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FDA Grants Orphan Drug Designation for Inobrodib for the Treatment of Multiple Myeloma

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CellCentric, a UK-based biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inobrodib (CCS1477) in the treatment of multiple myeloma.


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.  It can be taken by patients who have been unresponsive to other treatments, and in combination with existing standard of care drugs.


Orphan drug status is granted by the FDA to support the development of medicines for disorders that affect fewer than 200,000 people in the United States. Orphan drug designation benefits can include market exclusivity for up to seven years after regulatory approval, exemption of FDA application fees, and tax credits for qualified clinical trials.

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CellCentric's ongoing blood cancer trial (NCT04068597) involves patients with a range of haematological malignancies including multiple myeloma, but also non-Hodgkin lymphoma, acute myeloid leukaemia, and higher-risk myelodysplastic syndrome (MDS).


CellCentric plans to announce its expansion cohort data at the 65th ASH Annual Meeting and Exposition which will take place December 9-12, 2023, in San Diego. This will include data from a trial of inobrodib to treat multiple myeloma both as a monotherapy and in combination with pomalidomide and dexamethasone.


“Orphan drug designation for inobrodib is an important milestone in our journey to develop an additional therapeutic option for patients with multiple myeloma,” says Tomasz Knurowski, CellCentric’s Chief Medical Officer.  “We look forward to providing an update on our clinical data by the end of the year, which will help inform the next stage of development of inobrodib.”

 

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