Eisai Enters Into Exclusive Licensing Agreement with Roivant Concerning Investigational Anticancer Agent H3B-8800, a Splicing Modulator

TOKYO, Jan 6, 2022 – (JCN Newswire) – Eisai Co., Ltd. announced today that it has entered into a License Agreement granting the exclusive rights for global research, development, manufacture and sale of the investigational anticancer agent H3B-8800 to a subsidiary of Roivant Sciences Ltd. (Nasdaq: ROIV). H3B-8800 (Roivant’s Development Code: RVT-2001) is a splicing modulator compound, discovered by Eisai’s U.S. research subsidiary H3 Biomedicine Inc., 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), discovered by H3 Biomedicine Inc. 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.(1),(2) H3B-8800 binds to SF3B1, and demonstrated significant antitumor activity in preclinical models by modulating the disruption of mRNA splicing in cancer.(3) Eisai and H3 Biomedicine Inc. are currently conducting a Phase I clinical trial of H3B-8800 in the U.S. and Europe in patients with myelodysplastic syndrome carrying SF3B1 mutations.

Under the terms of the agreement, Eisai will receive a contractual up-front payment, development, and regulatory milestone payments for H3B-8800, and will also receive a certain amount of royalties on sales revenue of H3B-8800 after the launch.

Roivant is a biopharmaceutical company with a unique business model. Roivant builds and launches subsidiaries, called “Vants” which conduct efficient clinical development in diverse therapeutic areas. Eisai believes that this License Agreement with Roivant will lead to the maximization of the value of H3B-8800. Eisai will continue to accelerate its discovery of new medicines based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

About H3 Biomedicine, Inc.

H3 Biomedicine, Inc., a Cambridge, Massachusetts-based biopharmaceutical company specializing in the discovery and development of precision oncology treatments using its integrated data science, human biology and precision chemistry discovery engine with the goal of improving the lives of patients. The company was established on December 2010 as a subsidiary of Eisai’s U.S. pharmaceutical operation, Eisai Inc. H3 Biomedicine focuses on sustained long-term delivery of its pipeline, collaborating with Eisai Co., Ltd., who provides essential research funding and access to the capabilities and resources of a global pharmaceutical company.
For more information, please visit www.h3biomedicine.com.

About Roivant

Roivant’s mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants – nimble and focused biopharmaceutical and health technology companies.

For more information, please visit www.roivant.com.

(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.

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Eisai Co., Ltd.
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