KPG-818 / Kangpu Biopharma - LARVOL DELTA

Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Kangpu Biopharmaceuticals, Ltd. | Recruiting ➔ Completed | Trial completion date: May 2025 ➔ Dec 2024

Trial completion • Trial completion date • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology

Kangpu Biopharmaceuticals Received CDE Approval for Phase IIb Clinical Trial of KPG-818 in Moderate to Severe Cutaneous Manifestations of SLE (PRNewswire) - "Kangpu Biopharmaceuticals, Ltd. announced today that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved Phase IIb clinical trial of KPG-818 capsule for the treatment of moderate to severe cutaneous manifestations of systemic lupus erythematosus (SLE)."

New P2b trial • Systemic Lupus Erythematosus

Kangpu Biopharmaceuticals Received IND Approval from NMPA for KPG-818 to Treat Relapsed/Refractory Multiple Myeloma (PRNewswire) - "Kangpu Biopharmaceuticals, Ltd...today announced that the Company has received IND approval from the CDE (Center for Drug Evaluation) of China National Medical Products Administration (NMPA) for KPG-818 for the treatment of relapsed/refractory multiple myeloma (RRMM)."

New trial • Multiple Myeloma

Kangpu Completed Bridging Clinical Study of KPG-818 in China (PRNewswire) - "Kangpu Biopharmaceuticals...announced today that the Company has successfully completed a bridging clinical study of KPG-818 in healthy subjects in China....A total of 30 participants were randomized to three escalating cohorts (n=10 each; 8 KPG-818, 2 placebo) receiving 0.15 mg, 0.6 mg, 2 mg or placebo once daily. In the FE cohort, 12 participants received single dose of 0.6 mg KPG-818 with and without food.... In the Phase Ib/IIa clinical study in SLE patients (trial ID: NCT04643067) completed in the US, KPG-818 demonstrated promising efficacy and a favorable safety and tolerability profile."

Trial status • Small Lymphocytic Lymphoma

KPG-818, A NOVEL CEREBLON MODULATOR IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: RESULTS OF A RANDOMIZE, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2A STUDY (EULAR 2024) - P1/2 | "KPG-818 0.15 mg and 0.6 mg were generally well-tolerated in this SLE population over a 12-week of treatment. The proof-of-concept findings suggest a favorable benefit/risk ratio in SLE for KPG-818, a drug with a novel immunomodulatory mechanism of action, supporting further clinical development of KPG-818 in SLE."

Clinical • P2a data • Cutaneous Lupus Erythematosus • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Leukopenia • Lupus • Musculoskeletal Diseases • Neutropenia • Oncology • Orthopedics • Systemic Lupus Erythematosus • Targeted Protein Degradation • CRBN • IKZF1 • IL17RB

Kangpu Biopharmaceuticals to Present Results from Phase 2a of KPG-818 in SLE at EULAR 2024 (PRNewswire) - P1b/2a | N=64 | NCT04643067 | Sponsor: Kangpu Biopharmaceuticals, Ltd. | "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....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."

P2a data • Systemic Lupus Erythematosus

Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE (clinicaltrials.gov) - P1/2 | N=64 | Completed | Sponsor: Kangpu Biopharmaceuticals, Ltd. | Active, not recruiting ➔ Completed | Phase classification: P1b/2a ➔ P1/2 | Trial completion date: Dec 2023 ➔ Aug 2023

Phase classification • Trial completion • Trial completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CRBN • IKZF1

Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Kangpu Biopharmaceuticals, Ltd. | Trial completion date: May 2024 ➔ May 2025 | Trial primary completion date: Jan 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology

Therapeutic effects of KPG-818 in a trinitrobenzene sulfonic acid - induced mouse Crohn's/Ulcerative Colitis model (ECCO-IBD 2024) - "KPG-818 is a novel generation of lenalidomide derivative and small molecule immunomodulatory drug...KPG-818 showed similar therapeutic effects to Upadacitinib. Conclusion In this mouse model of chronic Crohn’s/ulcerative colitis, KPG-818 showed remarkable therapeutic effects in a dose-dependent manner. These data encourage the clinical evaluation of KPG-818 in inflammatory bowel diseases."

Preclinical • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL6 • TNFA

Kangpu Biopharmaceuticals to Present Preclinical Efficacy Data of KPG-818 in Crohn's Disease at the 19th Congress of ECCO (IND Application for Phase II in Progress) (PRNewswire) - "Kangpu Biopharmaceuticals...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....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."

Preclinical • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE (clinicaltrials.gov) - P1b/2a | N=64 | Active, not recruiting | Sponsor: Kangpu Biopharmaceuticals, Ltd. | Trial completion date: Jul 2023 ➔ Dec 2023

Trial completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE (clinicaltrials.gov) - P1b/2a | N=64 | Active, not recruiting | Sponsor: Kangpu Biopharmaceuticals, Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Kangpu Biopharmaceuticals, Ltd. | Trial completion date: Aug 2023 ➔ May 2024 | Trial primary completion date: Aug 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology

Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Kangpu Biopharmaceuticals, Ltd. | Trial completion date: Jan 2023 ➔ Aug 2023 | Trial primary completion date: Jan 2023 ➔ Aug 2023

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • Solid Tumor

KPG-818, a Novel Cereblon (CRBN) Modulator, in Patients with SLE: Results of a Phase Ib Multiple Ascending Dose Study (ACR Convergence 2022) - P1b/2a | "KPG 818 was generally well-tolerated in this SLE population over a 14-day of treatment. The drug-related AEs, mainly skin and hematologic disorders, were clinically manageable. Treatment with KPG-818 resulted in robust and dose-dependent modulatory effects including degradation of Aiolos, B cell depletion, down-regulation of pDC, and up-regulation of Treg."

Clinical • P1 data • Dermatology • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Oncology • Targeted Protein Degradation • Urticaria • CD19 • CD68 • CRBN • IKZF1 • IL17RB • TNFRSF13C

Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Kangpu Biopharmaceuticals, Ltd. | N=56 ➔ 30

Enrollment change • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • Solid Tumor

A Study to Assess the Safety and Tolerability, PK and Efficacy of KPG-818 in Mild to Moderate SLE Patients (clinicaltrials.gov) - P1b/2a | N=64 | Recruiting | Sponsor: Kangpu Biopharmaceuticals, Ltd. | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study to Assess the Safety and Tolerability, PK and Efficacy of KPG-818 in Mild to Moderate SLE Patients (clinicaltrials.gov) - P1b/2a; N=64; Recruiting; Sponsor: Kangpu Biopharmaceuticals, Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • PCR

Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Kangpu Biopharmaceuticals, Ltd.; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • CD20

A Study to Assess the Safety and Tolerability, PK and Efficacy of KPG-818 in Mild to Moderate SLE Patients (clinicaltrials.gov) - P1b/2a; N=64; Not yet recruiting; Sponsor: Kangpu Biopharmaceuticals, Ltd.; Initiation date: Dec 2020 ➔ Mar 2021

Clinical • Trial initiation date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Kangpu Biopharmaceuticals Initiates Phase Ib/IIa Clinical Trial of KPG-818 in Systemic Lupus Erythematosus (PRNewswire) - "Kangpu Biopharmaceuticals...announced that, after consulting with the U.S. Food and Drug Administration (FDA), the Company has initiated a Phase Ib/IIa clinical study of KPG-818 in patients with Systemic Lupus Erythematosus (SLE)."

Trial status • Lupus • Systemic Lupus Erythematosus

[VIRTUAL] KPG-818, a novel cereblon modulator, inhibits hematological malignancies in preclinical models (AACR-II 2020) - "The clinical use of lenalidomide in multiple myeloma (MM), mantle cell lymphoma (MCL) and myelodysplastic syndromes (MDS) represents a significant advance in the treatment of hematological malignancies and has altered the landscape of the blood cancer therapy. Importantly, KPG-818 prolongs the survival of the mouse cohorts bearing systemic human H929 multiple myeloma in a dose-dependent manner. Moreover, KPG-818 shows favorable DMPK and toxicity profiles in pre-clinical IND enabling studies.In summary, these immune modulation, anti-angiogenesis and antitumor results encourage the further clinical evaluation of KPG-818 in patients with Multiple Myeloma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma and other hematological malignancies."

Preclinical • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • CRBN • IL17RB • IL6

Kangpu to Present Two Posters at the 2020 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "KPG-121 significantly improves anti-tumor efficacies when combined with androgen-receptor antagonists including Enzalutamide, Abiraterone Acetate, Apalutamide, or Darolutamide in xenograft models when compared to the androgen-receptor antagonist therapy alone....In preclinical studies, KPG-818 demonstrates outstanding in vitro anti-inflammatory properties and broad spectrum of anti-proliferative activities as well as remarkable in vivo efficacy in animal models of multiple blood cancers."

Preclinical • Genito-urinary Cancer • Hematological Malignancies • Oncology • Prostate Cancer

Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Kangpu Biopharmaceuticals, Ltd.; Not yet recruiting ➔ Recruiting; N=40 ➔ 56; Trial completion date: Mar 2021 ➔ Dec 2021; Trial primary completion date: Mar 2021 ➔ Dec 2021

Clinical • Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology

Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Kangpu Biopharmaceuticals, Ltd.

Clinical • New P1 trial