New clinical trial, HIV Vacc-4x in combination with Revlimid® (Lenalidomide)

Oslo – 25.08.11 – Bionor Pharma ASA Announces Exploratory Study of its Lead Therapeutic HIV-Vaccine Candidate Vacc-4x in Combination with Leading Cancer Drug

The study will determine:

  1. The ability of Vacc-4x to improve immune function in patients that fail to regain a healthy immune defense despite that their viral load is well controlled on conventional HIV-medicines (antiretroviral therapy – ART).
  2. 1. The ability of Vacc-4x to improve immune function in patients that fail to regain a healthy immune defense despite that their viral load is well controlled on conventional HIV-medicines (antiretroviral therapy – ART).

The target patient population for the study will be HIV-patients whose immune system have not fully recovered (defined by CD4+ (helper) T-cell count in the interval 250-400 cells per mL) despite being on a long term antiretroviral therapy. This patient group is relatively similar to the patient population in Bionor Pharma’s previously reported phase IIa study, where positive effects on CD4+ counts were observed. With few treatment options, this patient group represents a high unmet medical need.

“This unique study provides a “first glimpse” at an innovative combination therapy for a patient group with a high unmet medical need,” commented Vidar Wendel Hansen, CMO of Bionor Pharma. “We view this as a recognition of the strength of our platform technology and Vacc-4x’s potential therapeutic effects.”

The study will be randomized, double blinded and placebo-controlled comprising 24 virtually controlled HIV-patients on ART. Twelve patients will receive Vacc-4x in combination with Revlimid®, while the other twelve will receive Vacc-4x alone. The treatment and observation period is 26 weeks. The trial will be preceded by an open-label dose finding study to select the most appropriate Revlimid® dose.

The study will be performed in Germany with Professor Jan van Lunzen of The University Medical Centre Hamburg-Eppendorf, serving as Principal Investigator.

“Vacc-4x has shown an ability to improve immune responses against viral replication, and we have reason to believe that Revlimid® may further improve these responses” said Professor Dr. med. Jan van Lunzen, MD. “We hope to demonstrate that the combination of Vacc-4x and Revlimid® can improve the patients’ immune function and help these patients.”

Revlimid® in combination with Vacc-4x is a novel approach to improving vaccine efficacy. Revlimid® has shown immune modulating properties by eliciting a broad range of immune stimulating effects that could enhance vaccine efficiency. These effects include activation of CD4+ and CD8+ (killer) T-cells.

“The use of a therapeutic vaccine combined with modulation of the immune system resonates well with the current thinking in the scientific community”, said Maja Sommerfelt, CSO (Chief Scientific Officer) in Bionor Pharma. The HIV scientific community increasingly shifting its focus to achieving lasting virus control and removal of virus through killing of infected immune cells in the body’s viral reservoirs.”

Bionor Pharma is the sponsor of the study, whose results are expected in H1 2013. Total budgeted costs are approx. USD 1.4 mill., that will be jointly funded.

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 nor do they reverse it.  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 often causes unwanted side-effects, and lifelong treatment with ARVs can significantly affect a patient’s quality of life and are proven to shorten life expectancy. Additionally, HIV can become resistant to virtually all forms of traditional ART, leaving a patient with no treatment options.

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 approx. NOK 65 bn, and every year approximately 3 million new people are infected by HIV.

About Revlimid® (Lenalidomide)

Revlimid is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 50 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

Revlimid is also approved in the United States, Canada and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.

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.

In a recent randomized double-blind international placebo-controlled Phase IIB study,   Vacc-4x showed statistically significant data for virus reduction. In the study, 135 patients stable on ART, in US, UK, Germany, Spain and Italy were enrolled. Of the 126 patients that completed the study, 2/3 were immunized with Vacc-4x and 1/3 were in the placebo group. All patients were taken off ART after 28 weeks and followed until week 52. The study revealed a statistically significant reduction in viral load compared to placebo (P=0.028), and further post-hoc analysis showed a significant reduction (log 0.55) of the mean viral load compared to pre-ART levels.

Positive ELISPOT data (a well-established immunological analysis method), give indications that Vacc-4x immunization may improve immune responses to p24 leading to a lower viral load set-point. Bionor Pharma is in the process of planning additional studies to test the potential of using Vacc-4x  in combination with ART and/or other substances to develop lasting virus control (“functional cure”) and potentially long term eradication of HIV.

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.

# # #