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

  • First human study started with PRO1184 and first patients treated

  • PRO1160 First-in-Human Study Approved to Start in US

  • Both PRO1184 and PRO1160 are based on a novel, proprietary and in-house developed linker-drug technology platform

SUZHOU, China and WOODINVILLE, Washington., January 3, 2023 /PRNewswire/ — ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, announced that 1) dosing has begun in the first human Phase 1 clinical trial of PRO1184 (NCT05579366). and 2) the Company received approval from the U.S. Food and Drug Administration (FDA) to initiate the Phase 1 clinical trial evaluating PRO1160.


PRO1184 is an ADC comprising an alpha-directed folate receptor 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 cancer and mesothelioma. This first-in-human study is actively recruiting at multiple clinical trial sites The United States.


PRO1160 is an antibody-drug conjugate (ADC) comprising an anti-CD70 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 recurrent nasopharyngeal carcinoma or advanced non-Hodgkin’s lymphoma. In pre-clinical studies, PRO1160 demonstrated the potential to be a first-in-class ADC therapeutic with a broad therapeutic window.

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

“With two clinical-stage programs, ProfoundBio is poised to validate our novel, proprietary and in-house developed ADC technology platform in the clinic and deliver a suite of best and/or early potential ADCs to patients with an unmet medical need.” said Baiteng Zhao, PhD, Co-Founder, Chief Executive Officer and Chairman of ProfoundBio, “We are closing out 2022 with several significant achievements, including FDA clearance of two INDs and a Series A+ funding round. I’m very excited about the momentum and I look forward to continuing to advance our lead programs in the clinic as well as advancing additional pipeline assets into pre-clinical development and further breakthroughs in ADC technologies in 2023.”

About ProfundBio

ProfoundBio is a clinical-stage biotechnology company focused on developing novel antibody-based therapeutics with therapeutic potential for cancer patients. Building on internally developed, innovative and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple drug candidates targeting solid tumors and hematologic malignancies in discovery, preclinical and clinical development stages. ProfundBio operates in both metropolitan and metropolitan areas Seattle area, WA, USA and Suzhou, China.

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SOURCE ProfundBio