Imugene Limited (ASX: IMU) witnessed a significant surge in its stock price today, rising by an impressive 29.032% to $0.080 per share, following the announcement of encouraging progress in its ongoing Phase 1b clinical trial of azer-cel. The stock experienced a trading volume of 107,824,460, reflecting the strong investor interest in the company’s recent developments. With a market capitalisation of $455.65 million, Imugene continues to capture attention within the biotech sector, especially with its innovative approaches to cancer treatment.
Figure 1: Performance of ASX: IMU (Imugene Limited) in the last 5 days
Significant Progress in Azer-cel Clinical Trial
Azer-cel, Imugene’s allogeneic CAR T-cell therapy, has shown promising results in treating diffuse large B-cell lymphoma (DLBCL), an aggressive type of non-Hodgkin’s lymphoma. DLBCL is not only the most common form of non-Hodgkin’s lymphoma, but it also poses a considerable treatment challenge, with approximately 80,500 cases diagnosed annually in the United States and 30,000 new cases emerging each year.
The Phase 1b clinical trial of azer-cel is taking place at 15 leading cancer centres across the United States, with plans to extend the trial to up to five additional sites in Australia. The trial involves two distinct cohorts, with Cohort A consisting of six patients who received azer-cel in combination with chemotherapy (lymphodepletion), and Cohort B comprising four patients treated with azer-cel, chemotherapy, and interleukin 2 (IL-2). IL-2 is a crucial cytokine that plays a significant role in aiding T-cells, which are essential in the immune response against cancer.
Promising Outcomes: Complete Responses Observed
The trial has yielded highly encouraging results, with three patients achieving complete responses. Notably, the first two patients in Cohort B, who got treatment with a combination of azer-cel, chemotherapy, and IL-2, have maintained their complete responses for over 120 and 90 days, respectively. Additionally, a third patient in Cohort A, who was treated with azer-cel and chemotherapy, also achieved a complete response.
These outcomes are particularly significant given the patient population involved in the trial. All patients had previously undergone four to five lines of therapy, including prior autologous CAR T treatments. It highlights the substantial challenge and unmet need within this patient group, making the results from the trial even more noteworthy.
Implications for Future Trials and Potential FDA Approval
The promising results from Cohort B, where IL-2 was added to the treatment regimen, have garnered significant attention and will be a crucial consideration in developing a potential FDA Phase 2/3 registration trial. Imugene’s decision to focus on this cohort underscores the importance of IL-2 in enhancing the efficacy of CAR T-cell therapies.
As the trial progresses, the company will enrol additional patients in Cohort B and closely monitor the durability of the responses. The potential success of this trial could position azer-cel as the first approved allogeneic CAR T-cell therapy for blood cancer, representing a major milestone in cancer treatment.
Addressing a Critical Medical Need
DLBCL represents a significant medical need, particularly for patients whose cancer has relapsed or is resistant to existing treatments. Introducing an effective allogeneic CAR T-cell therapy could revolutionise the treatment landscape for these patients, providing a new avenue of hope for those who have exhausted other options.
Imugene’s continued progress in this area and its expanding clinical trial footprint position the company as a critical player in the oncology sector. The recent stock surge reflects the market’s optimism about the potential of azer-cel and the broader implications of its success for both Imugene and the patients who stand to benefit from this groundbreaking therapy.
Market Performance and Future Outlook
Today’s price increase to $0.080 per share, within a 52-week range of $0.039 to $0.150, underscores the growing confidence in Imugene’s pipeline. As the company advances toward potentially pivotal trials and broader regulatory milestones, investor interest is likely to remain strong. With a market capitalisation of $455.65 million, Imugene is well-positioned to continue its innovative work in cancer treatment, aiming to deliver new solutions to meet critical medical needs.
