抗体業界のトレンド

This past week, the Biomedical Advanced Research and Development Authority (BARDA) has provided funding for several antibody-related drug development programs. BARDA is a U.S. government agency within the Department of Health and Human Services (HHS) that funds and supports the development of medical countermeasures to protect against public health threats, such as pandemics, bioterrorism, and other emergencies.

Antibody-drug conjugates (ADCs) have seen significant developments in regulatory review, with several notable announcements in the past few weeks. Innate Pharma received FDA clearance for its investigational new drug (IND) application for IPH4502, a novel topoisomerase I inhibitor ADC conjugated to exatecan targeting Nectin-4. Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, esophageal, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues.

Bispecific antibodies are rapidly transforming the therapeutic landscape, especially in oncology and autoimmune diseases. Such recombinant molecules can bind to two different antigens at the same time, offering greater specificity in targeting disease pathways. Since their introduction, the area of bispecifics has held tremendous promise in oncological cancers like multiple myeloma and lymphomas.

This report aims to explore the events and trends of the biopharmaceutical industry in Q3 (July, August, September).

A common theme emerging from recent antibody research is the development and validation of advanced diagnostic tools based on antibody detection. Multiple studies highlight the creation of novel biosensors and assays designed to enhance the sensitivity, specificity, and efficiency of detecting antibodies across various diseases.

T cell immunoreceptor with immunoglobulin and ITIM domain (TIGIT) is an immune receptor that plays a key role in suppressing T-cell activation and proliferation. As a newly identified checkpoint, it is highly expressed on various immune cells, including CD4+ and CD8+ T cells, NK cells.

The COVID-19 pandemic has reshaped global health strategies, pushing preventive measures to the forefront of public attention. Now, there is a renewed focus on fortifying defenses against future viral threats and ways to improve hospitalization rates. Here, we will explore the latest advancements in post-pandemic prevention strategies and the broader landscape of public health.

News from the IASLC 2024 World Conference on Lung Cancer (WCLC24) has provided several updates on the clinical trial space for non-small cell lung cancer (NSCLC), with several antibody-based drugs at the forefront. NSCLC is the most common type of lung cancer, accounting for about 85% of all cases.

These past few weeks, several antibody drug startups have progressed from the pre-seed stage to final funding rounds. In the pre-seed stage, the focus is on early research, often funded by founders, grants, or angel investors. As the company progresses to the seed stage, it seeks additional funding to validate its scientific concept and develop initial prototypes, attracting early-stage venture capital.

In August, the US FDA approved Galderma’s Nemluvio (nemolizumab) for adult patients living with prurigo nodularis (PN). Nemluvio is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31, a neuroimmune cytokine that drives multiple disease mechanisms in (PN). Prurigo nodularis is a chronic skin condition that affects approximately 181,000 patients in the United States

Anti-drug antibodies (ADAs) are immune system proteins that can develop in response to therapeutic drugs, particularly biologics like monoclonal antibodies. These biopharmaceuticals have significantly advanced therapies for cancer and autoimmune diseases, but their long-term use can elicit immunogenicity due to repeated administration. The host immune system may recognize epitopes in the biologic drug as foreign, triggering the production of ADAs. This can lead to the formation of drug–ADA immune complexes, which accelerate drug clearance and potentially neutralize the drug's efficacy.

VHH antibodies, also known as nanobodies, are single-domain antibodies that are derived from camelid heavy-chain antibodies. Due to their small size (~ 15 kDa) and diverse applications in bio-derived therapeutics, these antibodies have widespread attention in the research and development community, with some examples below from just this week!