Comprehensive Report on GLB-002: An Investigational IKZF1/3 Molecular Glue Degrader for Non-Hodgkin Lymphoma

1. Executive Summary

GLB-002 is an orally administered, next-generation, selective molecular glue degrader targeting the lymphoid transcription factors Ikaros (IKZF1) and Aiolos (IKZF3).[1] Developed by GluBio Therapeutics Inc., a clinical-stage biotechnology company specializing in Targeted Protein Degradation (TPD), GLB-002 represents a novel therapeutic approach for hematological malignancies.[1] The drug functions by inducing the ubiquitination and subsequent proteasomal degradation of IKZF1 and IKZF3, proteins known to be critical for the survival and proliferation of certain lymphoma and myeloma cells.

Currently, GLB-002 is undergoing evaluation in a Phase 1 clinical trial (NCT06219356; GLB-002-01). This first-in-human (FIH), open-label, multicenter study is actively recruiting patients in China with various subtypes of relapsed or refractory Non-Hodgkin Lymphoma (R/R NHL). The trial employs a dose escalation and expansion design to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of GLB-002 monotherapy.

Initial results from the first dose cohort (Cohort 1) have been reported as positive.[1] GLB-002 demonstrated excellent PK, PD, safety, and tolerability profiles at the initial dose level. Crucially, the expected extent of IKZF1/3 degradation was achieved, confirming target engagement in humans.[1] Following successful review by the Safety Review Committee, the trial has progressed to dose escalation, with the second cohort now open for enrollment.[1]