Monday, February 05, 2024
ProfoundBio, a biotechnology firm currently in the clinical stage, has commenced dosing in the Phase 1/2 clinical trial of PRO1107 (NCT06171789), an innovative antibody-drug conjugate (ADC) therapy for cancer.
ProfoundBio, emphasized the significance of this milestone, stating, "Introducing the first ADC utilizing our next-generation MMAE linker-drug platform into clinical trials marks a significant step forward in our commitment to developing ADCs that could potentially enhance patient outcomes." She highlighted encouraging preclinical data supporting PRO1107's potential for improved safety and efficacy compared to previous PTK7 ADCs. This is attributed to their LD343 platform, integrating a novel highly hydrophilic linker with the clinically validated MMAE payload, conjugated at a high drug-antibody ratio of 8.
The Phase 1/2 trial of PRO1107 is a global, open-label, multicenter study focusing on assessing its safety, tolerability, pharmacokinetics, and antitumor activity in patients with advanced solid tumors, including non-small cell lung, breast, and ovarian cancer. The trial comprises two parts: Part A, aimed at determining recommended optimal dose regimens through dose escalation and expansion, and Part B, focusing on treatment expansion to specific tumor types.
ProfoundBio, underscored the company's ability to efficiently bring innovative ADCs to patients in need, with three clinical-stage programs stemming from two distinct proprietary ADC technology platforms. He highlighted the LD343 linker-drug technology, initially presented at SITC 2023, as a potential game-changer for patients with various PTK7-expressing tumors.
PRO1107, targeting Protein Tyrosine Kinase 7 (PTK7), is an ADC featuring ProfoundBio's proprietary hydrophilic MMAE-based linker-drug, LD343, at a homogeneous drug-antibody ratio (DAR) of 8. This novel linker-drug design aims to maximize the delivery of the potent MMAE payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC.