Clinical stage cancer-fighting company Imugene has revealed that the phase-one trial of its anti-cancer virus “Vaxinia”, which is administered directly into the tumour, has passed the first cohort of its study, clearing the way for a second phase.
The first trial on the treatment of metastatic advanced solid tumours (MAST) was to evaluate the safety, tolerability and efficacy of Vaxinia when administered with Pembrolizumab.
The company says its successful trial completion means the evaluation regimen can proceed to a second of three planned cohorts. Each phase has been designed to evaluate and compare, in parallel, the respective outcomes of intratumoral (IT) treatment and intravenous (IV) injection treatment, while the dosage is progressively escalated through three strength levels.
Management has immediately moved to recruit a second round of patients for each of the IT and IV branches in the combination study. It is also chasing a fourth cohort for each of the branches for Vaxinia monotherapy dose escalation trials.
We’ve now seen a very significant number of patients dosed with VAXINIA as part of the MAST study, with those patients suffering as a result of a variety of tumour types. It’s exciting that we’re getting so close to finding out the impact that this treatment is having for these patients in need. Imugene managing director and chief executive officer Leslie Chong
Each combination trial cohort contains between three and six patients, meaning that a minimum of 18 or a maximum of 36 patients may be involved.
The phase-one MAST trial started by delivering a low dose of Vaxinia, in combination with Pembrolizumab, to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard-of-care treatment.
Pembrolizumab is a targeted therapy drug used in a type of immunotherapy known as an immune check-point inhibitor. It is a monoclonal antibody that binds to the protein “PD-1” on the surface of immune cells called “T” cells.
It works by keeping cancer cells from suppressing the immune system. allowing the immune system to attack and kill cancer cells.
The combination trials are being run in parallel with a slightly bigger trial using only Vaxinia on its own as a monotherapy. It comprises four respective cohorts for IT and IV administration and also comprises between three and six patients per cohort.
Vaxinia was developed by the United States-based City of Hope Medical Center as an oncolytic virus that has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.
The Vaxinia-only trial has already advanced through the first three cohorts and is now in its final stage. City of Hope joined with Imugene in May last year to reveal a first patient had been dosed in the phase-one trial to test its effectiveness against solid tumours.
The study, which is expected to run for two years, aims to eventually recruit up to 100 patients across some 10 trial sites in the US and Australia.
Imugene is a clinical-stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system in cancer patients to treat and eradicate tumours, potentially achieving a similar or greater effect than synthetically-manufactured monoclonal antibody and other immunotherapies. The company’s vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments.
It is already well-funded through a recent, strongly-supported $35 million placement and is well placed to deliver on its commercial and clinical milestones.
While viruses mostly get a bad rap, not all are bad and many natural viruses are vital to life on this planet. But having said that, somehow, using a virus to cure a cancer still seems like poetic justice.
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