A clinical phase 1/2 programme for Vacc-C5 as a component of functional HIV cure.

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. This approach 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/IIdose 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 the UK and Germany. Other Work Packages include: Project Management, Regulatory Affairs, Manufacturing of cGMP study drugs, and Commercialization and business development. The consortium consist of three partners; Bionor Immuno AS, is responsible for overall management of the consortium, for the manufacturing development; and for preparing the commercialisation. Smerud Medical Research Germany 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. St Georges Hospital will be the main site with a large number of patients eligible for enrollment in the study.