Imugene Ltd (ASX:IMU, OTC:IUGNF) now holds the Investigational New Drug (IND) Application for lead candidate azer-cel to target blood cancers.
The US Food and Drug Administration (FDA) has transferred the IND application for the allogeneic CD19 CAR T azer-cel from Precision Biosciences Inc. to Imugene.
This application transfer follows Imugene’s agreement with Precision Biosciences in August to acquire the worldwide exclusive licence to the first-in-class allogeneic (off the shelf) CD19 CAR T cell therapy program — azercabtagene zarpreleucel (azer-cel) — for autologous CAR T relapsed patients with blood cancers.
The decision also follows positive feedback earlier this month from the FDA on Imugene’s improved manufacturing princess for azer-cel.
Imugene managing director and CEO Leslie Chong said, “We are actively progressing the ongoing multi-centre Phase 1b (ClinicalTrials.gov ID NCT03666000) study using the recommended Phase 2 regimen of azer-cel as we prepare for the start of a potential Phase 2 registrational study at the earliest opportunity, and we expect the Clinicaltrials.gov ID will be updated to reflect Imugene being the sponsor imminently.”
Strong cash position
Today’s news comes after the completion of a share purchase plan on Monday that saw Imugene raise a further $18.2 million, adding to the $35 million raised in the recent placement conducted in conjunction with the acquisition of the exclusive licensing rights to azer-cel.
In a separately released presentation to the ASX today, Imugene revealed it now has a pro-forma cash balance of $186 million — one of the highest cash balances of ASX biotechs. Imugene says its current cash provides the $358 million capped company with a runway for approximately two years.