The first two blood cancer patients taking part in a United States-based trial, who had suffered relapses despite having treatment, have now been in remission for up to 120 days after being dosed with Imugene’s (ASX: IMU) azer-cel therapy.
In new results that the company says suggest “improved outcomes”, the patients have remained cancer-free for 120 days and 90 days, respectively, after undergoing the combination of the Imugene treatment with chemotherapy and a low dosage of the protein, interleukin 2 (IL-2).
IL-2 is a protein that helps increase the durability of modified T-cells, making them survive longer in the body and giving them time to kill more cancer cells. A patient in a separate cohort of the trial, who was treated with only azer-cel and chemotherapy, has also retained a “complete response”.
The treatment has been designed to tackle diffuse large B cell lymphoma (DLBCL), an aggressive and fast-growing type of non-Hodgkin’s lymphoma (NHL). All 10 patients in the two phase-1b trial cohorts have had seen their disease return following unsuccessful prior cancer treatments.
Imugene’s CAR T drug azer-cel treatment has been designed to inject “supercharged” cells from a healthy host into a patient. The cells then set about tracking down and killing cancer cells in the blood.
A complete response to the treatment indicates the full disappearance of all detectable signs of cancer in a patient’s body and is deemed an appropriate endpoint for treatment, depending on the amount of time they remain cancer-free.
Management says following the robust response rates of patients in “Cohort B”, it will continue to enrol more patients into that group and will monitor current and future patients for further responses. Should the promising results continue, Imugene believes it can provide a comprehensive package to the US Food and Drug Administration (FDA) for potential phase two and three registrational trials.
The company is positioning its azer-cel treatment to be the first approved off-the-shelf allogeneic – meaning cells or tissue from another person – CAR T cell therapy for blood cancer. Plans are also being made to open an additional five trial sites in Australia and to date, the azer-cell treatment has proven to be safe and tolerable.
All four patients enrolled in Cohort B have failed 4 to 5 prior treatments, including autologous CAR T therapy. All 4 patients remain on the study and given the robust response rates and durability seen to date, we will continue to enrol patients in the azer-cel plus IL-2 cohort and will closely follow all patients for further responses and durability.
Imugene Chief Medical Officer Paul Woodard MD
The company identified azer-cel’s cancer fighting potential and its seemingly multiple oncological applications some time ago. It then swept in late last year to acquire the exclusive worldwide license to the CAR T drug from NASDAQ-listed Precision Biosciences in exchange for an upfront payment of US$8 million (AU$11.8 million), in addition to US$13 million (AU$19.2 million) in deferred consideration and royalties.
The company believes azer-cell features multiple promising treatment applications. After studying its efficacy in blood cancers, Imugene plans to combine azer-cel with its novel onCARlytics program for the treatment of patients with solid tumours, opening a potentially significant market for therapy in the 90 per cent of cancers not classified as blood cancers.
Imugene says it is leveraging off a state-of-the-art manufacturing facility in Durham in North Carolina to provide the drug material for its clinical trials. The manufacturing facility also boasts access to 50 of the world’s most highly-experienced cell therapy and drug manufacturing personnel.
The company’s goal to commercialise the first approved off-the-shelf allogeneic CAR T cell therapy for cancer seems to be gaining momentum, with more trials being planned on the back of its early phase-1b success.
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