VarmX and CSL Form Strategic Collaboration Effort to Develop VMX-C001

CSL will receive support for the development of its lead asset along with acquiring all outstanding VarmX shares.
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VarmX announced its partnership with CSL, supporting the development of its lead asset VMX-C001, along with entering into an exclusive option agreement with VarmX shareholders that will see CSL acquiring all issued and withstanding shares of the company.

John Glasspool, chief executive officer of VarmX, touched on the collaboration effort, saying, “The collaboration with CSL represents a transformative step for VarmX. By securing full funding for the registrational trial, product development, CMC and pre-launch activities, we are well positioned to bring VMX-C001 to patients. We are proud to partner with CSL, whose expertise and global reach will be invaluable as we move forward.”

The terms of the collaboration agreement include CSL’s responsibility to fully fund VarmX’s global Phase III EquilibriX-S trial evaluating VMX-C001 in patients administered withdirect oral anticoagulants targeting activated factor Xa (FXa DOACs) requiring surgery. CSL will additionally fund and support VarmX’s late-stage product development, manufacturing, pe-launch commercial, and medical affair activities.

Also stated in the agreement is CSL’s upfront payment to VarmX shareholders of $117 million once the transaction fully closes for an exclusive option to acquire the company, while CSL holds the ability to exercise the option following the Phase III trial results. If CSL exercises its option, VarmX shareholders are entitled to an additional $388 million in acquisition fees, along with additional payments leading up to VMX-C001’s commercial launch, and upwards of $1.7 billion in sales-based success milestone payments.

Dr. Paul McKenzie, chief executive officer of CSL, commented on the partnership and the significance it brings to CSL, saying, “We are excited to partner with VarmX to develop a novel treatment and address a significant unmet need aligning strongly with our strategic ambition to deliver enduring patient impact. It also aligns with our portfolio of medicines designed to minimize bleeding, preserve a patient’s own blood supply, improve surgical and medical outcomes and support global public health approaches to patient blood management.”

VMX-C001 is an investigational recombinant modified Factor X protein administered as a rapid single-dose, effectively bypassing FXa anticoagulation activity and swiftly restores coagulation in patients administered with Factor Xa inhibitors in urgent surgery and severe bleeding situations.¹ The treatment also offers the potential to be used with all FXa DOACs along with the ability to be administered with additional common anticoagulants such as heparin, with no additional thrombotic risks. VMX-C001 was granted Fast Track Designation by FDA, recognizing its potential in restoring coagulation for patients on FXa DOACs who require emergency surgery. With an estimated 30 million patients in the U.S., Europe, and Japan expected to be on FXa DOACs by 2030, VMX-C001’s commercial launch is anticipated for 2029, aiming to provide widespread availability for the potential first approved treatment for patients with FXa DOCAs.

Bill Mezzanotte touched on CSL’s interest in the treatment option, saying, “CSL was particularly interested in VMX-C001’s unique mechanism of action, how it specifically targets Factor Xa inhibitors, compared to the more general action of other treatments, and the preclinical and early clinical data which led to U.S Food and Drug Administration (FDA) approval to proceed straight to a single Phase 3 study.”