CpG1018

The UVAX-1107 protein nanoparticle vaccine was safe and well-tolerated in healthy volunteers at the planned Interim Analysis #1 The planned Interim Analysis #1 was performed after two priming doses of UVAX-1107, out of the planned two priming vaccinations with UVAX-1107 followed by two booster vaccinations with UVAX-1107/UVAX-1197 A planned immunogenicity analysis showed robust vaccine-matched IgG antibody responses in 100% of subjects after receiving two priming doses of UVAX-1107 NEWARK, DE, USA I November 19, 2024 I Uvax Bio, LLC , (“Uvax” or “the Company”) a privately held, clinical-stage vaccine company utilizing rational design principles to deliver novel protein-based nanoparticle vaccines, today announced the results of the interim analysis from their first Phase 1 clinical trial evaluating the Company’s HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197, in healthy volunteers in Australia. In the first stage of this trial, the subjects received either UVAX-1107 adjuvanted with CpG 1018 ® (Dynavax) and aluminum hydroxide or placebo. UVAX-1107 utilizes Uvax Bio’s 1c-SApNP ® vaccine development platform to generate virus-like particles (VLPs) which closely resemble the target virus in size, shape, and multivalent antigen display; in this case, 20 copies of the native-like, prefusion-stabilized trimeric HIV-1 antigen. Safe and Well Tolerated “We are pleased that our first Phase 1 trial is progressing smoothly, and we have preliminary confirmation that UVAX-1107 was well tolerated at all doses by the study participants, and no vaccine-related serious adverse events were reported,” said Pedro Garbes, M.D., Vice President and Global Clinical Lead of Uvax Bio. “As per the time of this 1 st interim analysis, no participant was withdrawn from the study due to local/systemic reactogenicity; local and systemic adverse events were mild to moderate, transient, and they resolved on average within two days. These preliminary safety results are aligned with expectations for an adjuvanted protein-based vaccine.” Early Immune Responses UVAX-1107 was immunogenic and generated robust IgG responses to the vaccine antigen derived from an HIV-1 strain known as BG505. 100% of subjects in the vaccine group demonstrated antibody responses after two priming vaccinations with UVAX-1107. Antibody response titers increased >200-fold 14 days after the 2 nd dose as compared to the same period following the first dose. About the Uvax Bio HIV-101 Phase 1 HIV-1 Vaccine Trial The first-in-human clinical trial UVAX-HIV-101 (ClinicalTrials.gov ID NCT06541093) is evaluating two different regimens of the UVAX-1107 and UVAX-1197 vaccines in 34 healthy adult volunteers who meet the study eligibility criteria. The primary endpoints of the study will measure safety and immunogenicity of UVAX-1107 and UVAX-1197 after the priming and boosting dose series being evaluated in parallel arms. The study will also investigate whether either vaccine or the combination of both produces the optimal immunological response. Uvax Bio expects to report topline data from a 2 nd interim analysis after the first booster vaccination (out of two boosters with UVAX-1107/UVAX-1197/Placebo) for the Phase 1 trial in the first quarter of 2025. The need for an HIV Vaccine There is a tremendous unmet need for a vaccine to help protect against HIV-1 infection. The Joint United Nations Programme on HIV/AIDS estimates that 39 million people worldwide are currently living with HIV. According to the World Health Organization (WHO), an estimated 1.3 million people worldwide become infected with HIV annually. Globally, 9.2 million people living with HIV are not receiving treatment. The majority of new infections come from undiagnosed or undertreated HIV patients (WHO/CDC). About UVAX-1107 and UVAX-1197 The UVAX-1197 HIV-1 vaccine was designed and produced based on Uvax Bio’s proprietary 1c-SApNP ® technology. These vaccines employ two innovative technologies. This first is the unique antigen design of the uncleaved prefusion-optimized (UFO) HIV-1 envelope (Env) trimers. The second is the self-assembled, multi-layered protein nanoparticle which displays 20 copies of the UFO trimer in a symmetrical manner. UVAX-1107 employs a third advanced technology called “glycan-trimming” to remove a portion of the glycan shield to allow better access to the conserved neutralizing epitopes on HIV-1 Env. This third technology was recognized by the International Union of Pure and Applied Chemistry (IUPAC) – who dubbed it “low-sugar vaccination” – as one of the Top Ten Emerging Technologies in Chemistry for 2023. The UFO trimer, 1c-SApNP platform, and glycan trimming strategy were developed by Dr. Jiang Zhu’s laboratory at Scripps Research in La Jolla, CA ( https://www.scripps.edu/faculty/zhu/ ). About Uvax Bio Uvax Bio, LLC , a spin-off vaccine company from Scripps Research, employs proprietary 1c-SA p NP ® platform technology invented by Scripps researchers to develop and commercialize vaccines for challenging infectious diseases. The 1c-SA p NP ® platform utilizes the latest advances in computational and structural biology to design and produce complex protein structures (VLPs) that closely resemble the target virus in its infectious form. These intricately designed VLPs activate and prolong interaction with the immune system, which is expected to generate more potent and durable immune responses compared to soluble protein vaccines. Uvax Bio holds exclusive worldwide rights to the 1c-SApNP ® platform and an expanding portfolio of 12 patented vaccine candidates in development at stages ranging from optimization to clinical development. In addition to the leading clinical candidates for HIV-1, Uvax Bio is working to advance its vaccine candidates for influenza, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and hepatitis C virus (HCV). Uvax Bio vaccines are produced using a single-step, universal, cell-based manufacturing process. For more information, visit www.uvaxbio.com . UVAX HIV-101 Phase 1 Clinical Study Clinical Trials.gov https://clinicaltrials.gov/study/NCT06541093?term=NCT06541093&rank=1 SOURCE: Uvax Bio

EMERYVILLE, Calif., Nov. 11, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that it has entered into an Accelerated Share Repurchase transaction ("ASR") under an agreement with Goldman Sachs & Co. LLC to repurchase $100 million of the Company's common stock. Dynavax executed the ASR as part of the $200 million share repurchase program authorized by its Board of Directors in November 2024. Upon completion of this ASR, Dynavax will have $100 million remaining under the program. "Today's announcement of the accelerated share repurchase program reinforces our confidence in our business and our commitment to deliver value to our shareholders through our disciplined and thoughtful approach to capital allocation. We believe that our commercial success and financial position gives us the ability to strategically deploy capital, execute on our business strategy and invest in our long-term growth," said Kelly MacDonald, Chief Financial Officer of Dynavax. "We remain committed to leveraging our $200 million share repurchase program to create value for our shareholders through our balanced capital allocation strategy." Under terms of the agreement, Dynavax will pay $100 million to Goldman Sachs & Co. LLC and will initially receive approximately 6.1 million shares, with an aggregate value representing approximately 80% of the $100 million paid to Goldman Sachs & Co. LLC based on the $13.01 closing stock price of Dynavax's common stock on November 8, 2021. The final number of shares repurchased under the ASR will be based on the volume-weighted average prices of Dynavax's common stock during the term of the ASR, and subject to adjustments related to the terms and conditions of the ASR agreement. The final settlement of the ASR is expected to be completed in the first quarter of 2025. As of November 5, 2024, Dynavax had approximately 131.5 million shares outstanding. About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. For more information about our marketed products and development pipeline, visit . Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "toward," "will," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding our ability to execute on our strategic objectives, the anticipated benefits of our share repurchase program and the expected timing for completion of the ASR transaction. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that our share repurchase program may not provide the benefits anticipated, as well as other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the three months ended September 30, 2024 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at is not incorporated by reference in our current periodic reports with the SEC. For Investors/Media: Paul Cox [email protected] 510-665-0499 Nicole Arndt [email protected] 510-665-7264 SOURCE Dynavax Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED