On October 26, 2021 Aptevo Therapeutics Inc. ("Aptevo" or "the Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that the peer-reviewed journal Cancers published results of the Company’s research on mitigation of the risk of cytokine release syndrome (CRS) as well as its effective management in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are treated with APVO436, a bispecific antibody that has been engineered to redirect patients’ immune system against their cancer cells (Press release, Aptevo Therapeutics, OCT 26, 2021, View Source [SID1234591968]). Dr. Fatih Uckun, a leukemia expert and Chief Clinical Advisor to Aptevo, is the lead author of the newly published article.
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CRS is a potentially life-threatening complication of therapy with T-cell engaging bispecific antibodies. This study was undertaken to evaluate the risk, characteristics and biomarkers of treatment-emergent CRS in patients with relapsed/refractory AML or MDS who received weekly intravenous infusions of the CD3xCD123 bispecific antibody APVO436. According to the study, with the risk mitigation strategies put in place, only 10 of 46 patients (21.7%) treated with APVO436 developed CRS, which is considered a common side effect of bispecific antibodies. Further, the incidence of severe (Grade 3) or life threatening (Grade 4) CRS was only 8.7% (4 of 46 patients). The authors reported that CRS led to dose interruptions of APVO436 in 4 of 46 patients, a dose reduction in one patient and permanent discontinuation of the study drug in only one patient. In most cases, CRS events were transient and medically manageable with standard of care.
AML and MDS are very common forms of blood cancer in adults. Patients with AML or MDS who relapse following available standard of care treatments have a dismal prognosis and they are in urgent need for new treatment options. Aptevo believes that APVO436 may provide an important new option treating these cancers.
"We continue to learn more about the potential clinical impact of our lead leukemia drug candidate, APVO436, and we are hopeful that its continued development will provide the foundation for a more effective combination therapy as a new standard of care regimen that is less likely to fail," added Mr. Marvin White, the CEO of Aptevo.
About the Publication
The article, "Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436." has been published in Cancers as part of the Special Issue "Acute Myeloid Leukemia (AML)" and is available as follows:
Abstract: View Source
HTML Version: View Source/htm
PDF Version: View Source/pdf
Special Issue: View Source
Citation Reference: Uckun, F.M.; Watts, J.; Mims, A.; Patel, P.; Wang, E.; Shami, P.; Cull, E.; Lee, C.; Cogle, C.R.; Lin, T.L. Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436. Cancers 13, no. 21: 5287. View Source
About APVO436
Overexpression of CD123 is the hallmark of many forms of leukemia. Aptevo’s lead proprietary drug candidate, APVO436 is a bispecific CD3xCD123 ADAPTIR that is designed to redirect the immune system of the patient to destroy leukemia cells expressing the target CD123 molecule on their surface. This antibody-like recombinant protein therapeutic is designed to engage both leukemia cells and T-cells of the immune system and bring them closely together to trigger the destruction of leukemia cells. APVO436 has been engineered using Aptevo’s proprietary and enabling bioengineering methods and is designed to reduce the likelihood and severity of CRS. APVO436 has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act.