Bionor announces promising results from an interim analysis of the functional cure HIV study REDUC Part B
Indicating killing of reactivated HIV virus and reduction in latent viral reservoir when patients receive the therapeutic vaccine Vacc-4x prior to romidepsin
The study confirms that Bionor’s proprietary peptide vaccine, Vacc-4x, is a safe and tolerated potential functional cure for HIV
(Oslo, Norway, 4 May 2015) Bionor Pharma ASA (OSE:BIONOR), a peptide vaccine company advancing the potential first therapeutic vaccine towards a functional cure for HIV, today announces promising results from an interim analysis of Part B of the REDUC study. In the study, Bionor’s safe and tolerated vaccine candidate Vacc-4x and the HDAC inhibitor romidepsin (Istodax®, Celgene) are explored as a possible treatment regimen to reduce the persistent latent viral reservoir in HIV infected patients on anti-retroviral treatment.
The REDUC study is a Phase I/II trial, and a first step in validating Bionor’s strategy for Vacc-4x which the company sees as a component in a potential functional cure for HIV.
HIV treatment has evolved significantly in recent decades but the latent reservoir – in which the virus is dormant but invisible to anti-retroviral therapy – is a significant roadblock to managing HIV infection. In previous clinical trials, Vacc-4x demonstrated a significant reduction of HIV viral load set point and a long-term immune response in infected patients, supporting the company’s strategy to take Vacc-4x forward as a cure regimen for HIV. Vacc-4x has been designed to elicit a cell-based immune response by generating T-cells which can recognize and destroy infected HIV cells. In Part B of the REDUC study, Bionor combined Vacc-4x with romidepsin, which can reactivate and “kick awake” latent viral reservoirs.
In 2012 the HIV market generated sales of roughly $17 billion from the sale of anti-retroviral therapies. According to the Centers for Diseases Control, of the 1.1 million Americans with HIV, only 33% are prescribed anti-retrovirals, of which around three quarters are virally suppressed. HIV patients treated with anti-retrovirals face a lifetime of daily pills, often with side-effects and long-term health implications1 including cardiovascular disease, kidney, liver and bone problems.
The interim analysis announced today re-confirms that administration of romidepsin leads to activation of the virus in infected CD4+ T cells. Further, the results suggest that administration of Vacc-4x prior to an HDAC inhibitor enables killing of re-activated virus, as virus in plasma after reactivation is low or undetectable. Finally, results indicate a reduction of total HIV DNA levels in CD4+ cells, a measure used as surrogate for the size of the latent viral reservoir.
The interim analysis shows:
• viral load remained below the level of quantification in 7 out of 9 patients
• increases in histone acetylation levels correlating to the time of romidepsin-infusions, demonstrating the pharmacodynamic effect of romidepsin
• a rapid and temporary viral reactivation in CD4+ T cells following romidepsin-infusions
• the combination of Vacc-4x and romidepsin was safe and well tolerated
Bionor’s President and Chief Executive Officer, Dr. David H. Solomon, commented: “These results are an important milestone for Bionor in establishing the ability of Vacc-4x to ‘kill’ activated HIV virus and infected CD4 cells following romidepsin (Istodax®) reactivation of the latent HIV reservoir and to reduce the latent reservoir in HIV patients while on cART. They bring us a step further toward our goal of advancing treatments towards a functional cure for HIV, and we look forward to progressing with the next stage of the study.
Bionor is now the company with the most advanced therapeutic vaccine in development for a functional cure for HIV, and despite the challenges faced by the healthcare industry to date, our data validates that Vacc-4x represents the potential for a real breakthrough for HIV patients and caregivers.”
Next results will be in H2 2015 with the final report in January 2016 and are expected to be published in a peer-review journal.
Notes for Editors
Bionor Pharma is a leading biotechnology company advancing the first therapeutic vaccine towards a functional cure for HIV. The company’s focus is the research and development of peptide-based vaccines against viral diseases, primarily HIV.
Bionor Pharma’s current clinical development pipeline comprises two vaccine candidates for the treatment of HIV, Vacc-4x and Vacc-C5. Vacc-4x is the most advanced therapeutic vaccine in the HIV space and has demonstrated a reduction of viral load in a large, randomized, controlled Phase II trial, as well as safety and tolerability. Bionor Pharma’s current clinical focus is to explore whether Vacc-4x, used with other medicines as a combination therapy, can reduce the viral load even further, and the company, through a collaboration with Celgene Corp, is investigating Vacc-4x and romidepsin in the REDUC study.
Bionor is listed on the Oslo stock exchange, under the ticker BIONOR.
More information about Bionor is available at www.bionorpharma.com.
About the Trial
An Open Phase I/IIa Study to Evaluate the Safety and Effect of Therapeutic HIV-1 Immunization using Vacc-4x + rhuGM-CSF, and HIV-1 Reactivation using romidepsin, on the Viral Reservoir in Virologically Suppressed HIV-1 Infected Adults on cART, “REDUC”. Further details of the study are available on www.clinicaltrials.gov (NCT02092116).
The study’s principal objective is to measure the effect of treatment with Vacc-4x + rhuGM-CSF and cyclic romidepsin treatment on the HIV-1 latent reservoir in HIV-infected patients virologically suppressed on cART. The interim analysis was conducted to reconfirm that administration of romidepsin leads to activation of virus in infected CD4+ T cells and to assess a possible reduction of the latent viral reservoir provided by administration of Vacc-4x prior to romidepsin infusion. Further, the safety and tolerability was assessed. The interim analysis included nine out of 20 patients enrolled in the REDUC Part B study. All patients received six injections of Vacc-4x prior to administration of one cycle of romidepsin (three infusions).
The study was conducted in collaboration with Aarhus University Hospital, Denmark, which is leading research into the use of HDIs to reactivate latent reservoirs, and is part-funded by the Research Council of Norway GLOBVAC programme.
The company is now exploring how to exploit the characteristics of Vacc-4x to develop a functional cure for HIV.
For more information please contact:
Bionor Pharma ASA
President and Chief Executive Officer David Solomon:
Tel +0045 22 20 63 00
Consilium Strategic Communications
Mary-Jane Elliott / Ivar Milligan / Jessica Hodgson / Hendrik Thys
Tel: +44 (0)20 3709 5700