Genetic Immunity Partners with VectorBuilder for Phase 3 HIV Vaccine Trials

Genetic Immunity, a leader in developing plasmid DNA-based immunotherapies, has teamed up with VectorBuilder, an expert in gene delivery solutions, to push forward an innovative HIV vaccine into a late-stage clinical trial. Genetic Immunity is known for its pioneering work in DNA-based vaccines and has assembled a top-tier team to advance its lead candidate, a plasmid DNA HIV vaccine, into a Phase 3 trial. Success in earlier trials has set a promising stage for this critical Phase 3 pivotal trial.

VectorBuilder will play a crucial role in this collaboration by offering a Quality by Design (QbD) approach to Process Development, Process Characterization, and GMP Manufacturing services for Genetic Immunity. Their contribution will encompass the complete production of the plasmid DNA necessary for the clinical trial and eventually for commercial manufacturing.

Dr. Bruce Lahn, Chief Scientist at VectorBuilder, expressed his enthusiasm for supporting Genetic Immunity’s innovative HIV treatment approach. He highlighted the strong partnership and comprehensive understanding of the modality developed over the years, which is expected to increase the likelihood of success. VectorBuilder’s gene delivery solutions are designed to meet the stringent requirements of Genetic Immunity’s clinical and CMC development, ensuring the success of this significant vaccine trial and its future commercial distribution.

Dr. Philip C. Onyebujoh, Chief Medical Director of Genetic Immunity, emphasized the importance of the collaboration with VectorBuilder, noting it as a critical fusion of technological innovation and therapeutic advancement aimed at improving treatment outcomes for critical infectious diseases. He mentioned that the partnership synergistically advances therapeutic sciences to harness the power of immunomodulation, addressing various disease conditions, including cancers and infectious diseases prevalent in poverty-stricken regions. He expressed optimism about the continued growth of their partnership with VectorBuilder.

VectorBuilder is renowned globally for its gene delivery technologies. As a trusted partner in numerous laboratories and biotech/pharma companies worldwide, VectorBuilder offers comprehensive solutions for the design, development, and optimization of gene delivery from basic research to clinical applications. Their Vector Design Studio allows researchers to design and order custom vectors online easily, significantly streamlining the process. The company also boasts extensive vector production capacity, a vast inventory of vectors and components, and advanced capabilities in AAV capsid engineering, all supported by state-of-the-art GMP facilities. With robust R&D and CDMO manufacturing capacities, VectorBuilder aims to provide the most effective gene delivery solutions and develop new tools for genetic medicine and life sciences research.

Genetic Immunity, a Hungarian clinical-stage biotechnology company, focuses on discovering and developing plasmid DNA (pDNA) therapeutic vaccines for cancer and infectious diseases. Their flagship product, DermaVir®, is a therapeutic vaccine intended for the adjunctive treatment of HIV. Preclinical and early-phase clinical trials have shown that DermaVir® effectively boosts HIV-specific memory T-cell responses. The vaccine has demonstrated an excellent safety profile comparable to traditional vaccines used in healthy adults. DermaVir® is designed to complement antiretroviral therapy, offering an additional treatment option to help maintain undetectable HIV-RNA levels and improve the quality of life for people living with HIV.