An Expert Report on the Investigational Bispecific Antibody REGN-5837

I. Introduction to REGN-5837

REGN-5837 is an investigational bispecific monoclonal antibody currently under development by Regeneron Pharmaceuticals, Inc..[1] This therapeutic candidate is also known by several alternative designations, including anti-CD22 x anti-CD28 costimulatory bispecific monoclonal antibody REGN5837, anti-CD22/anti-CD28 bispecific antibody REGN5837, CD22xCD28 antibody REGN5837, and REGN 5837.[1] Its development represents a focused effort within the field of immuno-oncology, aiming to harness and enhance the body's immune system to combat hematological malignancies.

REGN-5837 is classified pharmacologically as an antineoplastic agent, a bispecific antibody, and an immunotherapy.[1] A key characteristic of REGN-5837 is its designation as a New Molecular Entity (NME).[1] This status signifies that its chemical structure is novel and has not been previously approved by regulatory authorities. The NME designation underscores the innovative nature of REGN-5837, suggesting it may offer a new therapeutic mechanism. However, as with all NMEs, this novelty also implies that its clinical safety and efficacy profile is less established compared to drugs belonging to existing pharmacological classes, a standard consideration throughout the drug development lifecycle. The core innovation of REGN-5837 lies in its dual targeting of CD22 and CD28 and its function as a costimulatory bispecific antibody, designed to amplify T-cell mediated anti-tumor responses.

Table 1: Overview of REGN-5837 Characteristics