Fresh from a strongly supported $35 million placement, ASX-listed immuno-oncology medtech Imugene is on a steadfast mission to activate the immune system of cancer patients to help treat and eradicate tumours.
The company recently entered into an agreement with Precision Biosciences to acquire a world-wide exclusive license for its off-the-shelf cell therapy CAR T drug “azer-cel”, which can treat and diffuse large B-cell lymphoma (DLBCL). The company says its treatment has been designed to inject healthy, “super-charged” cells into a patient, before setting them loose to try and track down and kill cancer.
While management says it had shored up its $35 million placement through strong interest and support from Australian and international investors, including specialist biotech institutional investors, it has also revealed a share purchase plan (SPP) aimed at raising about a further $30 million.
Allogeneic CAR T, what we are taking into a registrational to market product, is off the shelf. It’s not the patients’ own T-cells, it’s healthy donors that have been engineered for this therapy. So these super-charged T-cells are injected into the patients. The patients do not have to wait for their own very sick T cells to be processed, it’s on demand. Patients should not have to wait for their drug that can save their lives. Cancer evades or hides from the immune system, immune oncology therapeutics allow your immune system to see the cancer and to clear it or even lead to a cure. Imugene managing director and chief executive officer Leslie Chong
The company sets out a simple mission statement for a complex task, stating simply that it is committed to developing transformative cancer medicines to improve patients’ lives.
Its new licence acquisition from Precision gives it four unique platforms to maximise opportunities in cancer treatment and also has the potential to combine with the company’s “onCARlytics” program to form the foundation of a new approach to cell therapy.
Ms Chong says onCARlytics enhances the expression of “CD19”, which is a well-validated clinical target in blood on solid tumours. She says azer-cel is a supercharged allogeneic T cell designed to identify and kill malignant cells expressing CD19.
In return for the world-wide license, Precision will receive an US$8 million (AU$12.6 million) upfront payment, in addition to US$13 million (AU$20.4 million) in a deferred consideration on closing. Industry-standard royalties on potential net sales will also be applied.
In addition to the license rights, Imugene will also acquire the lease to a state-of-the-art manufacturing facility in North Carolina, drug material for completion of a phase-1b clinical trial and a highly-experienced cell therapy and manufacturing team of about 50 personnel. Importantly, the deal includes one of the most extensive data packages for a product of its kind, with more than 84 patients treated.
The company has the potential to start a registrational study next year and become the first approved allogeneic CAR T cell therapy for cancer with azer-cel.
Imugene says in its ongoing, multi-centre phase-1b clinical trial that includes 84 patients with Non-Hodgkin’s lymphoma and acute lymphocytic leukemia, azer-cel demonstrated clinically-meaningful activity with an acceptable safety profile. It believes the data set shows the potential for the drug to cure a late-stage blood cancer.
Alongside Imugene’s azer-cel deal and onCARlytics program, its pipeline also includes an oncolytic virus and B-cell immunotherapies aimed at treating a variety of solid tumours.
According to the Cancer Council of Victoria, immunotherapy is a treatment that uses the body’s own immune system to fight cancer. The main type of immunotherapy for cancer uses drugs known as checkpoint inhibitors, which remove barriers that stop the immune system from finding and attacking cancer.
Immunotherapy may be used on its own or with other cancer treatments. It is most often given when cancer has not responded to, or has returned after initial treatment. In some cases, it may be available as part of the first treatment plan.
Other types of immunotherapy stimulate the immune system to help it work better against cancer and include immune stimulants, CAR T-cell therapy and oncolytic virus therapy.
Imugene says azer-cel continues to demonstrate promising results in DLBCL patients who relapsed following CAR T, and is encouraged by the high overall response rates with molecular remissions in patients to date.
The company says it held a positive meeting with the powerful United States Food and Drug Administration in June to seek guidance for entering a phase-two registration study. The company says chemistry, manufacturing and controls discussions have gone well with the FDA and the intended commercial azer-cel product will be tested in the clinic and will be utilised in the potential registrational clinical trial.
With a swag full of cash set to arrive from new and existing shareholders and via an SPP, in addition to an exciting new therapy on its books, Imugene appears primed and ready to continue its groundbreaking fight against the beast known as cancer.
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