On February 5, 2024 ProfoundBio, a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, reported dosing has initiated in the Phase 1/2 first-in-human clinical trial of PRO1107 (NCT06171789) (Press release, ProfoundBio, FEB 5, 2024, View Source [SID1234639849]).

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"By bringing the first ADC with our next generation MMAE linker-drug platform to the clinic, we are furthering our commitment to developing ADCs with the potential for improved outcomes for patients," said Naomi Hunder, MD, chief medical officer of ProfoundBio. "We believe our preclinical data support the potential of PRO1107 to provide much improved safety and activity compared to prior PTK7 ADCs, demonstrating the compelling attributes of our LD343 platform, which incorporates our novel highly hydrophilic linker combined with the clinically validated MMAE payload conjugated at a high drug-antibody ratio of 8. We look forward to evaluating PRO1107 as a treatment for the broad population of patients with PTK7-expressing tumors, and we are thankful to the investigators and patients who make this research possible."

PRO1107 is being evaluated in a global, open-label, multicenter Phase 1/2 trial. This trial is designed to determine the safety, tolerability, pharmacokinetics, and antitumor activity of PRO1107 in patients with advanced solid tumors, including non-small cell lung, breast, and ovarian cancer. It is designed as a two part study: Part A, which is aimed at determining the recommended optimal dose regimen(s) through dose escalation and expansion, and Part B, which focuses on the expansion of treatment to specific tumor types.

"With three clinical-stage programs derived from two distinct proprietary ADC technology platforms, ProfoundBio is demonstrating our capability to efficiently bring innovative ADCs with best- and/or first-in-class potential to patients with unmet medical need. We first showcased this program and the LD343 linker-drug technology in our preclinical presentations at SITC (Free SITC Whitepaper) 2023, and we are thrilled to potentially provide benefit to patients across a wide range of PTK7-expressing tumors," said Baiteng Zhao, PhD, chief executive officer of ProfoundBio.

About PRO1107
PRO1107 is an ADC consisting of a Protein Tyrosine Kinase 7 (PTK7)-targeted antibody conjugated to ProfoundBio’s novel, proprietary hydrophilic MMAE-based linker-drug, LD343, at a homogeneous drug-antibody ratio (DAR) of 8. MMAE is a potent, membrane permeable microtubule inhibitor that has been clinically validated as an ADC payload by multiple vedotin-based ADCs incorporating MMAE at a DAR of ~4. LD343 incorporates a highly hydrophilic stable, cleavable linker designed to mask the hydrophobicity of conjugated MMAE on the ADC, enabling high DAR and efficient delivery of the MMAE payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC.