Press Release
Barcelona, March 2017
Pre-clinical studies were conducted at the beginning of iHivarna project to comply with regulatory requirements and fulfill phase I clinical trial application and the final results have recently been published in AIDS. Thus, we are happy to announce the results are public and available as well as an editorial comment about it.
Do not hesitate to look up for them:
- Guardo AC, Joe PT, Miralles L, Bargalló ME, Mothe B, Krasniqi A, Heirman C, García F, Thielemans K, Brander C, Aerts JL, Plana M; iHIVARNA consortium. Preclinical evaluation of an mRNA HIV vaccine combining rationally selected antigenic sequences and adjuvant signals (HTI-TriMix). AIDS. 2017 Jan 28;31(3):321-332. doi: 10.1097/QAD.
- Ahmad A, Rinaldo CR. A novel anti-HIV immunotherapy to cure HIV. AIDS. 2017 Jan 28;31(3):447-449. doi: 10.1097/QAD.
In this article, it is presented and discussed a preclinical evaluation a novel mRNA and dendritic cell-based formulation, where a combination of 2 selected antigenic sequences and adjuvant signals (HTI + TriMix) can induce a potent immune response in vitro and in vivo. The published results are a major advancement toward developing immunotherapy that is effective and scalable for HIV-infected patients.
iHIVARNA was the first EU-funded project we participated in. The principal aim of iHIVARNA is to successfully immunize antiretroviral-treated HIV-infected patients with 3 injections of the candidate universal HIV-TriMix-mRNA as an mRNA-based therapeutic vaccine with the final objective of achieving a functional cure of HIV infection. In order to fulfil this aim, the planned steps of the Project have been:
– The manufacturing of the HIV-TriMix-mRNA in GMP conditions to be used in clinical trials.
– A phase I dose escalation clinical trial and a phase II a-proof-of-concept clinical trial to test safety, efficacy and immunogenicity of the vaccine candidate.
– Ascertaining immune and viral predictors and correlates of protection.
– Asphalion participates in iHIVARNA project as a regulatory partner by developing and conducting the
following activities:
· Preparation of IBs and IMPDs
· Design of regulatory toxicology studies
· Revision of Phase I clinical results
· Regulatory Support during development
iHIVARNA: The research leading to this results has received funding from the European Comunity’s Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 602570.
About Asphalion:
ASPHALION is an International Scientific and Regulatory Affairs consultancy firm based in Barcelona and Munich. We offer comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies.
Since 2000, we have consistently grown and now have over 70 professional consultants with backgrounds in Life sciences (Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Medicine and Veterinary Medicine). Our consultants are experts in their field and are in direct contact with EU agencies (EMA and NCAs) for the development and implementation of new regulatory standards.
Asphalion provides a global range of services, for global clients.
Our services range from early development, throughout the registration, until marketing and post-commercialization phases of your product.
Through our network of regulatory consultants, Asphalion is in a position to support your worldwide scientific & regulatory activities. We make use of a dedicated US agent in the fields of Pharma/Biotech, Medical Devices and In Vitro Diagnostics.
Asphalion is actively participating in Horizon 2020 programme as a member of many project consortiums under this European Commission’s initiative that brings research ideas into the market.
