The last few decades have witnessed an acceleration in the discovery and development of therapeutic antibodies. They have revolutionized modern medicine, offering targeted therapies with high specificity and fewer side effects.
From monospecific human antibodies like erenumab for migraines, to bispecific murine antibodies like blinatumomab for cancer, therapeutic antibodies are highly valuable in treating various therapeutic areas, especially cancer. The number of FDA approvals for antibody drugs are quickly growing year by year.
The steady increase in the number of FDA-approved therapeutic antibodies, especially for cancer, reflects the incredible advancements in antibody research and clinical trials. Antibodies are now highly diverse, with different formats such as VHH, scFv, and Fab antibodies, as well as different expression systems such as CHO cells, murine cells, and E. coli.
Cancer in particular is dominating the antibody therapeutics space, since monoclonal antibodies can directly target tumor cells while simultaneously promoting the induction of long-lasting anti-tumor immune responses.
In the past year alone, five therapeutic antibodies for cancer have been approved.
Retifanlimab: Approved in March, this monospecific antibody targets PD-1 and is used to treat metastatic or recurrent locally advanced Merkel cell carcinoma.
Epcoritamab: On May 19, this bispecific antibody was approved to treat relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma.
Glofitamab: Approved in June, this bispecific is also used to treat selected relapsed or refractory large B-cell lymphomas, but has a Fab-Fc x Fab-Fab-Fc format rather than a full-length format.
Talquetamab: On Aug 9, the FDA granted accelerated approval for relapsed or refractory multiple myeloma.
Elranatamab: The latest antibody cancer drug to be approved, this bispecific antibody also treats multiple myeloma by targeting the CD3 T-cell engager.
This report aims to explore the events and trends of the biopharmaceutical industry in Q2 (April, May, June). Besides crovalimab and Vyloy, two more novel antibody drugs have been approved this year
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.
