Moderna Announces Initiation of Phase 1 Clinical Trial of mRNA-1469, Moderna's Investigational Vaccine Against Bundibugyo Ebolavirus
Rhea-AI Summary
Moderna (NASDAQ:MRNA) reported that Health Canada has authorized, and first participants have been vaccinated in, a Phase 1 clinical trial in Canada of mRNA-1469, its investigational mRNA vaccine candidate to prevent Bundibugyo ebolavirus (BDBV) disease, a strain of Ebola with no licensed vaccines.
According to Moderna, the first-in-human study (NCT07737717) at three Canadian sites will assess safety, tolerability and immunogenicity in about 80 healthy adult participants. The program is part of an expanded collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed up to US$50 million for preclinical work, Phase 1, and scaled manufacturing of additional clinical doses to support rapid progression to later-stage trials if results justify. Moderna states that, under its CEPI agreement, it will make at least 500,000 doses available for timely supply to low- and middle-income countries at access pricing if the vaccine is licensed.
Positive
- CEPI funding up to US$50 million for preclinical, Phase 1 and manufacturing support
- Phase 1 trial initiated in Canada with about 80 healthy adult participants
- Scaled manufacture of additional clinical doses planned in parallel with early development
- Commitment of at least 500,000 doses for low- and middle-income countries at access pricing if licensed
Negative
- None.
News Market Reaction – MRNA
In the Aug 4 session, MRNA gained 3.36%, reflecting a moderate positive market reaction. Argus tracked a peak move of +3.4% during that session. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 16 | Phase 1 trial initiation | Positive | -7.5% | First participant dosed in tumor-targeted cancer antigen therapy Phase 1 trial |
| Jun 08 | Trial authorization | Positive | +0.3% | UK authorization received for Phase 1/2 investigational mRNA cancer vaccine study |
| May 06 | Phase 3 clinical data | Positive | -0.5% | Published influenza vaccine efficacy data with regulatory reviews underway |
| Apr 21 | Phase 3 trial initiation | Positive | +2.5% | First participants dosed in pandemic influenza vaccine Phase 3 study |
| Apr 17 | Phase 1/2 clinical data | Positive | -1.8% | AACR presentation reported melanoma response data and FDA Fast Track designation |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-specific clinical-trial announcements produced mixed reactions, with 3 divergences and 2 alignments and an average move of -1.4%.
Key Terms
immunogenicity medical
first-in-human medical
filoviruses medical
pheic regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Phase 1 trial will evaluate safety and immune response for a strain of Ebola virus disease with no licensed vaccines indicated
Phase 1 trial is being conducted in Canada as part of our expanded collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), building on Moderna's prior filovirus research
CAMBRIDGE, MA / ACCESS Newswire / August 4, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that following Health Canada's authorization of the study, the first participants have been vaccinated in a Phase 1 clinical study in Canada evaluating mRNA-1469, the Company's investigational mRNA vaccine being evaluated to prevent Bundibugyo ebolavirus, or BDBV, disease.
The vaccine candidate is being developed using Moderna's mRNA platform, the same technology that demonstrated rapid development, scalability, and global deployment capabilities during the COVID-19 pandemic. The program also builds on Moderna's existing research and development efforts in filoviruses, including Ebola-related viruses.
"Vaccinating the first participants with mRNA-1469 marks an important milestone in advancing a vaccine candidate against Bundibugyo ebolavirus, for which no approved vaccine currently exists," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are grateful to CEPI, Health Canada, the investigators and study participants for their contributions to advance this work."
mRNA-1469 is being advanced under Moderna's expanded strategic collaboration with CEPI, who has committed up to US
"Getting Moderna's vaccine candidate into a Phase 1 trial this rapidly is a major step forward in the fight against this deadly outbreak," said Dr Richard Hatchett, CEPI's Chief Executive Officer. "This fast-growing epidemic is already the second-largest Ebola outbreak in history, and cases are rising more quickly than they did in the 2014 - 2016 West Africa epidemic which remains the largest on record. Every day matters, and every vaccine candidate in clinical trials gives us another shot at getting a safe, effective vaccine to the people who need it as swiftly as possible."
The first-in-human Phase 1 study (ClinicalTrials.gov identifier: NCT07737717) is being conducted at three sites in Canada, and will evaluate the safety, tolerability and immunogenicity of mRNA-1469 in healthy adult participants. The study is expected to enroll approximately 80 participants.
BDBV is one of the viruses that can cause Ebola disease and has been responsible for the active outbreak in the Democratic Republic of the Congo. Although vaccines are available against Zaire ebolavirus, no vaccine is currently approved to protect against disease caused by BDBV. The current outbreak was declared a Public Health Emergency of International Concern (PHEIC) and a Public Health Emergency of Continental Security (PHECS) by the World Health Organization and Africa CDC, respectively. It has already caused more than 3,000 confirmed cases and more than 1,400 deaths, making it one of the largest filovirus outbreaks in history.[1]
If licensed, Moderna is committed to enabling rapid supply and access of its BDBV vaccine to affected countries and to the populations that need them. As part of its agreement with CEPI, Moderna will make available at a minimum 500,000 doses for timely supply to low- and middle-income countries under access pricing.
About Moderna
Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.
With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.
Moderna Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's Phase 1 clinical trial of mRNA-1469; the capabilities of Moderna's mRNA platform; Moderna's strategic collaboration with CEPI and CEPI's investment; the ability to rapidly advance into Phase 2 and Phase 3 studies; and the potential for future licensure of a BDBV vaccine and Moderna's ability to enable rapid supply and access. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.
Moderna Contacts
Media:
Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651 Chris.Ridley@modernatx.com
Sacha Kennedy
Director, Communications and Media, Canada
sacha.kennedy@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834 Lavina.Talukdar@modernatx.com
[1] https://www.who.int/emergencies/alert-and-response
SOURCE: Moderna, Inc.
View the original press release on ACCESS Newswire