Bionxt sends cladribine API to CDMO partner

Executive Summary

• Bionxt Solutions completed key technology and analytical method transfers to its European CDMO, enabling scalable production of clinical‑grade sublingual thin‑film cladribine.
• The company will launch a large‑animal (pig) bioavailability study in October 2025, the final preclinical validation step before human trials.
• A first‑in‑human pilot study is targeted for Q1 2026, marking a major inflection point for the BNT23001 program.

Key Details

• Technology Transfers: Completed both process and analytical method transfers to European CDMO, ensuring reproducibility and regulatory compliance.
• API Status: Cladribine API ordered and in transit to CDMO for pilot batch manufacturing.
• Pilot Batch Production: Planned to produce clinical‑grade thin‑film dosage forms for preclinical and upcoming clinical phases.
• Analytical Optimization: Ongoing validation of analytical methods and final refinement of product/process parameters at the CDMO.
• Large‑Animal Study: Scheduled to begin October 2025 in pigs, a translational model for human GI absorption; aims to confirm bioavailability and optimize dosing.
• First‑in‑Human Trial: Pilot batch intended for a first‑in‑human clinical pilot study targeted for Q1 2026.
• Patent Strategy: Continued national patent filings and accelerated U.S. review under Track 1 to protect the formulation.

Notable Quotes

“With both our development program and global patent strategy advancing on schedule, Bionxt is steadily building the foundation for clinical translation and commercial success,” – Hugh Rogers, CEO, Bionxt Solutions Inc.