Following recent successes, Imugene has advanced its Phase 1 clinical study with the first Cohort 5 patients now receiving doses of the company’s novel potentially cancer-killing “CF33- hNIS” (VAXINIA) therapy. Imugene says Cohort 5 patient responses will be evaluated following their next monotherapy dose level by both intratumoural (IT) and intravenous (IV) delivery, with the first patients receiving doses on the 16th of January and 18th of January, respectively.
Additionally, Imugene is also enrolling new patients in a combination study, where VAXINIA is administered with the well-known checkpoint inhibitor and adjuvant pembrolizumab in both IT and IV delivery modes. It has so far selected 13 patients for that study.
Following the positive news on VAXINIA’s early signals and our FDA Fast Track Designation to the end of 2023, we are pleased to start the new year by announcing the ongoing progress of the MAST trial as we continue to see no safety issues with the drug. Imugene managing director and chief executive officer Leslie Chong
The current Phase 1 trial is designed to evaluate the safety, efficacy and patient dose responses to the company’s VAXINIA treatment in people diagnosed with MAST (Metastatic Advanced Solid Tumours).
By the 12th of January this year, 38 heavily pre-treated patients had received doses of VAXINIA, either as a monotherapy (VAXINIA only) or in combination with the adjuvant pembrolizumab. Of these patients, 19 received direct IT dosing while the remaining 19 received IV injections.
Patients include one with thymus cancer who is being treated at St Vincent’s Hospital in Fitzroy, Victoria and a melanoma (skin) cancer patient being treated at University of California in San Diego, California.
Among the monotherapy group, 24 patients have been dosed and encouragingly, among the 14-patient IT cohort, seven out of 15 patients (47 per cent) exhibit reduced tumour burden with, remarkably, three lesions being completely eradicated.
A further three patients (21 per cent) have shown what is described as an “objective response”, including a complete response (CR) in a single patient with bile duct cancer having now been in remission for over a year following mid-strength IT dosing with VAXINIA.
Management has responded to the remission success by saying it plans to expand the trial to take a closer look at bile duct cancers.
Additionally, two partial responses (PR) have been recorded in patients with melanomas, all having been given mid-strength doses.
Among the IV cohort comprising 17 patients, 53 per cent have achieved a best response of disease stabilisation (SD).
Most importantly, Imugene has observed changes in tumour burden among the trial patients that correlate with systemic immunological changes which are known to promote anti-tumour immunity.
Encouraged by the high levels of success with its mid-strength dosages, Imugene has elected to progress to the highest-strength Cohort 5 monotherapy by IT and IV delivery.
The multi-centre Phase 1 MAST trial began with delivery of low VAXINIA doses to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment.
The trial has since progressed through successive monotherapy and combination dose escalation cohorts and so far, the US-based City of Hope-developed VAXINIA oncolytic virus-based therapy has been shown in preclinical laboratory and animal models to shrink colon, lung, breast, ovarian and pancreatic cancer tumours.
City of Hope is a national cancer institute designated comprehensive cancer centre which is a world-renowned pioneer in cancer research, treatment and prevention.
Overall, Imugene’s study aims to recruit up to 100 patients across about 10 trial sites in the United States and Australia.
To date, the trial has advanced successfully through four previous monotherapy cohorts in both IT and IV modes of delivery, with no safety signals identified to date.
With every new revelation, Imugene appears to take one more step towards the ever-elusive objective of potentially eradicating at least some cancers and it is almost certain that its work is being watched by millions in anticipation of that goal being reached.
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