Multiple myeloma (MM) is a cancer of plasma cells in the bone marrow, which can cause bone damage, anemia, kidney dysfunction, and weakened immunity. Despite being incurable, advances in antibody therapies have shown significant progress in the management of the disease, highlighting the ongoing efforts in the development of more effective treatments. These include monoclonal antibodies, antibody-drug conjugates (ADCs), and bispecific antibodies (bsAbs), which target specific antigens expressed on myeloma cells, such as CD38 and BCMA, offering an alternative to chemotherapy.
This Monday, GSK announced a promising update for its ADC Blenrep (belantamab mafodotin), which targets BCMA (B-cell maturation antigen). When used in a three-drug regimen, it led to a significant improvement in progression-free survival in patients with relapsed or refractory multiple myeloma. The news comes after previously withdrawing Blenrep as a monotherapy last year, and now new phase 3 data suggest its effectiveness as part of a combination therapy with Takeda’s Velcade (bortezomib) and dexamethasone (BorDex).
Also last month, Daratumumab, an antibody that targets CD38 on MM cells, was evaluated for its addition to the standard therapy regimen (bortezomib, lenalidomide, and dexamethasone) for MM. This combination demonstrated superior efficacy across various measures in a study spanning nearly four years. It significantly improved progression-free survival at four years (84% vs. 68%), increased rates of complete response or stringent complete response (88% vs. 70%), and enhanced MRD (minimal residual disease) negativity rates (75% vs. 48%).
Meanwhile, two recent reviews by Lee et al. and Rodriguez-Otero et al. highlight the remarkable efficacy of bispecific antibodies that target either BCMA or GPRC5D in treating MM. These therapies, including teclistamab, elranatamab, and talquetamab, have received accelerated approval from health agencies, offering new hope to patients who have exhausted other options. However, challenges remain in optimizing dosing schedules, integrating these treatments with existing therapies, and overcoming resistance mechanisms.
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.