US-based clinical-stage immunotherapy firm Immune Design has started treatment of the first patient in a Phase I clinical study of ID-G305, a cancer immunotherapy investigational agent from the company’s GLAAS platform designed to stimulate multiple arms of the immune system.
The trial is designed to assess the safety, tolerability and immunogenicity of ID-G305 in patients with unresectable, relapsed, or metastatic cancer expressing the NY-ESO-1 antigen, including melanoma, sarcoma, lung, ovarian or breast cancer.
The open label, dose-escalation Phase I trial is being carried out in about 18 patients at several clinical centres in the US.
Moffitt Cancer Center medical director of Clinical Research Unit and principal investigator in the trial Amit Mahipal said the development of agents that harness the patient’s cellular immune system to kill tumour cells is a promising approach for the treatment of human malignancies.
"We look forward to evaluating this novel therapeutic candidate, ID-G305, and its ability to generate immune responses in cancer patients," Mahipal said.
The company said that ID-G305 triggers a potent and specific cellular and humoral anti-tumour response, as well as stimulating the innate immune response.
Immune Design chief medical officer Richard Kenney said: "The adjuvant component, GLA-SE, is a unique, potent, clinical-stage toll-like receptor-4 (TLR4) agonist that has demonstrated favorable clinical safety in multiple clinical trials to date.
"Combining this with the targeted NY-ESO-1 protein offers the potential to generate effective immune activity in cancer patients."
ID-G305 was generated from Immune Design’s GLAAS discovery platform, which uses a synthetic small molecule adjuvant glucopyranosyl lipid A (GLA), a novel TLR4 agonist.
This product candidate is part of the company’s ‘Specific Antigen’ approach, which drives the in vivo generation of a strong, antigen-specific CTL response against selected antigens present in the tumour.
It consists of recombinant NY-ESO-1 protein, which is expressed by a variety of cancers, formulated with GLA-SE.
The Ludwig Cancer Research and Cancer Research Institute,which the company has a collaborated with to advance cancer immunotherapy research, has provided the NY-ESO-1 protein.
Image: Optical Coherence Tomography image of a sarcoma. Photo: courtesy of Oaktree b.