IKZF1

HEFEI, China, April 28, 2025 /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). About Cutaneous Manifestations of SLE SLE is a complex, heterogeneous, inflammatory, chronic autoimmune disease in which the body's immune system attacks its own tissues, including skin, joints, and kidneys. Skin is the second most frequently affected organ system of SLE. The majority of SLE patients experience cutaneous manifestations over the course of the disease. Cutaneous manifestations of SLE carries a significant burden with regard to psychosocial well-being and medical costs. Treatment options for cutaneous manifestations of SLE are limited, and current therapies (e.g., glucocorticoids, antimalarials, immunosuppressants) often lack efficacy or carry systemic side effects. There are tremendous unmet medical needs for novel therapeutics, especially an oral agent. About KPG-818 KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It demonstrated high binding affinity to CRBN and potent degradation of zinc-finger transcription factors Aiolos (IKZF3) and Ikaros (IKZF1). KPG-818 effectively regulates immune cells (B cells, T cells, and pDC cells) and the release of multiple cytokines, possessing immunomodulatory, anti-angiogenic and anti-tumor effects. In the Phase IIa clinical study in SLE patients completed in the US, KPG-818 was well tolerated and demonstrated promising preliminary efficacy in SLE patients with cutaneous manifestations. KPG-818 was well tolerated in healthy subjects in a Phase I clinical study completed in China. About Kangpu Biopharmaceuticals, Ltd. 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 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 . SOURCE Kangpu Biopharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HEFEI, China I February 25, 2025 I Kangpu Biopharmaceuticals, Ltd. (“Kangpu”) 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). KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It demonstrated high cereblon (CRBN) binding affinity and potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors associated with B-cell development. KPG-818 possesses immunomodulatory, anti-angiogenic, and anti-tumor effects. The Phase I clinical trial of KPG-818 in the United States for the treatment of various hematological tumors has been completed. Preliminary results indicate that in RRMM patients who have previously received two immunomodulatory drugs (lenalidomide and pomalidomide), at least one proteasome inhibitor (bortezomib, ixazomib, or carfilzomib), and a CD38 monoclonal antibody (daratumumab or isatuximab), KPG-818 demonstrated good safety, tolerability, pharmacokinetic characteristics, and encouraging therapeutic effects. 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 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 www.KangpuGroup.com . SOURCE: Kangpu Biopharmaceuticals

On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.Full prescribing information for Adcetris will be posted on Drugs@FDA. Efficacy and SafetyApproval was based on ECHELON-3 (NCT04404283), a randomized, double-blind, placebo-controlled trial enrolling 230 adult patients with relapsed or refractory LBCL who were ineligible to receive an auto-HSCT or CAR T-cell therapy. Patients were randomized 1:1 to receive brentuximab vedotin plus lenalidomide and rituximab (BV+R2) or placebo plus lenalidomide and rituximab (Pbo+R2) until disease progression or unacceptable toxicity.The major efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures included progression-free survival (PFS) and objective response rate (ORR) per 2014 Lugano Criteria. The trial demonstrated a statistically significant OS improvement with a median OS of 13.8 months (95% CI: 10.3, 18.8) in the BV+R2 arm and 8.5 months (95% CI: 5.4, 11.7) in the Pbo+R2 arm (Hazard ratio [HR] 0.63, 95% CI: 0.45, 0.89; p-value 0.0085). The trial also demonstrated a statistically significant improvement in PFS and ORR. Median PFS was 4.2 months (95% CI: 2.9, 7.1) with BV+R2 and 2.6 months (95% CI: 1.4, 3.1) with Pbo+R2 (HR 0.53, 95% CI: 0.38, 0.73; p-value <0.0001). The ORR was 64.3% (95% CI: 54.7, 73.1) and 41.5% (95% CI: 32.5, 51.0), respectively.Adverse ReactionsThe most common adverse reactions (≥20%), excluding laboratory abnormalities in the BV+R2 arm were fatigue, diarrhea, peripheral neuropathy, rash, pneumonia, and COVID-19 infection. Grade 3 to 4 laboratory abnormalities occurring in more than 10% were decreased neutrophils, decreased lymphocytes, decreased platelets, and decreased hemoglobin. Peripheral neuropathy developed or worsened in 27% of patients, was predominantly sensory, and led to brentuximab vedotin dose reduction in 6% and discontinuation in 4.5%. The recommended brentuximab vedotin dose is 1.2 mg/kg up to a maximum of 120 mg in combination with lenalidomide and rituximab administered every three weeks until disease progression or unacceptable toxicity.This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X: @FDAOncology.