GluBio Announced Positive Preliminary Phase I Results for GLB-002 at the 2025 ASH Annual Meeting
December 10, 2025San Diego, California, Dec 10, 2025 - GluBio Therapeutics Inc., a clinical-stage, MGD-focused biotech company, announced positive preliminary results from the Phase I clinical trial of GLB-002 in patients with relapsed or refractory non-Hodgkin lymphoma (R/R NHL). The data were presented in a poster at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.
“We are pleased to share the positive progress of our internally developed novel molecular glue degrader, GLB-002, in treating relapsed/refractory non-Hodgkin lymphoma with the international community at the 2025 ASH Annual meeting. Preliminary data show that GLB-002 monotherapy has demonstrated durable objective responses and a favorable safety profile. A recommended Phase II dose has been established, laying a strong foundation for further development.” said Gang Lu, Ph.D., Founder, President and CEO of GluBio Therapeutics.
“Patient enrollment for the Phase I clinical study has been completed. We will continue to conduct long-term efficacy and safety follow-up assessments and will share relevant data at upcoming scientific milestones. Preparations for the Phase II clinical study are underway to further evaluate GLB-002 in the target patient population. We also plan to explore GLB-002 in combination with other therapies to provide patients with broader and more effective treatment options.”
Details of the GLB-002 presentation are as follows:
Title: Preliminary Results of a First-in-Human, Phase I Study of GLB-002, a Novel Molecular Glue Degrader of IKZF1/3, in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
Presentation Format: Poster
Presenter: Professor Yuqin Song, Beijing Cancer Hospital
Key Findings:
The ongoing Phase I clinical study NCT06219356 is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of GLB-002 in R/R NHL patients. As of June 13, 2025, 36 patients had been enrolled, including 17 (47.2%)with Follicular Lymphoma (FL) Grade 1-3a, 10 (27.8%)with Large B-cell Lymphoma (LBCL) or FL Grade 3b, and 9 (25.0%）with other NHL subtypes. The median age of enrolled patients was 60.5 years (range: 37-79), and the median number of prior lines of therapy was 3 (range: 2-8). 17 patients (47.2%) had previously received immunomodulatory imide drug treatment.
Efficacy Data:
As of the data cutoff on October 21, 2025, among 32 efficacy-evaluable NHL patients, GLB-002 monotherapy achieved an overall response rate (ORR) of 62.5% (20/32), and durable responses with the maximum duration of response (DOR) of 652 days across all dose levels.
-ORR was 64.3% (9/14) in NHL patients with prior immunomodulatory imide drug treatment.
-ORR was 71.4% (15/21) in NHL patients at the potential Recommended Phase II Dose (RP2D; 1 mg, 10/28), with a complete response (CR) rate of 19.0%.
-Among FL and Marginal Zone Lymphoma (MZL) patients at the potential RP2D , ORR was 75% (9/12).
Safety Data:
Twenty patients (55.6%) reported Grade ≥3 treatment-related adverse events (TRAEs). The most common events were neutropenia, leukopenia, lymphopenia, and thrombocytopenia, which were manageable with standard supportive care.
Conclusion:
GLB-002 monotherapy demonstrated a manageable safety profile and promising antitumor activities in R/R NHL patients. The potential RP2D (1mg, 10/28) demonstrates an optimal safety profile with maintained anticipated therapeutic efficacy.
About GLB-002
GLB-002 is a novel molecular glue degrader of IKZF1/3 selectively targeting Ikaros (IKZF1) and Aiolos (IKZF3) for degradation. Compared to classical IMiDs and other next-generation IKZF1/3 degraders, GLB-002 possesses improved IKZF1/3 degradation potency, efficacy and selectivity, and therefore is capable of triggering the near-complete degradation of IKZF1/3 in the picomolar concentration range with minimal effect on the protein levels of other common cereblon neosubstrates. In addition, GLB-002 exhibits strong in vitro and in vivo antitumor activities in all preclinical models of non-Hodgkin lymphoma (NHL) that are sensitive or resistant to treatment with IMiDs.