Initiation of recruitment for phase III clinical trial investigating abelacimab to treat thrombosis in patients diagnosed with GI/GU cancers

The MAGNOLIA study is recruiting patients who are at risk of thrombosis and diagnosed with gastrointestinal/genitourinary (GI/GU) cancers, which are cancers known to have a higher risk of bleeding than other cancers. The study is one of two complementary, international, multicenter trials where abelacimab is being studied in patients with cancer associated thrombosis (CAT), a condition for which there is an unmet need as currently available anticoagulants have been associated with an increased risk of bleeding.

In the MAGNOLIA trial, monthly treatment with abelacimab is being compared with once daily injection of dalteparin, the current anticoagulant standard of care in patients with GI/GU cancers, to assess the effects on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE, a leading cause of death in patients with cancer.

“Based on the positive Phase II data we have seen to date, we are hopeful that this trial will validate the promise of abelacimab as a much-needed new treatment option for this high-risk and difficult-to-treat patient population. With a 20-fold increase in risk of CAT in GI cancers compared to patients without cancer, we are particularly pleased that abelacimab is being explored to reduce VTE recurrence and bleeding in GI and GU cancers,” said Alok A. Khorana, M.D., Professor of Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University and member of the Abelacimab CAT Program Steering Committee.

“Because cancer patients who receive current anticoagulant treatment to manage VTE have a higher bleeding risk than patients without cancer receiving anticoagulants, it’s too often that physicians are forced to choose between preventing life-threatening clots, and putting their patients at risk of uncontrolled bleeding, particularly in patients with GI/GU cancers.”

The head-to-head design of this trial will provide critical information concerning the efficacy of this novel therapeutic in addressing VTE and bleeding, a devastating and unpredictable complication of cancer that can significantly impact a patient’s quality of life. Abelacimab is a dual-acting fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity and selectivity. It has the potential to achieve hemostasis-sparing anticoagulation: effective protection from thromboembolic events with a reduced risk of clinically significant bleeding compared to existing therapies.

Moreover, the once-monthly dosing profile may reduce the burden of a daily regimen for patients who are already traveling to the clinic to receive multiple therapies for their cancer care.

“Unfortunately, many patients at risk of thrombosis stop taking low molecular weight heparins, which require daily injections, after less than 2 months, and sadly patients don’t stay much longer on DOACs . Our hope is that the monthly dosing schedule of abelacimab and its potential enhanced safety profile will play a role in improving adherence and quality of life,” added Dr. Khorana. Scientific evidence suggests that abelacimab, which takes aim at an entirely new target, Factor XI (and its activated counterpart Factor XIa), could enable pharmacological ‘uncoupling’ of the physiological hemostasis and pathological thrombosis pathways. This approach would enable patients to achieve the delicate balance between the clotting necessary to prevent uncontrolled bleeding while being protected from life-threatening blood clots.

Venous thromboembolism (VTE), which includes both deep vein thrombosis and pulmonary embolism, is the second most prevalent cause of death in patients with cancer, second only to the disease itself. VTE affects an estimated 300,000-600,000 individuals in the U.S. each year, causing considerable morbidity and mortality.