Taicang, China, Feb 28, 2017 – Connect Biopharmaceuticals, Ltd., a clinical-stage company that discovers and develops novel immune modulators for the treatment of autoimmune diseases and cancer, today announces that it has received approval from the China Food and Drug Administration (CFDA) for its Clinical Trial Application (CTA) for CBP-307, a novel second-generation S1P1 agonist. The approval allows the company to conduct clinical studies in patients with several important autoimmune diseases such as inflammatory bowel disease (ulcerative colitis and Crohn’s disease), plague psoriasis, rheumatoid arthritis, and multiple sclerosis.

The company also announces that the first clinical indication for CBP-307 in China will be in people with moderate-to-severe ulcerative colitis (UC); and that it is on track to file an Investigational New Drug (IND) with the US Food and Drug Administration (FDA) to initiate a global trial in UC patients.

“We are extremely pleased to receive the clearance from the CFDA,” said Dr. Zheng Wei, Co-founder and CEO of Connect. “CBP-307 has already been evaluated in a thorough Phase 1 study in Australia in healthy volunteers, in which the drug showed potent activity in T cell modulation, ideal pharmacokinetics and excellent safety and tolerability. We are excited to begin clinical evaluation of this promising drug candidate in UC patients for whom effective and safe treatments are still lacking.”

“This approval marks an important milestone for Connect,” commented Dr. Wubin Pan, Co-founder, president and Chairman of Connect. “Conducting clinical studies in China is a key part of our overall plan to extend the therapeutic potential of all of our drug candidates. CBP-307 is one of several drug candidates in our portfolio that we believe can not only be a leader in China in their drug class, but also be sufficiently differentiated to be successful globally. We look forward to providing additional updates on the progress of our clinical development of CBP-307 in due course.”

About CBP-307

CBP-307 is a novel, orally-active, second-generation S1P1 agonist with best-in-class potential for the treatment of a broad range of autoimmune diseases. Pharmacologically, it has markedly improved receptor subtype selectivity over fingolimod, a first generation S1P1 modulator already approved as a treatment for relapsing remitting multiple sclerosis (RRMS). CBP-307 is extraordinarily potent, with an EC50 of 0.09 nM for S1P1 and has greater than 10,000 fold selectivity against S1P3, a S1P receptor subtype linked to tissue fibrosis. CBP-307 does not interfere with the hERG potassium ion channel and therefore has no safety concern of QT prolongation of some other drug candidates of the same class. Extensive preclinical studies have shown that CBP-307 is highly potent in reducing disease severity in autoimmune disease models and has an excellent safety and tolerability profile.

Connect has successfully completed a Phase 1b study of CBP-307 in Australia. The randomized, double-blind, placebo controlled study assessed the tolerability, pharmacokinetics and pharmacodynamics of CBP-307 at 0.15 mg and 0.25 mg once daily doses for 4 weeks in healthy volunteers. In the study CBP-307 demonstrated potent T cell modulation activity, with a rapid onset of T cell modulation after dosing initiation, and allowed complete recovery of T cell count within 1 week after dosing conclusion. In addition, the drug displayed ideal pharmacokinetics and excellent tolerability.

About Connect Biopharmaceuticals

Founded in 2012, Connect Biopharmaceuticals, Ltd. is a clinical-stage company that discovers and develops novel immune modulators for the treatment of inflammation and cancer. Connect has several drug candidates in its pipeline, including CBP-307, CBP-201, CBP-174 (an in-licensed drug candidate with exclusive global rights) and several early-stage discovery programs. The company is headquartered in Taicang, Suzhou, and has operations in Melbourne and San Diego.