Rentschler Biopharma has announced a collaboration to manufacture VarmX’s lead programme, VMX-C001, for phase 3 development and potential commercialisation.
VMX-C001 is a novel treatment to restore blood coagulation in patients requiring urgent surgery or experiencing severe bleeding while on FXa DOACs.
Rentschler Biopharma began supporting early development of VMX-C001 in 2022 at its Laupheim, Germany site and VarmX has since initiated its phase 3 programme using GMP material from Rentschler Biopharma. Building on the successful collaboration between both companies, all subsequent phase 3 clinical supply, including process validation, will be manufactured at Rentschler Biopharma’s Milford, MA site as part of the seamless transition into late-stage clinical and commercial production.
The CDMO brings strong expertise in producing a variety of biologics, including proven capabilities in intensified, perfusion-based processes, while also supporting fed-batch strategies.
Rentschler Biopharma provides clients with continuity, speed and reliability from early development through commercialisation and beyond. VMX-C001 is a modified, human factor X protein, designed to be insensitive to FXa DOACs, effectively bypassing their anticoagulant activity and swiftly restoring the coagulation cascade.
The product candidate was granted Fast Track Designation by the US Food & Drug Administration (FDA) and a phase 1 waiver from Japanese regulator PMDA in September 2025, recognizing the unmet need for treatments that can rapidly restore coagulation in patients receiving FXa DOACs.
VarmX signed a global strategic collaboration and option agreement with CSL in September 2025.
VarmX plans to initiate its global phase 3 EquilibriX-S trial in urgent surgery in early 2026.
By 2030, approximately 30 million patients in the US, Europe and Japan are expected to receive FXa DOACs as a chronic anticoagulation therapy, including stroke prevention in atrial fibrillation and the prevention of deep vein thrombosis.
Each week, more than 30,000 of these patients experience severe life-threatening bleeding or require emergency surgery, where the risk of bleeding poses a critical challenge1.
VMX-C001 has been developed with significant clinical advantages, including universal dosing regardless of the specific FXa DOAC used, rapid and easy administration, compatibility with common anticoagulants like heparin, and no additional thrombotic risk.
This strengthens the position of VMX-C001 to potentially become a new option for the substantial number of patients on FXa DOACs who need emergency surgery.
Reference
1. RBC and Cowen (2018–2024) Syneos Health Consulting (incl. Japan), and clinical literature
