Imugene has continued to set the ASX boards alight after revealing it had delivered the first dose of its azer-cel therapy to a patient suffering from “difficult-to-treat” diffuse large B-cell lymphoma (DLBCL) in the United States.
The company’s stock has risen nearly 285 per cent in less than three weeks as it continues to conduct a range of trials aimed at beating the scourge that is cancer. Management has described its latest revelation as a major company milestone as its share price jumped from just 3.9 cents on October 23 to touch a high today of 15c during intraday trading – with nearly $45 million worth of stock changing hands.
The phase-1b trial dosing of the patient with azer-cel, Imugene’s allogeneic cancer-fighting cell therapy also known as “CD19 CAR T”, comes after its successful first-phase trial featuring 84 patients across several leading US medical facilities. The company says the patient, who was dosed at the Banner Health in Phoenix, Arizona, is suffering from a sub-set of non-Hodgkin lymphoma (NHL) known as DLBCL.
Imugene chief medical officer Dr Paul Woodard says patients with the condition, who have relapsed after autologous CAR T therapy, have limited therapeutic options. It means new and more effective therapies are required to help give them greater hope of survival.
The company says azer-cel, which was manufactured at its state-of-the-art facility in North Carolina, is evolving into a potential first-in-class cell therapy drug.
It is a great credit to our team that the Phase-1b has been initiated and the first patient dosed in under three months since acquiring the technology. Imugene managing director and chief executive officer Leslie Chong
The company’s phase-1b allogeneic CAR T study is an ongoing multi-centre clinical trial for patients with NHL and B-cell acute lymphocytic leukaemia (ALL), both of which are forms of blood cancer.
NHL is a type of cancer that develops in the lymphatic system, which is part of the immune system that helps protect the body from infection and disease. ALL is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). Leukaemia may affect red blood cells, white blood cells and platelets.
Imugene says its proprietary next-generation azer-cel has already demonstrated clinically meaningful activity with an acceptable safety profile, including promising results in DLBCL patients who relapsed following CAR T therapy.
In September, the company revealed it had received positive feedback from the US Food and Drug Administration (FDA) for its azer-cel manufacturing process that is proposed to be used in the clinical trials and potentially for manufacturing of the commercial drug product.
It says that once the phase-1b study is completed, it will be able to next year begin a registrational study, subject to FDA approval, in a bid to establish the world’s first approved allogeneic CAR T cell therapy for cancer.
Management says that beyond using azer-cel in blood cancers, in the future it will also be combined with its own “onCARlytics” therapy for treatment of patients with solid tumours.
If that combination is successful, it would open a potentially massive market for azer-cel in one of modern medicine’s holy grails – namely, homing in on the 90 per cent of oncology that extends beyond blood cancers.
There is no doubt Imugene has a medical mission with momentum.
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