Celltrion has licensed a preclinical antibody aimed at autoimmune conditions from Maryland-based biotech Kaigene in a deal worth up to $580.5 million, marking another step for the South Korean drugmaker beyond its historical biosimilar focus.
The pipeline asset, called KG013, is a monoclonal antibody designed to target a proliferation-inducing ligand, a signaling protein involved in plasma cell survival and immunoglobulin production, according to an Oct. 22 release. By blocking this pathway, KG013 is intended to suppress the production of disease-causing antibodies associated with autoimmune conditions such as the kidney disease IgA nephropathy, also known as Berger's disease, which is the drug candidate's initial indication.
Kaigene will receive an undisclosed upfront payment and is eligible for additional milestone payments, bringing the deal's potential value to $580.5 million, plus royalties on net sales. The company also retains the option to co-market the drug in South Korea under the terms of the agreement.
IgA nephropathy affects about 160,000 diagnosed patients in the U.S., according to the company, but is particularly common in Asian populations, with about 30,000 patients in South Korea alone.
This isn't Kaigene's first rodeo with Celltrion. The companies crossed paths last November through another licensing deal, with Celltrion offering up to $744 million for two other preclinical autoimmune drug candidates, including a next-generation FcRn inhibitor called KG006 and a dual-acting antibody called KG002. Kaigene received $8 million upfront in that deal.
Celltrion has historically been known as a biosimilar maker, with copycat versions of blockbusters Remicade, Rituxan, Humira and others forming the foundation of its business. But in recent years, the company has dived into innovative medicines through licensing deals centered on antibodies. The latest deal fits that mold, according to Kaigene CEO Minjae Shin.
“Kaigene is building a comprehensive portfolio of therapies for pathogenic antibody-mediated diseases, and we believe KG013 has the potential to become a best-in-class treatment for IgA- and IgM-mediated diseases,” Shin said in the release.
“By working with Celltrion, a partner with comprehensive infrastructure for the global manufacturing, development and commercialization of antibody therapeutics, we aim to bring KG013 to patients worldwide and make a meaningful contribution to care in South Korea.”
Fueling Kaigene's pipeline are technologies such as a pathogenic antibody degrader platform and a nanobody-based delivery platform designed to shuttle molecules across the blood-brain barrier.