Breast cancer niche market development! Roche, Sanofi and SerD drugs enter key clinical

Wen Jie Sanofi and Roche recently pushed their respective selective estrogen receptor degradation agents (SerD) sar439859 and rg6171 into key clinical trials, prompting analysts to reexamine this mechanism of action Jefferies, a famous investment bank on Wall Street, expressed a bold view, calling it "a market opportunity of at least $2-3 billion" In July 2014, Roche acquired seragon with us $725 million, which ushered in a significant turning point in the mechanism of action and is believed to add some fresh blood to the breast cancer Arsenal Some analysts pointed out that an effective drug that can be administered orally may become a product that changes the rules of the game The story of SerD actually begins with the fluvias AstraZeneca's faslodex (fluvistrane) was listed in 2002, and its sales volume just exceeded $1 billion in 2018, the last full year before the expiration of its patent The low bioavailability and intramuscular injection of faslodex are believed to limit the potential of the drug, prompting the industry to start looking for an effective oral drug These drugs target a niche market for breast cancer, which is usually HER2 negative, but driven by estrogen receptor (ER) signals Faslodex has a second-line treatment label, which is used after the failure of aromatase inhibitor treatment According to the theory, binding with ER can change its activity The first generation of selective estrogen receptor modulators, including tamoxifen, had no covering effect on all receptor signals, which provided clues for SerD, suggesting that ER and its effects could be completely eliminated by degradation of receptors Structurally, the SerD consists of a molecular scaffold (the ligand binding pocket that hits the receptor) and a long side chain (called "degron", which leads to the degradation of the receptor) Jefferies cautions that developers have changed the composition of both in order to pursue the desired features However, the key clinical data is the final test Recently, Sanofi's new CEO has positioned sar439859 as one of the six growth drivers of the group, which makes the SerD mechanism the focus of the industry The second-line treatment phase II trial of the drug is likely to produce data by the end of this year, and if successful, will support regulatory application submission in 2021 Meanwhile, Roche revealed last month that rg6171 has entered phase III clinical trials Although the study has not been published on clinical trials.gov, Roche said it will test CDK4 inhibitors in combination with SerD for first-line treatment Roche's acquisition of two early SerD assets obtained by seragon has been abandoned before, and has now focused on rg6171 The company said that the drug is the best oral SerD drug in the same category, with higher in vivo efficacy compared with other SERDs.