DECEMBER 1, 2009, Providence, RI
EpiVax, Inc. today announced a collaborative research agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) aimed at evaluating EpiVax’s proprietary Tregitope technology, which could potentially reduce detrimental immune responses to certain drugs. In the course of the Roche-EpiVax collaboration, the EpiVax Tregitope technology will be evaluated for its effect on the immunogenicity of protein therapeutics.
Together, EpiVax and Roche will carry out in silico, in vitro and in vivo experiments aimed at establishing proof of concept. Under the agreement, Roche has a nonexclusive option to use Tregitope technology in its pipeline of protein therapeutic drugs with a right to a license the technology for specific products under pre-negotiated terms.
“Roche brings a wealth of experience, clinical expertise and resources to this collaboration. Working together, it is our intent to integrate the Tregitope technology into drugs that will improve human health on a global scale,” said Dr. Anne De Groot, CEO and CSO of EpiVax.
Because Tregitope uses the body’s own natural responses to induce tolerance, treatments
incorporating Tregitope have the potential to be far safer than administration of protein therapeutics with systemic immunosuppressants, a clinical approach to addressing immunogenicity that is relatively common. EpiVax believes the Tregitope technology could also be used for treatment of a broad range of auto-immune disorders as well as applications in the treatment of allergy, transplant, deimmunization, animal health and chronic infectious disease.
Tregitope is a set of regulatory T-cell epitopes found in the Fc region of IgG that induce the
activity of the body’s own natural regulatory T cells. When administered in conjunction with other antigens or protein immunogens, the response to these immunogens is diminished and altered if the antigen/immunogens are co-administered with Tregitopes. Preliminary in vitro and in vivo studies indicate that the modification of the immune response is due to the induction of natural T reg cells.
Examples of potentially immunogenic protein therapeutics include erythropoietin and alpha interferon, as well as antibodies that have immunosuppressive and anti-inflammatory properties such as humira and rituximab. Like vaccines, protein therapeutics can engender both cellular and humoral immune responses. Anti-drug antibodies (ADA) may neutralize the therapeutic effects of the drug and/or alter its
pharmacokinetics. Since the impact of immunogenicity can be quite severe, regulatory agencies are developing new guidelines for monitoring immunogenicity and drug developers are seeking to reduce immune responses through other means such as by inducing tolerance. The Tregitope technology induces the human body’s natural tolerance mechanisms, reducing the immunogenicity of co-administered proteins. The initial discovery was published in 2008, in the journal Blood, by EpiVax CEO and CIO
De Groot and Martin.
EpiVax, Inc. is dedicated to merging in silico, in vitro and in vivo immunology research to
generate new therapeutics as well as new vaccines for infectious diseases. T cell epitope mapping, the selection of target peptides from any protein sequence, is a powerful resource for the development of novel protein therapeutics. EpiVax research shows that peptides identified by EpiMatrixTM software are highly likely to provoke an immune response when presented to T cells; some of these epitopes were found to be regulatory T cell epitopes.
Others induce inflammatory immune response, the root cause of immunogenicity
problems in protein therapeutics. EpiVax tools can also be used to accurately
deimmunize proteins. For more information about EpiVax and their technology
platform, please visit www.epivax.com.