US-based Immune Design has started dosing patients in a Phase I clinical study of LV305, an immuno-oncology investigational agent from its DCVex lentiviral vector platform to treat patients with locally advanced, relapsed, or metastatic breast cancer, melanoma, non-small cell lung cancer, ovarian cancer or sarcoma.
The company is focused on the development of novel immune-based therapies for cancer and other chronic conditions.
A total of 36 patients at several clinical centres in the US will be enrolled in the open label, multi-centre Phase I study (NCT02122861), which is designed to assess the safety, tolerability and immunogenicity of LV305 in these patients.
Fred Hutchinson Cancer Research Center principal investigator Seth Pollack said: “The advancement of novel immuno-oncology agents such as LV305 that induce a tumour-specific in-vivo T-cell response holds promise for the development of new and targeted approaches to cancer treatment.”
Immune Design president and chief executive officer Carlos Paya said: “LV305 is an integral part of our prime-boost strategy that is designed to provide a superior approach to fighting cancer.
“Data from the trial will include immunogenicity and initial indications of efficacy, and is intended to support the combination of LV305 with a second proprietary agent, G305, into our prime-boost strategy known as CMB305. We intend to commence a Phase 1 trial for CMB by the end of 2014.”
Generated from the company’s DCVex platform, LV305 is designed to activate the immune system through the in-vivo generation of cytotoxic T cells (CTLs) initially against a specific tumour-associated antigen, NY-ESO-1.
The company said that preclinical tests have showed the ability of LV305 to reduce tumour growth of NY- ESO-1-expressing tumours, increase production of antigen-specific CD8 cells, and significantly improve the survival of tumour-bearing animals.
LV305 is the first step in the company’s new prime-boost approach to immuno-oncology, which includes combination with G305, generated from the GLAAS platform, to expand CTLs and potentially generate a potent, durable immune response.