FDA grants orphan drug status to H3 Biomedicine’s cancer treatment H3B-8800


H3 Biomedicine, a member of Eisai’s global Oncology Business Group, has received orphan drug designation from the US Food and Drug Administration (FDA) for its H3B-8800, a clinical compound used to treat patients with acute myelogenous leukaemia (AML) and chronic myelomonocytic leukaemia (CMML).

H3 Biomedicine is a clinical stage biopharmaceutical company that focuses on the discovery and development of precision medicines for oncology.

H3B-8800 is a potent, selective and orally bioavailable small molecule modulator of wild-type and mutant SF3b complexes.

H3 Biomedicine president and CEO Dr Markus Warmuth said: “Receiving the orphan drug designation for H3B-8800 is a critical milestone for H3’s ongoing cancer genomics driven drug discovery programme.

"Receiving the orphan drug designation for H3B-8800 is a critical milestone for H3’s ongoing cancer genomics driven drug discovery programme."

“We are pleased with the progress our scientific and clinical teams are making, and look forward to continue investigating H3B-8800 as a potential treatment option for patients with these diseases.”

The treatment is currently undergoing its Phase I clinical trials.

According to the American Cancer Society, AML is also known as acute myelocytic leukaemia, acute myelogenous leukaemia, acute granulocytic leukaemia or acute non-lymphocytic leukaemia, and is most commonly found in older people.

According to the society, CMML affects older adults and is a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood.