APTN Prepares for Global Phase 3 Trial of 'GPC-100' and Deploys Aprogen Clinical Team

[Financial News] APTN, a subsidiary of Aprogen, has begun building an operational framework for a global Phase 3 trial of GPC-100, a blood cancer drug candidate. The company aims to accelerate preparations for late-stage trials targeting approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) by combining the expertise of the U.S. researchers who led the Phase 2 trial with Aprogen's clinical and regulatory experience.
According to APTN on the 17th, the company is deploying Aprogen's clinical team to advance the Phase 3 trial of GPC-100 and is establishing a collaboration framework with the existing U.S. research team. Aprogen's clinical team consists of personnel with experience managing Phase 3 trials for Remicade biosimilars in Japan and the United States, obtaining Japanese marketing approval, and pursuing EMA and FDA approval for a Herceptin biosimilar.
APTN will first reanalyze the U.S. Phase 2 data and incorporate the findings into the Phase 3 design, while reviewing the chemistry, manufacturing, and controls (CMC) requirements for the clinical drug. It then plans to hold an end-of-Phase 2 meeting with the FDA to finalize the Phase 3 protocol and regulatory strategy.
The company will also reorganize its external advisory structure. Its scientific advisory board (SAB), which during the Phase 2 trial comprised experts from global pharmaceutical companies and clinicians from major U.S. hospitals, will be restructured for Phase 3. APTN also plans to strengthen cooperation with its existing clinical consultants and global contract research organizations (CROs).
GPC-100 is a mobilizing agent that moves hematopoietic stem cells and immune cells from the peripheral blood of patients with blood cancers, including multiple myeloma. APTN secured global exclusive rights to GPC-100 last August.
The company is focusing on the drug's speed of mobilization. While existing mobilizing agents take 10 to 14 hours to show an effect after administration, GPC-100 was reported to produce an increase in hematopoietic stem cells and immune cells within one hour of administration in a U.S. Phase 2 trial. The relevant clinical results were presented orally at the American Society of Hematology (ASH) meeting in the United States last December.
GPC-100 has been designated an orphan drug by the FDA. If it successfully completes the Phase 3 trial and regulatory process, it could secure orphan-drug exclusivity in the United States.
Meanwhile, APTN plans to first pursue approval for multiple myeloma before expanding the drug's application to acute myeloid leukemia (AML), sickle cell disease (SCD), and in vivo CAR-T.
An APTN official said, "We are preparing for Phase 3 by combining the experience of the U.S. researchers who conducted the Phase 2 trial, Aprogen's clinical team, and external experts." The official added, "We plan to finalize a detailed clinical strategy and protocol through consultations with the FDA."
[email protected] Reporter Kim Kyung-ah Reporter