The start of 2024 has seen leaps in deals for antibody therapeutics, especially ADCs (antibody-drug conjugates). This report aims to explore the events and trends of the biopharmaceutical industry in Q1. As of now, only two novel antibody drugs have been approved this year, but many more in regulatory review are expected to be fully approved.
1. Crovalimab is a monospecific, humanized IgG1 mAb targeting complement C5 for the treatment of atypical hemolytic uremic syndrome. Approved in China on February 8, it is in review by the EU and US.
2. Vyloy (zolbetuximab) is a chimeric IgG1 anti-claudin 18.2 mAb for the treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma. Approved in Japan on March 26, it is in review by the US, EU, and China.
Mergers and acquisitions have been ramping up dramatically since Pfizer’s historic USD$43B purchase of Seagen last year. Besides ADC therapeutics, bispecific antibodies (bsAbs) are also a popular commodity, especially T-cell engager (TCE) formats, demonstrated by three companies emerging from stealth mode this quarter with funding in the millions. The most high-profile M&A cases came from the US and EU, with deals up to USD$10.1B.
ADCs are at the frontier of therapeutic development for cancer because of their unique structure of a monoclonal antibody combined with a cytotoxic agent, and thus targets a specific cancer antigen without harming healthy cells. As of now, there are over 150 clinical-stage programs in the ADC field, with over 12% in late-phase (Phase III/IV) trials. Raking in over $2B in sales last year, Enhertu and Kadcyla are set for success.
While almost half of the anticipated drug launches currently in regulatory review in 2024 are being targeted for cancer, the monoclonal antibodies against Alzheimer’s disease are still in the spotlight. Central nervous system (CNS) disorders have historically been characterized by high unmet need, with Alzheimer’s alone having a 99% clinical trial failure rate over the past twenty years. With Leqembi’s historic approval last year, donanemab and trontinemab will hopefully follow.
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