ProfoundBio Announces Further Advancement of PRO1184 (Rinatabart Sesutecan) and PRO1160 Lead Programs in Clinic Details Category: Antibodies Posted on Saturday 27 May 2023 11:36 Hits: 120 PRO1160 treats first patient in US China NMPA clearance for PRO1184 (Rinatabart sesutecan). , Rina-S) and PRO1160 to initiate clinical trials Preliminary clinical data for Rina-S are encouraging
SUZHOU, China and WOODINVILLE, WA, USA I May 26, 2023 I ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, announced that the dosing in the first phase 1/2 study in humans of PRO1160 (NCT05721222) has started in the United States and the company has received approval from the National Medical Products Administration (NMPA) to initiate the PRO1160 study in China. The Company also received NMPA clearance to initiate the Rina-S Phase 1/2 initial human study in China. Preliminary results from the ongoing study (NCT05579366) show a promising clinical profile, with antitumor activity observed at tolerable doses.
“We continue to advance our next-generation antibody-drug conjugate (ADC) programs to bring new and better treatment options to patients with advanced cancer,” said Naomi Hunder, MD, CMO of ProfoundBio. “Rina-S and PRO1160 have the potential to be best-in-class therapies. Both utilize our novel hydrophilic linker and exatecan payload designed to reduce off-target toxicities and enhance antitumor activity through better bystander exposure and activity. We appreciate the enthusiastic support of global researchers as we gain experience with these novel compounds to fill a high unmet need.”
About Rinatabart Sesutecan (PRO1184)
Rina-S is an ADC comprising a folate receptor-directed alpha 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 cancer and mesothelioma. Applications for this first-in-human study are currently being actively submitted at multiple clinical trial sites in the United States and China.
About PRO1160
PRO1160 is an ADC comprising an anti-CD70 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 recurrent nasopharyngeal carcinoma or advanced non-Hodgkin’s lymphoma. In preclinical studies, PRO1160 demonstrated the potential to be the first and best-in-class CD70-gated ADC. The first human study is currently being recruited at multiple clinical trial sites in the United States.
About ProfoundBio
ProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics with the potential to treat cancer patients. Building on internally developed, innovative and proprietary technology platforms, ProfoundBio has developed a pipeline of multiple drug candidates in discovery, pre-clinical and clinical development stages for solid tumors and hematologic malignancies. ProfoundBio operates in both the US and China.
For more information, visit www.profoundbio.com.
SOURCE: ProfoundBio
