CAMBRIDGE, Mass., -- ONO PHARMA USA, INC. (President/CEO, Kunihiko Ito; “OPUS”) announced that it has initiated a Phase 1 study of ONO-7018, a mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitor, in patients with relapsed or refractory nonHodgkin lymphoma (“NHL”) or chronic lymphocytic leukemia (“CLL”) in the U.S.

This study is a multicenter, open label, dose escalation Phase 1 study (ONO-7018-01) to evaluate ONO-7018 in patients with relapsed or refractory NHL or CLL. For more information, please visit the following website at clinicaltrials.gov (NCT05515406).

"We are excited to initiate the Phase 1 study of ONO-7018 in the U.S. and hope that ONO-7018 will demonstrate clinical benefit to the patients with NHL or CLL in the U.S. in this clinical study.” said Masahiro Katayama, Executive Vice President, US/EU Head of Clinical Development, OPUS.

As for ONO-7018, Ono Pharmaceutical Co., Ltd. (Osaka, Japan; “Ono”) licensed ONO-7018 (CTX177), a MALT1 inhibitor, from Chordia Therapeutics Inc. (Kanagawa, Japan) in Dec 2020. Ono has exclusive global rights to develop, manufacture and commercialize ONO-7018. For more information, please click here.

About Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

NHL and CLL arise from the accumulation of monoclonal B or T lymphocytes in the body. Once NHL and CLL become refractory to standard chemotherapy and antibody-based therapies, the overall prognosis is poor, with limited long-term survival. Thus, novel and effective therapies are needed to address this high unmet medical need. NHL is the most common of lymphoid malignancies in the U.S. and Europe with more than 70,000 new cases diagnosed every year. CLL is the most common of leukemia in adults with an estimated 20,160 new cases in the U.S. in 2022.

About ONO-7018

ONO-7018 is a selective inhibitor against a mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1), which is known to be involved in an intracellular signaling pathway in lymphocytic blood cells. Activation of MALT1 is reported to play an important role in malignancies of lymphocytes. ONO-7018 is expected to exert anti-tumor effect against these malignancies by inhibiting of MALT1 activity. ONO-7018 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Chordia Therapeutics Inc.

Chordia is a clinical stage biotech company based in Fujisawa, Kanagawa Prefecture, Japan, engaged in the research and development of novel therapies for cancers. Chordia’s lead asset CLK inhibitor CTX-712 is under Phase 1 clinical study in Japan. CTX-712 potentially targets the vulnerability of cancer, and is expected to deliver benefit to patients of various types of cancer. In addition to CTX-712, Chordia is engaged in the research of several preclinical assets, including CTX-439, a CDK12 inhibitor, which is expected to be effective in cancers with specific abnormalities, as well as GCN2 inhibitors. For more information, please visit www.chordiatherapeutics.com.

About ONO PHARMA USA, INC.

ONO PHARMA USA, INC. (“OPUS”), established in 1998 as the U.S. subsidiary of Ono Pharmaceutical Co., Ltd. ("Ono”), is pursuing the clinical development of new drug candidates and aiming to establish its operation from the clinical development until the regulatory approval of products for commercialization in the U.S. In addition, OPUS has been engaged in promotion of the discovery alliances and licensing activities to expand Ono’s development pipeline and to pursue the commercialization opportunities in the U.S. For more information, please visit the company’s website at us.ono-pharma.com.

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ONO PHARMA USA, INC.
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