- Rentschler Biopharma and VarmX have agreed a collaboration to manufacture VMX-C001 for Phase 3 development and potential commercialisation.
- Phase 3 clinical supply and process validation will be produced at Rentschler Biopharma’s Milford, Massachusetts site.
Rentschler Biopharma has announced a collaboration with VarmX to manufacture VMX-C001, the biotech company’s lead programme, for Phase 3 clinical development and potential commercial supply. The agreement covers late-stage production of the candidate, which is being developed for patients requiring urgent surgery or experiencing severe bleeding while receiving factor Xa direct oral anticoagulants (FXa DOACs).
The CDMO began supporting early development of VMX-C001 in 2022 at its Laupheim site in Germany. VarmX has since initiated its Phase 3 programme using GMP material manufactured by Rentschler Biopharma. Under the expanded collaboration, all subsequent Phase 3 clinical supply, including process validation activities, will be manufactured at the company’s Milford, Massachusetts facility, supporting a transition into late-stage clinical and commercial production.
VMX-C001 is a modified human factor X protein designed to bypass the anticoagulant activity of FXa DOACs and restore blood coagulation. The candidate received Fast Track Designation from the US Food and Drug Administration and a Phase 1 waiver from Japan’s PMDA in September 2025. VarmX plans to initiate its global Phase 3 EquilibriX-S trial in urgent surgery in early 2026.
“Manufacturing readiness is key as we prepare to commence our landmark global EquilibriX-S Phase 3 trial, evaluating the ability of VMX-C001 to rapidly restore coagulation in patients taking any FXa DOAC undergoing urgent surgery.”
John Glasspool, Chief Executive Officer of VarmX
The collaboration reflects Rentschler Biopharma’s role in contract manufacturing for biologics across the development lifecycle. The company will support Phase 3 supply from its US site, complementing earlier development work in Europe, as VarmX advances VMX-C001 towards potential commercialisation.
