Ergomed to run Cel-Sci’s confirmatory Multikine trial in head and neck cancer

Ergomed Clinical Research will support Cel-Sci’s latest effort to win approval for its immunotherapy candidate, Multikine, in head and neck cancer under a contract announced this week.

Cel-Sci named Ergomed as contractor, explaining the CRO will provide clinical operations support for the “confirmatory registration study” that is due to start early next year at various research centres around the world.

The news comes just a few months after the FDA OKed the trial, which will test the therapy in newly diagnosed patients with advanced primary head and neck cancer who have low PD-L1 tumor expression and no lymph node involvement.

In a press statement, Cel-Sci chief Geert Kersten, said, “Ergomed is a trusted partner. Our past experience taught us that they are highly competent and motivated.

“Their enrollment was fast, and the study was clean. The plan is for the study to commence in Q1 2025 in multiple countries,” Kersten added.

Sy Pretorius, CEO of Ergomed Group, said, “We are excited to once again partner with CEL-SCI on this significant trial for Multikine.

“Our prior collaboration has set a strong foundation for this new phase, and we are committed to leveraging our global expertise in oncology clinical research to support this critical confirmatory study.”

Clinical development

Ergomed has been involved in the Multikine clinical program since 2013 after it was hired to replace former contractor inVentiv Clinical.

Ergomed took over a Phase III trial examining the immunotherapy as a treatment for head and neck cancer.

The results of the Phase III program, which were published in 2021, showed the therapy failed to improve on the overall survival achieved by the standard of care in the overall population of head and neck cancer patients.

Since then, Cel-Sci has focused on winning approval for Multikine based on benefits observed in a subpopulation of patients in the Phase III study.

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