Eisai Enters into Exclusive Global License Agreement with Roivant for Investigational Anticancer Agent H3B-8800 (RVT-2001)

On January 18, Eisai announced that the company has recently signed a licensing agreement with a subsidiary of Roivant Sciences Ltd., exclusively granting Roivant global rights to research, develop, manufacture, and sell the investigational anticancer drug H3B-8800. H3B-8800 (Roivant development code: RVT-2001) is a splicing modulator compound discovered by H3 Biomedicine Inc., Eisai's U.S.-based research and development subsidiary, and is currently under development as an investigational anticancer drug.

H3B-8800 is an orally available small molecule modulator of splicing factor 3B subunit 1 (SF3B1), discovered by H3 Biomedicine Inc. During the genetic code-based protein synthesis process, splicing removes introns, the base sequences of precursor messenger RNA (mRNA) that are not required for protein synthesis. Mutations in genes encoding splicing factors can be observed in various malignant hematological diseases and solid tumors. SF3B1 is a particularly common splicing factor gene mutation.^1,2H3B-8800 can bind to SF3B1 and demonstrate significant anti-tumor activity in preclinical models by eliminating the disruption of mRNA splicing in cancer patients.³Eisai and H3 Biomedicine are currently conducting a Phase I clinical trial of H3B-8800 in the United States and Europe for patients with myelodysplastic syndrome carrying SF3B1 mutations.

According to the terms of the agreement, Eisai will receive a contract upfront payment, development and registration milestone payments for H3B-8800, and after its market launch, will also receive royalties at a specific percentage based on the sales revenue of H3B-8800.

Note: The original text has been abridged.

References:

1 Yoshida, et al. (2011). Frequent pathway mutations of splicing machinery in myelodysplasia. Nature 478(7367): 64-69. doi: 10.1038/nature10496.

2 Seiler, et al. (2018). Somatic Mutational Landscape of Splicing Factor Genes and Their Functional Consequences across 33 Cancer Types. Cell Reports 23(1): 282-296.e4. doi: 10.1016/j.celrep.2018.01.088.

3 Seiler, et al. (2018). H3B-8800, an orally available small-molecule splicing modulator, induces lethality in spliceosome-mutant cancers. Nature Medicine 24(4): 497-504. doi: 10.1038/nm.4493.