Mar 19, 2010
By Abigail Moss
Immunovaccine (CVE: IMV), a Canada-based biotechnology company, has hired the clinical research organisation (CRO) Cato Research to run a US Phase I trial on its cancer vaccine, CEO Randal Chase said.
The trial will include five sites – including Duke University and sites in Pittsburgh, Chicago, Dallas and New York – and will be initiated imminently, he said, explaining that Immunovaccine has just been given the green light for its IND with the FDA.
The vaccine (DPX-0907) will be investigated in breast cancer, ovarian cancer and prostate cancer as single injection studies showed that Immunovaccine’s vaccine delivery technology could achieve 100% tumor eradication in high preclinical models, Chase claimed.
Realistically, safety data should be available at the interim in the 4Q10 and a full analysis by 2Q11, said Chase. He noted that discussions with the FDA had gone well to date, adding that no additional preclinical studies were required for the IND application process.
The Phase I trial will recruit up to 24 patients and one of the sites will only recruit ovarian cancer patients because on a predominance basis there are greater numbers of breast and prostate cancer patients and this ensures all three indications participate in the study, Chase explained. Dr Mike Morris, an oncologist at Duke University, will be the principal investigator, he added.
DPX-0907 is a combination of Immunovaccine's DepoVax delivery and enhancement technology and seven cancer specific antigens. The multi-peptide immunotherapy has shown promising preclinical evidence, Chase noted.
Immunovaccine is involved with two clinical manufacturing organisations (CMO). One is for the formulation of the vaccine, using Immunovaccine's specialised equipment, and this formulation is then shipped to the second CMO which deals with the lyophilisation process, Chase confirmed. He noted that Immunovaccine is currently manufacturing the clinical batch for delivery to the five clinical sites, adding that the lyophilisation makes the formulation robust and relatively simple to reconstitute for injection.
Immunovaccine has a market capitalisation of USD 56.5m (EUR 41.8m)
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