Kangpu Completes Patient Enrollment for Phase IIa Clinical Trial of KPG-818 in SLE in the US

Shanghai, China, March 20, 2023 -- Kangpu Biopharmaceuticals, a clinical-stage company based in Shanghai, China, announced today that the Company has completed patient enrollment for the Phase IIa clinical trial of KPG-818 aimed at the treatment of systemic lupus erythematosus (SLE) in the US.

The Phase IIa trial is a multicenter, randomized, double-blind, placebo-controlled study, with the first patient dosed in June 2022, to assess the safety and tolerability, pharmacokinetics, and preliminary efficacy of KPG-818 in patients with SLE. Patients were randomized in a 1:1:1:1 ratio to receive KPG-818 capsules at doses of 0.15 mg, 0.6 mg, 2 mg, or placebo orally once daily for 12 weeks. The clinical endpoints included incidence and severity of adverse events (AEs), baseline changes in activity scores of systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K), cutaneous lupus erythematosus disease area and severity index (CLASI), physician global assessment (PGA), tender and swollen joint counts as well as PK and PD parameters.

Systemic Lupus Erythematosus is a complex, heterogeneous, inflammatory, chronic auto-immune disease in which the body’s immune system attacks its own tissues, leading to widespread damage to various organs, including the kidneys, lungs, heart, brain, skin, joints, and blood vessels. As reported by Frost & Sullivan, the global population of SLE sufferers is projected to grow to 8.6 million by 2030. Only two biologics have been approved by the FDA for SLE in the last 60 years. With limited clinical treatment options available and no cure for the disease, effective management of SLE remains a huge challenge. Mrs. Yao WANG, chief medical officer of Kangpu Biopharmaceuticals, commented: “We are delighted to see the completion of patient enrollment for the Phase IIa study, which marks a significant advancement in the study of KPG-818. Both Phase Ia and Ib clinical trials in the US have demonstrated KPG-818’s good safety and tolerability. We hope that KPG-818 can provide an effective new treatment option for patients and address the urgent unmet medical treatment for this disease around the world."

About KPG-818

KPG-818 is a novel generation of small molecule modulators of CRBN E3 ubiquitin ligase complex CRL4-CRBN. It provides a potent induction of the ubiquitination and degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors critical in B-cell development. KPG-818 demonstrated outstanding in vitro anti-inflammatory properties and a broad spectrum of anti-proliferative activities as well as remarkable in vivo efficacy in animal models of multiple blood cancers. In the first-in-human Phase Ia single ascending dose (SAD) clinical study and the Phase Ib clinical study in SLE patients completed in the US, KPG-818 was well tolerated at all tested dose levels and demonstrated a favorable pharmacokinetic profile. KPG-818 is currently being developed in a Phase I study for the treatment of patients with hematological malignancies and a Phase Ib/IIa study for the treatment of patients with Systemic Lupus Erythematosus (SLE) in the United States (NCT04283097 and NCT04643067).

About Kangpu Biopharmaceuticals

Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative small molecules for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions, including targeted protein ubiquitination and degradation. Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms, including NeoMIDES^®, SelPDEiS^®, and X-SYNERGY^®, which the Company has patented globally.

For more information, please visit www.KangpuGroup.com.

Forward-Looking Statements

The statement(s) made in this press release describing Kangpu’s predictions, expectations and objectives may be forward-looking statements within the meaning of all applicable laws and regulations. These statements and expectations envisaged by the management are only estimates. Actual results may differ materially from such expectations due to risks, uncertainties and other factors, including, but not limited to, changes in regulatory and/or economic conditions, uncertain outcomes in the clinical studies, exposure to market risks, and other external and internal factors, which are beyond the control of Kangpu.