ROCKLAND IMMUNOCHEMICALS, INC. — Department of Health and Human Services SBIR Phase I: NCI

Description

ABSTRACT Radioimmunotherapy RIT targeting of cancer is limited by slow blood clearance resulting in unwanted prolonged exposure of normal tissues to radioactive agents Pre targeted radioimmunotherapy or PRIT using bispecific agents has been shown to be superior over traditional direct conjugation in target tonormal organ ratios While the clinical potential for pretargeted therapy with bispecific agent formats is clear progress has been hindered because they are often difficult to manufacture Rockland Immunochemicals Inc is teaming up with Abzyme Therapeutics LLC and the Department of Radiology University of Pittsburgh to develop bispecific nanobodies that can be used in both cancer diagnosis and pretargeted radioimmunotherapy In phase I bispecific recombinant nanobodies with one arm targeting cancer biomarker HER and another arm against Digoxigenin will be developed Properties of the bispecific nanobody including in vivo clearance tumor accumulation in vivo stability and bioavailability and its ability to capture digoxigenylated fluorescence dyes and radionuclides will be investigated In the Phase II selected bispecific nanobodies will be produced in a large scale Pharmacokinetic pharmacodynamics immunogenic and toxicological characteristics of agents will be investigated in pre targeted radioimmunotherapy using animal models to obtain data necessary for filing an Investigational New Drug application