Propanc Biopharma Engages European CDMO for GMP Production of PRP for 30-40 Patient Phase 1b Study
Propanc Biopharma has contracted a European CDMO to handle GMP manufacture of its lead asset PRP for the upcoming Phase 1b First-In-Human study in 30–40 advanced cancer patients. The company plans to file its clinical trial application later this year after completing non-clinical safety and tolerability studies.
1. CDMO Engagement and Manufacturing Scope
Propanc Biopharma has selected a European Contract Development and Manufacturing Organization to produce its lead proenzyme therapy, PRP, under GMP. The CDMO will provide end-to-end biologics production services, including plasmid DNA synthesis, recombinant protein expression, cell line generation, banking, characterization, analytical development, process development and both drug substance and drug product manufacturing.
2. Phase 1b Trial Design and Timeline
The engagement supports the upcoming Phase 1b First-In-Human study in 30–40 patients with advanced solid tumors, featuring once-weekly intravenous administration of PRP at doses informed by non-clinical safety and tolerability data. Propanc plans to submit its clinical trial application later this year following completion of preclinical requirements.
3. PRP Therapeutic Potential and Orphan Status
PRP operates by inducing cancer cell differentiation rather than direct cytotoxicity, and compassionate use data showed a median life extension of 19 months in 46 terminal patients without severe side effects. The candidate holds Orphan Drug Designation from the FDA for pancreatic cancer since 2017 and is positioned as a first-in-class therapy with potential survival benefits.