ProfoundBio Announces Initiation of First-in-Human Trial for PRO1184, a Folate Receptor Alpha-Directed ADC with a Topoisomerase 1 Inhibitor Payload, and Receives FDA "Study May Proceed" Letter for PRO1160, a CD70-Directed ADC

On January 3, 2023 ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, reported that first dosing has initiated in the Phase 1 first-in-human clinical trial of PRO1184 (NCT05579366), and second the company received clearance from the U.S. Food and Drug Administration (FDA) to initiate the Phase 1 clinical trial evaluating PRO1160 (Press release, ProfoundBio, JAN 3, 2023, View Source [SID1234625767]).

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PRO1184

PRO1184 is an ADC comprising a folate receptor alpha-directed antibody conjugated to the exatecan payload with ProfoundBio’s 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. This first-in-human study is actively enrolling with multiple clinical trial sites across the United States.

PRO1160

PRO1160 is an antibody-drug conjugate (ADC) comprising a CD70-directed antibody conjugated to the exatecan payload with ProfoundBio’s novel, proprietary hydrophilic linker. The Phase 1 study will evaluate the safety, activity, and pharmacokinetics of PRO1160 in patients with metastatic renal cell carcinoma, metastatic or relapsed nasopharyngeal carcinoma, or advanced non-Hodgkin lymphoma. In preclinical studies, PRO1160 demonstrated the potential to be a best-in-class ADC therapeutic with a wide therapeutic window.

"We are taking a major step forward with our next generation ADCs." said Naomi Hunder, MD, CMO of ProfoundBio. "Our preclinical data support the potential for improved safety and activity over prior programs targeting folate receptor alpha and CD70, based on our novel hydrophilic linker and exatecan payload. We are excited to bring these advancements to the clinic, where we hope to help a broader patient population due to a potentially wider therapeutic window and ability to target antigens with low-moderate or heterogeneous tumor expression."

"With two clinical-stage programs, ProfoundBio is poised to validate our novel, proprietary, and internally developed ADC technology platform in the clinic and to bring a series of ADCs with best- and/or first-in-class potential to patients with unmet medical need." said Baiteng Zhao, PhD, Co-founder, Chief Executive Officer, and Chair of the Board of ProfoundBio. "We conclude 2022 with several significant accomplishments including the FDA clearance of two INDs and a Series A+ funding round. I am very excited about the momentum and look forward to continued progress of our lead programs in the clinic as well as advancing more pipeline assets through preclinical development and making further breakthroughs in ADC technologies in 2023."