Imugene receives FDA approval to start human trial of CAR-T cell therapy for solid tumours

Cancer immunotherapy house Imugene (ASX: IMU) has received US Food and Drug Administration (FDA) approval to start a human trial targeting advanced or metastatic solid tumours.

The agency’s Investigational New Drug (IND) clearance relates to the company’s programs in the fast-emerging field of chimeric antigen receptor (CAR)-T cell therapies, which involve re-engineering the body’s T cells to produce artificial receptor for use in immunotherapy.

To date CAR-T therapies have been successful with blood cancers with several drugs approved, but targeting solid tumours has been more challenging.

OASIS re-forms

The FDA’s approval clears the way for the company to start recruiting for the phase I trial, to be known as OASIS.

OASIS will involve Imugene’s Car-T candidate onCARlytics being administered alongside the standard of care drug, blinatumomab (branded Blincyto).

onCARlytics combines the oncolytic virus CF33 with the transgene CD19. The mechanism of action involves CF33 infiltrating solid tumours and expressing CD19 on the cell surface.

It is hoped that when combined with the bispecific monoclonal antibody blinatumomab, these agents will target and eradicate solid tumours that otherwise cannot be treated with blinatumomab alone.

To be carried out in the US, the dose escalation and expansion study aims to evaluate the safety and efficacy of two routes of administration of CF33-CD19.

These are intratumoral injection (directly into the tumour) or intravenous infusion, either alone or in combination with blinatumomab.

‘Crucial step forward’

Imugene chief executive Leslie Chong described the FDA clearance as a “crucial step forward” for the company.

“The start of our onCARlytics study, which is first-in-class, is a significant milestone for clinicians treating patients faced with the challenge of solid tumour cancers, which to date have been untreatable with CD19- targeting biological drugs.”

She said achieving the goal reflected the perseverance and dedication of the research and development teams and at both the company and California’s City of Hope Medical Centre, from where the program was acquired.

Promising preclinical liver cancer data

On Thursday, Imugene said pre-clinical data presented to the American Society of Gene and Cell Therapy’s annual meeting showed that onCARlytics enhanced anti-tumour activity against the most common liver cancer.

The abstract investigated the combination of onCARlytics technology and Eureka Therapeutics’ Artemis cell receptor platform in in vivo studies.

It showed that the combination strategy can be applied to otherwise target-less tumours such as hepatocellular carcinoma (HCC), as well as a wide array of solid cancers as an effective immunotherapy approach.