Rho Federal Systems Division, Inc.

Pictured: Entrance to the Department of Health and Human Services/iStock, hapabapa The Department of Health and Human Services announced on Tuesday more than $1.4 billion in funding to support the development of next-generation COVID-19 vaccines and treatments. The investments are part of the HHS’s Project NextGen, a $5 billion initiative designed to help the U.S. “stay ahead of COVID-19,” according to the agency’s website. By fostering collaborations between the federal government and the private sector, Project NextGen—a successor to Operation Warp Speed—seeks to accelerate the development of new vaccines and therapies, usher them through clinical trials and the regulatory process, and see them through to market. Among the awardees is Regeneron, which secured a $326 million grant as part of its agreement with the Biomedical Advanced Research and Development Authority (BARDA). The New York biotech will use the money to cover up to 70% of costs for certain R&D activities for its preventive monoclonal antibody. In 2020, Regeneron developed an antibody cocktail with casirivimab and imdevimab to treat mild-to-moderate COVID-19. This won the FDA’s emergency use authorization in November of the same year, but in January 2022 the regulator limited its use after finding that it was unlikely to be effective against the dominant Omicron variant. In its press announcement Tuesday, Regeneron noted that the new monoclonal antibody program falls under a 2017 agreement with BARDA to “develop a portfolio of antibodies targeting up to 10 pathogens that pose significant risk to public health.” Regeneron and the HHS expect the new monoclonal antibody to start clinical trials this fall. Tuesday’s funding also includes a $1 billion grant to four clinical trial partners, including the contract research organizations ICON Government and Public Health Solutions, Pharm-Olam, Technical Resources International and Rho Federal Systems, as well as a $10 million award to Johnson & Johnson Innovation to bankroll startups targeting infectious disease treatment and prevention. The HHS will also give $100 million to Global Health Investment Corporation, a non-profit that manages the BARDA Ventures investment portfolio. “Project NextGen is a key part of the Biden-Harris Administration’s commitment to keeping people safe from COVID-19 variants,” HHS Secretary Xavier Becerra said in a statement, adding that Tuesday’s funding awards will spark more efforts across the industry to “quickly develop vaccines and continue to ensure availability of effective treatments.” HHS confirmed to Endpoints News that Pfizer and Moderna will not receive funding through Project NextGen. The agency also plans to announce additional awards under the project by the end of the year. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Regeneron will receive $326m to develop a new monoclonal antibody to prevent Covid-19 infection. Credit: Viacheslav Lopatin / Shutterstock.com. The US Department of Health and Human Services (HHS) has made a grant of more than $1.4bn to Project NextGen to facilitate the development of new vaccines and therapeutics for Covid-19. Project NextGen is a $5bn programme led by the Administration for Strategic Preparedness and Response’s (ASPR) Biomedical Advanced Research and Development Authority (BARDA) in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). Recommended Reports Reports LOA and PTSR Model - Ribociclib Succinate in Pediatric Diffuse Intrinsic Pontine Glioma GlobalData Reports LOA and PTSR Model - pneumococcal (24-valent) vaccine GlobalData View all Companies Intelligence The National Institute of Allergy and Infectious Diseases J Labs ICON Government and Public Health Solutions, Inc. Regeneron GmbH HH&S Ltd View all This initiative focuses on progressing vaccines and therapies into clinical trials, and their subsequent regulatory review and commercialisation for use by Americans. The latest funding includes a $1bn award to four BARDA clinical trial partners, ICON Government and Public Health Solutions, Pharm-Olam, Technical Resources and Rho Federal Systems, to carry out Phase IIb clinical trials of a vaccine. Regeneron will receive $326m to develop a new monoclonal antibody to prevent Covid-19 infection. Global Health Investment (GHIC) will be awarded $100m to advance technologies to expedite future responses. There is also an award of $10m to Johnson & Johnson Innovation (JLABS) for the Blue Knight initiative, a collaboration between BARDA and JLABS. HHS Secretary Xavier Becerra stated: “Project NextGen is a key part of the Biden-Harris administration’s commitment to keeping people safe from Covid-19 variants. “These awards are a catalyst for the programme – kickstarting efforts to more quickly develop vaccines and continue to ensure availability of effective treatments.”

The U.S. government will spend $1.4 billion across a series of contracts to develop new drugs and vaccines for COVID-19, the Department of Health and Human Services announced Tuesday.The awards represent the first major announcement by Project NextGen, a federal program designed to spur newer therapies and protective shots against the coronavirus.Announced in May, the program is a successor to the Operation Warp Speed initiative that helped bring the first COVID vaccines and drugs to market in record time.Yet Project NextGen has been put together at a time when urgency around COVID has cooled and demand for existing treatments has slowed. Pfizer, for instance, has warned of cost cuts amid falling sales of the shot it developed with German biotech BioNTech. It and its rivals are also more focused on updating shots to match newer variants, rather than making more substantive changes such as a pan-coronavirus vaccines or intranasal shot.The project is backed by $5 billion, far less than Operation Warp Speed eventually assembled, and doesnt have the same wherewithal to make the bulk purchases that fueled the massive vaccine rollout in the first pandemic years.Still, public health officials aim to develop new therapies, among them vaccines that can provide broader or longer-lasting protection, as well as antibody drugs more resilient to new viral variants.COVID infections and hospitalizations are climbing in the U.S., according to recent data from the Centers for Disease Control and Prevention, a trend thats expected to continue in the fall and winter. Newer versions of the virus called Eris and Fornax are now more prevalent.As the virus continues to evolve, we need new tools that keep pace with those changes, said Assistant Secretary for Preparedness and Response Dawn OConnell, in a statement. Project NextGen combines the research and development expertise at HHS with the lessons we have learned about the virus throughout the pandemic strengthening our preparedness for whatever comes next.In its announcement Tuesday, HHS said it awarded a $326 million contract to Regeneron Pharmaceuticals. The biotech was one of a few companies to successfully develop an antibody drug for COVID, medicines that helped protect people from some of the diseases worst outcomes. Yet that success was short-lived, as new coronavirus variants evaded the protection of Regenerons drug as well as others like it.The new contract will fund work on a newer antibody with broad neutralizing activity against the coronavirus, according to Regeneron. The biotech company will invent and propose a drug candidate and then work with the Biomedical Advanced Research and Development Authority to advance it.HHS will cover up to 70% of the development costs. The antibody will be designed for people who dont respond to, or cant take, the marketed vaccines, which HHS called a critical need and current gap in available care.Although COVID-19 has moved to an endemic stage, many people including those with immunocompromising conditions continue to face exposure that impacts their everyday life and could cause serious health consequences, said CEO Leonard Schleifer, in a statement.The bulk of the remaining funding, about $1 billion, is going to four clinical trial partners of BARDA: ICON Government and Public Health Solutions, Pharm-Olam, Technical Resources International and Rho Federal Systems. That money is meant to create a network of at-the-ready trials that can pivot to different vaccine candidates as theyre ready. The first trials could begin this winter, according to HHS.The last of the funds were awarded to Global Health Investment and Johnson & Johnson to help back newer development and manufacturing methods. Additional awards are expected by the end of the year as well, HHS said. '