This segment focuses on the development and commercialization of therapies aimed at intercepting and preventing the progression of type 1 diabetes (T1D). The lead product, teplizumab (TZIELD), is a monoclonal antibody designed to delay the onset of clinical T1D in at-risk individuals. Research & Development activities include ongoing clinical trials to evaluate the long-term efficacy and safety of teplizumab, as well as exploring novel biomarkers for early T1D detection. The segment leverages immunological insights and precision medicine approaches to identify and treat individuals at high risk of developing T1D, with the goal of preserving beta-cell function and improving patient outcomes. Future opportunities include expanding the use of teplizumab to newly diagnosed T1D patients and developing combination therapies for enhanced disease modification. Regulatory and clinical aspects are central to this segment, with a focus on post-market surveillance and adherence to FDA guidelines.

This segment is dedicated to developing therapies for various autoimmune diseases beyond type 1 diabetes. Key programs include PRV-3279, a bispecific antibody targeting lupus, and PRV-015, an anti-IL-15 monoclonal antibody for celiac disease. Research & Development efforts involve preclinical studies and clinical trials to assess the safety and efficacy of these candidates in specific patient populations. The segment employs advanced antibody engineering and immunological techniques to design targeted therapies that modulate the immune system and alleviate disease symptoms. Patient impact is a primary focus, with the goal of providing effective and well-tolerated treatments for individuals with autoimmune conditions. Market positioning involves identifying niche indications with unmet medical needs and establishing strategic partnerships for global development and commercialization. Future opportunities include expanding the pipeline to address additional autoimmune disorders and exploring novel therapeutic modalities.

This segment focuses on the development of vaccines to prevent infectious diseases that may trigger or exacerbate autoimmune conditions. The lead program is PRV-101, a coxsackievirus B (CVB) vaccine for the prevention of acute CVB infections and the onset of T1D. Research & Development activities include preclinical studies and clinical trials to evaluate the immunogenicity and safety of the vaccine candidate. The segment leverages virology and immunology expertise to design vaccines that elicit robust and durable immune responses against specific viral strains. Patient impact is a key consideration, with the goal of reducing the incidence of CVB infections and preventing the development of T1D in susceptible individuals. Market positioning involves targeting high-risk populations and collaborating with public health organizations for vaccine distribution and education. Future opportunities include expanding the vaccine pipeline to address other infectious agents associated with autoimmune diseases.