Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based biopharmaceutical firm Cleave Biosciences has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead drug candidate, CB-5083, to treat multiple myeloma.
Subscribe to our email newsletter
CB-5083 is a first-in-class, oral inhibitor of p97, a major enzyme that controls various aspects of protein homeostasis.
Currently, the company is evaluating CB-5083 in two Phase I trials including one in patients with multiple myeloma, and one in patients with solid tumor malignancies.
Cleave Biosciences chief executive officer Laura Shawver said: "The Orphan designation for CB-5083 recognizes its potential as a new therapeutic option for patients with multiple myeloma.
"Targeting protein homeostasis is a validated therapeutic approach for the treatment of patients with multiple myeloma and we’re making great progress in our data-rich Phase I trial to evaluate the safety of CB-5083 and further understand cancers’ dependency on the p97 pathway for growth and survival."
The company’s ongoing trials include an open-label, Phase I dose escalation/dose expansion trial to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of CB-5083 in multiple myeloma patients.
The trial evaluates CB-5083 in patients who have relapsed/refractory or refractory disease after receiving two or more lines of therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor.
The company intends to enroll about 60 patients at multiple US cancer centers that are part of the Multiple Myeloma Research Consortium.