On January 13, 2022 Amplia Therapeutics Limited (ASX: ATX) ("Amplia", the "Company") reported a GMP* manufacturing run of its clinical-stage drug candidate AMP945 has been successfully completed (Press release, Amplia Therapeutics, JAN 13, 2022, View Source;[email protected] [SID1234605465]). This provides additional drug substance to support toxicology studies and Phase 2 clinical trials in pancreatic cancer and lung fibrosis which are scheduled to start during 2022.

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Amplia’s contract manufacturing organisation (CMO) has successfully completed the manufacture of a 2 kg GMP batch of AMP945 within budget and on time. Previously, the maximum batch size of AMP945 that had been manufactured was 1 kg, meaning that the Company has now demonstrated a doubling of the scale at which AMP945 can be manufactured under GMP conditions. During the recently completed manufacturing run, the Company also implemented improvements to the manufacturing process for AMP945 that will support its future clinical and commercial development. Of note, long-term stability testing data has shown that AMP945 can be stored for periods of more than 24 months without detectable deterioration, an outcome that further supports commercial development of AMP945.

Amplia’s CEO, Dr John Lambert commented that "The successful doubling of our manufacturing capacity for clinical-grade AMP945 and the implementation of manufacturing improvements are outstanding outcomes which have exceeded our initial expectations. As well as providing material for our near-term development programs, these improvements lay a strong foundation for the AMP945 data package that will be required for future regulatory applications and its commercial development."

The Phase 2 clinical trial of AMP945 in patients with pancreatic cancer remains on track to commence during the current quarter. In addition, the extended (3-month) toxicology studies required to support the Phase 2 clinical trial of AMP945 in patients with fibrotic lung disease are on schedule to commence in February 2022 as previously advised.

* GMP: Good Manufacturing Practice

This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.