Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) earlier this week highlighted encouraging clinical progress for its Azer-Cel program after presenting new data at the American Society of Clinical Oncology (ASCO) conference in Chicago, one of the world's largest oncology events.
Managing director and CEO Leslie Chong said the company was selected to deliver an oral presentation from among more than 8,500 submissions received by the conference. According to Chong, attendance at the session was strong, with hundreds of participants present and standing-room-only conditions during the presentation.
The data focused on Imugene's cohort two study, which is evaluating Azer-Cel in patients with blood cancers who have not previously received approved CAR-T therapies. Chong reported that responses had been observed across several niche indications, including chronic lymphocytic leukemia (CLL), marginal zone lymphoma and Waldenström macroglobulinemia.
Importantly, Chong said some patients had maintained responses for more than six to seven months. One patient with CLL progressed from a partial response to a complete response after approximately five months, an outcome she noted can be difficult to achieve in that disease setting.
The level of engagement from oncologists, investors and pharmaceutical company representatives suggested growing interest in the program. Chong reported that the presentation generated substantial audience interaction and questions, indicating close attention to the study's findings.
Looking ahead, a key catalyst for Imugene will be continued patient enrolment and follow-up within the CAR-T naïve cohort. Additional durability data could further strengthen the clinical profile of Azer-Cel as more patients remain on study.
Another important catalyst is the company's BTK inhibitor combination program. Chong noted that BTK inhibitors serve a market worth approximately $12 billion annually. The study is investigating whether concurrent treatment with Azer-Cel can improve outcomes and potentially extend the effectiveness of existing therapies.
Chong said the company was "quite excited about the data" and highlighted the enthusiasm of investigators involved in the trial, including Dr Gupta, who presented the results at ASCO.
The conference also provided exposure to major pharmaceutical companies, an audience that could become increasingly relevant as clinical development progresses. While Chong said partnerships are an aspiration for many biotechnology companies, she emphasised the broader objective of delivering therapies capable of improving and extending patients' lives.
With ongoing enrolment, additional clinical updates and progress in combination studies, Imugene appears positioned to generate further news flow as development of Azer-Cel continues.
Key highlights
- Imugene secured an oral presentation slot at ASCO from among more than 8,500 submissions.
- Hundreds attended the Azer-Cel presentation, with standing-room-only participation.
- The company received strong engagement and a high volume of audience questions.
- Data presented came from the CAR-T naïve cohort in blood cancer patients.
- Responses were observed across multiple lymphoma and leukaemia indications.
- Some patients maintained responses beyond six to seven months.
- One CLL patient progressed from a partial response to a complete response.
- Imugene continues patient enrolment and follow-up in the ongoing study.
- The company has commenced treatment in a BTK inhibitor combination study.
- Management sees potential for both standalone and combination use of Azer-Cel.
- Pharmaceutical companies attending ASCO showed interest in emerging oncology therapies.
- Leslie Chong emphasised the company's mission to improve and extend patients' lives.
Proactive: Welcome back to Proactive Investors. I'm your host, Kerry Stevenson. I've asked Leslie Chong to join us again. The last time we spoke, Leslie was preparing to attend the American Society of Clinical Oncology (ASCO) conference in the US. More than 40,000 people attend the event and over 8,500 submissions are made. Imugene was selected to present. Leslie, you're still in Chicago. This is quite an achievement for Imugene. Can you explain what happened?
Leslie Chong: Around 40,000 people attend ASCO. We had hundreds of people attend our presentation. Many companies submit data but only a small number are selected for oral presentations. We were able to showcase Azer-Cel from Imugene, and attendance was so strong that some people had to stand because there were not enough seats. We also received the most questions at the end of the session, which tells me people were paying close attention to our study.
Proactive: What was it that generated so much interest?
Leslie Chong: We presented data from cohort two, our CAR-T naïve niche. These are patients with blood cancers who have not previously received approved CAR-T therapies. The basket study includes diseases such as chronic lymphocytic leukemia, marginal zone lymphoma and Waldenström macroglobulinemia. We are seeing responses across multiple indications. In CLL and marginal zone lymphoma in particular, patients are not only responding but maintaining those responses for six to seven months and beyond. One CLL patient moved from a partial response to a complete response after about five months, which is significant because complete responses are difficult to achieve in this disease.
Proactive: What are the next steps?
Leslie Chong: We will continue following patients and enrolling more participants into the niche indication cohort. We have also announced treatment of the first patient in our BTK inhibitor combination study. BTK inhibitors represent a market worth around $12 billion. If combining Azer-Cel with these therapies can improve outcomes and prolong treatment effectiveness, it could be very meaningful. We are excited about the data, and so are our investigators, including Dr Gupta, who presented the results.
Proactive: What exactly is an investigator?
Leslie Chong: Investigators are independent haematology-oncology specialists who conduct clinical trials on our behalf. They are world-leading oncologists who treat patients using our therapy and scientifically evaluate the asset throughout the study.
Proactive: ASCO attracts major pharmaceutical companies. Is partnering a potential strategy?
Leslie Chong: Partnerships are a goal for many emerging biotech companies. One reason I believe Azer-Cel is attractive is that it has the potential to combine with blockbuster medicines while also becoming a significant product in its own right. There is interest in innovative medicines, and collaborations can help bring treatments to patients more effectively. Whether independently or in combination, our goal is to improve and extend patients' lives.
Proactive: Helping patients is clearly a major motivation for you.
Leslie Chong: It is. Cancer has affected many families, including my own. My father passed away from gastric cancer and my mother is a lung cancer survivor. If we can meaningfully extend lives with Azer-Cel, either alone or in combination therapies, that makes the effort worthwhile. That's what ASCO is all about and why it's so energising to be part of this community.
Proactive: Thank you for joining us. We look forward to another update when you return to Australia.
Leslie Chong: Thank you.