ImmunoGen and Gilead to combine AML therapies

Dec. 9, 2022

Antibody-drug conjugate biotech ImmunoGen and pharma giant Gilead announced this week that they would be collaborating on the evaluation of two drugs that could be used in combination to treat acute myeloid leukemia (AML).

Scheduled to begin in 2023, the two companies will be assessing the safety and anti-leukemia activity of ImmunoGen's pivekimab sunirine (pivekimab) in combination with Gilead's magrolimab — a potential first-in-class investigational CD47 inhibitor — in patients with relapsed or refractory CD123-positive AML. The most common form of acute leukemia among adults, AML is also notoriously difficult to treat. In the United States alone, roughly 20,000 people are diagnosed with AML every year and 11,000 die from the disease. 

Pivekimab — also known as IMGN632 — is a CD123-targeting ADC for the treatment of hematological malignancies that uses ImmunoGen’s proprietary DNA targeting technology that has the capability of alkylating DNA without cross-linking. It received Orphan Drug and Breakthrough Therapy designation from the FDA. 

Gilead’s magrolimab is a humanized monoclonal antibody targeting the human cell surface antigen CD47, with potential immunostimulating and chemotherapeutic activities. Magrolimab was initially developed by Forty-Seven, which was acquired by Gilead in 2020 in a $4.9 billion deal. 

For the clinical collaboration, a new cohort will be added to ImmunoGen’s 802 study that will evaluate the combination treatment of the two drugs in up to 42 patients. Immunogen’s 802 open-label, multi center, phase 1b/2 trial is currently assessing the safety and tolerability of pivekimab when administered in combination with other drugs.