% response rate.
- Preliminary data from CAR-T naïve patients maintained response rates above 80%.
- Certain indications including follicular lymphoma and marginal zone lymphoma showed 100% responses in early data.
- Imugene secured an oral presentation slot at the ASCO conference.
- The company has already held FDA discussions regarding manufacturing and registration pathways.
- Imugene is exploring combination strategies with established oncology drugs.
- The company currently has 10 trial sites in the US and five in Australia.
- Patient outcomes highlighted the potential quality-of-life impact of the therapy.
Proactive: Welcome back to Proactive Investors. Ladies and gentlemen, I'm your host, Kerry Stevenson. I am delighted to have Dr Leslie Chong. She is the Managing Director of Imugene. Their ASX code is IMU. These guys are doing some clinical trials. There’s a lot to go through today. Leslie, welcome back. Great to see you as always.
Dr Leslie Chong: Thank you Kerry. So nice to see you again here on Proactive.
Proactive: Can you briefly describe your therapies, how they can impact patients and what makes them so impactful?
Dr Leslie Chong: Antigen receptor therapies, T-cell therapies, have been on the scene for over a decade now. The reason they are so impactful is they are a one-time dose and they have led to cures in various blood cancers.
However, there are challenges with autologous CAR-T therapies because they use the patient’s own T cells. Those cells are manufactured outside the body for four to six weeks, and sometimes the T cells cannot be regenerated. About 20% of patients either progress while waiting or cannot use their own T cells because they cannot be fortified.
What we have at Azer-Cel is an allogeneic CAR-T therapy. Rather than using a patient’s own cells, we use healthy donor T cells. The product is pre-engineered, frozen, batch manufactured and shipped to hospitals so it is available on demand.
When patients fail other therapies, including approved autologous CAR-T treatments, we can deliver treatment within one or two days. We already have a growing body of clinical data and have established a relationship with the FDA through a Type C meeting.
We have reported data in diffuse large B-cell lymphoma showing an 81% response rate in an autologous CAR-T failed population.
What we announced today relates to our second cohort, consisting of CAR-T naïve patients who either do not have access to approved CAR-T products or are not eligible for them. Preliminary data across 16 patients has been profound, maintaining response rates above 80%.
In indications such as marginal zone lymphoma, Waldenström’s macroglobulinemia and follicular lymphoma, we are seeing 100% response rates. These are very sick patients who have failed significant prior therapies.
We are also presenting at ASCO as one of the selected oral presenters, which is highly competitive and puts us on the global stage for cancer breakthrough therapies.
Proactive: Do you expect major pharmaceutical companies are watching closely? Why is this a pivotal time for investors to pay attention to Imugene?
Dr Leslie Chong: We are continuing to build our data package and have already engaged with the FDA regarding registration pathways and manufacturing. Having the FDA effectively validate your manufacturing process is a major milestone.
We are seeing remarkable responses in heavily pre-treated patients who have failed second- and third-line therapies, including BTK inhibitors and BCL2 inhibitors like venetoclax.
Proactive: Where are you in terms of the revenue side of things?
Dr Leslie Chong: I never discuss timelines to market because it is a competitive space. However, we are already in discussions with the FDA regarding registration pathways.
We are also looking at combining Azer-Cel with blockbuster inhibitors already on the market, including therapies in markets worth billions of dollars. We are having meaningful discussions with pharmaceutical companies.
Proactive: Would you say this is a pivotal time for Imugene?
Dr Leslie Chong: We have a stellar product in Azer-Cel. It is showing meaningful responses in very sick patients who have failed multiple therapies.
We have ten sites in the US and five in Australia. Some patients from our studies have appeared in Australian media discussing how the therapy has helped them spend more time with family and friends.
We are continuing to build critical data and the therapy appears to be working well in late-line patient populations.
Proactive: Always great to get an update from you. Ladies and gentlemen, that was Dr Leslie Chong from Imugene. If you want to find out more, visit the company website. Thanks so much for joining me today.
Dr Leslie Chong: Thank you so much for having me.