PARIS—Diaxonhit, a French biotechnology company engaged in projects from research to commercialization of in-vitro diagnostics for transplantation, infectious diseases and cancer, announced the successful clinical trial of one of its partners. InnaVirVax, with which Diaxonhit is developing a companion diagnostic, released encouraging results of a clinical study during the International AIDS Society Symposium held in Vancouver, British Columbia, in July.
InnaVirVax, a French biopharmaceutical company researching and developing therapeutic and diagnostic solutions for diseases linked to the immune system through its research on immune deregulations, presented the results of the IVVAC-3S/P1 study. The company’s VAC-3S had positive effects on four immunovirological markers of HIV infection, including a reduction in proviral DNA, a viral reservoir marker, which significantly correlated with the immune response to VAC-3S. The company believes that VAC-3S is well positioned for development in the “functional cure” area of HIV infection.
The companies reported that the primary goal of the IVVAC-3S/P1 study was achieved. VAC-3S immunotherapy was very well tolerated and an immune response was demonstrated, the intensity of which was clearly linked to the dose administered. Twenty-four weeks after the first dose, patients responding to the VAC-3S vaccine showed significant results regarding the following immunological effects: a significant rise in the percentage of CD4+ T-lymphocytes, a key marker for reconstitution of the pool of CD4+ T lymphocytes that are destroyed by HIV; a significant fall in the percentage of CD8+ T lymphocytes, a marker of immune activation that reflects deregulation of the immune system related to the infection; and a significant rise in the CD4/CD8 ratio, a marker of immune reconstitution in patients living with HIV.
“These promising results with the VAC-3S vaccine are a strong encouragement to move ahead with clinical development for a functional cure, the new frontier in this therapeutic indication, and we are looking forward to getting the results of the Phase 2a study,” said Joel Crouzet, CEO of InnaVirVax.
Incorporated in 2008, InnaVirVax took a vaccine project from the bench to first-in-human studies in three years by translating research initiated at the French National Institute for Health and Medical Research (INSERM) into immunotherapy. By 2012, InnaVirVax had developed its activities and become a clinical-stage company when VAC-3S, its lead vaccine project (a therapeutic HIV vaccine), entered Phase 1/2a. Today, InnaVirVax holds licensed patents from both INSERM and AP-HP.
Synergistically with VAC-3S development, Diaxonhit is developing two tests. DIAG-3S, a diagnostic test for the detection of anti-3S antibodies naturally secreted by patients infected by the HIV-1 virus, is designed to validate the use of the level of natural anti-3S antibodies measured by this test as an early marker of disease progression, thus enabling optimized care of HIV-1-infected patients. The DIAG-3S prototype test should be completed during the first half of 2016. Upon completion and validation, commercialization of the test could start independently of the VAC-3S vaccine development.
The other test, CO-3S, is a companion diagnostic for the VAC-3S vaccine that measures the level of anti-3S antibodies in vaccinated patients. This test will enable doctors to measure the immune response to the vaccine therapy, and adjust it accordingly.
According to Dr. Loïc Maurel, president of the management board of Diaxonhit, “If the VAC-3S vaccine enables HIV-infected patients to control their viral load without using the current antiretroviral treatments, the potential market for both tests under development would grow significantly. Like InnaVirVax, we are also looking forward to getting the results of the ongoing Phase 2a clinical study.”
Diaxonhit, formerly known as Exonhit SA, owns a portfolio of diagnostic products in three specialty areas: infectious diseases, Alzheimer’s disease and cancer. It consists of Tetanos Quick Stick (TQS), which is a unitary test enabling to determine the tetanus vaccination status within 10 minutes, and AclarusDx, a blood-based test for the detection of biomarkers specific for Alzheimer’s disease.
Recently, Diaxonhit granted an exclusive worldwide license to Felicitex Therapeutics Inc., a drug discovery company specializing in discovery and development of cancer treatments and diagnostic assays focused on quiescent cancer cells. Building upon discoveries made with its SpliceArray proprietary technology, Diaxonhit developed a program targeting the DYRK enzyme, which is involved in several pathogenic pathways related to cell proliferation. With this agreement, Felicitex acquired the rights for oncology to a lead series of novel small-molecule anti-cancer compounds, which are highly active and selective against DYRK as validated by Felicitex in a pancreatic cancer model.