On March 26, 2015 Immune Design reported the dosing of patients in a Phase 1b clinical trial of CMB305, a "prime-boost" immuno-oncology product candidate generated from the company’s ZVexTM and GLAASTM platforms (Press release, Immune Design, MAR 26, 2015, View Source [SID:1234502560]). CMB305 is the first product candidate of Immune Design’s Specific Antigen approach, which is one of the company’s two distinct approaches to fighting cancer. Schedule your 30 min Free 1stOncology Demo! CMB305 is a novel combination product that involves the sequential dosing of two complementary agents, LV305 and G305, and is designed to synergistically induce anti-tumor cytotoxic T lymphocytes (CTLs) to target tumors that express NY-ESO-1, a tumor antigen found in a broad set of tumors.
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"CMB305’s prime-boost approach leverages the activation of two separate arms of the patient’s immune system, that when combined under this novel approach, are designed to induce a strong and long lasting anti-tumor CD8 T cell response, as well as activate other complementary immune effectors that may help to fight cancer," said Carlos V. Paya, MD, PhD, chief executive officer of Immune Design.
The Phase 1b open label, multi-center trial (NCT02387125) is designed to evaluate the safety and tolerability, immunogenicity, and preliminary clinical efficacy of CMB305 in patients with locally advanced, relapsed or metastatic solid cancers expressing NY-ESO-1. The study is divided into two parts. Part 1 is a dose escalation study in up to 12 patients. Part 2 will be an expansion study of the optimal dose in approximately 27 patients.
About CMB305
CMB305 is an immuno-oncology product candidate combining two potentially synergistic agents. The first agent, LV305, is a hybrid vector from the ZVex platform that specifically targets dendritic cells (DCs) in vivo and delivers the RNA for NY-ESO-1, enabling the DCs to express the entire tumor antigen to potentially induce a diverse set of CTLs. G305 is the second agent and is designed to boost the CTL response via the induction of antigen-specific CD4 "helper" T cells. G305 consists of recombinant NY-ESO-1 protein formulated with a proprietary synthetic small molecule called glucopyranosyl lipid A (GLA), the novel TLR4 agonist at the core of the GLAAS platform. CMB305 is intended to be an "off-the shelf" therapy that does not require patient-specific manufacturing or ex vivo manipulation of patient samples. The NY-ESO-1 protein is provided by the Ludwig Institute for Cancer Research.