Clinical stage immune-oncology company Imugene has reported some eye-catching results in an update of its Phase 1 trial to assess the safety and efficacy of its cancer-killing CF33-hNIS Vaxinia therapy with one patient experiencing a “complete response” (CR) having now been in remission for over a year following intratumoural mid-strength dosing with Vaxinia.
In initial trial cohorts whose tumours received direct injection, 47 per cent of lesions showed tumour reduction, with three lesions being eradicated, while among intravenously injected cohorts, 53 per cent of patients achieved disease stabilisation as their best response.
This latest data reinforces the early positive responses we’ve seen in gastrointestinal cancers and for bile duct cancer. It provides an excellent platform to investigate the impact of VAXINIA at higher dose levels as we also expand the trial to additional patients with hard-to-treat biliary tract cancers. It is a proud moment for us to be able to present these results at ASCO-GI and promote the potential of VAXINIA and CF33 more broadly. Imugene managing director and chief executive officer Leslie Chong
But most importantly, Imugene says that among the trial patients, changes in tumour burden correlate with systemic immunological changes which are known to promote anti-tumour immunity.
The current Phase 1 trial is designed to evaluate the safety, efficacy and dose responses to the company’s CF33-hNIS Vaxinia therapy in patients diagnosed with MAST (Metastatic Advanced Solid Tumours).
By 12 January this year, 38 heavily pre-treated patients had received doses of Vaxinia, either as a monotherapy or in combination with the adjuvant pembrolizumab. Of these, 19 patients received direct IT dosing while the remaining 19 received IV injection.
Out of the 38 patients, 31 were categorized as capable of being evaluated for efficacy, having received their first scans at Day 42 of the trial.
Among the 14-patient IT cohort, seven out of 15 patients (47 per cent) exhibited reduced tumour burden with, remarkably, three lesions being completely eradicated.
Meanwhile, a further three patients (21 per cent) demonstrated what is described as an “objective response”, including the previously described complete response in a single patient with bile duct cancer, and two partial responses (PR) in patients with melanomas (skin cancer), all having been subject to mid-dose strength levels.
Among the IV cohort comprising 17 patients, 53 per cent achieved a best response of disease stabilisation (SD).
The company also noted that patients who received prior checkpoint blockade therapy derived clinical benefits with and without pembrolizumab.
Imugene has concluded all treatments to date are safe and tolerable and is planning and expansion of the trial for 10 to 20 patients with biliary tract cancers.
The company presented its early outcomes this week at the annual American Society of Clinical Oncology - Gastrointestinal Cancer Symposium (ASCO-GI) in San Francisco, showing that out of seven patients with gastrointestinal cancers who received CF33-hNIS Vaxinia therapy alone, including 3 colorectal, 2 biliary tract, 1 pancreatic and 1 liver cancer, all demonstrated positive responses to treatment, with a disease control rate (all CR, PR and SD) rated at 86 per cent.
With its successful eradication of at least some cancers in some patients during its early trial and especially while still at mid-dose levels of its CF33-hNIS Vaxinia therapy, Imugene appears to be embarking on the successful crossing of what has until recently been The Great Divide in finding successful cancer treatments.
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