Imugene (ASX: IMU) reports further encouraging early signs from Phase 1 CF33-hNIS study - Kalkine Media

Highlights

• As of 12 Jan, 38 patients have been dosed with CF33-hNIS virus under the Phase 1 VAXINIA study.
• The data to be presented this week at ASCO-GI shows that seven gastrointestinal cancer patients who were administered with CF33-hNIS alone demonstrated positive treatment effects as they achieved a disease control rate of 86%.
• The company plans trial expansion for 10-20 patients with biliary tract cancers.

Imugene (ASX: IMU) has shared a clinical trial update of its Phase 1 MAST (Metastatic Advanced Solid Tumours) study, which is examining the efficacy and safety of CF33-hNIS (VAXINIA), a novel cancer killing virus.

Positive early signs

As of 12 January 2024, under the dose escalation phase, 38 patients have been administered with VAXINIA. It includes 19 patients who have been dosed intratumourally (IT) and 19 patients dosed intravenously (IV) (either monotherapy or in combination with pembrolizumab).

31 patients were eligible to be assessed for efficacy. In the IT cohorts, which included 14 patients, 47% of injected lesions had a decline in tumour burden, 3 lesions were eradicated completely and 3 had objective response. While in IV cohorts which comprised 17 patients, 53% of patients achieved stable disease as their best response.

Prior checkpoint blockade therapy resulted in clinical benefits among patients with or without pembrolizumab.

The company intends to expand the trial for 10-20 patients with biliary duct cancer under an FDA fast track approval.

The results to be presented this week at the American Society of Clinical Oncology - Gastrointestinal Cancer Symposium (ASCO-GI) show that those seven gastrointestinal cancer patients who were administered with CF33-hNIS alone demonstrated positive treatment effects as they achieved a disease control rate (CR, PR and SD) of 86%.

One patient with biliary tract cancer, treated IT with mid-dose level showed pseudoprogression and post two cycles of therapy, it showed a 49% surge in tumour burden. By the fourth cycle, the patient achieved a complete response with no known recurrence in 430 days.

Another patient with bile duct cancer, after receiving IV-administered VAXINIA, achieved stable disease for >4 months. Noteworthy here is that the patient had earlier progressed on prior drug therapies.

About MAST trial

The Phase 1 MAST study started by giving a low dose of CF33-hNIS to individuals diagnosed with advanced or metastatic solid tumours. The patients included in the trial had minimum two prior lines of standard of care treatment. The aim of the study is to recruit cancer patients across around 10 trial sites in the Australia and US.

IMU shares jump

IMU shares jumped 7.14% to trade at AU$0.112 apiece at the time of writing on 17 January 2024.