Imugene Ltd (ASX:IMU, OTC:IUGNF) is acquiring the exclusive worldwide rights to develop and commercialise the azer-cel allogeneic CD19 CAR T cell therapy program from US-based Precision Biosciences, Inc, a move that could usher in potential breakthroughs in cancer therapy.
Azer-cel is designed to identify and eliminate malignant cells expressing CD19 oncolytic virus, with more than 84 patients treated safely and with compelling efficacy.
The Australian biotechnology company hopes to begin a registrational study of azer-cel for patients already treated with auto CAR T in 2024 following a positive meeting with the US Food and Drug Administration in June.
This sets the course for azer-cel, which is highly complementary to Imugene’s onCARlytics platform, to become the first FDA-approved allogeneic CAR T therapy for blood cancers.
Great potential
“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 third and fourth line DLBCL (diffuse large B cell lymphoma),” Imugene managing director and chief executive officer Leslie Chong said.
“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 allogeneic CAR T.”
Clinical trial success
In the ongoing multi-centre Phase 1b clinical trial involving 84 patients with non-Hodgkin's lymphoma (NHL) and acute lymphocytic leukemia (ALL), azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile.
The data, particularly compelling for DLBCL patients who relapsed following auto CAR T therapy, showcased an impressive 83% overall response rate (ORR) and 61% complete response rate (CRR).
Notably, the therapy achieved a durable response greater than or equal to six months in 55% of patients.
Beyond these findings, azer-cel exhibited promising results across a wider range of patients with relapsed/refractory NHL, regardless of prior auto CAR T therapy.
Pioneering appproach
“By adding azer-cel to the Imugene pipeline, our onCARlytics program will form the foundation of a novel and broadened approach to cell therapy,” Chong said.
“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.”
Deal details
The deal with Precision involves a US$21 million cash and deferred payment structure, and up to US$198 million performance-based payments over the development life of azer-cel.
Imugene will also acquire the lease to a state-of-the-art 32,800-square-feet GMP manufacturing facility in North Carolina, drug material for completion of a Phase 1b clinical trial and a highly experienced cell therapy and manufacturing team of about 50 people.
All cash payments will be funded through Imugene’s existing reserves, with the option to make some payments in shares.
Additionally, Imugene will pay US$3 million to Chimeric Therapeutics Ltd as introduction fee.
New horizon
Precision chief executive officer 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.”