On December 9, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported a clinical collaboration with Gilead Sciences, Inc. (Nasdaq: GILD) to evaluate the safety and anti-leukemia activity of pivekimab sunirine (pivekimab) in combination with magrolimab, a potential, first-in-class, investigational CD47 inhibitor, in patients with relapsed or refractory (R/R) CD123-positive acute myeloid leukemia (AML) (Press release, ImmunoGen, DEC 9, 2022, View Source [SID1234624994]).
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"AML is the most common form of acute leukemia among adults and accounts for the largest number of deaths from leukemia in both the United States and Europe," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "Given the potentially complementary mechanisms of action, the limited overlap in safety profiles, and the encouraging data seen with each agent in combinations to date, we are excited to explore this novel doublet in patients with relapsed/refractory AML, where few effective treatment options exist."
Expected to initiate in 2023, the collaboration will be a new cohort in ImmunoGen’s 802 study and will evaluate pivekimab in combination with magrolimab in up to 42 patients with R/R CD123-positive AML. The primary endpoint for this cohort is complete response (CR) rate. ImmunoGen’s 802 study is an open-label, multicenter, Phase 1b/2 trial to determine the safety and tolerability of pivekimab and assess the anti-leukemia activity of the agent when administered in combination with Vidaza (azacitidine) and/or Venclexta (venetoclax) in patients with relapsed and frontline CD123-positive AML.
ABOUT PIVEKIMAB SUNIRINE
Pivekimab sunirine is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and other CD123+ hematologic malignancies. Pivekimab is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with untreated and relapsed/refractory AML. Pivekimab uses one of ImmunoGen’s novel indolinobenzodiazepine (IGN) payloads, which alkylate DNA and cause single strand breaks without crosslinking. IGNs are designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads. The European Medicines Agency (EMA) granted orphan drug designation to pivekimab for the treatment of BPDCN in June 2020. Pivekimab also holds this designation in the U.S. In October 2020, the FDA granted pivekimab Breakthrough Therapy designation in relapsed/refractory BPDCN.
ABOUT MAGROLIMAB
Magrolimab is a potential, first-in-class, investigational treatment designed to inhibit the CD47 protein. CD47 binds to receptors on macrophages to transmit a "don’t eat me" signal used by cancer cells to escape natural cell death, called phagocytosis. Targeting the CD47 protein, magrolimab is intended to restore phagocytosis. Magrolimab is being studied in several hematologic cancers as well as solid tumor malignancies. Granted Fast Track Designation by the FDA for the treatment of myelodysplastic syndrome (MDS), AML, diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma, magrolimab has also been granted Orphan Drug Designation by the FDA for MDS and AML and by the European Medicines Agency for AML. More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.
Magrolimab is an investigational product and is not approved by any regulatory authority for any use; its safety and efficacy have not been established.
ABOUT ACUTE MYELOID LEUKEMIA (AML)
AML is a cancer of the bone marrow cells that produce white blood cells. It causes the marrow to increasingly generate abnormal, immature white blood cells (blasts) that do not mature into effective infection-fighting cells. The blasts quickly fill the bone marrow, impacting the production of normal platelets and red blood cells. The resulting deficiencies in normal blood cells leave the patient vulnerable to infections, bleeding problems, and anemia. It is estimated that, in the U.S. alone, more than 20,000 people will be diagnosed with AML this year and more than 11,000 will die from the disease.