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Lower viral load for Vacc-4x injected patients off ART 1 year

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In short: Patients injected with the Vacc-4x had an average of 0.44 log lower set point viral load compared to the placebo group after 1 year off ART.
Analysis of Immune Responses in Patients Treated with Vacc-4x Supports Further Development

Boston 12.09.2012 - Researchers from the Vaccine Immunotherapy Center at the Lausanne University Hospital presented yesterday immunological data from the phase II study with Vacc-4x during an oral session at the AIDS Vaccine 2012 conference in Boston.

News Summary

• Data from Vacc-4x study presented at the largest and most prestigious global scientific conference focused exclusively on AIDS vaccine research

• The comprehensive analysis of the Vacc-4x phase II study is providing important insight for further development towards commercialization

[BOSTON – 12 September 2012]  Researchers from the Vaccine Immunotherapy Center at the Lausanne University Hospital presented yesterday immunological data from the phase II study with Vacc-4x during an oral session at the AIDS Vaccine 2012 conference in Boston.  Vacc-4x is an investigational vaccine to treat patients with HIV, developed by Bionor Pharma. The data from immunological analysis, which was carried out at the Swiss laboratory, was presented by Kim Ellefsen-Lavoie, CTU (Clinical trials unit) Coordinator, Vaccine and Immunotherapy Center, University Hospital, Lausanne, Switzerland.

The data show that patients carrying a genetic variant (HLA B-35) associated with rapid disease progression of untreated HIV infection are just as likely to respond to Vacc-4x as other patients. This supports Bionor’s intention for the vaccine to function across broader patient populations. Complete findings from the analysis will be submitted for publication.

AIDS Vaccine 2012 webcasts all sessions for viewing and archiving within 24 hours of their presentation. Webcast will be available on this page:

“Immunological data from the phase II study with Vacc-4x are providing insight on how this therapeutic vaccine could lead to the observed reduction in viral load,” said Professor Giuseppe Pantaleo, MD, Chief of the Division of Immunology and Allergy, University Hospital, Lausanne, Switzerland.  “The results from this study will be valuable for the further development towards a potentially new class of HIV treatment and combination therapies.”

About Vacc-4x phase II study
The analysis has been conducted on data from the exploratory phase II study on Vacc-4x, with 136 HIV patients. In this randomized, multinational (USA, Germany, UK, Spain and Italy), double-blind, placebo-controlled study, two-thirds of patients received Vacc-4x, while one-third received placebo.  Patients given Vacc-4x experienced a statistically significant reduction in viral load set point (stabilized viral load) compared to placebo.

Immunological data from the abstract
After 6 immunizations on ART over 28 weeks, treatment was interrupted for up to 24 weeks (Vacc-4x n=88; placebo n=38). Immunological analyses (ELISPOT, proliferation, intracellular cytokine staining (ICS)) to HIV p24 were carried out at central laboratories. The HLA class I profile (Vacc-4x n=73, placebo n=32) was also determined.

For subjects that remained off ART until week 52 (Vacc-4x n=56, placebo n=25), there was a log 0.44 reduction in viral load set point between the Vacc-4x and placebo groups (p=0.0397). There was a similar distribution of HLA class I alleles in the two treatment arms, with the exception of the B35 allele (27% of Vacc-4x subjects versus 8% placebo subjects). The viral load of ELISPOT positive Vacc-4x subjects was significantly lower than that of placebo subjects (p=0.023). There was no significant difference in T-cell proliferation responses between Vacc-4x and placebo groups, however, the percentage of subjects showing proliferative CD4 and CD8 T-cell responses to Vacc-4x peptides increased over time only for the Vacc-4x group. ICS analysis showed a predominance of CD8-mediated T-cell responses to p24 that were significantly increased from baseline for the Vacc-4x group (p<0.043) but not for the placebo group (p>0.05). There was also a trend towards higher numbers of polyfunctional T-cells in the Vacc-4x group compared to the placebo group (p=0.188).

About AIDS Vaccine 2012 conference in Boston
AIDS Vaccine is the largest and most prestigious global scientific conference focused exclusively on AIDS vaccine research. Hosted annually by the Global HIV Vaccine Enterprise and local partners, AIDS Vaccine brings together the best and brightest scientific minds to exchange the latest research findings, explore new ideas, educate future leaders and engage a diverse community to help further research to develop a safe and effective HIV vaccine.

About Bionor Pharma ASA
Bionor Pharma is a leading vaccine company, listed on the Oslo Stock Exchange (OSE: BIONOR). The Company's investments in developing therapeutic vaccines exceed US$70 million. After private placement closed June 2012, with gross proceeds of NOK 57.6 million / US$9,6 million, the company has secured the funding of planned scientific and business related activities until late 2014. Cash as of Q2 2012: NOK 147.9 million / US$24.7 million.

Bionor's vaccines are based on the proprietary technology platform developed following more than two decades of research on peptides. The vaccines are designed to safely stimulate each person's immune system to combat specific viral diseases.

The Company’s lead HIV vaccine, Vacc-4x, has been investigated as a therapeutic vaccine in a completed, large exploratory phase II randomized, multinational (USA and 4 European countries) double-blind, placebo-controlled study.  This resulted in a statistically significant reduction in viral load by inducing killing of virus producing cells. Bionor Pharma`s second HIV vaccine, Vacc-C5, is developed to induce HIV antibodies that can reduce viral production and the harmful hyperactivation of the immune system that leads to AIDS.

Based on the completed phase II study with Vacc-4x, and finalized preclinical studies on Vacc-C5, Bionor Pharma is preparing three further studies that can lead towards phase III:

1. Vacc-4x in combination with Celgene`s immune modulator Revlimid®(Lenalidomide), in patients who fail to regain a normal immune function despite well controlled viral load on ART. The researchers will investigate whether Revlimid can further enhance the effect of Vacc-4x. The study was recently approved by German regulatory authorities to begin at four clinics in Germany.

2. Reboost with Vacc-4x in patients from the phase II study (USA and 4 European countries), to investigate whether this can result in further reduction in viral load.

3. Clinical phase I/II study with Vacc-C5, to investigate whether this vaccine leads to the formation of antibodies against HIV in humans, was recently approved by the Norwegian regulatory authorities to begin at Oslo University Hospital. Subsequent to this Vacc-C5 phase I/II study, Bionor intends to combine Vacc-4x with Vacc-C5, which could form the basis for both a therapeutic and a preventative HIV vaccine.

Quite interesting news. If we play with the numbers a bit and suppose I got the presentation right  ::)......

A patient starts with lets say a viral load set point of about 2000 copies, go on ART, inject the vaccine and go off ART for 1 year. A placebo group does the same but do not get the injection of Vacc-4x.

After 1 year off ART >
For the average subject in the study, viral load with the Vacc-4x injection would be about 800 copies where as a subject in the placebo group not injected with the Vacc-4x would read at about 2000 copies.

I just made an example of how it could turn out in reality (please correct me if Im wrong!)
0.44 might not sound much but its still a significant decrease. Since they also have the C5 vaccine and the plan is to combine the two into a final product this could turn into something viable for the future.     


The study starts with "exploratory phase II study on Vacc-4x, with 136 HIV patients."

Results are reported on "For subjects that remained off ART until week 52 (Vacc-4x n=56, placebo n=25)"

That's 55 of 136 patients (more than 40% of the subjects) who are not reported on. It's not clear (from this report) that this study demonstrates any benefit.

Key findings are the differences between the Vacc group and the placebo group, which are significant. Did the subjects go back on ART because of own will, health, study instructions etc etc? These are important points you should know before claiming "no benefit".


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