Cusatuzumab is a high-affinity monoclonal antibody that targets CD70 with the following modes of action:

1 Blocks CD70/CD27 signaling, leading to inhibition of leukemia stem cell proliferation and reduction in leukemic blast cells

2 Exerts direct Fc-mediated, effector functions via enhanced antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, and antibody-dependent cellular phagocytosis

Cusatuzumab

Cusatuzumab is a high-affinity, anti-CD70 monoclonal antibody that targets CD70, a surface protein that is transiently upregulated on immune cells upon activation but is not expressed in normal tissue or hematopoietic cells.  CD70 is expressed on various tumors, including acute myeloid leukemia (AML). Cusatuzumab blocks CD70/CD27 signaling, leading to inhibition of leukemia stem cell proliferation and reduction in leukemic blast cells. Cusatuzumab also exerts direct Fc-mediated, effector functions via enhanced antibody-de-pendent cellular cytotoxicity leading to apoptosis of leukemic blasts.

Safety

Cusatuzumab has been evaluated as monotherapy, and in combination with azacitidine and venetoclax in AML. Cusatuzumab has not demonstrated dose limiting toxicities over a range of doses in greater than 100 treated patients with AML.

Acute Myeloid Leukemia

Laboratory studies and early stage clinical trials in AML have shown that cusatuzumab can reduce leukemic stem cells and may enhance the action of azacitidine alone and azacitidine combined with venetoclax, two commonly drugs used in in AML. Applying a unique precision medicine platform, OncoVerity has identified subgroups of patients  with AML who may benefit from the addition of cusatuzumab to azacitidine and venetoclax.

Promising Insights

We are conducting a randomized, open-label, multicenter, multinational  clinical study (NCT06384261) to determine cusatuzumab’s ability to improve overall survival in combination with azacitidine and venetoclax in newly diagnosed patient with AML who are not candidates for intensive chemotherapy. Additionally, given its biologic and safety profile, cusatuzumab is a promising agent for other hematologic malignancies and solid tumors as well.