GeoVax and EmVenio Announce Collaboration to Expand Phase 2 COVID-19 Booster Vaccine Clinical Trial

Rhea-AI Summary

GeoVax Labs, Inc. (GOVX) has announced a collaboration with EmVenio Research to deploy a mobile clinical facility in Claremont, California, to enhance patient recruitment for its ongoing Phase 2 trial of the GEO-CM04S1 COVID-19 booster vaccine. This initiative aims to facilitate access to clinical trials for diverse populations, with a focus on evaluating the vaccine's safety and immunogenicity in healthy patients. GEO-CM04S1 is targeting individuals who have previously received FDA-approved mRNA vaccines. The trial will measure immune responses, including neutralizing antibodies and T-cell responses, to assess its effectiveness against COVID-19.

Positive

• Launch of mobile clinical facility to improve patient recruitment.
• Collaboration with EmVenio Research enhances trial access for diverse populations.
• GEO-CM04S1 targets a significant market for COVID-19 boosters.

Negative

• Trial results are still pending; no immediate market impact can be gauged.

Mobile Community Clinical Research Facility to be Deployed in California

ATLANTA, GA, Feb. 15, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, and EmVenio Research, a patient-focused decentralized trial global organization, today announced a collaboration to deploy a mobile clinical facility in the Claremont, California area to expand GeoVax’s ongoing Phase 2 clinical trial evaluating GEO-CM04S1 as a COVID-19 booster vaccine in healthy patients.

“This unique initiative will extend the reach of our COVID-19 vaccine booster trial by leveraging EmVenio Research’s localized clinical trial model. As we continue to advance and explore the potential of GEO-CM04S1 as a more robust and durable COVID-19 booster than currently approved vaccine boosters, this collaboration will help reduce the burden of patient recruitment as it brings clinical research to diverse populations directly in their communities,” said David Dodd, GeoVax Chairman and CEO.

GEO-CM04S1 is a synthetic attenuated modified vaccinia Ankara (sMVA) vector vaccine that expresses spike and nucleocapsid antigens of the SARS-CoV-2 (COVID-19) virus. It is being researched in two Phase 2 clinical trials, with this trial as a COVID-19 booster for patients who have already received an mRNA vaccine approved by the U.S. Food and Drug Administration (FDA) (ClinicalTrials.gov Identifier: NCT04639466). This trial will include 60 healthy individuals, 18 years of age or older, and is designed to specifically evaluate the safety profile and immunogenicity of 2 dose levels of GEO-CM04S1 as a booster shot. The immunological responses measured throughout the study will include both the level of SARS-CoV-2 neutralizing antibodies and specific T-cell responses. GEO-CM04S1 is also being studied as the first vaccine comparing an investigational multi-antigenic COVID-19 vaccine to current FDA-approved mRNA vaccines in people who are immunocompromised (ClinicalTrials.gov Identifier: NCT04977024).

“EmVenio Research has a passion for creating avenues to engage local communities unfamiliar with research to participate in clinical trials through our mobile Community Research Sites. These sites can move closer into the neighborhoods and communities of urban and rural communities alike to increase access to studies,” said Thad Wolfram, President of EmVenio. “Community volunteers have made this type of research successful, and we are excited to partner with GeoVax on this Phase 2 clinical trial to deliver a potential option for COVID prevention designed by local researchers at City of Hope in Duarte, CA.”

About EmVenio

EmVenio Research delivers localized trial access to diverse and underserved communities. We empower patients and embrace communities on their terms. Our research solutions cultivate a sustainable local ecosystem that benefits all stakeholders. Removing barriers and unlocking doors to innovation reduces risk and time associated with clinical research, while improving ROI. EmVenio Research’s global network of skilled clinicians, principal investigators, and state of the art Community Research sites enables us to provide services via home visits, onsite support at medical facilities, virtual visits, and mobile sites. Visit https://emvenio.com/ to learn more.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 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. In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, 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. 

GeoVax Media Relations Contact:
Nancy Turett
914-434-0311
nmturett@geovax.com

GeoVax Investor Relations Contact:
Rich Cockrell
CG Capital
404-736-3838
govx@cg.capital

EmVenio Media Contact:
302-740-0766
Katy.Keating@EmVenio.com

FAQ

What is the purpose of the GEO-CM04S1 Phase 2 trial?

The trial aims to evaluate the safety and immunogenicity of the GEO-CM04S1 COVID-19 booster vaccine in healthy patients who have received prior mRNA vaccines.

Where is the mobile clinical facility being deployed?

The mobile clinical facility is being deployed in Claremont, California to facilitate patient recruitment for the trial.

What type of vaccine is GEO-CM04S1?

GEO-CM04S1 is a synthetic attenuated modified vaccinia Ankara (sMVA) vector vaccine designed to enhance immune responses against COVID-19.

Who will participate in the GEO-CM04S1 trial?

The trial will include 60 healthy individuals aged 18 and older.

What potential market impacts could arise from the GEO-CM04S1 trial?

If successful, the GEO-CM04S1 vaccine could provide a more effective booster option for COVID-19, especially for immunocompromised patients.