PRO1160 first patient dosed in the US China NMPA clearance for PRO1184 (rinatabart sesutecan, Rina-S) and PRO1160 to initiate clinical trials Rina-S preliminary clinical data is encouraging
SUZHOU, China and WOODINVILLE, Wash., May 26, 2023 /PRNewswire/ — ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, announced that dosing in the Phase 1/2 first-in-human trial of PRO1160 (NCT05721222) has initiated in the US, and the company received approval from National Medical Products Administration (NMPA) to initiate the PRO1160 trial in China. The company also received NMPA approval to initiate the Rina-S Phase 1/2 first-in-human trial in China. Preliminary results from the on-going trial (NCT05579366) demonstrate a promising clinical profile, with anti-tumor activity observed at tolerable dose levels.
“We continue to advance our next-generation antibody-drug conjugate (ADC) programs in our mission to bring new and better treatment options to patients with advanced cancers.” said Naomi Hunder, MD, CMO of ProfoundBio. “Rina-S and PRO1160 have the potential to be best-in-class therapies; both leverage our novel hydrophilic linker and exatecan payload, designed to reduce off-target toxicities and improve anti-tumor activity through better exposure and stronger bystander activity. We are gratified to have enthusiastic support from global investigators as we gain experience with these novel agents to address high unmet needs.”
About rinatabart sesutecan (PRO1184)
Rina-S is an ADC comprising a folate receptor alpha-directed antibody conjugated to the exatecan payload with ProfoundBio’s novel, proprietary hydrophilic linker. The Phase 1/2 study will evaluate the safety, activity, and pharmacokinetics of Rina-S 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 and China.
PRO1160 is an ADC comprising a CD70-directed antibody conjugated to the exatecan payload with ProfoundBio’s novel, proprietary hydrophilic linker. The Phase 1/2 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 first- and best-in-class CD70-directed ADC. The first-in-human study is actively enrolling with multiple clinical trial sites across the United States.
ProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics with curative potential for patients with cancer. Built on internally developed, innovative, and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple drug candidates targeting solid tumors and hematological malignancies that are in discovery, preclinical, and clinical development stages. ProfoundBio has operations in both the US and China.
For more information, please visit www.profoundbio.com.