Hepatitis B vaccine(Merck Sharp & Dohme)

Appoints Emilio Emini and Lauren Silvernail to Board of Directors; Two Directors to Step Down at 2025 Annual Meeting Intends to Seek Stockholder Approval for Declassification of Board at 2025 Annual Meeting EMERYVILLE, Calif., Jan. 27, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) (the "Company"), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced the following changes to its Board of Directors as part of its ongoing refreshment program: Emilio Emini, Ph.D. and Lauren Silvernail have been appointed to the Board, effective February 3, 2025. Dr. Emini will serve as a Class III director with an initial term expiring at the Company's 2027 Annual Meeting and Ms. Silvernail will serve as a Class I director with an initial term expiring at the Company's 2025 Annual Meeting. Peggy Phillips, who has served on the Dynavax Board since 2006, will retire from the Board at the 2025 Annual Meeting. Julie Eastland will step down from the Board at the 2025 Annual Meeting given her recent appointment as chief executive officer of another public company. The Board expects to appoint Ms. Silvernail as Chair of the Audit Committee and Scott Myers as Chair of the Compensation Committee following the 2025 Annual Meeting. The Board intends to seek stockholder approval at the 2025 Annual Meeting for the declassification of the Board. If stockholders approve the proposal, directors standing for election at the Company's 2026 Annual Meeting and thereafter will stand for one-year terms. Beginning with the Company's 2028 Annual Meeting, all directors will stand for election annually. Following the 2025 Annual Meeting, the Board will be comprised of nine directors, with six of its eight independent directors having been appointed since 2020. "Emilio and Lauren are two renowned leaders in their respective fields and we expect that their tremendous expertise will be immediately additive as the Company continues to execute its strategic plan and deliver for our stakeholders. Emilio has been at the forefront of some of the most notable vaccines and brings a unique perspective at the intersection of R&D, academia and public health and Lauren brings a track record of financial and operational prowess and board leadership experience within the biopharma space," said Scott Myers, Chairman of the Dynavax Board of Directors. "On behalf of the Board, I want to extend my gratitude to Peggy and Julie who have made innumerable contributions to Dynavax's growth and success over the years. Our ongoing efforts to refresh our Board with fresh perspective and expertise and enhance our governance profile are key pillars of our commitment to support Dynavax's long-term growth objectives and the changes announced today underscore this commitment." Dr. Emini said, "Dynavax has an important mission, one that I firmly share, and I am excited to work alongside the Board and the Dynavax team, a group of world-class innovators and scientists serving patients globally." Ms. Silvernail said, "Dynavax is a clear category leader with its lead asset, HEPLISAV-B, and I am eager to work with the Board to help advance the Company's strategic and financial initiatives to capitalize on its positive momentum." "We have started 2025 with strong momentum, achieving record annual revenue for HEPLISAV-B in 2024 and advancing our pipeline programs, while returning capital to our stockholders with our active $200 million share repurchase program. Through the execution of our strategic growth pillars with discipline and rigor, we will continue to focus on delivering value for our stockholders and other stakeholders, and I am looking forward to working alongside Emilio and Lauren as we look to capture the significant opportunities ahead," said Ryan Spencer, Chief Executive Officer of Dynavax. About Emilio Emini Dr. Emini brings over 40 years of experience as an executive and academic across the biopharmaceutical industry and global public health roles, helping to develop and deliver multiple anti-infectious disease interventions. Prior to his retirement, Dr. Emini served as Chief Executive Officer of the Bill & Melinda Gates Medical Research Institute and as the Director of the Foundation's Tuberculosis and HIV Programs. At the Merck Research Laboratories, from 1983 to 2004, Dr. Emini led the biological research that developed the first highly active antiretroviral therapies for HIV and led multiple vaccine research teams that contributed to many successful developments, including the vaccines for human papillomavirus and rotavirus. Following a two-year leave from the industry at the International AIDS Vaccine Initiative, Dr. Emini joined Wyeth/Pfizer as the Senior Vice President of Vaccine R&D where he led the development of the Prevenar 13® vaccine for prevention of pneumococcal disease. Dr. Emini holds a Bachelor of Science from Manhattan College and a Ph.D. in Microbiology from the Cornell University Graduate School of Medicine. About Lauren Silvernail Ms. Silvernail has three decades of experience leading finance and business development functions across the pharmaceutical industry. She most recently served as Chief Financial Officer and Executive Vice President of Corporate Development of Evolus, Inc., from 2018 until her retirement in 2022, where she led fundraising, financial and partnership activities including establishing the infrastructure for the U.S. commercial launch of the company's first approved product. Previously, she served as Chief Financial Officer and Chief Business Officer at Revance Therapeutics, Inc., where she led the company's initial public offering and subsequent rounds of financing. Prior to that, Ms. Silvernail was Chief Financial Officer and Executive Vice President of Corporate Development at ISTA Pharmaceuticals until its sale to Bausch & Lomb. Prior to that, she held corporate development roles at Allergan and other companies. Ms. Silvernail is currently a director and Audit Committee Chair of Harrow and previously served as a director and Audit Committee Chair at Harpoon Therapeutics until its successful sale to Merck and a director and Corporate Governance Committee chair at Nicox S.A. She earned an M.B.A. in finance and accounting from the Anderson Graduate School of Management at UCLA, and a B.A. in Biophysics from the University of California, Berkeley. 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 the Company's plans to submit a declassification proposal at its 2025 Annual Meeting, expected contributions from newly appointed directors, the planned resignation of certain directors, anticipated committee appointments, expectations regarding delivering value for our stockholders, and our future growth and long-term performance. 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 circumstances surrounding or leading up to our 2025 Annual Meeting may change, risks relating to our ability to commercialize and supply HEPLISAV-B, and risks related to the implementation of our long-term growth objectives, 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

The U.S. Food and Drug Administration has a very busy calendar for the end of November and beginning of December. Here’s a look. The U.S. Food and Drug Administration (FDA) has a very busy calendar for the end of November and beginning of December. Here’s a look. Legend Biotech and Janssen’s Ciltacabtagene Autoleucel for Multiple Myeloma Legend Biotech and Janssen Biotech , a Johnson & Johnson company, had a target action date of November 29, 2021, for ciltacabtagene autoleucel (cilta-cel) for relapsed/refractory multiple myeloma. The therapy is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy. It is being reviewed under a Priority Review pathway. The submission was based on data from the pivotal Phase Ib/II CARTITUDE-1 study. On November 1, the two companies reported the FDA had extended the PDUFA date to February 28, 2022. “We are working closely with Janssen and the FDA to facilitate an efficient and thorough review of the BLA for cilta-cel,” said Ying Huang, chief executive officer and chief financial officer of Legend. “We remain confident that cilta-cel has shown great promise in patients with relapsed and refractory multiple myeloma, and we are focused on making this therapy available to them in the U.S. as soon as possible.” Adcom for Merck and Ridgeback’s EUA for Molnupiravir for COVID-19 The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) met to discuss Merck and Ridgeback Biotherapeutics antiviral drug, molnupiravir on November 30. On October 1, the two companies reported interim data on the Phase III trial in mild-to-moderate COVID-19. The data was strong, decreasing the risk for hospitalization and death in adults by about 50%. However, at the adcom meeting , the final analysis had the drug at about 30% effectiveness. Two concerns were also discussed. One is whether the drug is safe for pregnant women. The clinical studies didn’t include pregnant women, and because of the unusual way the drug works, there are concerns it might be unsafe for developing fetuses, although not much is known about the risk. The advisory committee said the drug should carry warnings about risk during pregnancy, but would still have the option to prescribe if the benefits and situation outweighed the risks. The Adcom also said the drug should not be used with children. The other issue was concerns it could cause vaccine-resistant COVID-19 mutations, which does happen with antiviral drugs. However, Merck’s research to date hasn’t indicated that occurs with molnupiravir. “We should worry about the dangers to pregnant women and the dangers of developing resistance,” said Eric Rubin, an infectious disease expert at the Harvard T.H. Chan School of Public Health and editor-in-chief of the New England Journal of Medicine. “But if we have a drug that works, we want that drug. We just have to figure out how best to use it given its limitations.” Amryt’s Oleogel-S10 for Epidermolysis Bullosa Amryt Pharma had a target action date of November 30 for its New Drug Application (NDA) for Oleogel-S10 for treatment of Epidermolysis Bullosa (EB). The drug is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic EB, a rare genetic skin disease affecting young children and adults. There are no approved treatments. It had previously received Fast Track Designation and Rare Pediatric Disease Designation from the FDA. On November 23, the company reported the FDA had extended the review period for the drug with a new PDUFA date of February 28, 2022. This was in response to new information the agency had requested. BeyondSpring’s Plinabulin for Chemotherapy-Induced Neutropenia BeyondSpring has a target action date of November 30 for its NDA for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). The drug is an IV infused small molecule that acts as a selective immunomodulating microtubule-binding agent (SIMBA), with immune anti-cancer activities. The NDA was based on data from the PROTECTIVE-2 Phase III trial as well as five supportive trials. The trial hit the primary endpoint in the rate of prevention of grade 4 neutropenia in Cycle 1 and hit all key secondary endpoints, including duration of severe neutropenia and absolute neutrophil count nadir. CTI BioPharma’s Pacritinib for Myelofibrosis CTI BioPharma has a target action date of November 30 for its NDA for pacritinib for myelofibrosis patients with severe thrombocytopenia. It is being evaluated under Priority Review. The NDA was based on data from the Phase III PERSIST-2 and PERSIST-1 and the Phase II PAC203 trials. The drug is an oral kinase inhibitor with specificity for JAK2, IRAK2, and CSF1R, but not JAK1. VBI Vaccines’ Hepatitis B Vaccine VBI Vaccines has a target action date of November 30 for its 3-antigen prophylactic hepatitis B vaccine candidate for prevention of infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. The BLA is supported by data from the two Phase III trials, PROTECT and CONSTANT, as well as other relevant data. At the company’s third-quarter report on November 8, Jeff Baxter, VBI’s president and chief executive officer said, “The third quarter of 2021 was a notably busy and productive time as we support the ongoing regulatory reviews of our prophylactic 3-antigen HBV vaccine candidate, prepare for the potential launch of this candidate in the U.S., Europe, and Canada, and advance both our immunotherapeutic vaccine candidates against GBM and chronic HBV, as well as our coronavirus pipeline, with the objective of creating vaccines that provide long-term breadth of protection with good safety and tolerability pro ” Exelixis’ Cabozantinib in Differentiated Thyroid Cancer Exelixis has a target action date of December 4 for its supplemental NDA (sNDA) for cabozantinib in differentiated thyroid cancer. The sNDA is based on data from the COSMIC-311 trial. COSMIC-311 compared Cabometyx to placebo in patients with radioactive iodine-refractory differentiated thyroid cancer patients who progressed after up to two previous VEGFR-targeted therapies. At a planned interim analysis, the drug met one of the trial’s primary endpoint, showing improvement in progression-free survival. Merck’s Keytruda for Stage II Melanoma Merck has a target action date for its supplemental BLA (sBLA) of December 4. The sBLA is based on interim analysis of the Phase III KEYNOTE-716 trial. The drug, an anti-PD-1 checkpoint inhibitor, hit the primary endpoint of recurrence-free survival (RFS) for adjuvant treatment of patients with surgically resected high-risk stage II melanoma. It was granted Priority Review.