We visited with GeoVax (OTC:GOVX) management at their facilities in Smyrna, Georgia to review their key programs and identify the expected path forward for the company. Over the last few years, GeoVax has expanded from a single program developing an HIV vaccine to a platform company that is using its modified vaccinia Ankara virus-like particles (MVA-VLP) technology to address a broad portfolio of hemorrhagic fevers, hepatitis viruses, malaria and cancer.
View Exhibit I
GeoVax’s most advanced program is a vaccine for human immunodeficiency virus (HIV), Clade B, which has completed a Phase IIa trial. This lead candidate, designated GOVX-B11, is expected to participate in a short Phase I trial in the near term to further evaluate safety and immunogenicity. Following favorable results from this Phase I, the company will pursue additional funding from National Institute of Allergy and Infectious Diseases (NIAID) to support a large Phase IIb efficacy trial. A successful Phase IIb would open the door for negotiations with large pharma and provide a registrational pathway, an exit strategy and potentially eventual commercialization.
While traversing the government grant process for HIV development, the company continues to advance on other fronts. It has developed a number of collaborations and partnerships with others in the space to advance vaccines for Ebola, Marburg, Sudan, Lassa and Zika viruses. GeoVax is also developing treatments for hepatitis B, malaria, human papillomavirus and cancer. Management’s strategy is to validate and demonstrate broad application of the company’s MVA-VLP platform.
GeoVax’s MVA-VLP can address many common weaknesses in the vaccine class as it uses non-infectious virus-like particles that closely resemble VLPs generated in vivo within vaccinated patients. The MVA-VLP vaccines can provide full and durable protection after one inoculation and elicit antibody and T-cell responses. It is not able to replicate in mammalian cells, contributing to the safety profile.
We will provide a short summary of the company’s most exciting programs and highlight partners’ and collaborators’ contributions to development efforts. Based on our conversations with management, we see the Ebola, Zika, HBV and immuno-oncology efforts as most exciting. With sufficient funding and luck, these programs can also be mechanisms for investors to monetize their investment in GeoVax and provide capital for further pipeline development.
The Ebola outbreak in the Democratic Republic of Congo (DRC), which was identified in August 2018, is one of the larger and more frightening surges in the disease. As of late December, there were almost 600 cases and over 350 deaths so from the hemorrhagic fever. Merck’s Ebola vaccine, V920, is being deployed in a ring vaccination approach. However, attempts to prevent the spread of the outbreak with vaccine administration have been hampered by violence and vaccine shortage, the latter of which has been exacerbated by long lead production times. Success of the current vaccine is also uncertain as it is not yet approved and is being used under a humanitarian exemption and has mild to moderate adverse side effects as well as other shortcomings that can potentially be addressed by an MVA-VLP.
GeoVax believes that its Ebola program (GEO-EM01) is the closest of the preclinical candidates to advance to Phase I human trials. The MVA-VLP based vaccine distinguishes itself with an absence of serious adverse side effects and improved stability in room temperature storage; two features that would improve upon the product now being used in the DRC. Concerns over the current expanding outbreak may provide the impetus for additional grants, funding and interest in advancing the GEO-EM01 to the proof of concept stage where it can be transferred to big pharma for registrational trials and potential approval.
Zika (GEO-ZM02) is another appealing program that may soon enter into clinical trials. A vaccine is badly needed in South America and throughout the tropical zone as the mosquito-borne virus has spread throughout Brazil in 2015 and after. Zika was declared a Public Health Emergency by the WHO in 2016, bringing increased attention to the significance of the outbreak. While the disease is usually not fatal, if it is contracted in a pregnant woman it can cause microcephaly and other brain malformations in babies.
GeoVax was granted an NIH award for Zika vaccine development for preclinical testing in non-human primates in preparation for human clinical trials. The grant amount will total $300,000 and is funding a second year of the Zika program which has already shown 100% single-dose protection in a mouse model. The Zika program is an attractive one for global pharma as a successful vaccine would be able to address the large population that lives in the tropical and even subtropical zones of the globe where there have been observed cases. With the NIH grant and a potential addition of a partner, the program could advance to the proof-of-concept stage in the next few years. Following proof-of-concept, we expect a partner would assume development and provide an upfront payment, milestones and eventual royalty to GeoVax as the Zika vaccine moves towards commercialization. We see an attractive program as we anticipate that a vaccine that will protect a mother’s unborn child from severe birth defects will be in high demand in the affected regions.
Global Risk of Zika
View Exhibit II
We think the immuno-oncology therapeutic vaccine GEO-CM01 is another exciting program that GeoVax is developing which could advance at an accelerated pace. Immuno-oncology is a rapidly expanding approach to treating cancer and can help address second leading cause of death in the US. Despite breakthroughs in cancer treatment in the last decades, many of the leading therapies only cure a minority1 of the patients that are given the therapy. Additionally, many successful cancer approaches are comprised of several drugs that attack the disease from multiple directions. There are a number of expedited pathways available for cancer drugs and pricing in this area is favorable. Vaccines can play a role with other immunotherapies in addressing cancer and success with GEO-CM01 is bound to attract attention from large pharma if early clinical trials demonstrate safety and efficacy.
GeoVax is working with multiple collaborators on the immuno-oncology program which is focused on an abnormal form of the cell surface-associated Mucin 1 (MUC1) protein and other tumor associated antigens (TAA). The collaborators include the University of Pittsburgh, ViaMune, Leidos and Vaxeal. Below we highlight the key partners for development of GEO-CM01 and the scope of the relationship.
View Exhibit III
With numerous opportunities to pursue TAA targets, we anticipate GeoVax will see success in the clinic in the near term. There is high demand from well-funded potential partners if GeoVax can advance its GEO-CM01 candidate to a point where it has demonstrated safety and efficacy. Strong pricing is available for immuno-oncology candidates in the $100,000+ per treatment range, especially if they dramatically increase the effectiveness when used in combination with other standards of care. This differentiating factor for a therapeutic vaccine suggests attractive value realization when passed to a partner for eventual registration studies.
GeoVax has expanded its pipeline, its platform and its opportunity set in the last several years, moving from an HIV-focused company to a platform company that is leveraging its MVA-VLP property to develop a portfolio of vaccines that can be used in both preventative and therapeutic settings. While still at an early stage, the company is working with many collaborators and is a favored candidate for government funding for its programs. We anticipate that GeoVax can advance its portfolio candidates to the Phase II proof of concept stage, which is an attractive point to transfer to a big pharma partner for registrational trials, approval and commercialization.
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1 For example, PD-1 and PD-L1 inhibitors eliminate cancer in 20% of the addressable population, leaving 80% in need of other therapy.