From the Chair
Magellan Continues to progress its operational and strategic plans. With a focus on a successful laboratory licensing process for the TGA, publication of the results of the Phase 1/2 trial, preparation for the Phase 3 trial in 2025 and ongoing planning for eventual manufacture of cells for our trial and others our team has been very busy.
You will find further details on these activities in this edition of the “Magellan Update”
Yours Faithfully,
Lou Panaccio
Publication of Phase I/IIa trial results
The results from our Phase 1/IIa clinical study have been published. The research findings are published in Osteoarthritis and Cartilage Open the open-access journal of Osteoarthritis Research Society International (OARSI), which publishes the evidence-based, international consensus guidelines on osteoarthritis management.
OARSI is the premier international organisation for scientists and health care professionals focused on the prevention and treatment of osteoarthritis.
Magellan’s CMO, Associate Professor Dr Julien Freitag advises: “The purpose of our Phase I/II trial was to confirm the safety of Magellan’s donor stem cell therapy and provide evidence of efficacy to direct further late-stage research. The observed results with statistically significant and reproducible symptomatic improvements seen in patients provides Magellan with confidence to progress to late-stage clinical development.” This trial provided the signal of efficacy we need to confidently pursue our Phase III study.
Meet one of Magellan’s Senior Scientists
Sara is a highly accomplished senior scientist at Magellan with a deep understanding of advanced cell and gene therapies. Her expertise in CAR-T cell manufacturing, combined with her experience in a GMP facility, knowledge of quality management systems and regulatory requirements, makes her a valuable asset in the field. Her background at Cell Therapies (Peter MacCallum Cancer Centre) ensures she has significant hands-on experience in cutting-edge therapeutic technologies, which is crucial for advancing innovations in regenerative medicine and cellular immunotherapy.
Sara’s interests outside of work include city’s blend of top-notch coffee spots, vibrant music festivals, and eclectic art shows. Whether she’s indulging in a leisurely brunch or reconnecting with friends and family, she is often as busy on the weekends as she is during the week. We enjoy having Sara as part of the Magellan Stem Cells team.
TGA Document Submission.
At the end of May 24 Magellan submitted a detailed dossier document to the TGA in response to the extensive report that we received from the TGA in April. The document contained some results of preliminary testing of our product MAG 200 with accompanying process documents. The TGA will review our progress and ask for more information in the coming months. We remain resolute that the TGA will approve licensing of Magellan’s GMP lab by Oct 24. Once we obtain a license for the lab we will be in a position to manufacture cells for trails and eventually for other organisation who require them.
Cell Manufacture with CDMO Capability
Magellan completed the building of its Laboratory facility late last year. Much testing is being performed in the GMP lab which is required by the TGA in order to apply for licensing of the facility. Not only will Magellan be able to manufacture cells for the upcoming Phase III trial in 2025 but the laboratory has been established to manufacture cells for other groups/companies who require cells for trails but eventually will require cells to be manufactured for products such companies hope to have approved in due course. This exciting scenario will enable Magellan to eventually become a Contract Manufacturing Manufacturing Organisation (CDMO)
