CellCentric has announced that the U.S. Food and Drug Administration (FDA) has granted its novel cancer drug, inobrodib, Fast Track designation for the treatment of patients with relapsed or refractory multiple myeloma.
The FDA’s Fast Track designation is designed to aid the development of new treatments, expediting the review of drugs to treat serious conditions and fill unmet medical needs.
Delivered as an oral capsule, inobrodib can be used at home without requiring intensive monitoring. It is a first in class drug, with a new mechanism of action. Inobrodib can be used by patients who have failed on other treatments, and in combination with existing standard of care drugs.
“This Fast Track designation underlines the potential of inobrodib to positively impact the lives of many people living with cancer, who could benefit from the ability to take the treatment at home,” said Debbie Haynes, chief operating officer, CellCentric.
“This decision allows us to move faster to develop a new therapeutic option that has shown to be effective even when cancer cells have become resistant to other drugs.”
The ongoing blood cancer trial involves patients with a range of hematological malignancies including multiple myeloma, but also non-Hodgkin lymphoma, acute myeloid leukemia or high risk myelodysplastic syndrome (MDS). It is investigating inobrodib (also known as CCS1477) as a monotherapy and in combination with common standard of care treatments, including pomalidomide and dexamethasone in multiple myeloma.
Inobrodib is a first in class drug which has shown clinical benefit in treating multiple specific cancer types, including both haematological malignancies and solid tumors. The most advanced data is in relapsed refractory multiple myeloma. As part of a phase 1/2a clinical programme, more than 200 patients have now been treated with inobrodib.
Inobrodib selectively binds to the bromodomain of p300 and CBP. Through this action, inobrodib reduces the expression of key drivers of cancer, including MYC, IRF4 and the androgen receptor (AR and its variants).
The FDA Fast Track approval is for relapsed refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
CellCentric is a U.K.-based biotechnology company with offices in Cambridge and Manchester. The company was spun out from the University of Cambridge by developmental biologist Azim Surani as he explored the potential of epigenetics to deliver new treatments.
From its origins, CellCentric built a network of research and evaluation relationships with more than 25 leading academic research groups worldwide. Having identified multiple unexplored potential drug targets, the company evolved into drug discovery and development, ultimately focusing on the inhibition of p300/CBP.
CellCentric was one of the contributors to a popular Labiotech article on what the cancer therapy space will look like in 2033.