Plague

Deep Track Capital, which owns about 13.5% of Dynavax\'s stock, is launching a proxy fight to steer the company\'s resources toward approved hepatitis B vaccine Heplisav.\n After privately vying for a change to Dynavax’s corporate strategy for months, life sciences investment firm Deep Track Capital is publicly launching a proxy fight in a bid to steer the company in a new direction.Deep Track has nominated four directors to Dynavax’s board and sent a letter to other shareholders Feb. 19 announcing its intention to refocus the company’s efforts to its sole approved asset, hepatitis B vaccine Heplisav, rather than what Deep Track calls a “misguided empire-building exercise” of pursuing external asset acquisitions.Deep Track’s senior members first invested in Dynavax about 15 years ago to support the development of Heplisav, according to the letter, and the firm currently owns about 13.5% of Dynavax’s shares.Deep Track outlined several concerns about Dynavax’s current board, which now has 11 members but will drop back down to the previous head count of nine after the elections at the company’s upcoming 2025 annual meeting.These concerns include the fact that none of the board members up for election, including Chairman Scott Myers, has ever purchased Dynavax stock on the open market; that Myers also serves as chairman of three other biotech companies; and that Dynavax staggers board elections rather than putting every member up for election at once.Deep Track’s four proposed candidates include the firm’s managing director Brett Erkman as well as three independent biotech execs: Jeffrey Farrow, chief financial officer at Tarsus Pharmaceuticals; Michael Mullette, interim CEO at Lykos Therapeutics; and Donald Santel, former president and CEO of Hyperion Therapeutics.“In our view, the board’s unwillingness to compromise, coupled with the urgency of addressing the risk that the company squanders its cash, warrants this level of change,” Deep Track wrote.Since 2021, Dynavax’s board has instructed management to seek out external assets to purchase, Deep Track detailed in the letter. However, “these efforts have yielded nothing, and we believe continuing this effort will only further distract management from growing Heplisav,” the investment firm said.Dynavax came out with a lengthy statement and attacked Deep Track Wednesday night. In the release, the biopharma said that the firm, \"and in particular its founder, David Kroin, have become fixated on a strategy for Dynavax based on significantly flawed financial and strategic assumptions.\" It said that whilst it had been attempting to work with Deep Track, the firm had instead been \"insistent on a value destructive plan,\" that included \"abandoning portfolio diversification\" and running what it called a \"strip-mining plan.\"That plan is being seen through, Dynavax argues, by this attempted change of board members. The company argues that it already has since August been seeking out new directors \"as part of its ongoing refreshment program.\" The biopharma added that Deep Track initially proposed three new directors, but that Dynavax only saw one as being \"additive to the Board.\" Dynavax said its board sees the proxy contest as \"unreasonable,\" but that it still \"remains committed to constructive and reasonable engagement with Deep Track, while ensuring that the best interests of all stockholders—not only those of Mr. Kroin and his fund—are protected and represented.\" Heplisav was approved in 2017 and is projected to generate more than $1 billion through 2030, according to Deep Track. Dynavax has two other vaccines currently in development: a wholly owned vaccine for shingles and a Department of Defense-partnered vaccine for plague. Deep Track made no mention of either candidate in its letter.Another early-stage asset, a combination vaccine for tetanus, diphtheria and acellular pertussis, was dropped in November 2024 after phase 1 data failed to impress.Last month, Dynavax revealed changes to its board that it said were part of a \"refreshment program.\" These include appointing Emilio Emini, Ph.D., and Lauren Silvernail to the board as well as seeking shareholder approval to phase out Dynavax\'s staggered board elections.Deep Track called these changes \"reactive,\" noting that Silvernail is connected to Myers through Harpoon Therapeutics just like the board member she is replacing, Julie Eastland. The firm also expressed concern that changes to the board\'s election structure, so that all board seats come up for election at the same time, won\'t be fully implemented until 2028.Dynavax reports its full-year 2024 results Feb. 20. 

EMERYVILLE, Calif., Oct. 24, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report third quarter 2024 financial results on Thursday, November 7, 2024, after the U.S. financial markets close. Dynavax will host a conference call and live audio webcast on Thursday, November 7, 2024, at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at . A replay of the webcast will be available for 30 days following the live event. To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call. 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 multiple adjuvanted COVID-19 vaccines. Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant with adjuvanted vaccine clinical programs for shingles and Tdap, and through global collaborations, currently focused on adjuvanted vaccines for COVID-19, plague, seasonal influenza and universal influenza. For more information about our marketed products and development pipeline, visit and follow Dynavax on LinkedIn and Twitter. 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

Unique international partnership marks significant momentum for new gene therapy entity PHILADELPHIA, Oct. 8, 2024 /PRNewswire/ -- Today, GEMMA Biotherapeutics ("GEMMABio") – a new therapeutics company founded by gene therapy pioneer Dr. Jim Wilson – announced a major agreement with the Oswaldo Cruz Foundation ("Fiocruz"), a public health research institution that is part of the Ministry of Health of Brazil and has extensive experience in biomanufacturing. GEMMABio partnered with Fiocruz – which is the main supplier of immunobiologics, biopharmaceuticals and diagnostics to the Brazilian Ministry of Health – to sponsor research that will bring gene therapy treatments to the people of Brazil under the Sistema Único de Saúde (SUS), Brazil's publicly funded health care system. Fiocruz will fund up to $100 million, which will be used to conduct clinical research and manufacturing – ultimately securing approval for programs that will allow the country to increase distribution of rare disease treatments and at a more affordable cost. "By combining our resources and knowledge, this collaboration represents a major advancement in making gene therapies accessible to more patients quickly and at a fraction of the typical cost," said Dr. Wilson, who will serve as President and CEO of GEMMABio. "We are optimistic that this deal will serve as a global example for expanding access to advanced medical therapies as well as pursuing non-traditional ways to capitalize biotech companies." A key component of the partnership will involve tech transfer, replicating GEMMABio's manufacturing technologies and process so that the companies can collaborate on programs and production in Brazil and for Fiocruz to utilize with other sponsors and programs. The agreement will also fund clinical development activities in Brazil for six core programs, including GM1 gangliosidosis (GM1), Krabbe Disease, Metachromatic leukodystrophy (MLD), and three unnamed programs. In return for their financial support, Fiocruz will be able to license related treatments to supply the Brazilian public health system. "Brazil has the largest public health system in the world, offering health services and products to more than 200 million people. We are very proud to bring this innovation to the Brazilian system, a technology that was previously restricted to those with higher incomes, will now be accessible to the entire Brazilian population" said Marco Krieger, Vice President of Production and Innovation in Health, Fiocruz. About GEMMABio GEMMABio is a therapeutics company focused on speeding the research of and global access to life-changing advanced therapies for those living with rare diseases. The company will provide research and product development functions to bring gene therapy discoveries from the bench to the bedside faster and affordably. GEMMABio is led by gene therapy industry pioneer Jim Wilson and his team of experts, who previously conducted their work in academia. Wilson is also the Chairperson of Franklin Biolabs, a Contract Research Organization. The collective goal of the two affiliated companies is to translate innovative scientific work into clinical trials, to then commercialize and distribute the new therapies around the world to patients who need them most. For more information, please visit gemmabiotx.com. About Fiocruz The Oswaldo Cruz Foundation (Fiocruz) is the largest biomedical research institution in Latin America, which also produces vaccines, medicines and in vitro diagnostics (IVD) to supply the Unified Health System (SUS, acronym in Portuguese for the Brazilian public health system). Linked to the Brazilian Ministry of Health, the Foundation was created on May 25, 1900 to initially manufacture serums and vaccines against bubonic plague. Since then, the institution has experienced an intense trajectory, which is intertwined with the development of public health in Brazil. Currently, Fiocruz is installed in 10 states, in addition to the Federal District, and has an office in Maputo, capital of Mozambique, Africa. In addition to the institutes based in Rio de Janeiro, the Foundation maintains units in the Northeast, North, Southeast and South regions of Brazil, and offices in Ceará, Mato Grosso do Sul, Piauí and Rondônia. In total, there are 16 technical-scientific units, focused on teaching, research, innovation, assistance, technological development and extension in the field of health. For more information, visit . Contact: Scott Hoeflich [email protected] SOURCE GEMMA Biotherapeutics and Franklin Biolabs WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED