Imugene granted worldwide licence for CD19 cell therapy program to treat relapsed cancer patients

Clinical-stage immuno-oncology company Imugene (ASX: IMU) has entered into an agreement with US-based Precision Biosciences to acquire a worldwide licence to Precision’s azer-cel (azercabtagene zapreleucel) allogeneic CD19 CAR T cell therapy program.

The licence grants Imugene the potential to start a registration-enabling clinical study in 2024 for patients with third and fourth line diffuse large B cell lymphoma and other blood cancer indications.

It could potentially become the first approved provider of allogeneic (allo) CAR T cell therapy for the treatment of these illnesses.

Azer-cel is being marketed as a potential first-in-class allogeneic CD19 CAR T candidate for a growing population of CAR T-relapsed patients with diffuse large B cell lymphoma.

It is believed to be highly-complementary to Imugene’s onCARlytics platform, with one of the most extensive clinical data sets for a CD19-directed allogeneic cell therapy and a fast-to-market development strategy.

CD19 is a well-validated clinical marker in blood cancers.

Terms of the agreement

Under the terms of the licensing agreement, Imugene will acquire exclusive worldwide rights to develop and commercialise azer-cel technology in oncology.

Consideration will be in the form of US$8 million cash upfront and US$13 million deferred, plus up to US$198 million in performance-based payments as well as industry-standard royalties on sales.

The deferred consideration has a term of 12 months and may be converted into shares or redeemed for cash at Imugene’s discretion.

As part of the agreement, Imugene will also acquire the lease to a state-of-the-art 3047 square metre manufacturing facility in North Carolina as well as drug material for the completion of a Phase 1b clinical trial and a team of 50 highly-experienced cell therapy and manufacturing staff.

Imugene will pay an introduction fee of US$3 million to Chimeric Therapeutics (ASX: CHM) in connection with the transaction.

In July, Imugene chief executive officer Leslie Chong resigned from her position as a non-executive director of Chimeric to focus on her role at Imugene.

Phase 1b trial

Ms Chong said Imugene would complete the Phase 1b trial before the clinical study.

“We plan to complete our ongoing multi-centre Phase 1b study using the recommended Phase 2 regimen and prepare for the start of the registrational study at the earliest opportunity,” she said.

“We are very excited as azer-cel has the potential to be the first approved allogeneic CAR T treatment program.”

Azer-cel is expected to sit well alongside the onCARlytics platform.

“By adding azer-cel to the Imugene pipeline, our onCARlytics program will form the foundation of a novel and broadened approach to cell therapy,” Ms Chong said.

“OnCARlytics can enhance the expression of CD19 on solid tumours [while] azer-cel is a supercharged allogeneic T cell designed to identify and kill malignant cells expressing the CD19 marker… we are thrilled about the potential benefit for patients from the combination of these two technologies.”

Clinically-meaningful results

In the Phase 1b clinical trial on 84 patients with non-Hodgkin’s lymphoma and acute lymphocytic leukemia, the use of azer-cel has demonstrated “clinically-meaningful results” with an acceptable safety profile.

Azer-cel achieved an 83% overall response rate and a 61% complete response rate with 55% durable response greater than or equal to six months in the difficult-to-treat auto CAR T relapse setting.

Notably, the azer-cel data was stronger in patients with diffuse large B cell lymphoma who had relapsed.

In the broader group of patients with relapsed/refractory non-Hodgkin’s lymphoma, azer-cel showed a 58% overall response rate and 41% complete response rate across all doses and lymphodepletion (chemotherapy) regimens.

This was irrespective of any prior treatment with auto CAR T cell therapy.

“Azer-cel continues to demonstrate promising results in diffuse large B cell lymphoma patients who relapsed following CAR T, and high overall response rates with molecular remissions in this patient setting are encouraging,” Ms Chong said.

“Based on this dataset, we believe azer-cel has the potential to improve outcomes in this large and growing population with high unmet need.”