April 1, 2014
Bionor Pharma ASA announced today the completion of enrollment of patients for part A of the Phase I/II REDUC study.
The trial combines Bionor Pharma’s lead vaccine candidate Vacc-4x and the HDAC inhibitor Istodax® (romidepsin). Part A of the study will establish the optimal dose of Istodax in a cohort of 6 patients based on safety and the effect on the latent HIV reservoir. The REDUC (“Kill & Kick”) trial’s objective is to address one of the core issues with the treatment of HIV that HIV hides in so-called latent cell reservoirs.
The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. HDACi have the potential to reactivate, or “kick” these latent infected cells. This will make the HIV infected cells visible to the immune system, which can be educated by Vacc-4x to eliminate or “kill” the infected cells. The REDUC trial is expected to read out in H2 2015.
The REDUC trial is part of the Company’s overall “Kick, Kill and Boost” strategy aiming at providing a functional cure for HIV. If successful, the functional cure will enable HIV infected patients to live without disease progression or transmission in the absence of conventional HIV therapy.
About the REDUC trial
REDUC is an open Phase I/IIa study to evaluate the safety and effect of Vacc-4x immunization and HDACi reactivation on the HIV reservoir in infected adults on conventional HIV therapy ART.
The REDUC trial will study the sequential combination of the HDACi Istodax and Vacc-4x in HIV patients. Part A of the study will establish the optimal dose of Istodax in 6 patients. Subject to successful completion of Part A, Part B of the trial will comprise vaccination with Vacc-4x followed by treatment with Istodax once a week for three weeks in 20 patients.
After an observation period patients will undergo a planned and analytical ART treatment interruption and will remain off ART for 18 weeks. Bionor Pharma is the study sponsor and Department of Infectious Diseases, Aarhus University Hospital, Denmark with Lead investigator Professor Lars Østergaard will be conducting the study.
The objectives of the study is to measure the effect of the combination of repeated vaccinations with Vacc-4x followed by treatment with Istodax measured by the size of the latent HIV reservoir in patients with HIV infection and to evaluate how well patients control their HIV infection after being taken off ART.
Bionor Pharma ASA
Synne H. Røine
Tel +47 99 22 98 92
About Bionor Pharma ASA
Bionor Pharma is a leading biotechnology company, searching for breakthrough products for the treatment and prevention of life-threatening viral diseases. The Company is listed on the Oslo Stock Exchange, and is developing vaccines for viral infections. The vaccines are based on a proprietary technology platform developed following more than two decades of research into peptides, and they are designed to safely stimulate the immune system to combat viral diseases.
The Company has a leading position in the global research field for therapeutic HIV vaccines, and has two vaccine candidates in the clinical stage of development: Vacc-4x aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells, and Vacc-C5 is designed to induce antibodies to HIV that can reduce the harmful hyperactivation of the immune system which can lead to AIDS.
Bionor Pharma is pursuing a functional cure for HIV by exploring the use of Vacc-4x with other agents, the so-called “Kick, Kill and Boost” strategy. Vacc-4x has in two trials shown a significant reduction of median viral load compared to patients’ historic median pre-ART viral load. Furthermore, in retrospective analyses, HIV patients with increased levels of C5 antibodies seem to respond better to Vacc-4x vaccination leading to a greater reduction of the median viral load when compared to patients’ historic median pre-ART viral load values. If successful, the Company’s functional cure strategy will enable HIV infected patients to live without disease progression or transmission in the absence of therapy.
The Company’s innovative technology platform is also well positioned to develop vaccines for other viral diseases, such as Influenza, HCV (Hepatitis C), HPV (Human papillomavirus) and CMV (Cytomegalovirus).
More information about Bionor Pharma is available at www.bionorpharma.com.