Kangpu's Novel Cereblon Modulator Shows 50% Response Rate in Heavily Pre-treated Multiple Myeloma Patients
核心洞察
Kangpu Biopharmaceuticals (搜索) will present Phase I clinical trial results of epaldeudomide (搜索) (KPG-818) at the 67th ASH Annual Meeting in December 2025.
The novel cereblon (搜索) modulator achieved a 50% overall response rate and 94% disease control rate in heavily pre-treated multiple myeloma (搜索) patients.
The drug demonstrated favorable safety profile with no febrile neutropenia or peripheral neuropathy events observed in the multicenter Phase I study.
Kangpu Biopharmaceuticals (搜索) announced promising Phase I clinical trial results for its novel cereblon (搜索) modulator epaldeudomide (搜索) (KPG-818) in treating hematological malignancies (搜索), with the company set to present findings at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida from December 6-9, 2025.
Clinical Trial Results Demonstrate Efficacy and Safety
The multicenter, open-label, multiple ascending dose Phase I clinical trial (NCT04283097) evaluated epaldeudomide (搜索)'s safety, tolerability, pharmacokinetics, and preliminary efficacy in adults with relapsed/refractory multiple myeloma (搜索) when combined with dexamethasone, or as monotherapy in other selected hematologic malignancies.
In heavily pre-treated multiple myeloma (搜索) patients, epaldeudomide (搜索) achieved an overall response rate of 50% with a disease control rate (including stable disease) of 94%. The study demonstrated favorable pharmacokinetic characteristics alongside good safety and tolerability profiles.
Notable Safety Profile
The trial revealed a particularly encouraging safety profile, with no febrile neutropenia of any grade observed throughout the study. Additionally, no peripheral neuropathy events of any grade were reported, addressing common concerns associated with treatments for hematological malignancies (搜索).
Mechanism of Action
Epaldeudomide (搜索) functions as a novel molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN (搜索). The drug exhibits high cereblon (搜索) (CRBN) binding affinity and demonstrates potent degradation of Aiolos (搜索) (IKZF3 (搜索)) and Ikaros (搜索) (IKZF1 (搜索)), two members of the Ikaros family of zinc-finger transcription factors associated with B-cell development.
The compound possesses broad-spectrum immunomodulatory effects, anti-angiogenic properties, and anti-tumor effects, positioning it as a potentially significant addition to the treatment landscape for hematological malignancies (搜索).
ASH Presentation Details
Dr. Aaron Rosenberg from UC Davis Comprehensive Cancer Center (搜索) will present the poster titled "KPG-818, a Novel Cereblon (搜索) (CRBN (搜索)) Modulator, in Patients with Hematological Malignancies (搜索): Results of a Phase I, Open-Label, Multiple Ascending Dose Study" on December 8 from 6:00-8:00 PM local time at OCCC - West Halls B3-B4.
The presentation falls under poster category 654 (Multiple Myeloma (搜索): Pharmacologic Therapies: Poster III) and has been assigned poster number 5809. The study's primary objective was to determine the recommended Phase II dose while establishing the drug's safety and efficacy profile.