The first of 40 patients have been recruited for a clinical trial of a potential treatment for metastatic melanoma being developed by Highlight Therapeutics.
Highlight Therapeutics is working with Pivotal, a Europe-wide full-service clinical research organization (CRO), on the study across 19 top-level centres in Spain and France.
The open-label Phase IIa study is assessing Highlight’s lead program BO-112 in combination with an anti-PD1 therapy in patients with unresectable or metastatic melanoma that have previously progressed to checkpoint inhibitors.
BO-112, which works by activating a series of processes in tumour cells that stop them from evading detection by the body’s immune system, as well as helping activate the immune cells, has been found to be very potent in earlier-stage trials.
Melanoma is the most malignant tumour of the skin and incidences are rapidly increasing in western countries but it has been considered an incurable disease with limited therapeutic options.
Recently, immunotherapy using drugs called checkpoint inhibitors, specifically anti-PD1, showed encouraging results with 30-36% of patients alive at five years, by helping to stop tumours from evading the body’s immune system.
Unfortunately, the median progression-free survival rate is less than 12 months, mainly due to people’s initially being or becoming resistant to anti-PD1 treatment, meaning most of those patients will die due to the tumour or its complications.
“This Phase IIa study is an important step forward in our strategy to develop effective cancer therapies which can be used in combination with checkpoint inhibitors,” said Dr Marisol Quintero, chief executive of Highlight Therapeutics .
“We are looking to produce a better immunological response in anti-PD1 therapy-sensitive patients, and to induce or maintain responses for those patients that progress or are initially treatment-resistant. BO-112 has the potential to be employed from the beginning of disease treatment and we believe it offers patients a resistant status after immunological treatment.
“We are encouraged by the effectiveness already seen in previously treated melanoma patients in the phase I study with BO-112 and we are pleased to be working once more with the highly experienced and dedicated team at Pivotal.”