A clinical phase I/II trial for the vaccine Vacc-C5 in HIV patients.

Bionor currently has two vaccines in clinical development (Vacc-4x and Vacc-C5) for functional HIV cure; i.e. leading to long-term remission of HIV infection in the absence of antiretroviral therapy (ART), the state-of-the art treatment for HIV today. A functional cure will provide a new paradigm in the treatment of HIV infection leading to durable remission which would represent a clear advance over current state-of-the-art. It would allow for improved quality of life, reduce the risks of long-term side effects from lifelong ART, the development of ART resistance as well as provide substantial cost savings for healthcare services. Vacc-C5 is a peptide based therapeutic vaccine candidate to induce a non-neutralizing antibody response to the constant domain (C5) on the HIV-1 envelope glycoprotein gp120 in conjugation with part of the transmembrane glycoprotein gp41. The presence of Ab towards the C5 region has previously been shown to correlate with a slower disease progression. The main work package is the phase I/II dose escalation clinical trial of Vacc-C5 to test the safety and tolerability of 3 dose levels in combination with an adjuvant (ISA-720) over 14 weeks. Patients will be recruited from HIV clinics in Sweden, the UK and Germany. The Work Packages include: Project Management, Regulatory Affairs, Manufacturing of cGMP study drugs, and Commercialization and business development. Bionor Immuno AS, is responsible for overall management and coordination of the subcontracted tasks, including the manufacturing development; and preparing for commercialisation. A main subcontractor Smerud Medical Research International will lead the regulatory science; prepare the documentation for the study; and manage the clinical trial administratively, incl. i.a. quality control (monitoring), data management and study reporting. Clinical sites involved are located in Sweden, the UK and Germany, with access to a large number of patients eligible for enrollment in the study.