How ONCOS-102 works
ONCOS-102 was engineered to replicate inside cancer cells only, leaving healthy cells unharmed. In addition, Targovax also inserted into the virus genome a gene coding for GM-CSF (granulocyte-macrophage-colony-stimulating factor) that will be made during the replication of the virus inside the tumor cells. GM-CSF is a protein that stimulates the immune system.
When administered, ONCOS-102 particles bind and enter to tumor cells specifically, resulting in their death. When the tumor cells die, they release tumor antigens or molecules that are capable of inducing an immune response, as well as new ONCOS-102 particles. This, together with the production of the co-stimulatory molecule GM-CSF, functions as a danger signal that is recognized by the immune system and leads to the death of more tumor cells.
ONCOS-102 in clinical trials
The safety, tolerability and recommended dose of ONCOS-102 were assessed in a Phase 1 study (NCT01598129) in 12 patients with advanced cancers. Results of the trial, published in the Journal for ImmunoTherapy of Cancer, revealed that treatment with ONCOS-102 in conjunction with low-dose Cytoxan (cyclophosphamide injection) was safe and well-tolerated at the tested doses, and was able to induce a tumor-specific immune response both at the injection site and throughout the body. More importantly, anti-tumor immunity came with signals of clinical benefit.
A Phase 1/2 study (NCT02879669) is currently evaluating the safety, immune activation, and clinical response of ONCOS-102 in combination with Alimta (pemetrexed) and Platinol (cisplatin) in 30 patients with malignant mesothelioma. In the Phase 1 portion of the trial, researchers will evaluate the safety of ONCOS-102 and Alimta/Platinol. In the Phase 2 portion, patients will be given either ONCOS-102 plus Alimta/Platinol or Alimta/Platinol alone. The preliminary results of the study suggested that the treatment is well-tolerated in the three patients already treated. The study is still recruiting participants at four locations in Spain.
A Phase 1 trial (NCT03003676) is evaluating ONCOS-102 followed by Keytruda (pembrolizumab) in 12 patients with advanced melanoma whose disease has progressed despite prior treatment. The main aim of the study is to determine the safety of the sequential treatment. Secondary endpoints include progression-free survival, objective response rate, and change in the size of individual lesions. Researchers also will evaluate changes in blood and tumor immune parameters. Early results from the study suggested that ONCOS-102 is well-tolerated and may induce an immune response, based on data from four patients treated to date. The study is recruiting patients at the Memorial Sloan Kettering Cancer Center in New York.
Finally, the safety and anti-tumor activity of ONCOS-102 in combination with imfinzi (durvalumab) are being assessed in a Phase 1/2 study (NCT02963831) for the treatment of people with advanced peritoneal malignancies. The study is currently enrolling up to 78 participants in New York and Florida.
The most common adverse effects of ONCOS-102 were flu-like symptoms and fever.
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