Imugene licenses allogeneic CAR-T with a potential registration study in 2024

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Australian company Imugene (ASX:IMU) has agreed with US-based Precision Biosciences to acquire a worldwide exclusive license to its azer-cel allogeneic CD19 CAR-T cell therapy program.

Imugene managing director and CEO, Leslie Chong, said, “Azer-cel has one of the most extensive clinical data sets for a CD19 directed allogeneic cell therapy, a fast-to-market development strategy and a potential registration-enabling clinical trial in 2024 for patients with 3rd and 4th line DLBCL [diffuse large B cell lymphoma].

"We plan to complete the ongoing multi-centre Phase 1b study using the recommended Phase 2 regimen as we prepare for the start of a potential registrational study at the earliest opportunity. We are very excited as azer-cel has the potential to be the first approved allo CAR-T.”

Ms Chong continued, “By adding azer-cel to the Imugene pipeline, our onCARlytics program will form the foundation of a novel and broadened approach to cell therapy. CD19 is a well validated clinical target in blood cancers. OnCARlytics can enhance the expression of CD19 on solid tumours. Azer-cel is a supercharged allogeneic T cell designed to identify and kill malignant cells expressing CD19. We are thrilled about the potential benefit for patients from the combination of these two technologies.”

Imugene said that in the ongoing multi-centre Phase 1b clinical trial that includes 84 patients with nonHodgkin’s lymphoma (NHL) and acute lymphocytic leukemia (ALL), azer-cel demonstrated clinically meaningful activity with an acceptable safety profile.

It said the azer-cel data were especially strong in patients with DLBCL who had relapsed following auto CAR-T therapy.

Azer-cel achieved an 83 per cent Overall Response Rate (ORR), a 61 per cent Complete Response (CR) Rate, with 55 per cent durable response greater than or equal to six months in this difficult to treat auto CAR-T relapse setting.

Imugene said an estimated that 60 to 70 per cent of patients treated with an approved auto CD19 CAR-T cell therapies will have cancer progression or recurrence. It said that in the broader group of patients with relapsed or refractory NHL, irrespective of prior treatment with auto CAR-T cell therapy, azer-cel showed encouraging response rates and an acceptable safety profile.

It said azer-cel continues to demonstrate promising results in DLBCL patients who relapsed following CAR-T.

Under the terms of the licence agreement, Imugene acquires the exclusive world-wide rights to develop and commercialize the azer-cel technology in oncology for which it has agreed to pay Precision Biosciences US$8 million cash and US$13 million in deferred consideration on closing. It will pay US$8 million on the satisfactory completion of the Phase 1b clinical trial and up to US$198 million performance-based payments over the development life of azer-cel linked to the achievement of certain value-inflection development milestones, including approval in multiple indications and sales in US and Europe.

Imugene will also acquire the lease to a manufacturing facility in North Carolina, drug material for completion of a Phase 1b clinical trial and an experienced cell therapy and manufacturing team of approximately 50 people.

Ms Chong continued, “We are confident in our understanding of product composition, dosing, activity, and safety. Based on recent discussions with the FDA, we believe there is rationale to advance azer-cel into a potential registrational study for patients already treated with auto CAR T as early as 2024. This accelerated development timeline would position azer-cel to be the first FDA-approved allogeneic CAR T therapy for blood cancers.”

Precision CEO Mr Michael Amoroso added, “We are delighted to form this partnership with Imugene to develop the exciting azer-cel technology. Our mutual commercial and scientific interests are closely aligned particularly through the formation of a Joint Steering Committee, through which Precision will allow Imugene to avail itself of our deep expertise in manufacturing and cell therapy. The opportunity for Imugene to combine its OnCARlytics technology with azer-cel opens a new frontier for Imugene and shows great promise. We look forward to following Imugene’s progress with great interest.”