FDA Grants Orphan Drug Designation to Ymmunobio’s CEACAM Antibody for the Treatment of Liver Cancer

On February 28, 2023 Ymmunobio, a preclinical stage biotech company specializing in the development of innovative treatments for cancer patients, reported that it has been granted Orphan Drug Designation (ODD) by the US Food & Drug Administration (FDA) for YB-200, a CEACAM1/5 antibody it is studying for the treatment of hepatocellular carcinoma (HCC) (Press release, Ymmunobio, FEB 28, 2023, View Source [SID1234627907]).

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"This designation is an important milestone in our development of CEACAM antibodies as anti-cancer treatments," said Ymmunobio Founder and CEO Katrin Rupalla, PhD. "We’re very pleased to continue our investigation into CEACAM antibodies for the treatment of hepatocellular carcinoma."

YB-200 belongs to a novel class of CEACAM1 antibodies with a dual action. It acts as a checkpoint inhibitor, but also has a direct immune agonistic effect on immune cells. The antibody is currently in preclinical development. The in vivo anti-tumor data in liver cancer were presented at the SITC (Free SITC Whitepaper) 37th Annual Meeting1 in a poster presentation2 entitled "Novel, immune agonistic CEACAM1/5 antibody (YB-200) demonstrates anti-tumor efficacy and significantly increases B-cell response in syngeneic liver Hepa1-6 tumor microenvironment."

Hepatocellular carcinoma3 (HCC), or liver cancer, occurs when a tumor grows on the liver. It is responsible for over 12,000 deaths per year in the United States, making it one of the most serious cancers in adults. HCC is most often diagnosed in people aged 50 and over.4

The FDA grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

To learn more about Ymmunobio’s activities and research, visit the website or reach out to [email protected].

*carcinoembryonic antigen-related cell adhesion molecules