Imugene and US firm NeoImmuneTech partner to develop next-gen cancer therapy

Imugene (ASX: IMU) and NeoImmuneTech have formed an Australian-US collaboration to further investigate the potential to combine two promising cancer treatments.

Sydney-headquartered clinical stage immuno-oncology company Imugene and NeoImmuneTech, a T-cell-focused biopharmaceutical company based in Maryland, USA, have come together to evaluate Imugene’s allogeneic CAR T azer-cel in combination with NeoImmuneTech’s proprietary immune T-cell amplifier NT-I7 for the treatment of cancer.

Combined, the two treatments are expected to lead to an increase in the number and cancer-fighting properties of a patient’s own T-cells during their treatment with azer-cel.

Azer-cel activity enhancer

“We are delighted to be working with NeoImmuneTech on the potential to enhance azer-cel activity as part of this research collaboration,” Imugene managing director and chief executive officer Leslie Chong said.

Imugene has already collected strong results from its azer-cel allogeneic CD19 CAR T cell therapy program with clinically meaningful activity identified within an acceptable safety profile in blood cancers such as lymphoma and leukemia.

NeoImmuneTech’s NT-I7 is the only long-acting human interleukin-7 (IL-7) cytokine in clinical stage development and has been found to play a key role in T-cell development and survival, boosting cancer fighting T-cell numbers, their health and functionality to enhance immune function and potentially provide improved cancer fighting benefits to patients.

Cytokines are small proteins that are crucial in controlling the growth and activity of other immune system cells and blood cells.

Ideal collaborative partner

Dr Se Hwan Yang, president and chief executive officer of NeoImmuneTech, said studies of NT-I7 have shown the treatment to exhibit favourable stability, activity and safety profiles on patient dosing compared with naturally occurring IL-7, making it an ideal combination partner for cell therapy drugs like azer-cel.

“NT-I7 has already shown encouraging results in multiple indications in immuno-oncology and infectious diseases, both as a monotherapy or in combination.”

“The research collaboration with Imugene, an industry leader in allogeneic cell therapy, could greatly expand the potential of our asset and accelerate its path to commercialisation, as we did in acute radiation syndrome,” Dr. Yang said.

Now underway, the strategic collaboration will continue for two years while relevant research activities are performed under the research plan. Such research activities will be performed exclusively in the United States.

Imugene will fund its component of the strategic collaboration through its existing planned research activities.

Each party has full intellectual property rights (patents) to their individual background technology.

Phase 1b trial

In early November, Imugene reported the dosing of the first patient in a phase 1b clinical trial using azer-cel.

The patient, who was dosed at Banner Health in Phoenix, Arizona, suffers from a difficult to treat subset of non-Hodgkin’s lymphoma (NHL) called diffuse-large B-cell lymphoma (DLBCL).

The Phase 1b allogeneic CAR T study is an ongoing multi-centre phase 1b clinical trial in patients with NHL and B-cell acute lymphocytic leukemia.

Azer-cel has demonstrated clinically-meaningful activity with an acceptable safety profile, including promising results in DLBCL patients who relapsed following CAR T.

Beyond using azer-cel in blood cancers, in the future it will also be combined with Imugene’s own onCARlytics for treatment of patients with solid tumours, potentially opening a large market for azer-cel in the 90% of oncology not beyond blood cancers.

Following completion of the Phase 1b study, there is potential to start a registrational study in 2024 and become the first approved allogeneic CAR T cell therapy for cancer.

In September 2023, Imugene received positive feedback from the US Food and Drug Administration on the azer-cel manufacturing process to be used in the registrational (to-market) clinical trial and potentially for manufacturing the commercial drug product.