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CStone Advances CS5001 ROR1-ADC to Phase Ib Trial for First-line DLBCL Treatment

• CStone Pharmaceuticals has submitted a Phase Ib clinical trial application in Australia to evaluate CS5001 in combination with R-CHOP as first-line treatment for diffuse large B-cell lymphoma.

• CS5001 has shown promising results in early trials, achieving 70% objective response rates in advanced B-cell lymphoma and 100% in Hodgkin lymphoma at the recommended Phase 2 dose.

• The global multi-center trial will explore multiple treatment approaches, including CS5001 monotherapy and combination therapies for both lymphomas and solid tumors.

CStone Pharmaceuticals has submitted a clinical trial application in Australia to evaluate CS5001, its innovative ROR1-targeting antibody-drug conjugate (ADC), in combination with standard first-line therapy for diffuse large B-cell lymphoma (DLBCL). This strategic move aims to expand the therapeutic potential of CS5001 across multiple cancer types and treatment lines.

Clinical Development Strategy

The Phase Ib trial encompasses multiple treatment approaches:
  • CS5001 combined with R-CHOP for treatment-naive DLBCL patients
  • CS5001 with standard-of-care for relapsed/refractory DLBCL
  • CS5001 monotherapy for ROR1-expressing solid tumors
  • Combination therapy with sugemalimab for advanced solid tumors
The global trial is currently enrolling patients across the United States, Australia, and China, with plans to expand into a potential Phase II registrational study for certain indications.

Promising Early Clinical Data

Recent data presented at major scientific conferences have demonstrated CS5001's significant therapeutic potential. At the recommended Phase 2 dose of 125 μg/kg, the drug achieved:
  • 70% objective response rate in advanced B-cell lymphoma
  • 100% objective response rate in Hodgkin lymphoma
  • Encouraging efficacy signals in solid tumors, including non-small cell lung cancer and pancreatic cancer
  • Favorable tolerability profile in heavily pre-treated patients

Innovative Drug Design

CS5001 features a unique design incorporating:
  • A proprietary tumor-cleavable linker
  • A pyrrolobenzodiazepine (PBD) prodrug that activates only within tumor tissue
  • Site-specific conjugation for precise drug-antibody ratio
  • Enhanced safety profile compared to traditional PBD payloads
Dr. Jason Yang, CEO and President of R&D at CStone, expressed optimism about the program: "The existing data underscore its broad potential in both lymphomas and solid tumors. As we advance from late-line monotherapy to frontline combination therapy, we are optimistic that CS5001 will provide significant clinical benefits to DLBCL patients and establish itself as a first-line treatment option."

Development Timeline and Global Rights

CStone acquired the exclusive global rights to develop and commercialize CS5001 outside South Korea through a 2020 licensing agreement with LigaChem Biosciences and ABL Bio. The company continues to advance the program through multiple parallel development pathways, with active recruitment ongoing for various cohorts in the global clinical trial program.
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