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Genetic Immunity (GI) Leverages VectorBuilder Partnership to Power Phase 3 HIV Vaccine Trials

Genetic Immunity, a leader in plasmid DNA-based immunotherapies, and VectorBuilder, a global specialist in gene delivery solutions, announced a strategic partnership to advance Genetic Immunity's innovative HIV vaccine into a late-stage clinical trial.

Renowned for its focus on developing cutting-edge DNA-based vaccines, Genetic Immunity has built an industry-leading team to deliver its lead candidate, a plasmid DNA HIV vaccine, into a Phase 3 trial. The therapy has demonstrated promising clinical readouts in previous trials, paving the way for the upcoming Phase 3 pivotal trial.

Under this collaboration, VectorBuilder will provide a Quality by Design (QbD) approach to Process Development, Process Characterization, and GMP Manufacturing services for Genetic Immunity. This includes end-to-end production of the plasmid DNA required for the clinical trial and future commercial manufacturing.

Dr. Bruce Lahn, Chief Scientist at VectorBuilder, said: “We are thrilled to support Genetic Immunity’s innovative approach to HIV treatment. After working closely with them over the last few years, we have created a wonderful partnership that has allowed us to holistically understand their modality to ensure we have a high probability of success. Our comprehensive gene delivery solutions are designed to meet the stringent requirements of GIs clinical and CMC development, and we are committed to ensuring the success of this important vaccine trial and beyond to commercial rollout.”

Dr. Philip C. Onyebujoh [Chief Medical Director of Genetic Immunity]: “Genetic Immunity’s partnership with VectorBuilder represents an important fusion of technological innovation and therapeutic advancement towards providing interventions that are expected to improve treatment outcomes for the control of critical infectious diseases. This partnership offers a unique coupling that synergistically creates, drives, and advances therapeutic sciences to harness the power of immunomodulation to address a host of disease conditions, including cancers and infectious diseases of poverty. We welcome our partnership with VectorBuilder and look forward to further growth together.”

For more information about VectorBuilder’s services, visit VectorBuilder.

For details on Genetic Immunity’s vaccine development, visit Genetic Immunity.

About VectorBuilder Inc.

VectorBuilder is a global leader in gene delivery technologies. As a trusted partner in thousands of labs and biotech/pharma companies around the world, VectorBuilder is a one-stop shop for the design, development and optimization of gene delivery solutions from basic research to clinical applications. Its award-winning Vector Design Studio is a transformative innovation that allows researchers to easily design and order custom vectors online, freeing them from the tedious work of cloning and packaging vectors in the lab. The global company boasts high-throughput vector production capacity, vast vector and component inventories, one-on-one CRO solutions that include advanced AAV capsid engineering capabilities and state-of-the-art GMP facilities. With leading R&D and CDMO manufacturing capacity, the VectorBuilder team strives to provide the most effective gene delivery solutions and develop new tools for life sciences research and genetic medicine.

About Genetic Immunity

GI.HU Ltd. is a Hungarian clinical-stage biotechnology company focusing on discovering and developing plasmid-based DNA (pDNA) therapeutic vaccines for cancer and infectious diseases. For example, therapeutic vaccines for HIV control are designed to improve the immune response to HIV antigens in HIV-infected people, aiming at attaining functional cure. Genetic Immunity’s lead product candidate DermaVir® is a therapeutic vaccine for the adjunctive treatment of HIV. The preclinical and early phase clinical trials have demonstrated an effective boosting of HIV-specific memory T-cell responses. DermaVir® has an excellent safety profile similar to traditional vaccines used in healthy adults. The intended use of DermaVir® is to complement antiretroviral therapy as an add-on treatment option to maintain undetectable HIV-RNA levels with associated improvement in the quality of life of people living with HIV.

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