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About GeoVax Labs, Inc.
GeoVax Labs, Inc. (Nasdaq: GOVX) is a clinical-stage biotechnology company specializing in the development of innovative vaccines and immunotherapies for some of the world's most challenging infectious diseases and solid tumor cancers. The company's proprietary Modified Vaccinia Ankara (MVA) viral vector platform underpins its advanced research and development efforts, enabling the production of vaccines that stimulate both humoral and cellular immune responses. This dual mechanism mimics natural infection processes, providing a robust and comprehensive approach to disease prevention and treatment.
Core Areas of Focus
GeoVax's research and development pipeline spans two primary domains:
- Infectious Diseases: The company is actively developing vaccines for high-priority infectious diseases, including COVID-19 (GEO-CM04S1), Mpox (Monkeypox), Zika virus, malaria, and hemorrhagic fever viruses such as Ebola, Marburg, and Lassa. Its leading COVID-19 candidate, GEO-CM04S1, is designed to provide enhanced protection for immunocompromised patients by targeting both the spike (S) and nucleocapsid (N) antigens of the virus, offering broader immune coverage.
- Oncology: GeoVax is advancing novel therapies for solid tumor cancers. Its flagship oncology program, Gedeptin®, utilizes gene-directed oncolytic therapy to target advanced head and neck cancers. Additionally, the company is exploring therapeutic cancer vaccines, including its MVA-VLP-MUC1 candidate, which has shown promising preclinical results in reducing tumor growth and preventing recurrence in cancers such as breast, colon, and ovarian.
Proprietary Technology
At the heart of GeoVax's innovation is its MVA-VLP platform. This technology enables in vivo production of non-infectious virus-like particles (VLPs) directly within the cells of vaccinated individuals. By presenting multiple antigens to the immune system simultaneously, the platform elicits a robust immune response, including both antibody production and T cell activation. This approach is particularly valuable for developing vaccines that address rapidly mutating pathogens and complex diseases like cancer.
Clinical Development and Market Position
GeoVax's clinical programs are strategically designed to address unmet medical needs. Its lead candidate, GEO-CM04S1, is currently in Phase 2 clinical trials as both a primary vaccine for immunocompromised populations and a booster for healthy individuals. The company's oncology portfolio is anchored by Gedeptin®, which has completed Phase 1/2 trials and is moving toward Phase 2 studies in combination with immune checkpoint inhibitors. GeoVax's focus on underserved patient populations, such as those with chronic lymphocytic leukemia (CLL) or hematologic cancers, positions it uniquely within the biotechnology landscape.
Intellectual Property and Manufacturing
GeoVax boasts a robust intellectual property portfolio, with over 120 granted or pending patents across 24 patent families. This includes proprietary rights to its MVA platform and vaccine candidates. The company has also established scalable manufacturing capabilities, leveraging partnerships with contract development and manufacturing organizations (CDMOs) to ensure cost-effective production of its vaccine candidates.
Challenges and Opportunities
Operating in a competitive and highly regulated industry, GeoVax faces challenges such as securing funding for late-stage clinical trials, navigating regulatory pathways, and differentiating its products in a crowded market. However, its focus on high-need areas, such as immunocompromised patients and emerging infectious diseases, provides significant opportunities for impact and growth.
Conclusion
GeoVax Labs, Inc. represents a pioneering force in the biotechnology sector, leveraging its proprietary MVA-VLP platform to develop next-generation vaccines and therapies. With a diverse pipeline addressing both infectious diseases and oncology, the company is well-positioned to make meaningful contributions to global health challenges. Its emphasis on innovation, intellectual property, and scalable manufacturing underscores its commitment to advancing medical science and improving patient outcomes.
GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines, will present at the Emerging Growth Conference on August 21, 2024. Chairman and CEO David Dodd will deliver a live, interactive presentation at 4:10pm ET, discussing recent Mpox developments and milestones related to the BARDA Project NextGen Award for their next-generation COVID-19 vaccine.
The event offers shareholders and investors the opportunity to interact with Mr. Dodd in real-time. Attendees can submit questions in advance or during the event. Registration is required to attend and receive updates. For those unable to join live, an archived webcast will be available on EmergingGrowth.com and the Emerging Growth YouTube Channel.
GeoVax Labs, Inc. (Nasdaq: GOVX) has appointed Teresa Lambe, PhD, OBE, FMedSci to its Scientific Advisory Board. Prof. Lambe, a renowned vaccinology and immunology expert from the Oxford Vaccine Group, was a key figure in developing the Oxford/AstraZeneca COVID-19 vaccine. Her research focuses on designing vaccination strategies based on post-infection immune responses. GeoVax's Chief Scientific Officer, Dr. Mark Newman, highlighted how Prof. Lambe's expertise aligns with their vaccine and immunotherapy programs, including the recent BARDA Project NextGen Award for next-generation COVID-19 vaccines. David Dodd, GeoVax's Chairman and CEO, emphasized the importance of Prof. Lambe's insights for advancing their clinical trials and bringing new therapies to market.
GeoVax Labs, Inc. (Nasdaq: GOVX) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. Awarded BARDA Project NextGen (PNG) contract worth over $350 million to advance GEO-CM04S1, their next-generation COVID-19 vaccine, into a 10,000-participant Phase 2b study.
2. Partnered with Allucent, a global CRO, to conduct the Phase 2b trial.
3. Advancing Gedeptin® into an expanded Phase 2 clinical trial for first-recurrence head and neck cancer, with activation expected in H1 2025.
4. Produced first lot of GEO-CM04S1 with a commercial manufacturing platform.
5. Q2 2024 net loss of $5,064,042 ($1.99 per share), compared to $5,927,620 ($3.79 per share) in Q2 2023.
6. Cash balance of $1,561,712 as of June 30, 2024.
GeoVax Labs, Inc. (Nasdaq: GOVX) has announced plans for a Phase 2 trial of its Gedeptin® cancer therapy following a clinical advisory committee review. The trial will focus on first-recurrence head and neck cancer, combining Gedeptin with an immune checkpoint inhibitor. This decision comes after reviewing the completed PNP-002 Phase 1b/2a and PNP-001 Phase 1 trials, which demonstrated acceptable safety and efficacy in advanced head and neck squamous cell carcinoma (HNSCC) patients.
The planned Phase 2 trial aims to establish the efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor. It will involve approximately 6 patients, with pathologic response rate as the primary endpoint. GeoVax anticipates trial activation during the first half of 2025. The company is also pursuing development plans for Gedeptin in additional solid tumor indications in partnership with leading academic oncology centers.
GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company focused on developing immunotherapies and vaccines for cancer and infectious diseases, has announced it will release its second quarter 2024 financial results on Tuesday, August 6, 2024, after U.S. markets close. The company will host a live conference call and webcast at 4:30 p.m. ET on the same day to discuss the financial results and provide a corporate update.
Investors and interested parties can join the conference call using the following details:
- Domestic: (800) 715-9871
- International: +1 (646) 307-1963
- Conference ID: 3852178
A webcast of the call will be available at https://edge.media-server.com/mmc/p/qj3e68n8, with a replay accessible for three months after the event.