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 Australia’s most lethal gynaecological cancer, taking more than 1,000 lives each year. 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.

Professor 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 research effort to expand CAR T-cell therapy beyond blood cancer, and we’re excited to be working with Cartherics to stage this first-in-human clinical trial in ovarian cancer.”

Professor 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."

There is an unmet need for new treatments options for patients with ovarian cancer as more than 80% of ovarian cancer patients experience a recurrence after initially having successful surgery and treatment. 

The key aspects of the collaborative research are to develop clinical-scale manufacturing of CTH-004 and conduct a Phase I clinical trial. This program will be led at Peter Mac by the Centre of Excellence in Cellular Immunotherapy, with manufacturing being conducted at Peter Mac’s manufacturing partners Cell Therapies Pty Ltd. 

The clinical trial will initially enroll 6-12 patients with ovarian cancer who have failed prior treatment with chemotherapy. The primary goal of the clinical trial is to investigate the safety of CTH-004 in this patient population.

Cartherics and Peter Mac recently announced a collaboration for another Cartherics autologous CAR-T product, CTH-001.  Based on pre-clinical data, the collaborators have agreed that Peter Mac will focus its efforts on CTH-004.