The United States Food and Drug Administration has stamped Imugene as the exclusive sponsor for its allogeneic “azer-cel” cancer treatment after transferring an investigational new drug (IND) application to the company from Precision Biosciences.
The move means Imugene will now own all of the data that comes from the clinical trials it runs with human patients in its fight against diffuse large B-cell lymphoma (DLBCL). The company plans to test its proposed commercial azer-cel product in pivotal clinical trials next year.
Just last month, Imugene revealed it had entered into an agreement with Precision to acquire the worldwide exclusive license for its off-the-shelf cell therapy CAR T drug, azer-cel. The treatment has been designed to inject healthy, “super-charged” cells into a patient, before setting them loose to try and track down and kill cancer.
In exchange, NASDAQ-listed Precision will receive an US$8 million (AU$12.6 million) upfront payment, in addition to US$13 million (AU$20.4 million) in a deferred consideration on closing. Industry-standard royalties on potential net sales will also be applied.
But the FDA’s latest imprimatur now represents a significant step forward. Precision had initially lodged the IND application, which was approved by the US FDA and has now been transferred to Imugene.
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. Imugene managing director and chief executive officer Leslie Chong
The company revealed in June that talks with the US FDA had been encouraging as it sought guidance for entering a phase-two registration study. Then, just over a fortnight ago, it said it had received more positive feedback from the US FDA on its proposed trials and the potential for the commercial manufacturing of azer-cel.
Imugene’s new licence acquisition from Precision now gives it four platforms for cancer treatment, in addition to being able to combine the azer-cell treatment with its “onCARlytics” program to form the basis of a whole new approach to cell therapy.
The company will also acquire the lease to a state-of-the-art manufacturing facility in North Carolina, drug material for the completion of a phase-1b clinical trial and access to a highly-experienced cell therapy and manufacturing team of about 50 personnel. Significantly, the deal with Precision also comes loaded with one of the most extensive data packages for a product of its kind, with more than 84 patients already treated.
It all means Imugene’s mission to commercialise the first approved off-the-shelf allogeneic CAR T cell therapy for cancer with azer-cel is gaining momentum.
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