Targovax has been granted a European patent for its lead product ONCOS-102, a cancer vaccine that is being clinically evaluated in mesothelioma, with tests planned for other solid tumors. The composition of matter patent, no 2,379,586, expires in 2029 and follows a U.S. patent for the vaccine granted in May.
ONCOS-102 has also been designated orphan drug by both the U.S. Food and Drug Administration and the European Medicines Agency as a potential treatment for ovarian cancer and soft tissue sarcoma, as well as mesothelioma.
“This European patent is an important addition to Targovax’s intellectual property portfolio covering our ONCOS platform and the engineered oncolytic viruses that arise from it,” Jon Amund Eriksen, chief technology innovation officer and co-founder of Targovax, said in a news release.
ONCOS-102 derives from Targovax’s ONCOS platform, which generates viruses that preferentially infect cancer cells, called oncolytic viruses, and that function as tumor-targeted immune activators. According to Targovax, this platform has the potential to generate safer and more efficacious therapies than Imlygic, the first approved oncolytic virus therapy.
ONCOS-102 has three main characteristics that drive its anti-tumor activity, the company reports. First, the virus has a replaced protein from a different virus that facilitates its entry into tumor cells; second, it has a gene deletion to ensure the virus only replicates in cancer cells, and not in healthy cells; third, it produces the GM-CSF protein, which induces a strong systemic anti-tumor T-cell response.
Recent data from a Phase 1 clinical trial (NCT01598129) evaluating the safety and recommended dose of ONCOS-102 in heavily pretreated patients with advanced cancers revealed that this cancer vaccine induces tumor-specific immune activation both at the systemic and tumor level. Importantly, ONCOS-102 treatment induced stable disease in 40 percent of treated patients.
Targovax reported data from a preclinical study in July showing that combining ONCOS-102 with standard of care platinum-based agents, Alimta (pemetrexed) and Platinol (cisplatin), had synergistic effects in human mesothelioma cells and mesothelioma animal models, inducing immunogenic cell death.
A randomized, open-label Phase 1b/2 trial (NCT02879669), taking place in Spain, is now evaluating ONCOS-102 in combination with Alimta and Platinol in patients with malignant pleural mesothelioma. The trial will enroll 30 patients and will be conducted in two parts. The Phase 1b non-randomized safety part, which dosed its first patient in June, will assess the safety of the combination in six patients, with its primary outcome being the number of patients with any (severe and non-severe) adverse events.
Phase 2 will randomize 24 patients to receive Alimta and Platinol with or without ONCOS-102, to assess immune activation, clinical response, and the correlation between clinical outcome and the immunological data.
The company is planning other Phase 1/2 clinical trials to assess ONCOS-102 in a number of solid tumors, including melanoma, ovarian cancer, prostate cancer, pleural mesothelioma.