Johnson & Johnson Inks $1.2B Deal for Oral STAT6 Inhibitor KP-723 from Kaken Pharmaceutical

December 26,Johnson & JohnsonAnnouncement with Kaken Pharmaceuticals Co., Ltd.KakenFor those currently under developmentSTAT6 Projectfor global development, production, and commercialization.

According to the agreement, Kaken will grant Johnson & Johnson an exclusive global license for the development, manufacturing, and commercialization of the STAT6 program, including an oral STAT6 inhibitor currently in preclinical development.KP-723Kaken will advance KP-723 to complete Phase I clinical trials, after which Johnson & Johnson will conduct clinical development and commercialization globally. Kaken will retain commercialization rights in Japan, while Johnson & Johnson has the option to enter into a co-promotion agreement with Kaken.

Kaken will receive from Johnson & Johnson$30 million upfront payment. According to the development progress and sales milestones, Kaken will be eligible to receive up to$1.2175 billion in successful payments, as well as a low double-digit global sales royalty.

STAT6 is a transcription factor that plays a crucial role in regulating immune responses, allergic reactions, and other biological processes. The STAT family currently comprises seven proteins, including STAT1, STAT2, STAT3, STAT4, STAT5a, STAT5b, and STAT6, with all genes located on different chromosomes but sharing a conserved sequence structure. Among them, STAT6 serves as a key molecule in the JAK/STAT signaling pathway, playing an essential function in maintaining pathway activity and gene expression.

In recent years, research on STAT6 has gradually become a hotspot in the biopharmaceutical field, as the abnormal expression of this factor is closely related to the occurrence of various diseases, including asthma, cancer, and others.

From a market perspective, therapies related to STAT6 hold tremendous potential, particularly in the treatment of chronic diseases and autoimmune disorders. The U.S. biopharmaceutical market is the largest globally, and Johnson & Johnson's strong presence and extensive sales network in this market will provide robust support for Kaken’s entry into the U.S.

KP-723 is a novel oral STAT6 inhibitor currently in the preclinical research stage. Kaken plans to initiate a Phase I trial for atopic dermatitis (AD) next year and may potentially apply the drug to other Th2-mediated diseases, including asthma.

Atopic Dermatitis (AD) is a chronic, recurrent, inflammatory skin disease that commonly occurs in infants and children but can also affect adults. As patients often have comorbid allergic rhinitis, asthma, and other atopic conditions, it is considered a systemic disease. The global number of atopic dermatitis patients reached 680 million in 2022, including 360 million children and adolescents. It is projected to reach 750 million by 2030, with 380 million being children and adolescents.

Johnson & Johnson's layout and acquisition for the atopic dermatitis indication is not the first time.

In May this year, Johnson & Johnson reached two acquisition deals successively. The first was the $850 million acquisition of Proteologix, obtaining multiple bispecific antibody therapies, including PX128, a bispecific antibody targeting IL-13 and TSLP, which is about to enter Phase I clinical development for moderate to severe AD and moderate to severe asthma.

Subsequently, Johnson & Johnson acquired Yellow Jersey Therapeutics, a subsidiary of Numab, for approximately $1.25 billion in cash, obtaining global rights to NM26, a bispecific antibody for the treatment of AD. NM26 targets IL-4Rα and IL-31 and is about to enter Phase II studies.