US-based biotechnology company ProfoundBio has begun dosing subjects in a Phase I/II first-in-human clinical trial of PRO1107, a novel therapeutic being tested for advanced solid tumours.

The trial aims to explore PRO1107’s tolerability, safety, pharmacokinetics and anti-tumour activity in various forms of cancer, including non-small cell lung, breast and ovarian cancer.

The global, open-label, multi-centre study is structured in two parts.

Part A will focus on dose escalation and expansion to identify the recommended optimal dose regimens, while Part B will expand the treatment to specific tumour types.

PRO1107 is an antibody-drug conjugate (ADC) comprising a Protein Tyrosine Kinase 7 (PTK7)-targeted antibody coupled to ProfoundBio’s hydrophilic monomethyl auristatin E (MMAE)-based linker-drug, LD343, at a homogeneous drug-antibody ratio (DAR) of eight. 

ProfoundBio chief medical officer Naomi Hunder said: “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.

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“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 eight.

“We look forward to evaluating PRO1107 as a treatment for the broad population of patients with PTK7-expressing tumours, and we are thankful to the investigators and patients who make this research possible.”

Based in Seattle, Washington, ProfoundBio focuses on developing antibody-based therapeutics for cancer.

The company’s pipeline includes multiple ADC drug candidates intended to treat both solid tumours and haematological malignancies.

These include drugs such as rinatabart sesutecan targeting folate receptor-alpha, PRO1160 targeting CD70 and PRO1107 targeting PTK7, as well as PRO1286, a bispecific ADC aimed at two solid tumour antigens.