Center For Vaccine Research

TUESDAY, June 25, 2024 -- As scorching summer temperatures drive Americans indoors and millions travel for vacations and family gatherings, COVID infections are again climbing, U.S. health officials warned Monday. In evidence that suggests a COVID summer wave is underway, case counts are most likely increasing in 39 states and aren’t declining anywhere in the country, new data from the U.S. Centers for Disease Control and Prevention shows. While the CDC no longer tracks COVID cases, it still estimates spread of the virus using data on emergency department visits. Both COVID deaths and ED visits have risen in the last week, while hospitalizations climbed 25% from May 26 to June 1, according to the latest CDC data . “It looks like the summer wave is starting to begin,” Dr. Thomas Russo , chief of infectious diseases at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, told NBC News . Several new COVID variants are likely contributing to the summer spike in cases, Dr. Dan Barouch , director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told NBC News. “We’re seeing the start of an uptick of infections that is coincident with new variants that are developing: KP.2 and KP.3 and LB.1. It does appear that those variants do have an advantage over the prior ones,” he added. All three variants are descendants of JN.1, the version of the coronavirus that dominated this winter. KP.2 became the dominant variant last month, and then KP.3 took over in early June, NBC News reported. Along with a third variant that shares the same key mutations, KP.1.1, the group now accounts for around 63% of all COVID infections in the United States, CDC data shows. Meanwhile, LB.1 accounts for another 17.5% of COVID infections. Experts said its rapid growth indicates that it’s likely to become dominant soon. Still, “it’s sort of the newest kid on the block,” Barouch said. “There’s not much known about it.” A preprint study released this month, which hasn’t yet been peer-reviewed, suggests LB.1 is more infectious and could be better at evading protection from vaccines or previous infections. “Assuming that preliminary data is true, that it’s more immune-evasive and that it’s more infectious than KP.2 and KP.3, that’s a winning formula to infect more people,” Russo noted. Apart from variants, experts said cases will probably continue to rise as people retreat indoors to escape the heat and gather to celebrate the Fourth of July. Russo recommended that people who are vulnerable to infection and severe illness, or who are more likely to attend large parties or gatherings, consider getting the latest COVID vaccine. He added that a monoclonal antibody drug called Pemgarda has been available since April for immunocompromised people. The antiviral medication Paxlovid can also lower the likelihood of hospitalization or death. As for young, healthy people, they can hold out for the updated COVID vaccines expected to arrive this fall, experts said. This month, the U.S. Food and Drug Administration advised vaccine manufacturers to target the KP.2 variant. The CDC’s Advisory Committee on Immunization Practices is set to meet Thursday to decide who should get those shots. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

CULVER CITY, Calif.--( BUSINESS WIRE )--ImmunityBio ( NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced the recent publication of preclinical data in the online issue of Science , First Release indicating that combination therapy with N-803, an IL-15 superagonist, and broadly neutralizing antibodies may potentially enable the immune system to manage human immunodeficiency virus (HIV) without the need for antiretroviral treatment. In the preclinical non-human primate study, researchers led by Dr. James Whitney, Ph.D. and funded by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases (NIAID) demonstrated that using N-803, in combination with broadly neutralizing antibodies (bNAbs), led to sustained viral control after discontinuation of antiretroviral therapy (ART) in ART-suppressed rhesus macaques infected with simian-human immunodeficiency virus AD8 (SHIV-AD8). Treatment with N-803 and bNAbs led to immune activation and transient viremia, but only limited reductions in the SHIV reservoir. Upon ART discontinuation, all animals experienced viral rebound, followed by long-term virus control for up to 10 months in approximately 70% of those treated with N-803 and bNAbs. "The viral reservoir in people with HIV is established within the first few days of infection and cannot be eliminated by the body’s immune system or currently available treatments, representing a significant obstacle in curing an established HIV infection,” said James B. Whitney, M.D., study author and researcher at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and Harvard Medical School. “When combined with broadly neutralizing antibodies, N-803 has the potential to provide viral control without significant reduction in the viral reservoir, which further suggests that the complete eradication of this reservoir may not be required to induce sustained remission after discontinuing antiretroviral therapy." Following on from and directly attributable to these preclinical results, two clinical trials were designed to investigate the ability of N-803 and bNAbs to reduce viral loads in HIV-infected individuals on antiretroviral therapy. These Phase 1 clinical trials are investigating N-803 in combination with bNAbs in HIV-infected individuals and will include an analytical treatment interruption (ATI) to determine the effect of the immunotherapies on post therapy viral loads. (ACTG A5386, NCT04340596: and NCT05245292 at the Rockefeller University). The studies are actively enrolling participants. To learn more about ImmunityBio’s HIV research, please visit our website. ImmunityBio’s IL-15 superagonist N-803 (also called Anktiva® and nogapendekin alfa inbakicept) The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells. N-803 is a novel investigational IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its proposed mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding with generation of memory T-cells while avoiding T-reg stimulation. N-803 is designed to have improved pharmacokinetic properties, longer persistence in lymphoid tissues and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo. N-803 is currently being evaluated in adult patients in two clinical NMIBC trials. QUILT-2.005 is investigating use of N-803 in combination with BCG for patients with BCG-naïve NMIBC; QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC CIS and Papillary Disease. N-803 is investigational. Safety and efficacy have not been established by any Health Authority or Agency, including the FDA. About ImmunityBio ImmunityBio is a vertically-integrated, clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. We are applying our science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, please visit: www.immunitybio.com Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding pre-clinical study results and plans, information regarding potential benefit to patients, potential additional studies and trials, methods, regulatory pathways, and ImmunityBio’s investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) the risks and uncertainties associated with the regulatory review process including without limitation the Company’s BLA resubmission following receipt of the complete response letter (CRL) from the FDA and the ability of ImmunityBio and its third party contract manufacturing organizations to adequately address the issues raised in the CRL, (ii) whether or not the pre-clinical study referenced in this release will continue to progress as anticipated, (iii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, (iv) ImmunityBio’s ability to retain and hire key personnel, (v) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (vi) ImmunityBio’s ability to successfully commercialize its product candidates and uncertainties around regulatory reviews and approvals, (vii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its product candidates and future approved products, and (viii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 1, 2023 and the Company’s Form 10-Q filed with the SEC on November 9, 2023, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov . ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

A type of nanoparticle called a metal organic framework (MOF) could be used to deliver vaccines and act as an adjuvant. Researchers find these particles provoke a strong immune response by activating the innate immune system through cell proteins called toll-like receptors. Many vaccines, including vaccines for hepatitis B and whooping cough, consist of fragments of viral or bacterial proteins. These vaccines often include other molecules called adjuvants, which help to boost the immune system's response to the protein. Most of these adjuvants consist of aluminum salts or other molecules that provoke a nonspecific immune response. A team of MIT researchers has now shown that a type of nanoparticle called a metal organic framework (MOF) can also provoke a strong immune response, by activating the innate immune system -- the body's first line of defense against any pathogen -- through cell proteins called toll-like receptors. In a study of mice, the researchers showed that this MOF could successfully encapsulate and deliver part of the SARS-CoV-2 spike protein, while also acting as an adjuvant once the MOF is broken down inside cells. While more work would be needed to adapt these particles for use as vaccines, the study demonstrates that this type of structure can be useful for generating a strong immune response, the researchers say. "Understanding how the drug delivery vehicle can enhance an adjuvant immune response is something that could be very helpful in designing new vaccines," says Ana Jaklenec, a principal investigator at MIT's Koch Institute for Integrative Cancer Research and one of the senior authors of the new study. Robert Langer, an MIT Institute Professor and member of the Koch Institute, and Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a professor at Harvard Medical School, are also senior authors of the paper, which appears today in Science Advances. The paper's lead author is former MIT postdoc and Ibn Khaldun Fellow Shahad Alsaiari. Immune activation In this study, the researchers focused on a MOF called ZIF-8, which consists of a lattice of tetrahedral units made up of a zinc ion attached to four molecules of imidazole, an organic compound. Previous work has shown that ZIF-8 can significantly boost immune responses, but it wasn't known exactly how this particle activates the immune system. To try to figure that out, the MIT team created an experimental vaccine consisting of the SARS-CoV-2 receptor-binding protein (RBD) embedded within ZIF-8 particles. These particles are between 100 and 200 nanometers in diameter, a size that allows them to get into the body's lymph nodes directly or through immune cells such as macrophages. Once the particles enter the cells, the MOFs are broken down, releasing the viral proteins. The researchers found that the imidazole components then activate toll-like receptors (TLRs), which help to stimulate the innate immune response. "This process is analogous to establishing a covert operative team at the molecular level to transport essential elements of the Covid-19 virus to the body's immune system, where they can activate specific immune responses to boost vaccine efficacy," Alsaiari says. RNA sequencing of cells from the lymph nodes showed that mice vaccinated with ZIF-8 particles carrying the viral protein strongly activated a TLR pathway known as TLR-7, which led to greater production of cytokines and other molecules involved in inflammation. Mice vaccinated with these particles generated a much stronger response to the viral protein than mice that received the protein on its own. "Not only are we delivering the protein in a more controlled way through a nanoparticle, but the compositional structure of this particle is also acting as an adjuvant," Jaklenec says. "We were able to achieve very specific responses to the Covid protein, and with a dose-sparing effect compared to using the protein by itself to vaccinate." Vaccine access While this study and others have demonstrated ZIF-8's immunogenic ability, more work needs to be done to evaluate the particles' safety and potential to be scaled up for large-scale manufacturing. If ZIF-8 is not developed as a vaccine carrier, the findings from the study should help to guide researchers in developing similar nanoparticles that could be used to deliver subunit vaccines, Jaklenec says. "Most subunit vaccines usually have two separate components: an antigen and an adjuvant," Jaklenec says. "Designing new vaccines that utilize nanoparticles with specific chemical moieties which not only aid in antigen delivery but can also activate particular immune pathways have the potential to enhance vaccine potency." One advantage to developing a subunit vaccine for Covid-19 is that such vaccines are usually easier and cheaper to manufacture than mRNA vaccines, which could make it easier to distribute them around the world, the researchers say. "Subunit vaccines have been around for a long time, and they tend to be cheaper to produce, so that opens up more access to vaccines, especially in times of pandemic," Jaklenec says. The research was funded by Ibn Khaldun Fellowships for Saudi Arabian Women and in part by the Koch Institute Support (core) Grant from the U.S. National Cancer Institute.