Genelux Corporation announced the start of two Phase 1b, dose-escalation studies of its leading investigational oncolytic virotherapy, GL-ONC1, in ovarian and other cancers. The trials are being conducted at the Florida Hospital Cancer Institute (FHCI) in Orlando and the Moores Cancer Center at UC San Diego Health, and both sites are now recruiting patients.
GL-ONC1 is a genetically stable oncolytic virus designed to locate, enter, colonize and destroy cancer cells without harming healthy tissues or organs. The therapy is based on the vaccinia virus (Lister strain), which was used safely in millions of people as the vaccine against smallpox. Genelux has modified this virus to increase its anti-tumor activity, tumor selectivity and safety without limiting its ability to replicate in cancer cells.
Thomas Zindrick, president and CEO of Genelux, said in a press release, “The initiation of these two trials with leading U.S. medical institutions is a significant milestone in the clinical advancement of GL-ONC1 and will provide Genelux with significant near-term data milestones. Following positive results in four completed clinical trials, including the two Phase 1 trials in head and neck cancer and mesothelioma presented at the 2015 ASCO Annual Meeting, which confirmed the safety and favorable trend of clinical benefits of GL-ONC1 administered either intravenously (IV) or intrapleurally, we are excited to have commenced further evaluation of our lead oncolytic virotherapy.
“Our next primary goal is to establish the optimized parameters of a strategic Phase 2 clinical trial design in ovarian cancer. … We look forward to continuing enrollment and providing first clinical results of both studies by the first half of 2017,” he added.
The trial at the Florida Hospital Cancer Institute, (NCT02759588), led Dr. Robert Holloway, will determine if GL-ONC1 oncolytic immunotherapy is well-tolerated and shows anti-tumor activity in patients with recurrent ovarian cancer and peritoneal carcinomatosis. The primary endpoints are the incidence of treatment-emergent adverse events, and safety and tolerability of multiple doses of GL-ONC1 administered via intraperitoneal catheter. The first two patients have been dosed and so far the treatment was well-tolerated.
GL-ONC1 is administered intraperitoneally at high doses in a condensed period. Following an interim analysis of this study, Genelux is planning a Phase 2a expansion of the trial following analysis of interim data, and GL-ONC1 will likely be given as a combination treatment, to test its potential augmented effect. Data from this study will help to determine the optimal parameters for a Phase 2 trial design, focusing on the registration pathway in ovarian cancer.
“Ovarian cancer remains a challenging cancer to treat effectively,” Holloway, MD, medical director of Gynecologic Oncology at the Florida institute, said. “In clinical trials to date, GL-ONC1 has demonstrated safety and promising broad-spectrum anti-cancer activity across a number of tumor types, including ovarian cancer, and we are very enthusiastic about evaluating this oncolytic immunotherapy as a potentially vital treatment option for women with recurrent ovarian cancer.”
Researchers at the Moores Cancer Center are conducting an open label, non-randomized Phase 1b study (NCT02714374) to investigate the safety and effect of intravenous GL-ONC1 administered with or without Soliris (eculizumab), a monoclonal antibody, prior to surgery in patients with solid organ cancers. Enrolled patients are undergoing surgery for curative purposes or for palliative resection. The study is being led by surgical oncologist Dr. Kaitlyn Kelly.
This trial aims to establish the optimal systemic administration of GL-ONC1. The first three patients have been dosed and the treatment has been well-tolerated. Results will help to inform the doses to further augment the anti-tumor activity of GL-ONC1 virotherapy, particularly in metastatic diseases. Following interim data analysis, Genelux is also planning to conduct a Phase 2a expansion study.
“In previous trials across various tumor types and via multiple different administrations, GL-ONC1 has successfully demonstrated an enhanced ability to select, infiltrate and destroy tumors while leaving healthy tissue unharmed,” Kelly said. “We are excited to collaborate with Genelux to initiate this clinical trial in solid organ cancers to expand our evaluation of systemic administration and identify tumor types to focus on for further development of this unique oncolytic vaccinia virus for immunotherapy of cancers.”