Eisai out-licenses cancer candidate H3B-8800 to Roivant

Japanese pharma major Eisai (TYO:  4523) has granting the exclusive rights for global research, development, manufacture and sale of the investigational anticancer agent H3B-8800 to a subsidiary of London-headquartered Roivant Sciences (Nasdaq: ROIV).

H3B-8800 (Roivant’s development code: RVT-2001) is a splicing modulator compound, discovered by Eisai’s US research subsidiary H3 Biomedicine, which is undergoing development as an investigational anticancer agent. H3B-8800 is an orally-available small molecule modulator of splicing factor 3B subunit 1 (SF3B1).

Splicing occurs to remove introns that are base sequence of pre-messenger RNA (mRNA), unneeded for protein synthesis, in the process of synthesizing proteins based on the genetic code. Mutations in splicing factor-encoding genes are observed in multiple hematological malignancies and solid tumors. SF3B1 is a particularly frequent gene mutation in splicing factors. H3B-8800 binds to SF3B1, and demonstrated significant antitumor activity in pre-clinical models by modulating the disruption of mRNA splicing in cancer. Eisai and H3 Biomedicine are currently conducting a Phase I clinical trial of H3B-8800 in the USA and Europe in patients with myelodysplastic syndrome carrying SF3B1 mutations.