Tanja Obradovic, Oncology Medical Strategy Adviser, Clinical Drug Development Expert, shared a post on LinkedIn:
“Anti – mesothelin antibody – drug conjugate (ADC) on the horizon? FDA granted fast track designation to RC88 (RemeGen Biosciences), a mesothelin – targeting antibody – drug conjugate (ADC) for the treatment of patients with platinum – resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer. And company just finished Phase II in China with results pending (NCT06173037).
Future of this approach is highly risky considering history of failure targeting mesothelin in the clinical development with most notable recent disappointments by Zymeworks Inc.’ T – cell engager ZW171 (terminated NCT06523803) and just announced stopping of Phase I (NCT06466187) by Pfizer of PF08052666. First next signal of how this mechanism performs in the clinic should come this year from the read out of Context Therapeutics T – cell engager CT – 95 ongoing phase I across solid tumors (NCT06756035).
With RemGen announcing plans to open RC88 international multicenter phase II clinical studies across the United States, China, the European Union, and other regions, oncology community is certain to closely monitor reports. This may be the case when drug modality is not primary influencer upon clinical benefit outcome but choice of the target.”
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