Iván Márquez Rodas MD, Ph.D. of the Medical Oncology Department, Hospital Gregorio Marañon, Madrid, Spain Speaks about Highlight & Pivotal start Phase IIa Melanoma Trial.
Link to Article:
https://www.globenewswire.com/news-release/2021/03/02/2185058/0/en/Highlight-Pivotal-start-Phase-IIa-melanoma-trial.html
Highlight Therapeutics and Pivotal collaborate on melanoma therapy, launching a Phase IIa study to assess the effectiveness and safety of BO-112.
* In unresectable or metastatic melanoma patients, the trial would look at using Highlight’s BO-112 in conjunction with an anti-PD1 drug.
* In Spain and France, recruitment has already started in 19 top-level centers.
* Despite the ongoing difficulties faced during the COVID-19 pandemic, there were no gaps in recruitment.
Highlight Therapeutics, Inc. (“Highlight”), a clinical-stage biopharmaceutical company developing RNA-based cancer therapies, and Pivotal, a Europe-wide full-service CRO, announced today that the first patients have been enrolled in a Phase IIa study evaluating Highlight’s lead program BO-112 in combination with an anti-PD1 therapy in patients with unresectable or metastatic melanoma who have received at least one prior treatment.
Melanoma is the most dangerous form of skin cancer, though it is rarely found in other organs. This tumor is becoming more common in western countries, and once it has spread, it is considered an incurable condition with few treatment options. Anti-PD1 (checkpoint inhibitor) immunotherapy has recently shown promising results, with 30-36 percent of patients alive after 5 years. Unfortunately, due to primary or acquired resistance to anti-PD1 therapy, the median PFS (progression-free survival) is less than 12 months, and the majority of those patients will die from the tumor or its complications.
This non-comparative Phase IIa open-label clinical trial was conducted in 19 locations around Spain and France. A minimum of 40 patients with non-resectable melanoma will be included in the study. Following the start of the phase I trial in 2016, this is the third trial with BO-112. Despite the challenges posed by the COVID-19 pandemic, a second trial in gastrointestinal tumors was launched in 2020, with the first cohorts having already been successfully completed, and the recruitment of this phase IIa trial in melanoma has now begun.
The anti-tumor efficacy and systemic exposure of repeated intratumoral injections of BO-112 into a tumoral lesion, in conjunction with anti-PD1 administered intravenously, will be assessed in this review. BO-112 has anti-tumor properties of its own, but it also affects many pathways involved in Checkpoint inhibitor resistance.