Benzinga | Aug 5, 2021 08:38AM EDT

Portage Biotech Highlights First Patient Dosed in IMP-MEL Study of PORT-2 for the Treatment of Melanoma and Non-Small Cell Lung Cancer

Portage Biotech Inc., (NASDAQ:PRTG) ("Portage" or the "Company") a clinical-stage immuno-oncology company focused on the development of therapies targeting cancer treatment resistance, today announced that the first patient has been dosed in the Oxford-led IMP-MEL study, a Phase 1/2, open-label, dose-escalation and randomized expansion clinical trial assessing the safety, tolerability and efficacy of PORT-2, a liposome formulation of the invariant natural killer T-cell (iNKT) agonist IMM60 developed for the treatment of solid tumors.

Preclinical data for PORT-2 demonstrated good tolerability and a strong cancer-specific B- and T-cell response. It also showed a robust innate and adaptive immune response and an increase in expression of PD-L1 on cancer cells. Combining PORT-2 with checkpoint inhibitors led to increased immune activation and PD-L1 expression, suggesting rationale for enhanced activity of the combination treatment.

"PORT-2 offers a novel, targeted approach to address a variety of today's most common cancers, many of which are often elusive or resistant to treatment. Preclinical data show that our iNKT agonist can stimulate a broad response from both the innate and adaptive immune systems, helping the body recognize and attack these cancers," said Dr. Ian Walters, chief executive officer of Portage Biotech. "This first-in-human trial features a robust design with a multi-arm comparison against standard of care therapies currently used in the clinic, which we believe has the potential to accelerate our research as we evaluate the effectiveness of PORT-2 both as a monotherapy and in combination with PD-1 checkpoint inhibitors."

The IMP-MEL study is expected to enroll 100 patients at Oxford and other centers and will evaluate PORT-2 both as a monotherapy and in combination with approved PD-1 inhibitor Keytruda in the treatment of Melanoma and Non-Small Cell Lung Cancer (NSCLC).

"Checkpoint inhibitor therapies have enormous opportunity in the treatment of solid tumors, but unfortunately, many cancers develop a resistance to these therapies leaving many patients without adequate treatment options," said Mark Middleton, Departmental Head of Oncology and Professor of Experimental Medicine at the University of Oxford. "We're constantly seeking new therapies that are capable of addressing resistance and enabling a durable response in patients with cancer. Should PORT-2 prove successful, this novel iNKT agonist therapy could potentially re-sensitize patients to checkpoint inhibitor treatment and could activate that durable immune response. It's a very exciting new avenue for oncology research."

The IMP-MEL study is part of a comprehensive clinical development plan to evaluate Portage's iNKT agonist therapies, PORT-2 and PORT-3. PORT-3, which is a nanoparticle co-formulation of IMM60 and a NY-ESO-1 peptide antigen, is also currently being evaluated in a Phase 1 clinical trial initiated in April 2021 at Radboud University, Netherlands.

The IMP-MEL study is supported by the NIHR Biomedical Research Centre. The trial is actively recruiting at the University of Oxford, United Kingdom. For more information, please visit https://www.isrctn.com #ISRCTN80472712