On December 16, 2020 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, reported that it has dosed its first patient in a Phase 1b clinical trial of CERC-007 (Press release, Cerecor, DEC 16, 2020, View Source [SID1234573113]). CERC-007 is a high affinity, fully human anti-IL-18 monoclonal antibody (mAb) being developed for patients with relapsed or refractory multiple myeloma (MM). The study will determine the recommended Phase 2 dose, safety and preliminary efficacy of CERC-007. The Company anticipates initial data to be reported in the first quarter of 2021.
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"We are very excited to have dosed our first patient. We are on track for initial data during the first quarter of 2021," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "Multiple myeloma is the second most common form of blood cancer and is characterized by anemia, bone pain and fatigue with the majority of patients relapsing or becoming refractory on current treatments. Elevated levels of IL-18 are correlated with poor survival in patients with multiple myeloma.1 The approximately 50% mortality rate at five years reinforces the need for novel and targeted therapies, such as CERC-007, as another treatment option."
The Phase 1b clinical trial is a U.S. multicenter, open-label, dose-escalation, sequential group study of CERC-007 as a monotherapy in approximately 30 patients with relapsed or refractory MM. The primary objectives of the study will be to determine the safety and tolerability of CERC-007, the recommended Phase 2 dose, and preliminary efficacy as measured by response rate in accordance with International Myeloma Working Group (IMWG) criteria.
About Multiple Myeloma
Multiple myeloma is the second most common blood cancer, with approximately 140,000 patients in the United States.2 Multiple myeloma is characterized by an excess proliferation of plasma cells. Despite increased availability of new agents, the disease is characterized by a pattern of recurrent relapses and remains incurable for the majority of patients, with a 5-year survival rate of approximately 50%.2
About CERC-007
CERC-007 is a high affinity, fully human monoclonal antibody targeting the proinflammatory cytokine IL-18. It is in development for multiple auto-immune diseases, including Still’s disease (adult onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM).