—Phase I Study of ONCOS-102 in Late-stage Refractory Cancer Patients Successfully Completed and Presented at CIMT Annual Meeting—
Oncos Therapeutics, Ltd., a clinical stage biotechnology company specializing in the development of targeted cancer immunotherapeutics, presented Phase I clinical data demonstrating that local administration of its lead compound, ONCOS-102, is able to induce a systemic, tumor-specific immune response in late-stage cancer patients. The data were presented in two separate podium presentations on May 7th and 8th at the Annual Meeting of the Association for Cancer Immunotherapy (CIMT) in Mainz, Germany.
In the single center Phase I study conducted at Docrates Cancer Center in Helsinki, Finland, a total of 12 patients with advanced solid tumors of different types were treated with up to nine intratumoral injections at three different dose levels of ONCOS-102 – a modified, tumor-targeted, human adenovirus armed with a potent immune-stimulating transgene, GM-CSF. The treatment displayed an excellent safety profile and the study confirmed the dose level for a forthcoming Phase II clinical trial. Four out of ten evaluable patients (40%) had stable disease (SD) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) evaluation three months after starting ONCOS-102 treatment.
“Demonstrating the induction of tumor-targeted immune responses in late stage cancer patients is a significant achievement in cancer immunotherapy, even though the number of study subjects was limited in this trial,” said Magnus Jaderberg, M.D., Chief Medical Officer of Oncos. During the trial, a number of biological samples were collected prior to and after ONCOS-102 treatment to evaluate the biological activity of the therapy. Sample analysis showed that the treatment triggered an immediate innate immune response as measured by:
- a temporary increase in pro-inflammatory cytokines; and
- infiltration of innate immune cells into the tumor area.
These responses were seen in both blood and tumor biopsies. Also, an infiltration of CD8+ T cells of cytotoxic phenotype was seen in post-treatment biopsies. Analysis of the antigen specificity of cytotoxic T cells in peripheral blood prior to and after treatment with ONCOS-102 showed that the therapy induced a tumor-specific immunity in patients with advanced solid tumors.
“These results clearly demonstrate the potential of our immunotherapy platform,” said Frans Wuite, M.D., President and Chief Executive Officer of Oncos. “We now intend to move our lead compound forward to Phase II in selected indications in combination with other anti-cancer treatments, including immune checkpoint inhibitors.”
ONCOS-102 (Ad5/3-D24-GMCSF) is a modified, tumor-targeted human adenovirus capable of local delivery of a potent immune-stimulating transgene, granulocyte-macrophage colonystimulating factor (GM-CSF) to the tumor microenvironment. In addition to this Phase I study, the safety of ONCOS-102 has been demonstrated in over 100 patients with refractory cancers who received treatment with ONCOS-102 under compassionate use circumstances.
About Oncos Therapeutics
Oncos Therapeutics, Ltd. is a privately funded, clinical-stage biotechnology company focused on the development and commercialization of targeted cancer immunotherapy products that induce a tailored immune response targeted against each patient's unique cancer cells. In addition to its lead product, ONCOS-102, Oncos has generated a pipeline of clinical candidates using its adenovirus-based cancer immunotherapeutics platform. The company’s lead investor is HealthCap, one of the largest specialized providers of venture capital within life sciences in Europe. Oncos, founded in 2009, is headquartered in Helsinki, Finland and has an office in Switzerland.
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Dr. Frans Wuite, President and CEO
Oncos Therapeutics Ltd.
+41 79 340 8218
Dr. Anca Alexandru
MacDougall Biomedical Communications
+49 163 613 3359