News
San Diego, California, Feb 23, 2024 – GluBio Therapeutics
Inc., a clinical-stage, TPD-focused biotech company announced the successful completion
of the first Safety Review Committee (SRC) meeting for
phase 1 clinical trial of GLB-002, a next-generation IKZF1/3 selective molecular
glue degrader, in patients with relapsed or refractory non-Hodgkin lymphoma
(R/R NHL). In cohort 1, GLB-002 exhibited excellent pharmacokinetics, pharmacodynamics,
safety and tolerability, and achieved the expected extent of IKZF1/3 degradation.
The cohort 2 is now open for patient recruitment, which marks the entry of this
clinical trial into a new stage.
“We are very delighted that we have successfully completed the dosing and Dose Limiting Toxicities (DLT) observation for cohort 1 within 2 months of study kickoff for the GLB-002 phase 1 study, to begin evaluating its safety and preliminary efficacy at the next dose level.” said Gang Lu, Ph.D., Founder, President and CEO of GluBio Therapeutics, “GLB-002 is our second molecular glue degrader that has advanced into clinical trial in the past 3 years, demonstrating GluBio’s excellent R&D strength and efficient execution. We will continue the close collaboration with experts from the Beijing Cancer Hospital and other participating sites to accelerate the GLB-002 clinical trial. Based on the initial PK/PD readout, we are optimistic that GLB-002 will become a novel treatment option for R/R NHL in the near future, and benefit more patients in dire need.”
About GLB-002
Phase 1 Clinical Trial
GLB-002-01 is
a first-in-human (FIH), phase 1, multicenter, dose escalation and expansion
study designed to evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics and preliminary efficacy of GLB-002 in patients with relapsed
or refractory non-Hodgkin lymphomas (R/R NHL).
The study is led by Prof. Yuqin Song from Beijing Cancer Hospital. Investigators
with years of experience and expertise in diagnosis, treatment and clinical
studies of NHL from multiple top cancer hospitals in China also participate in
this study. To learn more about the GLB-002 clinical trial, please visit https://clinicaltrials.gov/. Trial identifier: NCT0621935.
About
GluBio Therapeutics Inc.
GluBio
Therapeutics Inc. is a clinical-stage, TPD-focused biotech company dedicated to
develop innovative, impactful, and disease-modifying therapies for unmet
medical needs. The company was founded in March 2021. GluBio founders and key
team members have many years of experience in developing molecular glue and
PROTAC drugs in large MNC pharmaceutical companies. Currently, the company headquartered in San Diego, CA, has research operations in both the United States and Shanghai, China. Since its
establishment, the company has raised a total capital of nearly US$90M from top-tier
life sciences investors, including Hillhouse Ventures, Qiming Venture Partners,
Eli Lilly Asia Ventures, Kaitai Capital and Legend Capital.
GluBio has established a multi-dimensional protein degradation screening
platform, a target identification and validation platform, a molecular glue
rational design platform, as well as a proprietary molecular glue library. Taking
full advantage of the world’s leading TPD discovery platforms, the company
dedicates to the discovery and development of “First-in-class” and “Best-in-class”
small molecule TPD drugs. For more information, please visit www.glubiotx.com.