sunaciclib (AU-07) / Qianhong Bio-Pharma, Aucentra - LARVOL DELTA

QHRD107 (CDK9 Inhibitor), venetoclax, and azacitidine combination therapy (107VA regimen) in relapsed/refractory Acute Myeloid Leukemia: Data updates and subgroup analysis (ASH 2025) - P2 | "The 107VA regimen demonstrated high response rates in VEN-AZA relapse or refractoryAML, particularly in patients with TP53 mutations and myelodysplasia-related features. Based on thesedata, a phase 2b randomized controlled study comparing 107VA with other salvage regimens is currentlybeing conducted for patients who relapse after VEN-AZA treatment."

Combination therapy • IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • CEBPA • FLT3 • NPM1 • RUNX1 • RUNX1T1 • TP53

High Remission Rates in Relapsed/Refractory Acute Myeloid Leukemia with QHRD107 (CDK9 Inhibitor), Venetoclax, and Azacitidine Combination Therapy (107VA regimen) : Preliminary Results of a Phase 2a Study (ASH 2024) - P1, P2 | "Common non-hematologic treatment-related adverse effects (TRAE) included diarrhea (66.7%, 4.2% ≥ G3), hypokalemia (50.0%, 8.3% ≥ G3), hepatic injury (50.0%), vomiting (45.8%), nausea (33.3%), infection (41.7%, 25.0% ≥ G3), and lactate dehydrogenase increase (29.2%). Conclusions : The 107VA regimen was well tolerated at tested doses and showed preliminarily activity in patients, with a high rate of cCR rate observed in those resistant to VEN-AZA therapy."

Clinical • Combination therapy • IO biomarker • P2a data • Acute Myelogenous Leukemia • Hepatology • Infectious Disease • Liver Failure • TP53

HIGH REMISSION RATES IN RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA WITH QHRD107 (CDK9 INHIBITOR), VENETOCLAX, AND AZACITIDINE COMBINATION THERAPY (107VA REGIMEN): PRELIMINARY RESULTS FROM A PHASE 2A STUDY (EHA 2025) - "The 107VA regimen demonstrated preliminarily activity and was well tolerated at tested doses, showing a high cCR rate, particularly in pateints relapsed from VEN-AZA therapy."

Clinical • Combination therapy • IO biomarker • P2a data • Acute Myelogenous Leukemia • Hepatology • Infectious Disease • Liver Failure • TP53

Phase IIa Study to Assess Safety and Efficacy in the Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=53 | Recruiting | Sponsor: Changzhou Qianhong Bio-pharma Co., Ltd.

New P2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

CDK9 inhibition inhibits multiple oncogenic transcriptional and epigenetic pathways in prostate cancer. (PubMed, Br J Cancer) - "Our work demonstrates that CDK9 inhibition disrupts multiple oncogenic pathways and positions CDKI-73 as a promising therapeutic agent for prostate cancer, particularly aggressive, therapy-resistant subtypes."

IO biomarker • Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • BCL2 • BRD4