KPG-818

HEFEI, China, June 10, 2024 /PRNewswire/ -- Kangpu Biopharmaceuticals today announced that a poster tour presentation highlighting the Phase 2a clinical data of KPG-818 in patients with Systemic Lupus Erythematosus (SLE) will be presented at the upcoming Annual European Congress of Rheumatology EULAR 2024, taking place in Vienna, Austria, June 12-15, 2024. Poster tour presentation details: Abstract Title: KPG-818, a Novel Cereblon Modulator in Patients with Systemic Lupus Erythematosus: Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study Abstract number: POS0057 Abstract authors: Robert Levin, et al. Poster tour title: Clinical Poster Tours: Systemic lupus - Of old and new therapies Poster tour date and time: Wednesday, June 12, 2024, 15:30 - 16:30 CEST Poster tour location: Hall C The Phase 2a trial is a multicenter, randomized, double-blind, placebo-controlled study, to assess the safety and tolerability, pharmacokinetics, and preliminary efficacy of KPG-818 in patients with SLE, and to select dosing regimens for Phase 2b study. 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. Endpoints included baseline changes in activity scores of SLE disease activity index 2000 (SLEDAI-2K), cutaneous lupus erythematosus disease area and severity index (CLASI), physician global assessment (PGA). The results showed that KPG-818 0.15 mg and 0.6 mg were generally well tolerated after 12 weeks of drug administration. Compared with placebo arm, 0.15 mg arm exhibited obvious improvements in SLEDAI-2K and CLASI scores at week 12. KPG-818 demonstrated a favorable pharmacokinetic profile, reduced the total B cell count and increased Treg in SLE patients. SLE is a complex, heterogeneous, inflammatory, chronic auto-immune disease in which the body's immune system attacks its own tissues. As reported by Frost & Sullivan, the global population of SLE patients is projected to grow to 8.6 million by 2030. As no small molecule drug was approved by the FDA for SLE in the last 60 years, there are huge unmet clinical needs. Dr. Robert W. Levin, the immediate past President of the Florida Society of Rheumatology and PI of this study, said: "KPG-818 demonstrated very promising preliminary efficacy, especially in SLE patients with cutaneous manifestation. There are tremendous unmet medical needs for more treatment options, especially an oral agent." Discovered by Kangpu Biopharmaceuticals and acting as molecular glue, KPG-818 is a modulator of Cereblon (CRBN) E3 ubiquitin ligase complex CRL4CRBN. The compound demonstrated potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1). KPG-818 showed outstanding in vitro anti-inflammatory properties, broad spectrum of anti-proliferative activities, and remarkable in vivo efficacy in multiple blood cancer animal models. A bridge study (CTR20241116) for the treatment of SLE has been initiated in China. Meanwhile, a Phase 1 study of KPG-818 for the treatment of patients with hematological malignancies is being completed in the United States (NCT04283097). 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 autoimmune diseases, solid tumors, hematologic malignancies, 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®, gDACs®, and X-SYNERGY®. For more information, please visit . CONTACT: Florence Liu, [email protected] SOURCE Kangpu Biopharmaceuticals

HEFEI, China, Feb. 20, 2024 /PRNewswire/ -- Kangpu Biopharmaceuticals, a clinical-stage company dedicated to the discovery and development of novel therapeutics for the treatment of cancer, autoimmune diseases, and inflammation, through targeted protein degradation technology, today announced that a poster on preclinical efficacy data of KPG-818 in Crohn's disease will be presented at the upcoming 19th Congress of European Crohn's and Colitis Organisation (ECCO), taking place in Stockholm, Sweden, February 21-24, 2024. Poster Title: Therapeutic Effects of KPG-818 in a Trinitrobenzene Sulfonic Acid-Induced Mouse Crohn's/Ulcerative Colitis Model Abstract Number: EC24-0844 Exhibition Zone: Poster Exhibition, Hall A Presentation Number: P131 Crohn's disease is a chronic and difficult-to-treat autoimmune disorder. The current available therapeutic options for this condition are very limited, and there remain significant unmet medical needs. In preclinical studies, KPG-818 demonstrated potent therapeutic efficacy in mouse model of Crohn's disease. KPG-818 significantly improved clinical symptoms, colorectitis, ulcers, and local immune cell infiltration in the model animals. Based on the recent Pre-IND meeting with the FDA, Kangpu Biopharmaceuticals will submit IND application for Phase II clinical trials of KPG-818 for Crohn's disease in the United States. About KPG-818 KPG-818 is a novel generation of small molecule modulators of CRBN E3 ubiquitin ligase complex CRL4-CRBN. It provides potent 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 showed 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 Phase Ib/IIa clinical study in SLE patients (trial ID: NCT04643067) completed in the United States, KPG-818 demonstrated good safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy. Currently, Phase I clinical trials (trial ID: NCT04283097) for the treatment of various blood cancers are being conducted in the United States. About Kangpu Biopharmaceuticals Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative therapeutics for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions including targeted protein ubiquitination and degradation. Kangpu Biopharmaceuticals has built a rich and solid pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technologies, including NeoMIDESTM, SelPDEiS®, and X-SYNERGY®, developed and patented worldwide by the Company. For more information, please visit . Forward-Looking Statements The statement(s) made in this press release describing Kangpu Biopharmaceuticals' predictions, expectations, and objectives may be forward-looking statements within the meaning of applicable laws and regulations. These statements and expectations envisaged by the management are only estimates and 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 these clinical studies, exposure to market risks, and other external and internal factors, which are beyond the control of Kangpu Biopharmaceuticals. SOURCE Kangpu Biopharmaceuticals