Tronsound long-acting IL-36R antibody obtained FDA clinical IND

SAN DIE, USA, Shanghai, China, and Sydney, Australia, February 2023, 2—Inmagene Biopharmaceuticals ("Transnat") announced that the U.S. Food and Drug Administration (FDA) has approved a Phase I clinical trial application (IND) for its drug candidate IMG-8. IMG-008 is the world's first long-acting antibody targeting IL-008R to enter the clinical stage, with a longer half-life and higher exposure than traditional IL-36R antibodies.

IMG-008 is a humanized monoclonal antibody (mAb) that specifically targets the human interleukin-36 receptor (IL-36R), effectively blocking IL-36 signaling and reducing cytokine release and inflammatory response. In preclinical studies, IMG-008 has a half-life more than 4 times longer and more than 2 times higher exposure than spesolimab analogues. IMG-008 may provide treatment for a variety of inflammatory diseases, such as generalized pustular psoriasis (GPP) and hidradenitis suppurativa (HS). People with these disorders often suffer from severe inflammation, recurrent symptoms, and obesity-related complications.

The IND-declared Phase I clinical study is a randomized, double-blind, placebo-controlled dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of IMG-008 in healthy adult subjects. Current studies have shown that the long half-life and higher exposure of IMG-008 may lead to increased efficacy, frequency of administration or dose reduction, which, once proven, will benefit not only the treatment of the acute phase of the disease, but also the treatment of the disease attack prevention or efficacy maintenance phase.

"IMG-008 was developed by Chuangxiang's proprietary QuadraTek® new drug discovery platform, which demonstrates our outstanding innovation capabilities. Transsound is pushing many innovative drugs like IMG-008 from early detection to global clinical studies. Wan Yuntao, chief development officer of Chuangxiang, said.

About IMG-008

IMG-008 is a novel long-acting antagonistic monoclonal antibody targeting IL-36R. It originated from Chuangxiang's proprietary QuadraTek® new drug discovery and development platform and is being developed for the treatment of a variety of autoimmune and inflammatory diseases. IL-36 cytokines belong to the IL-1 family and play an important role in regulating the innate immune system, which may lead to pathological inflammatory responses if it is uncontrollably activated and expressed. Preclinical studies have shown that IMG-008 binds to IL-36R with high affinity and has potent in vitro activity to block IL-36R downstream signaling and cytokine release. IMG-008 has a longer half-life and higher exposure in monkeys than spesolimab analogues.

About Tron Bio

Chuangxiang is a clinical-stage global biotechnology company focused on the development of new drugs for immune-related diseases. Transsound has four clinical-stage drug candidates, the most mature candidate in its pipeline is IMG-020 (izokibep), which is ongoing and global pivotal clinical trials for indications such as hidradenitis suppurativa and psoriatic arthritis. The Phase 020 clinical trial IND of IMG-3 for the treatment of plaque psoriasis has been approved by the China CDE. In addition, two products, IMG-004 and IMG-007, are completing global Phase 1 clinical trials, and another product, IMG-008, is entering Phase 1 clinical trials.