In an Australian first, clinical cancer researcher and developer Imugene (ASX: IMU) will launch its first “azer-cel” clinical trial against a difficult-to-treat form of non-Hodgkins lymphoma at Sydney’s Royal Prince Alfred Hospital.
Azer-cel is Imugene’s “allogeneic off-the-shelf CAR T-cell therapy” which targets a specific protein, CD19, often found on the surface of B-cells, including the cancerous cells in B-cell lymphomas.
Imugene says the up-coming Sydney trial will be the first clinical trial of azer-cel against refractory or relapsed diffuse large B-cell lymphomas (DLBCL) in Australia and plans are already underway to potentially expand the trial to four additional sites in the country.
Imugene says DLBCL is a challenging and aggressive form of non-Hodgkins lymphoma and its imminent Australian trials are being established because the company’s azer-cel therapy has shown to be a promising therapeutic option in its US clinical evaluations.
In a medical context, the term “allogeneic” refers to a form of treatment which uses healthy T-cells from another person. Azer-cel uses donor T-cells which are pre-manufactured and ready for use in identifying and destroying cancer cells in the blood, resulting in faster treatment options from a product that is more broadly available compared to “autologous” therapies.
Autologous treatments use a patient’s own cells which require them to be harvested from that patient and further engineered before they can be used.
DLBCL develops from the B-cells in the lymphatic system which under normal conditions are responsible for producing antibodies, typically to fight infectious disease.
The disease develops when some of a person’s B-cells become cancerous and abnormal, usually growing uncontrollably and not expiring naturally as part of the body’s normal function.
Non-Hodgkin’s lymphoma (NHL) is a type of blood cancer and diffuse large B-cell lymphomas are an aggressive, fast-growing and most common form of NHL, with about 80,500 cases per year and about 30,000 new cases per year in the U.S.
In US trials, DLBCL patients who have been dosed with azer-cel have already demonstrated a high degree of success, with three patients achieving “complete response”, with 90- and 120-day durability. Additionally, azer-cel has been shown by the US trials to be safe and tolerable.
Remarkably, all of the US trial patients who responded positively to azer-cel failed up to five previous lines of alternative treatments, including autologous CAR T therapy.
Imugene says its Cohort B patients in particular in the US trial who received a combination of azer-cel, lympho-depletion (chemotherapy) and the protein, interleukin 2 (IL-2) showed what it calls “robust clinical activity” or positive signs of effectiveness.
IL-2 is a protein used to improve the durability of modified T-cells, allowing them to survive longer in the body and hence attack a greater number of cancer cells.
Encouragingly, one patient in a separate cohort of the trial who was treated with only azer-cel and chemotherapy has also achieved a complete response.
We’re proud to be able to bring this trial to Imugene’s home country and provide an opportunity for Australian patients to benefit from this unique technology. This is the first of up to five sites we plan to open in Australia, as we seek to speed up enrolment and deliver improved outcomes in this form of blood cancer.
Imugene’s Managing Director and CEO Leslie Chong
A “complete response” indicates elimination of all detectable signs of cancer in a patient’s body and is considered an appropriate end-point for treatment, depending on the amount of time they remain cancer-free.
Imugene says relapsed or refractory DLBCL still has a very high unmet medical need, citing typically the 60-65 per cent of patients treated by the current methods - including autologous CD19 CAR T – who eventually relapse.
The multiple complete response outcomes from early-trials with Imugene’s azer-cel therapy are significant, not merely in terms of medical statistics but also because even the faintest glimmers of hope and confidence show that - just maybe - the fight against even one of the insidious suite of cancers may be winnable.
The results to date could also represent a breakthrough because previously, patients living with DLBCL had limited alternative treatment avenues beyond the more conventional forms of chemotherapy.
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