IMBiologics (CEO Ha Kyung-sik) announced on the 17th that it signed a license out (L/O) agreement with Navigator Medicines of the United States for 'IMB-101', a bispecific antibody-based autoimmune disease treatment in phase 1 clinical trials.

IMB-101 is IMBiologics' lead pipeline, a dual antibody new drug candidate targeting OX40L and TNF simultaneously, and is currently undergoing phase 1 clinical trials in the United States. It is designed as a hybrid of a phase 1a clinical trial involving single administration to healthy adults and a phase 1b clinical trial involving repeated administration to patients, and safety, tolerability, pharmacokinetics, and pharmacodynamic properties will be evaluated.

Dosing for the phase 1a clinical trial is expected to be completed soon, and the phase 1b clinical trial targeting patients is scheduled to begin in the second half of the year. The company expects it to be a best-in-class drug in the class that can expand its indications as a treatment for various autoimmune diseases due to the nature of the substance's mechanism of action (MoA). IMB-102, the company's single antibody pipeline targeting only OX40L, was also included in this agreement.

According to the contract details announced by IMBiologics, the rights area is global (including Japan) excluding Asia, the contract deposit with no obligation to return is a total of $20 million (approximately 27 billion won), and up to a maximum of 20 million won as milestones according to the development and commercialization stage. You will receive $924.75 million (KRW 1.279 trillion).

In addition, royalties based on annual net sales can be received up to a double-digit percentage (%), and if a third-party sublicense occurs, profits can be distributed separately according to a set ratio for each development stage.

Ha Kyung-sik, CEO of IMBiologics, said, "We trust Navigator Medicine's capabilities and experience in the field of autoimmune diseases, and we hope to work closely with them in the future to successfully launch IMB-101 and IMB-102 into the market and help patients' lives. “We will do our best to become a company that is truly achievable,” he said. “We will set the maximum goals that can be realistically achieved, and we will work harder to earn the market’s trust as a company that always achieves its goals well and keeps its promises.”

Stefan Thomas, CEO of Navigator Medicine, said, "We are very pleased to begin this partnership with IMBiologics, which is developing top-level OX40L targeting antibody drugs based on its excellent development experience and capabilities." He added, "IMB-101 and IMB-102. “We plan to continue developing and quickly provide these drugs to patients who need them,” he said.

Meanwhile, IMBiologics is a new antibody drug research and development bio venture established in August 2020, and attracted market attention by attracting 20 billion won in Series B investment last year.