Patients with ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma could benefit from an antibody drug conjugate (ADC) after clearance of an investigational new drug (IND) was approved by the US Food and Drug Administration (FDA).
ProfoundBio received the FDA’s ‘study may proceed’ letter today (August 3) to evaluate PRO1184, a folate receptor alpha-directed ADC with a topoisomerase 1 inhibitor payload in patients with advanced cancer.
PRO1184 is an ADC 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.
Baiteng Zhao, CEO at ProfoundBio, said: “Earlier this year, the PRO1184 preclinical data presented at AACR 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.”
Additionally, ProfoundBio announced the appointment of Naomi Hunder, as chief medical officer.
Hunder said: “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.”
ProfoundBio is an oncology biotherapeutics company focused on the development of novel antibody-based therapeutics with curative potential for patients with cancer.