China-based macromolecular targeted therapy developer ProfoundBio (Suzhou) Co., Ltd announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) PRO1184 in advanced tumors. The announcement was made alongside the appointment of Dr. Naomi Hunder as the company’s chief medical officer (CMO).
Drug Details
PRO1184 targets folate receptor alpha (FRα) and uses exatecan as the payload. It features a novel hydrophilic linker with intellectual properties. Preclinical studies have shown good in vivo activity and a favorable safety profile. ProfoundBio plans to initiate a Phase I clinical study to assess the safety, activity, and pharmacokinetics of PRO1184 in ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma.
Leadership Addition
Dr. Naomi Hunder brings 15 years of oncology experience to ProfoundBio, spanning drug development from molecule design to commercialization. Prior to joining ProfoundBio, she held key roles including vice president of clinical development at Seattle Genetics, Acerta Pharma, and Silverback Therapeutics. She led the clinical development of ADC product Adcetris and advanced the development and marketing of Calquence (acalabrutinib). Dr. Hunder holds a BS in Biology from Carleton College, an MD from Jefferson Medical College, and completed medical oncology research at the Fred Hutchinson Cancer Research Center/University of Washington.-Fineline Info & Tech
