On June 13, 2022 Chiome Bioscience Inc. reported that new contract with additional institutes had been finalized and the first patient has been dosed CBA-1205, the first-in-class antibody, in the second part (expansion part) of Phase I study(Press release, Chiome Bioscience, JUN 13, 2022, View Source jp/xcontents/45830/87891347/f845/469b/96ae/2719ff6df264/20220613150323815s.pdf [SID1234625710]).

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In the first part of Phase I study, CBA-1205 exhibited good safety and tolerability. In the second part, two doses will be given to the patients with hepatocellular carcinoma to evaluate safety and to determine the optimum dose for further development. Also, the exploratory efficacy and pharmacokinetics will be investigated.

The study will be conducted at National Cancer Center Hospital, National Cancer Center Hospital East. Additional institutes will be at Kanagawa Cancer Center and Niigata University Medical and Dental Hospital.

We hope that CBA-1205 exhibits good safety and efficacy profile in the second part that is key for early licensing deal. We will announce the progress in a timely manner.

There is no impact on the financial performance in the fiscal period ending December 31, 2022.

＜About CBA-1205＞

CBA-1205 is a humanized IgG1 afucosylated monoclonal antibody targeting cell surface antigen "DLK-1 (Delta-like 1 homolog)" which expresses on hapatocellular carcinoma and other solid cancers. CBA-1205 exhibits potent and specific anti-tumor activity in various DLK1 expressing cancer models by increasing ADCC (antibody-dependent cellular cytotoxicity). DLK-1 is known to control the proliferation and differentiation of stem cells, progenitor cells,
and other immature cells. CBA-1205 is expected to offer a new therapeutic option for the treatment of DLK-1 expressing cancer such as hepatocellular carcinoma. The present phase I clinical study is the first trial all over the world and CBA-1205 exhibited safety and tolerability.