Cell therapy development firm Caladrius Biosciences has received a grant of up to $12.2m from the California Institute for Regenerative Medicine (CIRM) to evaluate its CLBS03 in a Phase II clinical trial in patients with type 1 diabetes (T1D).
CLBS03 is an investigational cell therapy that utilises the numerically and functionally enhanced regulatory T-cells (Tregs) from patients to treat autoimmune disease.
It is designed to restore immune balance by increasing the number and activity of patient’s Tregs and uses their innate capabilities to alter different facets of the effector arm of the immune system.
The randomised, double-blind, placebo-controlled Phase II trial is to be conducted in collaboration with Sanford Research and will evaluate the therapy in adolescents with recent-onset T1D.
Caladrius chief executive officer David Mazzo said: “We firmly believe that this therapy has the potential to improve the lives of people with T1D and this grant helps us advance our Phase II clinical study with the goal of determining the potential for CLBS03 to be an effective therapy in this important indication.
“This grant substantiates our approach to identify and secure non-dilutive funding for our development programmes, and helps position Caladrius as a leader among cell therapy and autoimmune disease therapy developers.”
The firm intends to use the CIRM grant to cover all manufacturing and development expenses in California, US, along with other trial costs dependent upon the number of subjects enrolled in the state.
The US Food and Drug Administration (FDA) has granted orphan drug and fast-track designations to CLBS03, which has also obtained advanced therapeutic medicinal product classification from the European Medicines Agency.