Vacc-4x presented at AIDS Vaccine 2011 in Bangkok

(BANGKOK, Sep 12, 2011) Bionor Pharma presented Vacc-4x on “Global HIV Vaccine Enterprise” press conference at AIDS Vaccine 2011 in Bangkok. Results from Phase IIB Placebo Controlled Study of Bionor’s Vacc-4x show excellent safety profile and statistically significant viral load reduction in patients with HIV who suspend antiretroviral therapy.

The vaccine, developed by Bionor Pharma, is designed to target immune responses to conserved domains of p24 since sustained immune responses to p24 have been proven to be associated with delayed disease progression.

The results were announced by Professor Jan van Lunzen, Medical Director of the Infectious Diseases Unit at the University Medical Centre Hamburg-Eppendorf, Germany and an investigator on the placebo controlled, multi-national, multi-center Vacc-4x trial.

Bionor Pharma was the only company with therapeutic HIV-vaccine having a presentation at Global HIV Vaccine Enterprise (GHVE) press conference, where the aim was to present promising HIV projects.

GHVE is a unique alliance of organizations that has the convening power to bring together an inclusive global alliance of top researchers, funders, advocacy groups, and stakeholders to catalyze fresh thinking, set new directions and advance global cooperation to develop an HIV vaccine.

Among the key findings reported at the AIDS Vaccine 2011 conference:

  • Significant viral load reduction compared to pre-treatment levels. Patients on Vacc-4x experienced viral reduction of 70% (more than half a log) compared to their viral load levels before initiating ART. This reduction was not seen in the patients receiving placebo.
  • Confirmation that HIV can be targeted at its “Achilles heel,” the known conserved domain p24. The viral load of immune response (ELISPOT) positive Vacc-4x subjects was significantly lower than that of ELISPOT positive subjects in the placebo group (p=0.023) indicating that Vacc-4x immunization may improve immune responses to p24 leading to a lower viral load levels, or set point. From this researchers conclude that Vacc-4x appears to refine a patient’s immune system to create a better response to p24.
  • Improved viral load “set point.” A statistically significant treatment difference in plasma viral load set point between the Vacc-4x and placebo groups in subjects after 28 weeks of ART.
  • Vacc-4x extended the time period patients could stay off ART.Subjects receiving the vaccine were almost twice as likely to remain off ART for more than one year compared to the placebo group (30% versus 18%). This is in agreement with the follow up data from the phase IIa study from Ullevål University Hospital between 2003 and 2006 that showed patients vaccinated with Vacc-4x could stay off ART for on average 31 months.
  • Vacc-4x potential to prevent transmission of HIV. Because Vacc-4x can significantly lower viral load, and because researchers know that communities with lower viral load transmit the disease less successfully, the vaccine may be a candidate to slow the spread of HIV transmission – a finding that could have major implications for the developing world where a vaccine would be easier to administer and less expensive than current options.

The p24 Conserved Domain: The Holy Grail of HIV Cure Research

Conserved domains are shared between diverse strains and are immunologically vulnerable. A recent cover article from the Proceedings of the National Academy of Sciences (USA) has highlighted a number of conserved sectors on p24 as immunologically vulnerable and where immune escape results in defective virus. Vacc-4x is derived from two of these sectors.

“Because we know that p24 cannot be changed without affecting viral fitness and that Vacc-4x is also derived from such conserved regions on p24, we can see why this vaccine has the potential to significantly inhibit HIV,” said Professor Richard Pollard, Chief, Infectious Diseases, University of California-Davis Medical Center.

“These results prove that Vacc-4x acts like a flashlight, lighting the way for the immune system to address the virus at its Achilles heel – a proven conserved domain of HIV,” said Dr. van Lunzen. “We have far too few strategies that could lead us to a cure for HIV. Vacc-4x may be a bridge to lead researchers toward a way to ‘plug the leak’ or permanently stop the virus from mutating, which is not addressed by any current treatment.”

The Need for a Therapeutic Vaccine

Although combination antiretroviral drug therapies are the standard treatment used to treat people living with HIV, they do not fully prevent HIV infection and fail to eradicate the virus once HIV infection is established. Patients who stop taking ART, experience HIV replication and infection rebounds, and compliance is a significant problem due to cost and availability.

In the USA alone, thousands of people living with the virus are on a “wait list” to obtain these treatments. ART may cause unwanted side-effects, and lifelong treatment with ARVs can significantly affect a patient’s quality of life. Additionally, HIV can become resistant to virtually all forms of traditional ART if good adherence is lacking, leaving a patient with limited treatment options. Studies show most patients on HIV at some point have adherence issues.

On this basis alternative treatments are required, and a therapeutic vaccine that fights HIV by mobilizing the patient’s own immune system without any serious side effects, is strongly wanted.

The number of HIV-infected globally is approximately 35 million. Today, HIV-medicines constitute a market of at least US $12 billon, and every year approximately 3 million new people are infected by HIV.

About Vacc-4x

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.

Bionor recently announced that the manufacturer of Revlimid (lenalidomide) has agreed to jointly fund a phase I/II trial in HIV patients with stable 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.

About Bionor Pharma

Bionor Pharma (OSL: BIONOR) is a Norwegian biotech company developing therapeutic and preventive peptide vaccines for chronic viral infections. The company has patented synthetic peptides from low-mutating parts of the virus, modified to improve immunogenicity and efficacy. No serious side-effects have been observed by the use of the company’s vaccines.

HIV is the first disease targeted, with cell-mediated and humoral peptides in clinical development.

Bionor’s patented technology platform is broadly applicable. In addition to the most advanced HIV-vaccine candidate, Vacc-4x, the company has a humoral HIV-vaccine candidate, Vacc-C5, which is planned to be tested clinically in Q1 2012. In addition, the company has vaccine candidates in pre-clinical development for other chronic infections, such as Hepatitis C, Influenza and cancer induced by human papilloma virus.

About Bionor Pharma ASA

Bionor Pharma is a biopharmaceutical, listed company based in Oslo, Norway. (OSE: BIONOR) The Company’s investments in developing therapeutic vaccines are more than US$60 million. Bionor’s vaccines are based on the proprietary technology platform developed following decades of research on peptides. The vaccines are designed to safely activate each person’s immune system to combat viral disease.

The Company’s lead investigational product, the HIV therapeutic vaccine Vacc-4x, has completed a phase IIb multinational (USA, Germany, UK, Spain and Italy), placebo controlled double-blind trial, which found a statistically significant reduction in viral load in treated subjects. The second HIV therapeutic vaccine, Vacc-C5 is expected to be ready for first in man clinical trial 2Q 2012, and is developed to induce antibodies to HIV that can reduce immune hyper activation associated with HIV infection. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, a treatment that can potentially revolutionize the management of HIV infections and could form the basis for both a therapeutic and a preventative vaccine.

Bionor researchers has been investigating three potential pathways to market for the HIV vaccine candidates Vacc-4x and Vacc-C5, through further clinical studies:

  1. Vacc-4x revaccination study with patients who participated on the phase IIb study, which aims to further reduce their viral load set point, during periods that the patients are not on traditional medicine (antiretroviral therapy (ART)).
  2. Vacc-4x combined with Revlimid® (lenalidomide), for patients with unmet medical needs today, no longer responding well to ART.
  3. Vacc-C5 clinical trial phase I/II, subsequent Vacc-C5 in combination with Vacc-4x.
  4. 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), HPV (Human Papilloma Virus) and CMV (Cytomegalovirus). Preclinical studies with Vacc-Flu (Universal Influenza vaccine) and Vacc-HCV (Hepatitis C vaccine) are planned to be finalized in second half 2012.

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