Andrés Cervantes, MD from Pivotal discusses Highlight Therapeutics & Pivotal advance into a Phase IIa trial to examine Gastro-Intestinal cancer therapy.
Highlight Therapeutics, ('Highlight'), a clinical-stage biopharmaceutical company developing RNA-based cancer therapies, and Pivotal, a Europe-wide full-service CRO, today reported that the first cohort of patients to test Highlight's BO-112 lead program in combination with anti-PD1 therapy in patients with colorectal or liver metastasis were recruited in a Phase IIa trial.
This open-label, Phase IIa clinical trial is a four-country, non-comparative, two-cohort study. Cohort A will consist of 11 colorectal cancer patients for Part 1 and will extend to an additional 15 for Part 2. Cohort B will consist of 18 patients with Part 1 gastric or gastroesophageal junction cancer, extending to Part 2 for an additional 25 patients. Despite the challenges of the COVID-19 pandemic, the first cohort of 11 patients has already been enrolled, with trial centers rapidly launched in Spain, Italy, and Belgium.
The research will assess the efficacy, tolerability, anti-tumor activity, and systemic exposure in conjunction with intravenous anti-PD1 to repeated intratumoral injections of BO-112 into a hepatic metastatic lesion.
Liver metastasis is a liver malignant tumor that has spread with minimal viable care from another cancer-affected organ. Owing to its abundant, dual blood supply, the liver is the most common site for metastatic cancer, with metastatic tumors 20 times more common in the liver than primary tumors. About 25-50 percent of colorectal cancer patients and 30-50 percent of gastric/gastro-esophageal junction cancer patients experience liver metastasis, resulting in high rates of morbidity and mortality and a non-response rate of approx. 90% of the anti-PD1 treatments.