A Phase I/II clinical trial has been initiated to evaluate the safety and dose-sparing effect of an adjuvant patch that will be used in combination with an injectable H5N1 influenza vaccine.
The patch, made by Iomai Corp. (MD, USA), contains a strong adjuvant that can stimulate immune responses to the injected vaccine and may reduce the dose of antigen needed in the vaccine. This dose-sparing effect is desirable, especially in pandemic vaccines, as lower vaccine dose means wider vaccine coverage. This trial is funded by the US Department of Health and Human Services.
“This is the first human trial of the Iomai immunostimulant patch for use with a pandemic-like influenza vaccine and the results of this study will give us crucial information about the ability of the patch to extend the vaccine supply in the event of a pandemic,” said Stanley Erck, Iomai’s president and chief executive officer. “Our patch is designed to solve the pressing problem of inadequate pandemic vaccine stocks, and we believe the results of this trial will validate our unique and flexible dose-sparing approach.”
The study involves approximately 500 volunteers. If successful, Iomai’s patch-based adjuvants may be used with many other existing vaccines in order to reduce antigen dose and/or number of vaccine injections.
Source: Iomai Corporation, MD, USA: www.iomai.com
ImmuFact® IMP321 enters Phase I trial for metastatic melanoma
Immutep SA (France) has announced the initiation of an open-label, single-arm Phase I clinical trial using ImmuFact® IMP321 in patients with advanced melanoma.
ImmuFact IMP321 is a highly potent T-cell immunostimulatory factor that can enhance T-cell responses. It is the soluble form of CD223, a natural lymphocyte receptor that binds to MHC class II molecules on antigen-presenting cells. This binding enhances cross-presentation of antigens to T cells, resulting in strong and long-lasting antitumor or antiviral cytotoxic T-cell responses when IMP321 is used alone or as an adjuvant coinjected with antigens.
This new trial involves melanoma patients who have received adoptive T-cell transfer after immunosuppression by chemotherapy. The patients will receive IMP321 as an adjuvant to a therapeutic cancer vaccine containing a peptide melanoma antigen (Melan-A/MART1). The main aim is to evaluate safety and efficacy of the combined treatment. This study will be carried out of the Fondation du Centre Pluridisciplinaire d’Oncologie and the Ludwig Institute for Cancer Research (Lausanne, Switzerland).
“We are very pleased to start this trial in metastatic melanoma patients, which should provide information about the potency of IMP321 as an adjuvant for the induction of specific antitumor CD8 T-cell responses after lymphodepletion and adoptive T-cell transfer,” said Verena Voelter, a principal investigator of this study.
Previously, two randomized, single-blind, dose-escalating Phase I studies have been completed in 108 healthy individuals using IMP321 to demonstrate IMP321’s safety and efficacy as an adjuvant in therapeutic vaccines.
“We are delighted to announce another cancer vaccine trial using our immunopotentiator agent IMP321,” said Frederic Triebel, Immutep’s scientific and medical director. “This new class of non-Toll-like receptor agonist may represent the extra boost that peptide antigens need for a strong and prolonged cytotoxic T-cell activity”.
The product is currently being tested in four clinical trials in different cancers, including this new study.
Source: Immutep SA, France: www.immutep.com
VaxfectinTM-adjuvanted DNA vaccine enters Phase I trial
Vical Inc. (CA, USA) has started to enroll volunteers for its double-blind, placebo-controlled Phase I trial using the company’s VaxfectinTM-formulated plasmid DNA (pDNA) influenza vaccine. The study will assess safety, tolerability and immune responses of the vaccine.
“We have designed a promising pandemic influenza vaccine and demonstrated its effectiveness against a highly lethal H5N1 challenge in ferrets, the best available animal model,” said Vijay Samant, Vical’s President and Chief Executive Officer, “and we have now begun testing in humans.”
The vaccine contains DNA plasmids encoding nucleoprotein, ion-channel protein and hemagglutinin from a H5N1 influenza virus strain. The vaccine is formulated with Vaxfectin adjuvant, “which was designed for pDNA vaccines but also has demonstrated significant dose-sparing and immune-enhancing results with the Sanofi Pasteur trivalent inactivated influenza vaccine in animals,” said Larry Smith, Vical’s Vice-President of vaccine research.
Source: Vical Inc., CA, USA: www.vical.com