On August 3, 2022 ProfoundBio, an oncology biotherapeutics company focused on the development of novel antibody-based therapeutics, reported that it has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug application (IND) to evaluate PRO1184 in patients with advanced cancer (Press release, ProfoundBio, AUG 3, 2022, View Source [SID1234617643]). PRO1184 is an antibody-drug conjugate comprising a folate receptor alpha (FRa) directed antibody conjugated to an exatecan payload with a novel, proprietary hydrophilic linker. The Phase 1 study will evaluate the safety, activity and pharmacokinetics of PRO1184 in patients with ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma.

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Additionally, ProfoundBio announced the appointment of Naomi Hunder, M.D., as Chief Medical Officer.

"I am thrilled to welcome Dr. Hunder to the ProfoundBio leadership team, especially during this pivotal transition into a clinical-stage oncology company. Dr. Hunder brings tremendous expertise and experience in the development of targeted therapeutics, particularly ADCs, and a fierce drive to bring better therapeutics to patients with cancer." said Baiteng Zhao, PhD, Chief Executive Office. "Earlier this year, the PRO1184 preclinical data presented at AACR (Free AACR Whitepaper) annual meeting demonstrated potent anti-tumor activity in multiple mouse CDX models and a favorable therapeutic index. With the US FDA clearance for the PRO1184 first-in-human study, we look forward to fulfilling the promise of these preclinical results and establishing the potential of PRO1184 for patients with advanced cancers."

"ProfoundBio’s mission is to help patients with cancer through the discovery and development of novel targeted therapeutics with curative potential. We believe we have an opportunity to improve on the activity of FRα-targeted ADCs by both updating the drug conjugate and utilizing a novel hydrophilic linker that improves pharmacodynamic and safety parameters in preclinical studies. I’m thrilled to be joining ProfoundBio at this time, when FDA’s clearance enables us to initiate clinical studies and progress our mission." said Dr. Hunder.

Dr. Hunder is a medical oncologist and joins ProfoundBio with 15 years of experience leading development programs from initial design to global regulatory approvals and commercialization. Dr. Hunder most recently served as Chief Medical Officer of Silverback Therapeutics, a company focused on the advancement of novel immunotherapies. Previously she was Vice President (VP) of Clinical Development and Medical Affairs at Acerta Pharma, with a key role in the development and approval of Calquence. Prior to Acerta, Naomi was VP of Clinical Development at Seattle Genetics, and was the clinical development lead for Adcetris. A board certified medical oncologist, Naomi received her M.D. from Jefferson Medical College and her Internal Medicine training at the University of Pennsylvania. She completed her oncology fellowship training at Fred Hutchinson Cancer Research Center/University of Washington. Naomi received her B.A in Biology from Carleton College.