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GeoVax has a full pipeline of programs with HIV holding the most advanced position with Phase II work being done. The remainder of the portfolio is centered on infectious disease and immuno-oncology preclinical work. Below, we summarize current status of the programs.
Cancer Immunotherapy – Collaborations with Leidos, University of Pittsburgh and ViaMune are underway. Work with Leidos is evaluating the delivery of a PD-1 checkpoint inhibitor with the MVA-VLP platform. The academic collaboration is focused on MUC1 with the goal of raising protective anti-tumor antibodies and T cell responses in cancer patients. Efforts with ViaMune are also centered on MUC1 and is seeking to combine a MUC1 vaccine for use with checkpoint inhibitors. Preclinical work in animal models have shown efficacy. Additional work with Vaxeal, Emory Vaccine Center, Virometrix and Leidos are also taking place in immuno-oncology. The immuno-oncology program is likely to be advanced into the clinic if sufficient capital is raised and GeoVax is prioritizing efforts in this area.
HIV Immunotherapy – In 2018, GeoVax received $256,000 for its HIV program from the NIH Small Business Innovative Research (SBIR) grant. Clinical trials for HIV are ongoing. The company plans another Phase I study in the near future with further evaluation of the protein boost. Looking forward, we anticipate a Phase IIb HVTN efficacy trial to being in the next few months. We also foresee human clinical trials starting with the AGT collaboration in 2H:19 where GeoVax’s vaccine will be used to prime T cells in a Phase I study seeking a cure. Following the end of the quarter, GeoVax announced the presentation of Protein-Supplemented DNA/MVA Vaccines: Preclinical Immunogenicity and Protection for Transmitted/Founder and CD4-induced gp120 Proteins at the International AIDS Society Conference in Mexico City. The talk highlighted the results of gp120 boosts which enhanced the magnitude and breadth of binding antibodies to gp120.
Ebola & Marburg – An ongoing outbreak in Congo has highlighted the need for a safe, effective and durable vaccine that can remain viable at room temperatures. GeoVax has had several publications of its preclinical Ebola trial results published in Atlas of Science and Nature. The study demonstrated 100% single-dose protection in a large primate model. The company has offered the vaccines to public health agencies to use for free if they decide to advance their development. In July, the company announced 100% protection from preclinical challenge studies utilizing the Marburg virus vaccine.
Lassa fever – A $300,000 Fast Track Phase I/II SBIR grant was received in support of further advancing the Lassa fever development program. Total project budget is $1.9 million for a Phase II award, which we anticipate will be secured. A U.S. Department of Defense (DoD) award for $2,442,307 was also granted in a cooperative agreement to develop Lassa vaccine. The Lassa vaccine has demonstrated 100% single dose protection in a mouse model.
Zika – A two year, $600,000 Small Business Innovative Research (SBIR) grant was awarded in June 2017 in support of the development program. Efforts will focus on preclinical testing of the Zika vaccine in nonhuman primates in preparation for human clinical trials. The Zika program is likely to be advanced into human clinical trials if sufficient funding is raised. Furthermore, there are ongoing discussions with Brazilian entities which may yield additional collaborations.
GeoVax has a full pipeline of programs with HIV holding the most advanced position with Phase II work being done. The remainder of the portfolio is centered on infectious disease and immuno-oncology preclinical work. Below, we summarize current status of the programs.
Cancer Immunotherapy – Collaborations with Leidos, University of Pittsburgh and ViaMune are underway. Work with Leidos is evaluating the delivery of a PD-1 checkpoint inhibitor with the MVA-VLP platform. The academic collaboration is focused on MUC1 with the goal of raising protective anti-tumor antibodies and T cell responses in cancer patients. Efforts with ViaMune are also centered on MUC1 and is seeking to combine a MUC1 vaccine for use with checkpoint inhibitors. Preclinical work in animal models have shown efficacy. Additional work with Vaxeal, Emory Vaccine Center, Virometrix and Leidos are also taking place in immuno-oncology. The immuno-oncology program is likely to be advanced into the clinic if sufficient capital is raised and GeoVax is prioritizing efforts in this area.
HIV Immunotherapy – In 2018, GeoVax received $256,000 for its HIV program from the NIH Small Business Innovative Research (SBIR) grant. Clinical trials for HIV are ongoing. The company plans another Phase I study in the near future with further evaluation of the protein boost. Looking forward, we anticipate a Phase IIb HVTN efficacy trial to being in the next few months. We also foresee human clinical trials starting with the AGT collaboration in 2H:19 where GeoVax’s vaccine will be used to prime T cells in a Phase I study seeking a cure. Following the end of the quarter, GeoVax announced the presentation of Protein-Supplemented DNA/MVA Vaccines: Preclinical Immunogenicity and Protection for Transmitted/Founder and CD4-induced gp120 Proteins at the International AIDS Society Conference in Mexico City. The talk highlighted the results of gp120 boosts which enhanced the magnitude and breadth of binding antibodies to gp120.
Ebola & Marburg – An ongoing outbreak in Congo has highlighted the need for a safe, effective and durable vaccine that can remain viable at room temperatures. GeoVax has had several publications of its preclinical Ebola trial results published in Atlas of Science and Nature. The study demonstrated 100% single-dose protection in a large primate model. The company has offered the vaccines to public health agencies to use for free if they decide to advance their development. In July, the company announced 100% protection from preclinical challenge studies utilizing the Marburg virus vaccine.
Lassa fever – A $300,000 Fast Track Phase I/II SBIR grant was received in support of further advancing the Lassa fever development program. Total project budget is $1.9 million for a Phase II award, which we anticipate will be secured. A U.S. Department of Defense (DoD) award for $2,442,307 was also granted in a cooperative agreement to develop Lassa vaccine. The Lassa vaccine has demonstrated 100% single dose protection in a mouse model.
Zika – A two year, $600,000 Small Business Innovative Research (SBIR) grant was awarded in June 2017 in support of the development program. Efforts will focus on preclinical testing of the Zika vaccine in nonhuman primates in preparation for human clinical trials. The Zika program is likely to be advanced into human clinical trials if sufficient funding is raised. Furthermore, there are ongoing discussions with Brazilian entities which may yield additional collaborations.
