Quarterly Roundup: Imugene (ASX: IMU) Shows Swift Strides in Crucial Trials

Highlights

• Positive early signs reported in Phase 1 MAST trial of VAXINIA.
• VAXINIA received Fast Track Designation from the US FDA for bile duct cancer.
• In Phase 1 trial for onCARlytics, first patient has been dosed.
• Phase 1b trial for azer-cel has commenced.
• Phase 2 neoadjuvant neoPOLEM clinical trial (with PD1-Vaxx) to open this year.

Imugene Limited (ASX: IMU) has reported multiple developments across the ongoing trials in the quarter ended 31 December 2024. The quarter witnessed positive early signs in the Phase 1 MAST (Metastatic Advanced Solid Tumours) trial of VAXINIA, dosing of first patient in Phase 1 trial for onCARlytics and beginning of Phase 1b trial for azer-cel.

During the quarter, the company entered into a strategic partnership with NeoImmuneTech around NI-I7 use with azer-cel.

Significant developments across trial for VAXINIA

During the latest quarter, the company shared positive early data from Phase 1 MAST trial of VAXINIA. As of November 2023, total 34 pre-treated patients were dosed with VAXINIA, in which 16 received intratumoural administration and 18 receiving intravenous dosing.

The most significant outcome included a Complete Response seen in a patient with advanced bile duct cancer and a Partial Response was seen in patient with advanced melanoma. Moreover, 16 instances of Stable Disease were reported, projecting the VAXINIA’s potential as an effective treatment alterative in oncology.

Most notable results were reported from gastrointestinal cancer patients, following which IMU planned to expand the trial to 20 patients with bile duct cancer.

During the reported period, VAXINIA received Fast Track Designation for bile duct cancer from the US Food and Drug Administration (FDA). This development potentially boosts the VAXINIA’s journey towards availability and approval to patients.

onCARlytics Phase 1 trial begins

In October 2023, the company commenced Phase 1 trial for onCARlytics. The first patient under the trial was dosed during the quarter.

The trial is being conducted on patients with solid tumours, and the trial aims at testing the safety and efficacy of two routes of administration- intravenous (IV) infusion and – intratumoural (IT) injection.

First patient dosed under Phase 1b trial using azer-cel technology

As a part of the Phase 1b clinical trial using its azer-cel technology, IMU completed dosing of the first patient. The trial is focused on patients with B-cell acute lymphocytic leukemia (ALL) and non-Hodgkin’s lymphoma (NHL).

The Phase 1b trial follows the finalisation of a Phase 1 study across the US centres in 84 patients. The trial had showed significant efficacy and safety signals from azer-cel. After the finalisation of Phase 1b trial, there is opportunity to begin a registration study in 2024.

PD1-Vaxx Phase 2 neoPOLEM clinical trial

In December 2023, the company informed about the commencement of a Phase 2 neoPOLEM trial for PD1-Vaxx in Australia and the UK, in patients with colorectal cancer. The trial is expected to start in 2024, and around 44 patients will be enrolled across nearly 10 sites.

The company also shared that it would secure a patent in Europe for PD1-Vaxx.

IMU shares traded at AU$0.110 apiece at the time of writing on 12 February 2024.