GLR2007 / Gan & Lee Pharma - LARVOL DELTA

Evaluation of GLR2007 for Advanced Solid Tumors (clinicaltrials.gov) - P1b/2 | N=19 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA | Active, not recruiting ➔ Completed | N=66 ➔ 19

Enrollment change • Metastases • Trial completion • Brain Cancer • Breast Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • NTRK • NTRK1 • ROS1

Investigational cyclin-dependent kinase 4/6 inhibitor GLR2007 demonstrates activity against isocitrate dehydrogenase wild-type glioblastoma and other solid tumors in mice xenograft models. (PubMed, Front Oncol) - "Currently marketed CDK4/6 inhibitors, including abemaciclib, have shown preclinical efficacy in solid tumors, but factors such as poor blood-brain barrier (BBB) penetration limit their efficacy in GBM. A xenograft model showed that, compared with vehicle control, 50 mg/kg GLR2007 induced 95.9% tumor growth inhibition (TGI) (P<0.001) in GBM orthotopic xenografts, 81.4% TGI (P=0.037) in breast cancer orthotopic xenografts, and 91.5% TGI (P<0.001) in colorectal cancer subcutaneous xenografts. These studies show possible BBB penetration of GLR2007 and demonstrate its potential as a CDK4/6 inhibitor for the treatment of solid tumors, including GBM."

Journal • Preclinical • Brain Cancer • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Glioblastoma • Hepatology • Liver Cancer • Oncology • Solid Tumor

Evaluation of GLR2007 for Advanced Solid Tumors (clinicaltrials.gov) - P1b/2; N=66; Active, not recruiting; Sponsor: Gan and Lee Pharmaceuticals, USA; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Brain Cancer • Breast Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • MRI • NTRK • NTRK1 • ROS1

Preclinical evaluation of novel CDK4/6 inhibitor GLR2007 in glioblastoma models (SNO 2021) - "Total radioactivity levels in the brain exceeded those in plasma by 2.3–4.5-fold from 2–6 h after dosing. These preclinical studies suggest the potential of GLR2007 for the treatment of GBM, supported by evidence that GLR2007 showed numerically greater anti-tumor efficacy than approved CDK4/6 inhibitors palbociclib and abemaciclib in GBM xenograft models, and evidence of substantial central nervous system distribution."

Preclinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

[VIRTUAL] Preclinical evaluation of novel CDK4/6 inhibitor GLR2007 in glioblastoma models (EANO 2021) - "Studies performed in rats demonstrated the distribution of [14C]GLR2007 in whole brain tissue following a single oral dose, with total radioactivity levels in the brain exceeding those in plasma by 2.3-4.5-fold from 2-6 h after dosing. Conclusion These preclinical studies suggest the potential of GLR2007 for the treatment of GBM, supported by evidence that GLR2007 showed numerically greater anti-tumor efficacy than approved CDK4/6 inhibitors palbociclib and abemaciclib in GBM xenograft models, and evidence of substantial central nervous system distribution."

Preclinical • Brain Cancer • Breast Cancer • Glioblastoma • Oncology • Solid Tumor

[VIRTUAL] Preclinical evaluation of novel CDK4/6 inhibitor GLR2007 in breast and lung cancer models (ESMO 2021) - "Currently marketed CDK4/6 inhibitors abemaciclib, palbociclib, and ribociclib have shown preclinical efficacy in solid tumors including breast cancer and non-small cell lung cancer. In a number of tumor cell lines, GLR2007 inhibited proliferation at lower IC50 values compared to abemaciclib. GLR2007 demonstrated significant antitumor efficacy in xenograft models compared to vehicle controls. These preclinical studies demonstrate the potential of GLR2007 as a novel CDK4/6 inhibitor for the treatment of breast and lung cancer."

Preclinical • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] Preclinical evaluation of novel CDK4/6 inhibitor GLR2007 in glioblastoma models. (ASCO 2021) - "CDK4/6 inhibitors palbociclib and abemaciclib are approved for the treatment of breast cancer, but poor blood–brain barrier (BBB) penetration limits their efficacy in GBM . These preclinical studies demonstrate the potential of GLR2007 as a novel CDK4/6 inhibitor for treatment of GBM . GLR2007 showed numerically greater anti-tumor efficacy than approved CDK4/6 inhibitors in xenograft models, and evidence of substantial central nervous system penetration."

Preclinical • Brain Cancer • Breast Cancer • Glioblastoma • Oncology • Solid Tumor

Gan & Lee receives EMA orphan drug designation for Phase I drug candidate GLR2007 for the treatment of glioma (PRNewswire) - "Gan & Lee Pharmaceuticals Co., Ltd...announced that the European Medicine Agency (EMA) Committee for Orphan Medicinal Products granted orphan drug designation for the investigational compound GLR2007, for the treatment of glioma."

European regulatory • Glioma • Oncology

Phase 1 Drug Candidate GLR2007 Developed by Gan & Lee has been Granted Fast Track Designation by the U.S. FDA (PRNewswire) - "Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee)...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for GLR2007, for the treatment of patients with glioblastoma."

Fast track designation • Glioblastoma • Oncology • Solid Tumor

"#GanandLeePharmaceuticals reported Phase 1 Drug Candidate #GLR2007 Developed by Gan & Lee has been Granted #FastTrackDesignation by the U.S. #FDA https://t.co/xr59Ep4w77" (@1stOncology)

Fast track designation

Gan & Lee’s CDK4/6 inhibitor under clinical review in China (GBI Health) - "China-based Gan & Lee Pharmaceuticals (603087.SH) announced that a clinical trial filing for its cyclin-dependent kinase 4/6 (CDK4/6) inhibitor GLR2007 has been accepted for review by the National Medical Products Administration (NMPA). GLR2007 is currently under development to treat advanced malignant tumors including gliomas, and entered into Phase I clinical trials in the US in July this year."

Non-US regulatory • Glioma • Oncology • Solid Tumor

Phase 1 Drug Candidate GLR2007 Developed by Gan & Lee has been Granted Orphan Drug Designation by the US FDA (PRNewswire) - "Gan & Lee Pharmaceuticals...announced that the U.S Food and Drug Administration (FDA) has granted Orphan Drug Designation for GLR2007, for the treatment of malignant glioma. GLR2007 is a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor that Gan & Lee is developing for the treatment of advanced solid tumors. Glioma is a broad term describing neuroepithelial tumors originating from glial cells of the central nervous system, including astrocytic tumors such as glioblastomas (GBM)."

Orphan drug • Glioblastoma • Glioma • Oncology • Solid Tumor

Gan & Lee Pharmaceuticals Initiates First-in Human Phase 1 Clinical Trial for New Anti-tumor Drug GLR2007 (PRNewswire) - "Today marks a major milestone for Gan & Lee Pharmaceuticals Co., Ltd....with the initiation of our first-in-human Phase 1 clinical trial for GLR2007, our internally-invented, cyclin-dependent kinase 4/6 (CDK4/6) inhibitor as a potential therapy for advanced solid tumors. CDK4/6 activity is central to cell cycle regulation and has a key role in the occurrence and progression of a variety of cancers."

Enrollment open • Oncology • Solid Tumor