$PPCBJun 16, 2026, 8:45 AM ETAI processed
PPCB lines up CDMO GMP runs for PRP ahead of Phase 1b FIH in 30–40 patients
AI Summary
Propanc's CEO visited a European CDMO and the company set target dates to prepare PRP for a First‐In‐Human Phase 1b: preproduction August 2026, engineering run October 2026 and GMP manufacture starting December 2026, with four weeks of stability data expected to support an Australian clinical trial application in 2026. PRP is a fixed IV combination of two proenzymes (trypsinogen and chymotrypsinogen) planned for once‐weekly dosing in a 30–40 patient advanced solid tumor FIH study aiming to address cancer recurrence/metastasis.
Positives
- Concrete manufacturing timeline established (preprod Aug 2026; engineering run Oct 2026; GMP manufacture Dec 2026).
- Company expects a minimal four‑week stability dataset post‑engineering run to support a Phase 1b clinical trial application in Australia in 2026.
- Planned FIH Phase 1b will enroll 30–40 advanced solid tumor patients, giving a defined near‑term clinical enrollment target.
Negatives
- Timelines are forward‑looking targets and subject to change or regulatory review.
- Only four weeks of stability data is planned to support the trial application, which may be judged insufficient by regulators.
- No clinical efficacy or safety data yet—program is at early FIH stage and carries typical development risk.