INmune Bio, a clinical-stage biotechnology company developing anti-cancer therapies to reprogram the innate immune system to fight disease, has received Clinical Trial Authorization (CTA) by the United Kingdom regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA), for a Phase I clinical trial of its lead therapeutic candidate INKmune™.
The innate immune drug will be used to treat relapsed and refractory ovarian cancer in a UK based trial.
Ovarian cancer ranks fifth in cancer deaths among women. In 2018 alone, the American Cancer Society estimated 22,240 new cases in the US. Unfortunately, when ovarian cancer relapse occurs, the average survival is between 12 to 18 months, and fewer than 1 in 10 patients survive beyond five years following standard chemotherapy treatment.
“The CTA approval for the first clinical trial of INKmune is a major milestone for the company,” said RJ Tesi, M.D, chief executive officer and co-founder of INmune Bio.
“INKmune is our second cancer program to enter the clinic and will be tested in women with relapsed and refractory ovarian cancer, which accounts for more deaths than any other cancer of the female reproductive system.”
Scientists are developing novel cancer therapies designed to harness the patient’s immune system to help control the cancer. Natural killer (NK) cells are part of the immune system. They can target, attack and eliminate residual disease – cancer cells that are left after chemotherapy, and, as a result, help patients stay in remission. This means that NK cells have the potential to become a successful immunotherapy as they can target malignant cells without being direct effectors of graft-versus-host disease.
INKmune’s novel approach is designed to switch on the patient’s NK cells to attack residual disease that can be the cause of treatment failure.
“This approval represents external validation of our pre-clinical data set using Tumor Primed NK cells against a range of cancer cells which are insensitive to NK killing,” Mark Lowdell, MD, Chief Scientific Officer and co-founder of INmune Bio, said.
“The way that INKmune activates the patient’s own immune system means that it could be used for many types of cancer; women with ovarian cancer are just the first of many patients we hope to treat with INKmune,” Lowdell concluded.
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