March 2023: Peter MacCallum Cancer Centre (Peter Mac) in Australia and Cartherics Pty Ltd have entered into a collaborative development programme agreement (CDPA) to develop CTH-002 for the treatment of ovarian cancer.
The clinical trial to be conducted by Peter Mac will be the first time a CAR-T cell therapy product containing the genetic modifications incorporated into CTH-004 has been tested in humans.
Ovarian cancer is the most lethal gynaecological cancer in Australia, claiming over 1,000 lives annually. With a five-year survival rate of only 49%, there is an urgent need for research to give those diagnosed a better chance of survival.
Simon Harrison, director of the Centre of Excellence in Cellular Immunotherapy at Peter Mac, said: “CAR-T-cell therapy is a powerful immunotherapy that is uniquely tailored for each patient and which re-purposes their own T-cells to fight their cancer.
“It has emerged as a new treatment paradigm in blood cancer where it can produce complete responses, meaning their blood cancer has disappeared, in patients who have exhausted all other treatment options. The Centre of Excellence in Cellular Immunotherapy at Peter Mac is part of an international effort to expand CAR T-cell therapy beyond blood cancer, and we are thrilled to be collaborating with Cartherics on this first-in-human clinical trial for ovarian cancer.
Alan Trounson, CEO of Cartherics, said: “There are many patients needing help to control ovarian cancer and CAR-T therapy could be a game changer for them. It is our priority to ensure this potential therapy is tested in clinical trials as soon as possible.”
Cartherics board advisor, Heather Hawkins said: “As an ovarian cancer survivor and patient advocate, I am truly grateful for the vision, skill and dedication of the Cartherics team who are working tirelessly – seeking to improve the survival rates and the quality of life of women diagnosed with ovarian cancer. This announcement brings a real sense of progress and hope in this space.”
More than 80% of ovarian cancer patients who initially undergo successful surgery and treatment experience a recurrence.
The primary objectives of the collaborative research are to manufacture CTH-004 at a clinical scale and conduct a phase I clinical trial. This programme will be led by the Centre of Excellence in Cellular Immunotherapy at Peter Mac, while manufacturing will be carried out by Peter Mac’s manufacturing partners Cell Therapies Pty Ltd.
The clinical trial will initially enrol six to twelve patients with ovarian cancer whose prior chemotherapy treatment failed. The primary objective of this clinical trial is to assess the safety of CTH-004 in this patient population.
Cartherics and Peter Mac recently announced a partnership for CTH-001, another autologous CAR-T product developed by Cartherics. The collaborators have agreed, based on preclinical data, that Peter Mac will concentrate its efforts on CTH-004.
About ovarian cancer
Ovarian cancer is a disease in which abnormal cell growth in one or both ovaries leads to the development of cancer. Approximately 314,000 new ovarian cancer cases and 207,000 deaths occurred globally in 2020.
In its early stages, ovarian cancer is typically asymptomatic and is frequently diagnosed at a late stage. Surgery and chemotherapy are the most common treatments, either alone or in combination. More than 80% of ovarian cancer patients who initially undergo successful surgery and treatment experience a recurrence.
About Peter MacCallum Cancer Centre
Peter MacCallum Cancer Centre is a world-class cancer research, education, and treatment facility, as well as Australia’s only public health service devoted exclusively to cancer care. The centre employs 3,300 people, including more than 750 laboratory and clinical researchers, all of whom are dedicated to providing better cancer treatments, care, and potential cures.
The Centre of Excellence in Cellular Immunotherapy at Peter Mac supports, develops, and translates novel cell and gene therapies using its established suppliers and manufacturing partners, such as Cell Therapies Pty Ltd, to enable the use of these products in clinical trials for cancer patients.
Additionally, the company is creating autologous CAR-T cell therapies. These utilise modified T cells from the patient’s immune system that are effective against the patient’s cancer cells. CTH-004 is produced by genetically modifying patient T cells to insert a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes involved in T cell function suppression.
CAR T-Cell therapy in China has grown at a very rapid rate and currently there are more than 750 clinical trials being conducted in China on different types of cancer.