Cerecor Announces FDA Acceptance of Investigational New Drug Application for CERC-007 for Treatment of Relapsed or Refractory Multiple Myeloma
- Category: Antibodies
- Published on Tuesday, 08 December 2020 17:57
- Hits: 893
ROCKVILLE, MD and CHESTERBROOK, PA, USA I December 08, 2020 I Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, today announced that its Investigational New Drug Application (IND) to study the use of CERC-007 to treat relapsed or refractory multiple myeloma (MM) has been accepted by the United States Food and Drug Administration (FDA) and is now open. The first study will be a U.S. multicenter Phase 1b clinical trial. Initial data is expected in the first quarter of 2021.
“Elevated levels of IL-18 are correlated with poor survival in patients with multiple myeloma1,” said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. “Targeting and reducing IL-18 using CERC-007 may substantially benefit relapsed or refractory multiple myeloma patients. Our first study under this new IND will give us important information about the pharmacokinetics, pharmacodynamics, dose, safety and preliminary efficacy that should illuminate the path forward. We look forward to sharing the data with the scientific and medical communities in the first quarter of 2021.”
The planned 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
CERC-007 is a 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).
Cerecor is a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases. The company is advancing its clinical-stage pipeline of innovative therapies that address unmet patient needs within rare and orphan diseases. The company's rare disease pipeline includes CERC-801, CERC-802 and CERC-803, which are in development for congenital disorders of glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in development for the treatment of complex lymphatic malformations. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical development for treatment of severe pediatric-onset Crohn's disease, and COVID-19 acute respiratory distress syndrome. CERC-007 targets the cytokine IL-18 and is in clinical development for the treatment of Still’s disease (adult onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM). CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval.
For more information about Cerecor, please visit www.cerecor.com