GeoVax Comments on FDA Approval of Keytruda(R) in Head and Neck Cancer, Underscoring Potential for Gedeptin(R) Combination Therapy
ATLANTA, GA - June 24, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today commented on the U.S. Food and Drug Administration's recent approval of Keytruda(R) (pembrolizumab) for use in resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) tumors expressing PD-L1 as determined by an FDA approved test. This regulatory milestone marks a significant advancement in the curative-intent treatment landscape for head and neck cancer and affirms the therapeutic strategy underlying GeoVax's Gedeptin(R) development program.
An editorial by Rosenberg and Vokes in New England Journal of Medicine (NEJM) noted that the study forming the basis of FDA's approval represents the first demonstration of benefit for PD-1 inhibition in the curative setting for HNSCC, with implications for evolving neoadjuvant immunotherapy paradigms.
GeoVax is planning to initiate a Phase 2 clinical trial of Gedeptin(R) in combination with a checkpoint inhibitor, such as pembrolizumab, in patients with locally advanced HNSCC scheduled for curative-intent surgery. The trial aims to improve tumor clearance and reduce relapse by combining the immune-priming effect of Gedeptin's targeted cytotoxicity with the systemic immune activation of checkpoint inhibition.
The Phase 2 study, expected to launch in 2026, will evaluate pathologic response, recurrence rates, and biomarker-defined immunologic changes when Gedeptin is used as neoadjuvant therapy with checkpoint inhibitors. Importantly, the NEJM editorial emphasized the need to optimize patient selection and treatment duration in the immunotherapy era, aligning with GeoVax's biomarker-driven approach.
'The NEJM publication and FDA approval of Keytruda in resectable HNSCC signals a new era in curative-intent cancer therapy,' said David Dodd, Chairman and CEO of GeoVax. 'By combining Gedeptin therapy with pembrolizumab, we aim to enhance local tumor eradication while unlocking systemic anti-tumor immunity, potentially reducing both local and distant recurrence.'
'We believe Gedeptin's tumor-targeted cytotoxicity can enhance immunotherapy efficacy, particularly in the perioperative window where anti-tumor immunity can be primed,' added Dr. Kelly McKee, GeoVax's Chief Medical Officer. 'We are excited to embark on the next phase of Gedeptin development as we attempt to build on the important advances being made in this disease.'
For more information about the KEYNOTE-689 study, see the June 18, 2025 publication in the New England Journal of Medicine.
About Gedeptin
Gedeptin(R) is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally via an adenoviral vector encoding purine nucleoside phosphorylase (PNP). Upon systemic administration of fludarabine, the enzyme catalyzes the generation of a cytotoxic agent selectively within the tumor microenvironment. This mechanism provides dual cytotoxicity and immune modulation with minimal systemic exposure.
Gedeptin has been granted Orphan Drug Designation by the FDA for the treatment of oral and pharyngeal cancers and is protected by a growing intellectual property portfolio. GeoVax's ongoing innovation in immune-sensitizing therapies supports a broader strategy to complement checkpoint inhibitors and overcome tumor immune resistance across solid tumor types.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.
Company Contact:
[email protected]
678-384-7220
Investor Relations Contact:
[email protected]
212-698-8696
Media Contact:
Jessica Starman
[email protected]
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Associated Press
a few seconds ago
- Associated Press
Silvaco To Present at the Rosenblatt 5th Annual Technology Summit
SANTA CLARA, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Silvaco Group, Inc. (Nasdaq: SVCO, 'Silvaco'), a provider of TCAD, EDA software, and SIP solutions that enable innovative semiconductor design and digital twin modeling through AI software and innovation, today announced that Silvaco's Chief Executive Officer, Dr. Babak Taheri, will participate in a fireside chat at the Rosenblatt 5th Annual Technology Summit on Monday, August 18, at 11 a.m. Eastern time. A live webcast, as well as a replay, of the presentation will be available on the company's investor relations website at Date: Monday, August 18, 2025 Time: 11:00 a.m. Eastern time Webcast: Here (live and replay) About Silvaco Silvaco is a provider of TCAD, EDA software, and SIP solutions that enable semiconductor design and digital twin modeling through AI software and innovation. Silvaco's solutions are used for semiconductor and photonics processes, devices, and systems development across display, power devices, automotive, memory, high performance compute, foundries, photonics, internet of things, and 5G/6G mobile markets for complex SoC design. Silvaco is headquartered in Santa Clara, California, and has a global presence with offices located in North America, Europe, Egypt, Brazil, China, Japan, Korea, Singapore, Vietnam, and Taiwan. Media Contact: Tiffany Behany [email protected] Investor Contact: Greg McNiff [email protected]
Associated Press
a few seconds ago
- Associated Press
Fusion Fuel Signs Non-Binding Letter of Intent to Enter Joint Venture for Specialized Fuel Project in South Africa
DUBLIN, Ireland, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Fusion Fuel Green PLC (NASDAQ: HTOO) ('Fusion Fuel' or the 'Company'), a provider of integrated energy solutions, today announced the signing of a non-binding Letter of Intent ('LOI') to form a joint venture ('JV') with a privately-held South Africa-based specialized fuel company (the 'Partner') aimed at delivering a specialized fuel solution for a project in South Africa. The first project for the JV has been awarded to the Partner by a subsidiary of a multinational food and beverage corporation. The proposed transaction aligns with Fusion Fuel's strategic focus on near-term, revenue-generating, integrated energy investments. The project utilizes the Partner's proprietary boiler technology. The first energy solution as part of the JV is planned for deployment at a South African commercial facility and is expected to provide immediate commercial use and strong visibility on cash flow. Key terms of the LOI include: The LOI is non-binding and remains subject to satisfactory due diligence, finalization of definitive agreements, and customary closing conditions. The parties are targeting execution of definitive agreement and closing during the third quarter of 2025. 'The LOI signifies a significant milestone in our commercial strategy,' said John-Paul Backwell, CEO of Fusion Fuel. 'Not merely a development opportunity, it would allow us to invest in an awarded and contracted project with immediate revenue implications. The Partner's technology aligns well with our diverse and integrated energy platform, and we are excited to introduce this innovation to the market as we accelerate our international expansion. This potential transaction complements our previously-announced non-binding Heads of Terms to acquire a UK-based energy distribution company, thereby boosting our portfolio value, contingent upon the successful completion of both transactions. ' About Fusion Fuel Green PLC Fusion Fuel Green PLC provides integrated energy engineering, distribution, and green hydrogen solutions through its Al Shola Gas and BrightHy Solutions platforms. With operations spanning LPG supply to hydrogen solutions, the Company supports decarbonization across industrial, residential, and commercial sectors. Forward-Looking Statements This press release includes 'forward-looking statements' within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or the Company's future financial or operating performance. In some cases, you can identify these statements because they contain words such as 'may,' 'will,' 'believes,' 'expects,' 'anticipates,' 'estimates,' 'projects,' 'intends,' 'should,' 'seeks,' 'future,' 'continue,' 'plan,' 'target,' 'predict,' 'potential,' or the negative of such terms, or other comparable terminology that concern the Company's expectations, strategy, plans, or intentions. Forward-looking statements relating to expectations about future results or events are based upon information available to the Company as of today's date and are not guarantees of the future performance of the Company, and actual results may vary materially from the results and expectations discussed. The Company's expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the Company's ability to enter into definitive agreements with the Partner and the Target (as defined in the Company's press release issued on May 27, 2025), the ability of the parties to each of the LOI and the Heads of Terms (as defined in the Company's press release issued on May 27, 2025) to complete their due diligence and all other closing conditions prior to the closing of such definitive agreements, the ability of the parties to the LOI and the Heads of Terms to obtain all necessary regulatory, shareholder, and other consents and approvals in connection with the contemplated transactions, the ability of the Company to satisfy its financing commitments for the project contemplated by the LOI and the acquisition contemplated by the Heads of Terms, the ability of the project contemplated by the LOI and the Target to generate the expected free cash flows or net income necessary for the Company to generate the anticipated returns on its contemplated financial commitments or consideration in connection with these transactions, and the risks and uncertainties described under Item 3. 'Key Information – D. Risk Factors' and elsewhere in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the 'SEC') on May 9, 2025 (the 'Annual Report'), and other filings with the SEC. Should any of these risks or uncertainties materialize, or should the underlying assumptions about the Company's business and the commercial markets in which the Company operates prove incorrect, actual results may vary materially from those described as anticipated, estimated or expected in the Annual Report. All subsequent written and oral forward-looking statements concerning the Company or other matters and attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. The Company does not undertake any obligation to publicly update any of these forward-looking statements to reflect events or circumstances that may arise after the date hereof, except as required by law. Investor Relations Contact [email protected]
Associated Press
31 minutes ago
- Associated Press
Amphastar Announces FDA Approval for Iron Sucrose Injection, USP
According to the FDA, Amphastar's iron sucrose injection meets the criteria for bioequivalence and therapeutic equivalence to Venofer® for the treatment of iron deficiency anemia in patients with chronic kidney disease RANCHO CUCAMONGA, CA / ACCESS Newswire / August 11, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, today announced that the U.S. Food and Drug Administration ('FDA') has approved the Company's Abbreviated New Drug Application ('ANDA') for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002. Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). 'We are delighted to announce the FDA approval of our generic iron sucrose injection,' said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. 'This approval, once again, demonstrates our dedication to developing complex generics and leveraging cutting-edge, in-house manufacturing expertise to produce both active pharmaceutical ingredients and finished drug products under the highest regulatory standards in the U.S. We look forward to launching our iron sucrose injection in the third quarter of 2025.' According to IQVIA, the U.S. sales for Venofer® were approximately $513 million for the 12 months ended June 30, 2025. Pipeline Information The Company currently has three abbreviated new drug applications ('ANDAs') and one biosimilar insulin candidate filed with the FDA targeting products with a combined market size exceeding $2.5 billion, along with three biosimilar products in development targeting products with a market size exceeding $6 billion, and two generic products in development targeting products with a market size of over $1 billion. This market information is based on IQVIA data for the 12 months ended June 30, 2025. The Company is developing multiple proprietary products with injectable and intranasal dosage forms. About Amphastar Pharmaceuticals, Inc. Amphastar is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information and resources are available at Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar®, BAQSIMI®, Primatene MIST®, REXTOVY®, Amphadase®, and Cortrosyn®, are the property of Amphastar. Forward Looking Statements All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the impact of BAQSIMI® and Primatene MIST®, including their potential for continued revenue growth, the strategic trajectory of and market for our product pipeline, our ability to leverage our existing expertise and technology, expansion of our headquarters, including quadrupling our production capacity and manufacturing capabilities, the resilience of our supply chain, our ability to expand our automation capabilities and integrate advanced technologies, our ability to create new jobs in the future, and other future events. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'anticipate,' 'predict,' 'potential,' 'continue,' 'expect,' 'intend,' 'plan,' 'project,' 'believe,' 'estimate,' and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission ('SEC'), including in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 8, 2025, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, and our other filings or reports that we may file with the SEC. In particular, there can be no guarantee that our sales strategies will be successful, or that we will continue to experience significant sales of BAQSIMI®. You can locate these reports through our website at and on the SEC's website at The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change. Contact Information: Amphastar Pharmaceuticals, Inc. Bill Peters Chief Financial Officer (909) 980-9484 SOURCE: Amphastar Pharmaceuticals, Inc. press release
