Imugene has taken a further leap forward in its mission to track down and kill cancer tumours by advancing to the final cohort stages for both of the intravenous dose escalation trials of its “Vaxinia” virus.
It opens the door for the company’s final monotherapy trial using just the Vaxinia (CF33-hNIS) virus and concurrent testing for a combination treatment that also includes the checkpoint inhibitor drug, pembrolizumab.
Also known as “Keytruda”, pembrolizumab is used to try and stop cancer cells from suppressing the immune system, allowing it to attack and kill the cancer cells. Both of Imugene’s phase-one trials have been designed to test the safety of Vaxinia as a therapy for patients with metastatic advanced solid tumours.
The trials kicked off in May last year and are expected to run for about two years.
As we get closer to opening and completing the final cohorts planned at the beginning of the trial, we have an opportunity to expand the trial by enrolling patients in additional cohorts for the monotherapy dose escalation component. This will provide us with a far more robust data set to analyse at the conclusion of the MAST study and provide us with a stronger platform as we further the clinical development of CF33 and VAXINIA. Imugene managing director and chief executive officer Leslie Chong.
The company says having passed the evaluation stage for the most recent sections of its respective dose-escalation trials, it will now seek participants for a fifth and final assessment of its intravenous monotherapy and a third and final cohort for the intravenous combination therapy.
The entire suite of Imugene’s phase-one monotherapy trials, including intratumoural injections, comprises 10 groups of patients. Each group is made up of between three to six patients.
Additionally, there are six groups testing Vaxinia in combination with Keytruda, again with half of them using direct injections into tumours and the other half intravenously. Each group is also made up of between three to six patients.
Patients selected for each of the test cohorts comprise those with metastatic or advanced solid tumours who have had at least two previous lines of standard of care treatment.
Imugene revealed in September that its trial of its first cohort tested with the direct intratumoral injection of the combination treatment had passed evaluation and it began recruiting for a second trial group of patients. In total, it hopes to recruit up to 100 patients across some 10 trial sites in the United States and Australia.
The trials represent the first application of a new drug or drug combination in humans and will form the foundation for a clinical drug development process.
Dose escalation trials are a stepped process of gradually increasing the dose strength of treatments to test for adverse reactions in patients, the effectiveness in bringing about the desired response to the treatment and to help determine optimal dose levels and maximum tolerated dosage.
The oncolytic Vaxinia virus was developed by the Los Angeles-based City of Hope – a world-renowned cancer research and treatment organisation. Its previous research has demonstrated oncolytic viruses can stimulate the immune system to respond to and kill cancer and can also make those systems more responsive to other immunotherapies, including checkpoint inhibitors.
Imugene says Vaxinia has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models and has the potential to improve outcomes for patients in their battle with cancer.
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