GeoVax Advancing GEO-MVA Vaccine Candidate to Bolster Global Supply Options
ATLANTA, GA - February 27, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX) commented on today's statement from The World Health Organization (WHO) concerning Mpox. In its statement the WHO reaffirmed the severity of the ongoing Mpox epidemic, issuing its third declaration within six months of Mpox as a Public Health Emergency of International Concern (PHEIC). This follows the initial declaration on August 14, 2024, and the second on November 22, 2024, underscoring the persistent and escalating nature of the outbreak.
The WHO's declaration comes as Mpox cases, including the more virulent and transmissible Clade 1B strain, continue to erupt globally, with its geographic spread widening. Since 2022, nearly 128,000 confirmed Mpox cases across 130 countries have been reported. The Democratic Republic of the Congo (DRC) has been particularly hard hit having reported more than 60,000 cases and 1,300 deaths in 2024.
Clade 1 Mpox has now spread beyond Africa with cases reported in France, Germany, India, Sweden, Thailand, the U.K., Canada, the U.S., and other nations. In the United States, Clade 1 Mpox cases have now been confirmed in New York, California, Georgia, and New Hampshire, raising significant concerns about its continued spread. These cases underscore the increasing risk of domestic outbreaks and the urgent need for expanded vaccine access and preparedness.
Vaccine Supply Challenges Persist as Outbreaks Grow
Despite the clear global threat, vaccine supply remains critically insufficient:
Severe shortages - African health agencies have requested 20 million doses in 2025, yet only 2-5 million doses are expected to be available.
Single-source dependency - The world remains heavily reliant on a single non-U.S. manufacturer for the preferred Mpox vaccine, posing risks of supply chain disruptions.
High costs and access limitations - In some regions, the preferred Mpox vaccine remains overly expensive, restricting vaccination efforts, particularly in lower-income regions.
GeoVax GEO-MVA: A Critical Potential Solution to the Mpox Vaccine Supply Crisis
GeoVax is actively addressing these challenges with the development of GEO-MVA, its Mpox vaccine candidate. GeoVax has successfully manufactured and released the first clinical drug substance batch of GEO-MVA, with fill/finish and release of clinical product expected for mid-year, supporting the planned initiation of the clinical evaluation of GEO-MVA in the second half of this year.
GEO-MVA, in conjunction with the GeoVax development program of implementing an advanced manufacturing process for MVA vaccines, may offer several key advantages to complement and potentially strengthen the global Mpox response:
Expanded manufacturing capacity at lower cost - The advanced MVA manufacturing process is directed towards establishing a higher yield, increased production capability with lower production costs.
U.S.-based production - GEO-MVA can be manufactured domestically, reducing dependence on foreign supply chains and enhancing biosecurity.
GeoVax has strategic partnerships with OXB (France) and ProBioGen (Berlin) to support production scale-up and is working closely with regulatory agencies to expedite approvals and ensure equitable vaccine distribution.
A Call to Action: Strengthening the Global Response
With WHO's latest emergency declaration confirming the continued and growing global threat of Mpox, immediate action is required:
Expedited regulatory approval pathways for GEO-MVA and the advanced MVA manufacturing process in order to support an increased global vaccine supply.
Expand policy and funding support for alternative vaccine manufacturing sources.
Enhance collaboration with global health agencies to ensure vaccine equity, especially in underserved regions.
"Today's WHO announcement highlights the urgency of expanding Mpox vaccine supply and ensuring rapid response capabilities," said David Dodd, Chairman & CEO of GeoVax. "GeoVax remains committed to bolstering global preparedness through GEO-MVA and our efforts to establish an advanced MVA manufacturing process, offering a scalable, accessible, and domestically produced solution to combat this ongoing public health crisis."
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world's most threatening infectious diseases and therapies for solid tumor cancers. The company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin(R) combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax's business plans. The words "believe," "look forward to," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax's immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax's viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax's immuno-oncology products and preventative vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
