US-based Biomarck Pharmaceuticals has started a Phase II clinical trial of its investigational candidate BIO-11006 for the treatment of patients with advanced non-small cell lung cancer (NSCLC).

BIO-11006 is a peptide being developed to specifically target the MARCKS protein to inhibit cancer cell division and movement.

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The controlled Phase II trial is designed to assess the drug candidate’s safety and efficacy in combination with standard of care (SoC) at ten clinical sites in India, compared with SoC alone.

The trial’s primary endpoint is progression-free survival (PFS) at three months, while the secondary endpoints include overall survival (OS) and body weight.

Biomarck Pharmaceuticals CEO Dr Brian Dickson said: “Although advances have been made recently in the treatment of advanced NSCLC especially with immunotherapy, the five-year survival rate remains disappointingly low.

“These immunotherapeutic agents have significant side-effects and quality of life remains a critical issue to both patients and their treating oncologists.”

“These immunotherapeutic agents have significant side-effects and quality of life remains a critical issue to both patients and their treating oncologists.”

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In preclinical models, BIO-11006 is reported to have demonstrated the ability to minimise primary tumour size and prevent development of secondary tumours.

The drug candidate further showed synergistic activity with other chemotherapeutic agents and prevented weight loss.

Its safety database was found to be encouraging during prior clinical studies in a total of more than 200 subjects.

Dickson added: “The initiation of this clinical study represents a significant milestone for Biomarck as we progress to clinically develop our patented portfolio in diseases, such as NSCLC that cause significant morbidity and mortality. This represents a first-in-class therapy.”