Researchers Study Nasal Administration of Bionor Pharma’s Therapeutic HIV Vaccine in Fully Enrolled Trial
Oslo 04.01.2012 - Researchers Study Nasal Administration of Bionor Pharma’s Therapeutic HIV Vaccine Vacc-4x Combined with Eurocine Vaccines’ Endocine™ in Fully Enrolled Trial; New Treatment Option Would Offer Easier Treatment Access for HIV Patients Globally.
• Bionor Pharma’s Vacc-4x is an investigational therapeutic HIV vaccine that has already shown in a placebo-controlled Phase IIb study to statistically significant reduce viral load in patients when delivered by injection.
• Researchers seek to study if nasal administration with Eurocine Vaccines´ Endocine™ will further boost responses to help patients better manage HIV through more accessible and efficient delivery.
• Researchers designed Vacc-4x to work by targeting the “Achilles Heel” of the virus, the region of the virus known to be common and stable in all types for HIV. Patients on Vacc-4x have experienced no serious side-effects.
• The study, which has now fully enrolled, is conducted by researchers from Oslo University Hospital and funded by The Research Council of Norway (RCN)’s GLOBVAC program.
• The study is expected to be completed 1Q 2012.
(4 January – Oslo, Norway) Bionor Pharma ASA (BIONOR: OSLO), Eurocine Vaccines AB and Oslo University Hospital today announced that the nasal immunization study combining Bionor Pharma’s Vacc-4x and Eurocine Vaccines’ adjuvant Endocine is fully enrolled.
Vacc-4x is a therapeutic HIV-vaccine based on four synthetic slightly modified peptide sequences from conserved parts of the P24 capsid protein of the HIV-virus. Endocine is an adjuvant shown to enhance the immune response to vaccine antigens delivered nasally.
Researchers at Oslo University Hospital are testing the effect of nasal delivery of Vacc-4x in combination with Eurocine Vaccines’ adjuvant Endocine. This will be compared with the effect of Endocine alone.
"We are pleased to report that patients have been generally very supportive to participate in this study» said Professor Dag Kvale, MD, Ph.D., Principal Investigator at Oslo University Hospital. “We are hopeful that nasal immunization could make a potentially new class of HIV treatment even easier to administer.”
“Successful results from this study could have favorable implications for delivery options for other Bionor vaccine candidates, as Influenza A and Hepatitis C,” said Steen Krøyer, CEO, Bionor Pharma ASA.
“We chose to study the combination of Vacc-4x and Endocine because of its potential to help the growing number of HIV patients who have unmet medical needs,” said Hans Arwidsson, CEO, Eurocine Vaccines AB. “When good business decisions are also good for global health, everyone wins.”
About the Study
The clinical study is a single-blinded placebo-controlled clinical trial consisting of 24 HIV-patients stable on anti-retroviral therapy (ART). Eighteen patients will be given Endocine in combination with the Vacc-4x in three different dose groups, while the remaining six patients from the placebo group will receive Endocine only. All patients will remain on ART throughout the study. The study is expected to be completed 1Q 2012.
The clinical costs will be covered by a grant from The Research Council of Norway (RCN) of US$ 1.2 million (NOK 6.9 million), under the GLOBVAC program.
Vacc-4x is a therapeutic HIV-vaccine based on four synthetic, slightly modified peptide sequences from conserved parts of the p24 capsid protein of the HIV-virus. The chosen peptides are from conserved (low-mutating) parts of the virus, and the modification has been made to increase immunogenicity of the vaccine. The product has patent protection.
A randomized, double-blind, international, placebo-controlled, multicenter phase IIb study demonstrated with statistical significance that Vacc-4x decreased HIV viral load by 70%. Bionor researchers would like to investigate the potential for Vacc-4x to promote sustained viral control ("functional cure”), either alone or in combination with other products.
Bionor recently announced that the manufacturer of Revlimid® (lenalidomide) has agreed to jointly fund a phase I/II trial in HIV patients who are stable while on ART. All patients will remain on ART and all patients will receive Vacc-4x. Half of the patients in the double blind randomized trial will also receive Revlimid to see if it improves the efficacy of Vacc-4x.
According to the UN organization UNAIDS, 34 million people were living with HIV in 2010. Approximately three million new people are infected annually. Pharmaceutical sales to treat HIV are US$ 10.6 billion (NOK 63 billion) annually, and treatment cost per patient is US$ 13,500-15,000 (NOK 80-90,000) per year.
About Eurocine Vaccines
Eurocine Vaccines is a publicly listed, clinical-stage company developing nasal vaccines that meet important medical needs. The vaccines are developed up to proof of concept (clinical phase I/II) and licensed to partners for further development and commercialization. The company’s proprietary vaccine adjuvant technologies, which are a key element of the nasal vaccines, are also offered to license partners for development in various indications.
More information about Eurocine Vaccines, its research and products, is available at www.eurocine-vaccines.com
About Bionor Pharma
Bionor Pharma is a biopharmaceutical company based in Oslo, Norway. The Company’s lead investigational product, the HIV therapeutic vaccine Vacc-4x, has completed a Phase IIB multinational, placebo controlled double-blind trial, which found a statistically significant reduction in viral load in treated subjects. Patients given the vaccine were 70 percent more likely to remain off ART two years after being injected with the vaccine.
Vacc-C5 is developed to induce antibodies to HIV that can reduce immune hyperactivation associated with HIV infection. Bionor intends to bring Vacc-C5 into the clinic in 1Q 2012. Because researchers have already found that patients with antibodies to the C5 region on HIV have little virus in their blood and slow disease progression, Bionor anticipates that Vacc-C5 will offer an important weapon toward finding a functional cure for HIV.
Vacc-4x in combination with Vacc-C5 can potentially revolutionize the management of HIV infection and could form the basis for a preventative HIV vaccine.
The Company’s innovative technology platform is also well suited to the development of vaccines for a wide range of other viral diseases, such as Influenza, HCV (Hepatitis C) and HPV (Human Papilloma Virus). Preclinical studies on Vacc-Flu (Universal Influenza vaccine) and Vacc-HCV (Hepatitis C vaccine) are planned to be finalized in second half 2012, preparing for the clinical stage of development and partnering.
Bionor’s vaccines are based on the proprietary technology platform developed following several years of research on peptides. The vaccines are designed to safely activate each person's immune system to combat viral disease.
Bionor seeks to create positive cash flow at an early stage of development by signing partnering deals with biotechnology and pharmaceutical companies. This includes short-term out-licensing of products with royalty payments or direct funding of clinical trials, such as Bionor’s agreement signed in August 2011 with one of the world’s largest Biotech companies. The collaboration includes a clinical trial on patients/subjects with HIV using a combination of Vacc-4x, and the cancer drug Revlimid.
More information about Bionor Pharma, its research and products, is available at www.bionorpharma.com
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Bionor Pharma ASA, Oslo: +47 23 01 09 60/ Skien: +47 35 90 85 00
Steen Krøyer, CEO
Birger Sørensen, EVP Head of Vaccines
Vidar Wendel-Hansen, CMO
David Sheon 202 422-6999