Approved "reboost" with Vacc-4x
05.12.2012 - Final Approvals Received for International Study to Reboost Patients From the Completed Vacc-4x Phase II Trial
Approximately 40 Patients Will Participate at 11 Clinics in USA and Europe
* Study design: Open, clinical phase II study, with two Vacc-4x immunizations
while patients remain on conventional HIV medication (Antiretroviral
Therapy, ART), followed by up to 16 weeks of treatment interruption
* Primary endpoints: Changes in viral load compared to the previous study, and
immune responses to the vaccine
* Aim of the study: To determine whether a lower viral load level ("set
point") can be achieved by reboosting previously Vacc-4x vaccinated HIV
infected patients, indicating a potential for "stair stepping" down viral
load through "booster" injections
* Funding from GLOBVAC: Bionor Pharma was awarded NOK 10.48M/US$1.85M from
Globvac in July 2012, primarily to fund the reboost study
(Oslo, 5 December 2012) Bionor Pharma ASA (OSE: BIONOR) announced today that
the new reboost study of patients from the previously conducted large phase II
study with Vacc-4x, has been approved by all necessary regulatory authorities
and will begin immediately at 11 clinics in USA, Germany, England, Spain and
The study is being conducted to investigate whether further reduction in viral
load can be obtained in patients who participated in the previous Vacc-4x phase
II study. Bionor Pharma was awarded NOK 10.48 million / US$ 1.85 million from
Globvac (Research Council of Norway`s program for Global Health- and Vaccine
Research) in July 2012 towards funding for this study. Researchers hope the
study will lead to a better understanding of how Vacc-4x can contribute to a
"functional cure" for HIV, where the patients' immune system, with the help of
the vaccine, becomes capable of keeping the virus under control.
About the Vacc-4x phase II reboost study
Up to 40 patients at 11 clinics, all from the previous phase II study with Vacc-
4x, will take part in this reboost study. Patients will be given two booster
immunizations with Vacc-4x while on ART. After an additional 8 weeks on ART,
patients stop ART treatment for up to 16 weeks. The whole study period is
approximately 37 weeks for each patient.
Results from the previous Vacc-4x phase II study
The virological data showed statistically significant 64% reduction of viral
load "set point" (average of the last two viral load measurements before
restarting ART) in patients receiving Vacc-4x compared to those given placebo.
Moreover, the HIV viral load set point in patients given Vacc-4x was 60% lower
than pre-ART (level before starting conventional HIV therapy, ART). In the
placebo group, no change compared to pre-ART was observed.
Step towards long lasting HIV viral control with repeated Vacc-4x immunizations
ART is not a cure, but blocks virus production only while patients take this
medication. ART must therefore be a lifelong treatment. Bionor Pharma's
therapeutic vaccine Vacc-4x aims to induce long lasting virus control, either in
combination with ART or without it, by training immune cells to seek out and
kill virus-producing cells. The observed 64% reduction in viral load set point
in patients who received Vacc-4x compared to placebo in the phase II study
therefore represents a potential step towards "functional cure" for HIV.
In clinical practice, periods of ART interruption for various reasons or non-
adherence are not uncommon.
In these situations, therapeutic vaccination to strengthen the immune system's
ability to control the viral infection could provide an important health
Global HIV challenge
According to global authorities, 34 million people were living with HIV in
2011. There are approximately 2.7 million new HIV infected annually. 1.7 million
people died from AIDS in 2011, and since the beginning of the epidemic, more
than 60 million people have contracted HIV and nearly 30 million have died of
HIV-related causes .
Only one out of four HIV-infected patients currently has access to ART
treatment. According to recent CDC studies, less than 25 percent of people
prescribed conventional HIV medicine stay permanently on the treatment.
Pharmaceutical sales to treat HIV are approximately US$ 10.6 billion (NOK 63
billion) annually, and treatment cost per patient is approx. US$ 15,000 (NOK
90,000) per year.
About Bionor Pharma ASA
Bionor Pharma is a leading vaccine company, listed on the Oslo Stock Exchange.
The Company's investments in developing therapeutic vaccines exceed US$70
million. Following closure of a private placement in June 2012, with gross
proceeds of US$9.6 million, the Company has secured funding of planned
scientific and business related activities until mid 2014.
Bionor Pharma's vaccines are based on the proprietary technology platform
developed following more than two decades of research on peptides, and they are
designed to safely stimulate the immune system to combat viral diseases.
HIV vaccines, Bionor Pharma`s leading projects
In addition to the previously mentioned research into Vacc-4x, Bionor Pharma has
developed a second HIV vaccine candidate, Vacc-C5, to induce HIV antibodies that
can reduce the harmful hyperactivation of the immune system, caused by HIV
infection, which leads to AIDS.
Bionor Pharma is in the process of conducting 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 system despite
having a well-controlled viral load on ART. The researchers will investigate
whether Revlimid can enhance the effect of Vacc-4x. The placebo- controlled
study was approved by German regulatory authorities to begin at four clinics in
Germany in Q3 2012, and is currently recruiting patients.
2. Reboost with Vacc-4x in patients from the previous phase II study (USA and 4
European countries), to investigate whether this can result in a further
reduction in viral load.
3. Clinical phase I/II study with Vacc-C5, to investigate safety, and whether
this vaccine leads to the formation of antibodies against HIV in humans. The
open study has been approved by the Norwegian regulatory authorities to begin at
Oslo University Hospital, and is currently recruiting patients.
First results from the above studies are expected in 2013.
Bionor Pharma is exploring the possibility to combine Vacc-4x and Vacc-C5 (Vacc-
HIV), as the basis for both a therapeutic and a preventive HIV vaccine.
Vaccines for other viral diseases
The Company's innovative technology platform is also well suited to develop
vaccines for other viral diseases, including Influenza, HCV (Hepatitis C), CMV
(Cytomegalovirus) and HPV (Human papillomavirus). The universal influenza
vaccine (Vacc-Flu) and Hepatitis C vaccine (Vacc-HCV) are in the preclinical
phase of development.
Based on the three new studies with Bionor Pharma's HIV vaccines, and the
preclinical data from studies with the universal influenza- and Hepatitis C
vaccines, the Company has started a structured process for commercialization of
the vaccine technology and products.
More information about Bionor Pharma is available at www.bionorpharma.com.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act). Vacc-4x, Vacc-C5, Vacc-Flu, Vacc-HCV, Vacc-
CMV and Vacc-HPV are investigational treatments that have not been approved for
marketing by any regulatory authority.
Bionor Pharma ASA, Oslo: +47 23 01 09 60
Hilde Aalling Syvertsen, Director Communications & Corporate Affairs
David Sheon +1 202 422-6999