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News Article | July 24, 2017
Site: www.eurekalert.org

Results from an early-stage clinical trial called APPROACH show that an investigational HIV vaccine regimen was well-tolerated and generated immune responses against HIV in healthy adults. The APPROACH findings, as well as results expected in late 2017 from another early-stage clinical trial called TRAVERSE, will form the basis of the decision whether to move forward with a larger trial in southern Africa to evaluate vaccine safety and efficacy among women at risk of acquiring HIV. The APPROACH results will be presented July 24 at the 9th International AIDS Society Conference on HIV Science in Paris. The experimental vaccine regimens evaluated in APPROACH are based on "mosaic" vaccines designed to induce immunological responses against a wide variety of HIV subtypes responsible for HIV infections globally. Different HIV subtypes, or clades, predominate in various geographic regions around the world. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, funded pre-clinical development of these vaccines. Together with other partners, NIAID supported the APPROACH trial, which is sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The manufacture and clinical development of the mosaic vaccines are led by Janssen. "A safe and effective HIV vaccine would be a powerful tool to reduce new HIV infections worldwide and help bring about a durable end to the HIV/AIDS pandemic," said NIAID Director Anthony S. Fauci, M.D. "By exploring multiple promising avenues of vaccine development research, we expand our opportunities to achieve these goals." APPROACH involved nearly 400 volunteers in the United States, Rwanda, Uganda, South Africa and Thailand who were randomly assigned to receive one of seven experimental vaccine regimens or a placebo. APPROACH found that different mosaic vaccine regimens were well-tolerated and capable of generating anti-HIV immune responses in healthy, HIV-negative adults. Notably, the vaccine regimen that was most protective in pre-clinical studies in animals elicited among the greatest immune responses in the study participants. However, further research will be needed because the ability to elicit anti-HIV immune responses does not necessarily indicate that a candidate vaccine regimen can prevent HIV acquisition. According to the researchers, the findings from APPROACH, as well as from animal studies, support further evaluation of a lead candidate regimen in a clinical trial to assess its safety and efficacy. Plans for such a clinical trial to be conducted in southern Africa are in development, with projected enrollment of 2,600 healthy, HIV-negative women. Should the larger trial move forward, it is expected to begin enrollment in late 2017 or early 2018. In APPROACH, study participants received four vaccinations over 48 weeks: two doses of an initial, or "prime," vaccine, followed by two doses of a booster vaccine. The experimental regimens all incorporated the same vaccine components in the prime vaccination, known as Ad26.Mos.HIV. The vaccine uses a strain of common-cold virus (adenovirus serotype 26, or Ad26), engineered so that it does not cause illness, as a vector to deliver three mosaic antigens created from genes from many HIV variants. The booster vaccination included various combinations of the Ad26.Mos.HIV components or a different mosaic component, called MVA-Mosaic, and/or two different doses of clade C HIV gp140 envelope protein containing an aluminum adjuvant to boost immune responses. The Ad26-based mosaic vaccines were initially developed by the laboratory of NIAID grantee Dan H. Barouch, M.D., Ph.D., and Janssen. In pre-clinical studies, regimens incorporating these mosaic vaccines protected monkeys against infection with an HIV-like virus called simian human immunodeficiency virus (SHIV). The most effective prime-boost regimen reduced the risk of infection per exposure to SHIV by 94 percent and resulted in 66 percent complete protection after six exposures. Researchers identified and characterized the vaccine-induced immune responses that correlated with this protection. "The promising, early-stage results from the APPROACH study support further evaluation of these candidate vaccines to assess their ability to protect those at risk of acquiring HIV," said Dr. Barouch, a principal investigator for APPROACH. He also is director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston and professor of medicine at Harvard Medical School. Following the third vaccination, most APPROACH participants had developed antibody and cellular immune responses against HIV. The different boost vaccines altered the magnitude and character of these immune responses, with the regimen that showed greatest protection in monkey studies also eliciting among the greatest immune responses in humans. The anti-HIV immune responses increased after the fourth vaccination. The researchers conclude that further evaluation of this approach would use a regimen comprising two Ad26 mosaic primes and two boosts with Ad26 mosaic and clade C gp140. The ongoing TRAVERSE trial is comparing Ad26-based regimens containing three mosaic antigens (trivalent) with Ad26-based regimens containing four mosaic antigens (tetravalent). Results from TRAVERSE are expected in late 2017. Other support for APPROACH comes from the NIAID-funded HIV Vaccine Trials Network, the U.S. Military HIV Research Program, the International AIDS Vaccine Initiative, Beth Israel Deaconess Medical Center and the Ragon Institute of MGH, MIT and Harvard. For more information about APPROACH, see ClinicalTrials.gov using identifier NCT02315703. For more information about TRAVERSE, see ClinicalTrials.gov using identifier NCT02788045. NIAID conducts and supports research -- at NIH, throughout the United States, and worldwide--to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website. About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www. .


PARIS, France--(BUSINESS WIRE)--Johnson & Johnson today announced encouraging first-in-human clinical data for an investigational HIV-1 vaccine regimen in development at its Janssen Pharmaceutical Companies. In an oral presentation of the early stage Phase 1/2a APPROACH study at the 9th IAS Conference on HIV Science (IAS 2017), the “mosaic”-based vaccine regimen from Janssen Vaccines & Prevention B.V. (Janssen) appeared to be well-tolerated and elicited HIV-1 antibody responses in 100% of healthy volunteers (n=393). “ Finding a preventive vaccine has proven to be one of the biggest scientific challenges in the 35-year quest to end the HIV pandemic. A successful preventive vaccine for HIV will need to provide broad protection against a wide range of viral strains,” said Professor Dan Barouch, Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a key collaborator for APPROACH. “ These promising, early-stage results suggest that these vaccines utilizing mosaic immunogens should be evaluated further for their potential ability to achieve this historic goal.” Significant progress has been made in the global battle against HIV/AIDS, including the development of critical antiretroviral treatments and HIV prevention tools, yet the disease remains one of the greatest global health threats of our time. An estimated 37 million people are currently living with HIV-1 globally, and nearly 2 million people become newly infected each year. An effective HIV vaccine is elusive due to the unique properties of the virus – including its genetic diversity and ability to mutate rapidly. Mosaic-based vaccines contain immunogens created using genes from different HIV subtypes responsible for HIV-1 infections worldwide. These immunogens are delivered through viral vectors, including Janssen’s AdVac® technology based on adenovirus serotype 26 (Ad26). The viral vectors are combined with other components such as soluble proteins to form mosaic-based prime-boost vaccine regimens that first prime and then boost the immune system, with the aim of producing stronger and longer-lasting immunity to HIV. Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson said, “ In recent years, a new optimism has emerged that we will find an effective HIV vaccine in our lifetime. The results from today’s study add to that belief and we look forward to advancing to the next stage of clinical development as quickly as possible.” In pre-clinical studies, regimens incorporating mosaic vaccines demonstrated protection against infection with an HIV-like virus. The most effective prime-boost regimen in these studies reduced the per-exposure risk of infection by 94 percent and resulted in 66 percent complete protection after six exposures. Based on immunologic responses observed in APPROACH, as well as protection observed in pre-clinical studies, a lead HIV-1 vaccine regimen comprising Janssen’s Ad26 mosaic candidate and the Clade C gp140 soluble protein has been selected as the basis for further evaluation in a potential Phase 2b proof-of-concept efficacy study. Should this study move forward, Janssen and its global partners anticipate initiating this investigation in southern African countries in late 2017 or early 2018. APPROACH (HIV-V-A004/NCT02315703) is a multi-center, randomized, parallel-group, placebo-controlled, double-blind Phase 1/2a study in 393 healthy HIV-uninfected adults in the US, Rwanda, Uganda, South Africa and Thailand. It is evaluating the safety, tolerability and immunogenicity of various mosaic-based, prime-boost vaccine regimens for HIV-1. These vaccine regimens contain two prime doses of the mosaic viral vector Ad26.Mos.HIV and two boosts of either Ad26.Mos.HIV, MVA-Mosaic and/or different doses of the soluble protein Clade C gp140 adjuvanted with aluminum phosphate. Vaccination schedules have been completed for all study participants and 12-month follow-up after the 4th dose is underway. Results presented at IAS 2017 suggest that all vaccine regimens appeared to be well-tolerated. Injection site pain, headache and fatigue were the most common reported adverse events. The primary analysis post 3rd vaccination showed that most active vaccine regimens elicited antibody responses in 100% of study participants. Antibody titers against autologous Clade C and heterologous cross-clade Env antigens increased in groups boosted with gp140 protein, irrespective of vector. After the 4th vaccination, humoral and cellular responses further increased. The APPROACH study was sponsored by Janssen with support from partner organizations including Beth Israel Deaconess Medical Center (BIDMC); the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR), with the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF); the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH); the Ragon Institute; the International AIDS Vaccine Initiative (IAVI); and the HIV Vaccine Trials Network (HVTN). Janssen’s HIV-1 AdVac®-based vaccine regimen, along with the company’s investigational Ebola and inactivated polio vaccine candidates, utilize Janssen’s PER.C6® production cell line technology, which has the potential to reduce costs by increasing vaccine production at lower reactor volume. Since 2005, Janssen Vaccines & Prevention B.V. has been participating in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526 and AI096040. Janssen’s HIV vaccine program has also received funding from the United States Military HIV Research Program and the Ragon Institute. Please visit www.jnj.com/HIV for further details on the breadth of HIV science being presented by Johnson & Johnson companies and its partners. Caring for the world one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 126,400 employees at more than 230 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal. This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, regarding development of a potential preventive vaccine for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Vaccines & Prevention B.V. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.


Results from Clinical Trial with FIT Biotech's HIV Vaccine Candidate Presented at the International AIDS Society (IAS) Conference in Paris FIT Biotech Oy ("Company") announced today that a scientific poster on a Vaccine Research Institute (VRI) clinical trial results involving the Company's HIV vaccine candidate, GTU-MultiHIV B, was presented at the 9TH IAS Conference on HIV Science in Paris, France. The title of the poster is: Immunogenicity and safety of 4 prime-boost combinations of HIV vaccine candidates (MVA HIV-B; LIPO-5; GTU-MultiHIV B) in healthy volunteers - Inserm-ANRS VRI01 phase I/II randomized trial. The lead author is Dr. J.-D. Lelièvre of the VRI, Inserm, University Paris-Créteil, France. The clinical trial in the scientific poster was conducted through the VRI program (Inserm-ANRS) and enrolled HIV-negative subjects.  It tested four different prime-boost regimens. The major findings are: "We are making progress towards a functional cure for HIV, and having the support of the HIV community is key for succeeding in this", commented Santeri Kiviluoto, Chief Scientific Officer. FIT Biotech is a part of a major research consortium EHVA that develops new vaccines against HIV. The project is funded by the EU Horizon 2020 framework programme. FIT Biotech Oy is a biotechnology company established in 1995. The company develops and licenses its patented GTU® (Gene Transport Unit) vector technology for new-generation medical treatments. GTU® is a gene transport technology that meets an important medical challenge in the usability of gene therapy and DNA vaccines. FIT Biotech applies GTU® technology in its drug development programmes. Application areas include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines. FIT Biotech shares are listed on the First North Finland marketplace maintained by Nasdaq Helsinki Oy. The Vaccine Research Institute (VRI), Laboratory of excellence, was established by the French National Agency for Research on AIDS and viral hepatitis (ANRS - France Recherche Nord & Sud Sida-HIV Hépatites) and the University of Paris-Est Créteil (UPEC) to conduct research to accelerate the development of effective vaccines against HIV/AIDS (Human Immunodeficiency Virus / Acquired ImmunoDeficiency Syndrome), HCV (Hepatitis C Virus) and emerging infectious diseases. VRI's structure strengthens the links between basic and translational research, patient associations and the socio-economic world. VRI stems from the existing ANRS vaccine research program and includes research teams with multidisciplinary expertise, a network of national and international eminent scientists, a network of clinical centers, core facilities, and industry and charitable partners. It is based at the Henri Mondor hospital, Créteil, France. The Labex VRI is supported by the "Investissements d'Avenir" program managed by the ANR under reference ANR-10-LABX-77-01 http://vaccine-research-institute.fr/en Press contact: Mireille CENTLIVRE E-mail: mireille.centlivre@u-pec.fr Tel: +33 (0) 1 49 81 39 07 ANRS (French National Agency for Research on AIDS and viral hepatitis - France Recherche Nord & Sud Sida-HIV Hépatites) is the leading organization for research on the HIV/AIDS and hepatitis epidemics in France, and a leader in the fight against these diseases in developing countries. In 2012, ANRS became an autonomous agency within Inserm. ANRS objectives are to acquire and increase new knowledge in order to improve the prevention of HIV/AIDS and HCV and to care for people infected. ANRS brings together research scientists from all disciplines and doctors belonging to research organizations (Inserm, CNRS, Institut Pasteur, IRD), universities and hospitals all over France. The Agency's vaccine research program is managed by VRI (Vaccine Research Institute). http://www.anrs.fr/


News Article | June 29, 2017
Site: www.eurekalert.org

New multicenter research, which included Vanderbilt University Medical Center investigators, could change treatment approaches to simple skin abscesses, infections often caused by Staphylococcus aureus (staph) bacteria. The study, published in the New England Journal of Medicine, shows that adults and children who have simple abscesses five centimeters or smaller in diameter have higher cure rates if the abscess is drained in combination with antibiotic treatment, either trimethoprim-sulfamethoxazole (TMP/SMX or Bactrim) or clindamycin, compared to drainage alone. "We drained the abscess, measured it carefully to make sure it was less than five centimeters and then we randomized participants to receive a placebo or one of the antibiotics -- clindamycin or TMP/SMX. What we saw is that in fact antibiotics are helpful. You are more likely to get better if you have antibiotics on board than if you don't. And we also saw in children that clindamycin was associated with fewer recurrences in the one month of follow up," said Buddy Creech, M.D., MPH, associate professor of Pediatric Infectious Diseases and director of the Vanderbilt Vaccine Research Program (VVRP). Staph, including methicillin-resistant S. aureus (MRSA) strains, causes most skin and soft tissue infections, but the appropriate strategy for the treatment of these infections has not been defined. Clindamycin and TMP/SMX are often recommended for outpatient treatment of abscesses because of their low cost and their ability to fight community-acquired MRSA strains, but data on efficacy and safety have been limited, prompting the current study. Researchers enrolled 786 participants at six sites, including Vanderbilt; University of Chicago Medical Center; San Francisco General Hospital; Harbor-University of California, Los Angeles, Medical Center; Washington University, St. Louis; and Morehouse School of Medicine-Emory University. Of the participants, 505 were adults and 281 were children. Bacteria isolated from the abscesses included 527 samples identified as staph and 388 samples identified as methicillin-resistant S. aureus (MRSA). Patients were randomized to receive either a placebo, clindamycin, or TMP/SMX for 10 days after the drainage of the abscess. Researchers found that clindamycin and TMP/SMX were equally effective in adults, while clindamycin in children had a slightly higher cure rate in children and more frequently prevented recurrence of infection. Clindamycin had an overall cure rate of about 83 percent of participants; TMP/SMX about 82 percent; and the placebo about 70 percent. Creech noted that it's important for physicians to culture the fluid from drained abscesses so that infectious disease experts can track strains throughout the community and treat with appropriate antibiotics. In the case of this study, some participants had a clindamycin-resistant staph, rendering that antibiotic ineffective. "Because antibiotics only work if the germ is susceptible to that antibiotic we really need to know the types of strains that are circulating in a community -- not just for the individual patient but public health in general," Creech said. Other Vanderbilt researchers include: Derek Williams, M.D., MPH, assistant professor of Pediatric Hospital Medicine; Wesley Self, M.D., MPH, assistant professor of Emergency Medicine; and Isaac Thomsen, M.D., assistant professor of Pediatric Infectious Diseases. The research was funded with grants from the National Institute of Allergy and Infectious Diseases (HHSN272200700031C) and the National Center for Research Resources (UL1RR033176, now at the National Center for Advancing Translational Sciences, UL1TR000124).


PHILADELPHIA, Aug. 14, 2017 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced that it has commenced full data analysis of an intranasal human safety study of Ampligen® plus FluMist® known as AMP-600. The study was previously closed, but the initiation of full data analysis awaited the FDA’s evaluation of preliminary reports of blinded study findings. That evaluation was completed per formal notification from the FDA on August 9, 2017.  Intranasal Ampligen was generally well-tolerated in the study. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/2c45a31f-f28f-4f39-ac32-c5cf3f42a501 This study is the first to evaluate the human safety of nasally-administered Ampligen. Test subjects in other human studies of Ampligen, including the pancreatic cancer treatment program currently underway in The Netherlands, have been administered Ampligen intravenously (IV).  All told, approximately 100,000 IV doses of Ampligen have been administered and found to be generally well-tolerated. Hemispherx believes that the top line data from the intranasal safety study, coupled with extensive pre-clinical data, support further development of Ampligen as a broadly applicable highly selective Toll-like Receptor 3 (TLR-3) based new generation, immune enhancing adjuvant for intranasally-administered vaccines. “We’re very encouraged by the outcome of this study, establishing a foundation for Ampligen as an intranasal adjuvant. This shows Ampligen’s potential to take us to the next step of developing Ampligen either as a strain-specific or more universal influenza intranasal vaccine immune enhancing adjuvant”, said Thomas Equels, Hemispherx’s Chief Executive Officer. “This safety study was the first milestone to our ultimate goal, which is to combine Ampligen with a non-live virus vaccine to produce stronger and broader coverage and to confer longer immunity than is possible with the vaccine alone. I firmly believe that Ampligen’s multi-faceted impact on the immune system redefines the term adjuvant.” Ampligen is a highly selective TLR-3 agonist that induces the innate immune responses required for adaptive protective immunity.  Monkeys immunized with H5N1 vaccine and Ampligen showed enhanced protection after being challenged with a homologous highly pathogenic H5N1 virus. Pre-clinical studies also showed cross-protection against H5N1 viruses using trivalent seasonal influenza vaccine in mouse models. In theory, Ampligen induced cross-protection may extend to any vaccine for viruses subject to a high mutation rate and genetic drift. Ampligen is currently being developed as an immuno-oncology agent in solid cancer tumors and as a treatment in Chronic Fatigue Syndrome (CFS). Studies have shown that the two totally different indications both benefit from Ampligen’s foundational strength as an immuno-therapeutic. The company has completed a pivotal Phase 3 clinical trial in ME/CFS, where it is the only late-stage drug in the pipeline for this disease. The U.S. FDA has advised that potential approval for commercial sale in the U.S. for a ME/CFS indication will require the conduct and review of a follow up confirmatory clinical trial.  Hemispherx is supplying the drug for use by pancreatic cancer patients in an Early Access Program sponsored by the Dutch government. In AMP-600, Ampligen was nasally-administered as an adjuvant in conjunction with FluMist®, a seasonal live-virus flu vaccine, to healthy human volunteers at the University of Alabama at Birmingham under the auspices of Paul Goepfert, MD, Associate Professor of Medicine in the Division of Infectious Diseases and Director of the Alabama Vaccine Research Clinic. Twenty-five subjects were enrolled, twelve in Stage 1 and thirteen in Stage 2. The data from the AMP-600 safety study extends the pre-clinical results into humans.  In the study, Ampligen was generally well-tolerated when administered intranasally with a live-virus influenza vaccine.  Future studies with non-live virus vaccines will seek to replicate Ampligen’s efficacy as shown in the animal model results. “Our next milestone for intranasal Ampligen is to collaborate with an established vaccine maker to administer Ampligen intranasally with a non-live virus vaccine,” said Equels, “this next milestone will allow us to determine Ampligen’s clinical efficacy as a viral vaccine adjuvant and to evaluate it as a mechanism for providing cross protection from virus mutations as well as other forms of the virus. We have every expectation of results similar to the prior animal studies.” Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutics rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and are legally available only through clinical trials.  For more information about Hemispherx visit www.hemispherx.net. Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, no assurance can be given that Hemispherx will be able to engage one or more partners to conduct studies to confirm that Ampligen® is effective as a universal viral vaccine adjuvant or its effectiveness when administered intranasally or that any future studies will confirm such effectiveness. Moreover, conducting such studies will require Hemispherx to obtain additional financing and no assurance can be given that such funding will be available. While we are planning possible cancer trials of Ampligen in the U.S., we will need significant additional funding to commence and conduct such studies.  Any forward-looking statements set forth in this press release speak only as of the date of this press release.  We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


News Article | June 20, 2017
Site: www.eurekalert.org

LA JOLLA, CA -- For decades, HIV has successfully evaded all efforts to create an effective vaccine but researchers at The Scripps Research Institute (TSRI) and the La Jolla Institute for Allergy and Immunology (LJI) are steadily inching closer. Their latest study, published in the current issue of Immunity, demonstrates that optimizing the mode and timing of vaccine delivery is crucial to inducing a protective immune response in a preclinical model. More than any other factors, administering the vaccine candidate subcutaneously and increasing the time intervals between immunizations improved the efficacy of the experimental vaccine and reliably induced neutralizing antibodies. Neutralizing antibodies are a key component of an effective immune response. They latch onto and inactive invading viruses before they can gain a foothold in the body and have been notoriously difficult to generate for HIV. "This study is an important staging point on the long journey toward an HIV vaccine," says TSRI Professor Dennis R. Burton, Ph.D, who is also scientific director of the International AIDS Vaccine Initiative (IAVI) Neutralizing Antibody Center and of the National Institutes of Health's Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID) at TSRI. "The vaccine candidates we worked with here are probably the most promising prototypes out there, and one will go into people in 2018," says Burton. "There had been a lot of big question marks and this study was designed to get as many answers as possible before we go into human clinical trials," adds senior co-author Shane Crotty, Ph.D., a professor in LJI's Division of Vaccine Discovery. "We are confident that our results will be predictive going forward." HIV has faded from the headlines, mainly because the development of antiretroviral drugs has turned AIDS into a chronic, manageable disease. Yet, only about half of the roughly 36.7 million people currently infected with HIV worldwide are able to get the medicines they need to control the virus. At the same time, the rate of new infections has remained stubbornly high, emphasizing the need for a preventive vaccine. The latest findings are the culmination of years of collaborative and painstaking research by a dozen research teams centered around the development, improvement, and study of artificial protein trimers that faithfully mimic a protein spike found on the viral surface. At the core of this effort is the CHAVI-ID immunogen working group, comprised of TSRI's own William R. Schief, Ph.D., Andrew B. Ward, Ph.D., Ian A. Wilson, D.Phil. and Richard T. Wyatt, Ph.D., in addition to Crotty and Burton. This group of laboratories in collaboration with Darrell J. Irvine, Ph.D., professor at MIT, and Rogier W. Sanders, Ph.D., professor at the University of Amsterdam, provided the cutting-edge immunogens tested in the study. The recombinant trimers, or SOSIPs as they are called, were unreliable in earlier, smaller studies conducted in non-human primates. Non-human primates, and especially rhesus macaques, are considered the most appropriate pre-clinical model for HIV vaccine studies, because their immune system most closely resembles that of humans. "The animals' immune responses, although the right kind, weren't very robust and a few didn't respond at all," explains Colin Havenar-Daughton, Ph.D., a scientific associate in the Crotty lab. "That caused significant concern that the immunogen wouldn't consistently trigger an effective immune response in all individuals in a human clinical trial." In an effort to reliably induce a neutralizing antibody response, the collaborators tested multiple variations of the trimers and immunization protocols side-by-side to determine the best strategy going forward. Crotty and Burton and their colleagues teamed up with Professor Dan Barouch, M.D., Ph.D., Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, who coordinated the immunizations. The design of the study was largely guided by what the collaborators had learned in a previous study via fine needling sampling of the lymph nodes, where the scientists observed follicular helper T cells help direct the maturation steps of antibody-producing B cells. Administering the vaccine subcutaneously versus the more conventional intramuscular route, and spacing the injection at 8 weeks instead of the more common 4-6 weeks, reliably induced a strong functional immune response in all animals. Using an osmotic pump to slowly release the vaccine over a period of two weeks resulted in the highest neutralizing antibody titers ever measured following SOSIP immunizations in non-human primates. While osmotic pumps are not a practical way to deliver vaccines, they illustrate an important point. "Depending on how we gave the vaccine, there was a bigger difference due to immunization route than we would have predicted," says Matthias Pauthner, a graduate student in Burton's lab and the study's co-lead author. "We can help translate what we know now into the clinic." "Elicitation of robust Tier 2 neutralizing antibody responses in non-human primates by HIV envelope trimer immunization using optimized approaches." Matthias Pauthner, Colin Havenar-Daughton, Devin Sok, Joseph P. Nkolola, Raiza Bastidas, Archana V. Boopathy, Diane G. Carnathan, Abishek Chandrashekar, Kimberly M. Cirelli, Christopher A. Cottrell, Alexey M. Eroshkin, Javier Guenaga, Kirti Kaushik, Daniel W. Kulp, Junyan Liu, Laura E. McCoy, Aaron L. Oom, Gabriel Ozorowski, Kai Post, Shailendra K. Sharma, Jon M. Steichen, Steven W. de Taeye, Talar Tokatlian, Alba Torrents de la Peña, Salvatore T. Butera, Celia C. LaBranche, David C. Montefiori, Guido Silvestri, Ian A. Wilson, Darrell J. Irvine, Rogier W. Sanders, William R. Schief, Andrew B. Ward, Richard T. Wyatt, Dan H. Barouch, Shane Crotty and Dennis Burton. Immunity (2017). Doi: 10.1016/j.immuni.2017.05.007 The study was supported by the National Institutes of Health (NIAID-NIH Contract Number HHSN27201100016C) and CHAVI-ID (NIAID UM1AI100663). About La Jolla Institute for Allergy and Immunology The La Jolla Institute for Allergy and Immunology is dedicated to understanding the intricacies and power of the immune system so that we may apply that knowledge to promote human health and prevent a wide range of diseases. Since its founding in 1988 as an independent, nonprofit research organization, the Institute has made numerous advances leading toward its goal: life without disease. The Scripps Research Institute (TSRI) is one of the world's largest independent, not-for-profit organizations focusing on research in the biomedical sciences. TSRI is internationally recognized for its contributions to science and health, including its role in laying the foundation for new treatments for cancer, rheumatoid arthritis, hemophilia, and other diseases. An institution that evolved from the Scripps Metabolic Clinic founded by philanthropist Ellen Browning Scripps in 1924, the institute now employs more than 2,500 people on its campuses in La Jolla, CA, and Jupiter, FL, where its renowned scientists--including two Nobel laureates and 20 members of the National Academies of Science, Engineering or Medicine--work toward their next discoveries. The institute's graduate program, which awards PhD degrees in biology and chemistry, ranks among the top ten of its kind in the nation. In October 2016, TSRI announced a strategic affiliation with the California Institute for Biomedical Research (Calibr), representing a renewed commitment to the discovery and development of new medicines to address unmet medical needs. For more information, see http://www. .


NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that it has started a Phase 1 trial in healthy volunteers of PF-06760805, an investigational vaccine designed to help protect against Group B Streptococcus (GBS) infection. In newborns, GBS manifests as sepsis, pneumonia, and meningitis,2 with potentially fatal outcomes for some, and long-lasting neurological damage in 46 to 50 percent of those infected.3 “Because their immune systems are still immature, GBS can have potentially devastating effects on newborns,” said Carol J. Baker, M.D., Professor of Pediatrics-Infectious Disease at the Baylor College of Medicine in Houston, Texas. “The global health community would welcome a vaccine that could help reduce the impact of GBS everywhere, particularly in areas where the routine administration of antibiotics is not common practice.” Women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. The U.S. and certain developed countries have established recommendations for women to be screened for GBS during their third trimester of pregnancy, and administered prophylactic antibiotics during labor to prevent transmission to their newborns at delivery.4,5 However, this requires a robust health delivery infrastructure that is not widely available globally. “Pfizer is proud to take this important first step to support our efforts to ultimately develop a GBS vaccine with the potential to immunize a mother to help protect her infant against a devastating disease,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. The risk of developing GBS is highest in the first three months of a newborn’s life.6 While there is variation in the incidence of GBS infant disease among regions of the world, the disease is potentially devastating. A successfully developed, efficacious vaccine could be an important strategy for global disease prevention. The trial is designed as a Phase 1/2 randomized, placebo-controlled, observer-blinded study in healthy adults 18 to 49 years of age with no history of a GBS infection, and will be conducted in the United States. Because of the urgent need to help protect newborns in low- and middle-income countries from this devastating condition, and the intent to make a successfully developed vaccine available globally as quickly as possible, Pfizer is pursuing a clinical development strategy in high-, middle- and low-income countries. In 2016, Pfizer received a grant from the Bill & Melinda Gates Foundation to conduct a Phase 1/2 clinical trial of Pfizer’s vaccine candidate against GBS infection in South Africa, which has one of the highest invasive GBS disease incidences of 2.38 cases per 1,000 live births.7 At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of June 19, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s vaccine candidate against Group B Streptococcus (GBS), including their potential benefits that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with preliminary data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether and when drug applications may be filed in any jurisdictions for any potential indications for Pfizer’s vaccine candidate against GBS; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Pfizer’s vaccine candidate against GBS; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. _______________________________ 1 Centers for Disease Control and Prevention (CDC) “2010 Guidelines for the Prevention of Perinatal Group B Streptococcal Disease”. Accessed June 5, 2017. Available at https://www.cdc.gov/groupbstrep/guidelines/guidelines.html 2 Kwatra G, et al. “Prevalence of maternal colonization with group b streptococcus: a systematic review and meta-analysis. Lancet Infectious Disease 2016; 16:1076-84. Accessed May 25, 2017. Available at https://www.ncbi.nlm.nih.gov/pubmed/27236858 3 Kwatra G, et al. “Prevalence of maternal colonization with group b streptococcus: a systematic review and meta-analysis. Lancet Infectious Disease 2016; 16:1076-84. Accessed May 25, 2017. Available at https://www.ncbi.nlm.nih.gov/pubmed/27236858 4 Centers for Disease Control and Prevention (CDC) “2010 Guidelines for the Prevention of Perinatal Group B Streptococcal Disease”. Accessed June 5, 2017. Available at https://www.cdc.gov/groupbstrep/guidelines/guidelines.html 5 Di Renzo G.C, et al. “Intrapartum GBS screening and antibiotic prophylaxis: a European consensus conference.” The Journal of Maternal-Fetal & Neonatal Medicine 2014.28(7): 766-82. Accessed on June 8, 2017. Available at http://www.tandfonline.com/doi/full/10.3109/14767058.2014.934804 6 Edmond KM, Kortsalioudaki C, Scott S, et al.: “Group B streptococcal disease in infants aged younger than 3 months: systematic review and meta-analysis.” Lancet. 2012;379(9815):547–556. 10.1016/S0140-6736(11)61651-6. Accessed May 25, 2017. Available at https://www.ncbi.nlm.nih.gov/pubmed/22226047 7 Dangor Z, Lala SG, et al., “Burden of Invasive Group B Streptococcus Disease and Early Neurological Sequelae in South African Infants.” Accessed May 25, 2017. Available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123014#sec014


News Article | June 20, 2017
Site: www.sciencedaily.com

For decades, HIV has successfully evaded all efforts to create an effective vaccine but researchers at The Scripps Research Institute (TSRI) and the La Jolla Institute for Allergy and Immunology (LJI) are steadily inching closer. Their latest study, published in the current issue of Immunity, demonstrates that optimizing the mode and timing of vaccine delivery is crucial to inducing a protective immune response in a preclinical model. More than any other factors, administering the vaccine candidate subcutaneously and increasing the time intervals between immunizations improved the efficacy of the experimental vaccine and reliably induced neutralizing antibodies. Neutralizing antibodies are a key component of an effective immune response. They latch onto and inactive invading viruses before they can gain a foothold in the body and have been notoriously difficult to generate for HIV. "This study is an important staging point on the long journey toward an HIV vaccine," says TSRI Professor Dennis R. Burton, Ph.D, who is also scientific director of the International AIDS Vaccine Initiative (IAVI) Neutralizing Antibody Center and of the National Institutes of Health's Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID) at TSRI. "The vaccine candidates we worked with here are probably the most promising prototypes out there, and one will go into people in 2018," says Burton. "There had been a lot of big question marks and this study was designed to get as many answers as possible before we go into human clinical trials," adds senior co-author Shane Crotty, Ph.D., a professor in LJI's Division of Vaccine Discovery. "We are confident that our results will be predictive going forward." HIV has faded from the headlines, mainly because the development of antiretroviral drugs has turned AIDS into a chronic, manageable disease. Yet, only about half of the roughly 36.7 million people currently infected with HIV worldwide are able to get the medicines they need to control the virus. At the same time, the rate of new infections has remained stubbornly high, emphasizing the need for a preventive vaccine. The latest findings are the culmination of years of collaborative and painstaking research by a dozen research teams centered around the development, improvement, and study of artificial protein trimers that faithfully mimic a protein spike found on the viral surface. At the core of this effort is the CHAVI-ID immunogen working group, comprised of TSRI's own William R. Schief, Ph.D., Andrew B. Ward, Ph.D., Ian A. Wilson, D.Phil. and Richard T. Wyatt, Ph.D., in addition to Crotty and Burton. This group of laboratories in collaboration with Darrell J. Irvine, Ph.D., professor at MIT, and Rogier W. Sanders, Ph.D., professor at the University of Amsterdam, provided the cutting-edge immunogens tested in the study. The recombinant trimers, or SOSIPs as they are called, were unreliable in earlier, smaller studies conducted in non-human primates. Non-human primates, and especially rhesus macaques, are considered the most appropriate pre-clinical model for HIV vaccine studies, because their immune system most closely resembles that of humans. "The animals' immune responses, although the right kind, weren't very robust and a few didn't respond at all," explains Colin Havenar-Daughton, Ph.D., a scientific associate in the Crotty lab. "That caused significant concern that the immunogen wouldn't consistently trigger an effective immune response in all individuals in a human clinical trial." In an effort to reliably induce a neutralizing antibody response, the collaborators tested multiple variations of the trimers and immunization protocols side-by-side to determine the best strategy going forward. Crotty and Burton and their colleagues teamed up with Professor Dan Barouch, M.D., Ph.D., Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, who coordinated the immunizations. The design of the study was largely guided by what the collaborators had learned in a previous study via fine needling sampling of the lymph nodes, where the scientists observed follicular helper T cells help direct the maturation steps of antibody-producing B cells. Administering the vaccine subcutaneously versus the more conventional intramuscular route, and spacing the injection at 8 weeks instead of the more common 4-6 weeks, reliably induced a strong functional immune response in all animals. Using an osmotic pump to slowly release the vaccine over a period of two weeks resulted in the highest neutralizing antibody titers ever measured following SOSIP immunizations in non-human primates. While osmotic pumps are not a practical way to deliver vaccines, they illustrate an important point. "Depending on how we gave the vaccine, there was a bigger difference due to immunization route than we would have predicted," says Matthias Pauthner, a graduate student in Burton's lab and the study's co-lead author. "We can help translate what we know now into the clinic."


News Article | April 27, 2016
Site: www.nature.com

The recent launch of multiple major US cancer initiatives has infused cash into immunotherapy, one of the most promising new methods of cancer treatment. But researchers warn that the money may be wasted without concrete plans to coordinate the programmes. “There’s a lack of overt leadership, and in the absence of a logical strategy we have a tendency to throw plates of spaghetti against the wall and hope it sticks,” says Ira Mellman, vice-president of cancer immunology at the biotechnology company Genentech in South San Francisco, California. The broadest programme is the US govern­ment’s National Cancer Moonshot, which hopes to receive US$1 billion by next year for 8 areas of cancer research. Immunotherapy, which recalibrates the body’s own immune defence against cancer, is among them. It “is poised to be a critical part of our nation’s anticancer strategy”, the project’s leader, US vice-president Joe Biden, said last week at the annual meeting of the American Association for Cancer Research (AACR) in New Orleans, Louisiana. An advisory panel will release more-detailed plans for the government programme in June. Meanwhile, three privately funded immuno­therapy research projects are gearing up: the $250-million Parker Institute for Cancer Immunotherapy, funded by Sean Parker, co-founder of the music-file-sharing company Napster, and announced on 13 April; a $125-million Immunotherapy Center at Johns Hopkins University in Baltimore, Maryland, unveiled in March; and the Cancer MoonShot 2020 Program, announced in January by biotechnology billionaire Patrick Soon-Shiong. This sudden proliferation of cancer initiatives is reminiscent of the spate of brain-research projects launched in the past few years — some of which have foundered through poor leadership. Europe’s Human Brain Project, for instance, almost ran aground after a series of top-down decisions alienated the neuroscience community. By contrast, the US BRAIN Initiative set priorities after consulting with neuroscientists, and awarded grants through a conventional peer-reviewed process, ensuring community acceptance. Now cancer researchers are left wondering how their moonshots will proceed. At the AACR meeting, Biden said that he had met representatives of many cancer-funding projects. “Why is all of that being done separately?” he asked scientists in the audience, noting that progress is accelerated by collaboration. The privately funded initiatives are more concerned with meeting their own goals — and satisfying their funders — than with coordinating efforts in the field. “I don’t see my role as trying to answer this larger question about how does this all fit together,” says Jeffrey Bluestone, chief executive of the Parker Institute. “I’m focused on how to make sure what we do is impactful for patients.” But Douglas Lowy, acting director of the US National Cancer Institute (NCI), which is coordinating the government moonshot, notes an overlap with the leadership of the various projects. Soon-Shiong, Bluestone and leaders of immunotherapy initiatives at Johns Hopkins and the University of Texas MD Anderson Cancer Center in Houston are on the government initiative’s advisory panel. And on 18 April, the Biden moonshot launched a website to solicit research ideas. The aim, Lowy says, is to ensure that research areas recommended by the advisory panel do not duplicate topics being covered by the private initiatives. There is wide agreement on major questions regarding immunotherapy, how­ever. For instance, researchers don’t understand why the approach works in only 15–20% of patients. Combining immunotherapies, and studying what distinguishes patients who respond, could make treatments more effective. Pharmaceutical companies are already developing new drugs and testing therapies in combination. Philip Gotwals, executive director of oncology research at the Novartis Institutes for BioMedical Research in Cambridge, Massachusetts, estimates that industry has spent upwards of $1 billion on the field. But scientists see a lack of basic cancer immunology research, even in the new programmes. “Many of these initiatives are moving forward ideas that are already out there,” says David Raulet, faculty director of the Immunotherapeutics and Vaccine Research Initiative at the University of California, Berkeley, which began in March. Many researchers are looking to the Biden project to make a big investment in basic cancer immunology and to address broader barriers to research, such as data hoarding. Gotwals, for instance, notes that the results of industry-sponsored clinical trials now under way could help other companies to decide which approaches to test, but that results are typically not made public until 9–12 months after a trial ends. Companies are reluctant to share data before then, both to comply with regulatory requirements and to protect their intellectual property. “It’s not trivial to figure out how to make that work,” Gotwals says. Biden seems to be hearing that message. At the AACR meeting, he said that data sharing often comes up when he speaks to scientists about the moonshot. Lowy says that the NCI is already planning to open a Genomic Data Commons in June to host detailed information on cancer patients. Sharing data collected in company-sponsored clinical trials is trickier because patients must give informed consent. In the meantime, the government moonshot faces a major hurdle: its funding is at the mercy of legislators who may be loath to give US President Barack Obama a victory in his last year in office. “It will be very difficult for us to initiate all of the programmes that we’re looking forward to the blue-ribbon panel recommending if there isn’t funding,” Lowy says.


News Article | November 10, 2016
Site: www.sciencedaily.com

The administration of VRC01, a potent and broadly neutralizing HIV-specific antibody, is safe, is well-tolerated, generated high plasma concentrations and modestly delayed the return of HIV viral rebound in HIV-1 infected individuals after they stopped receiving antiretroviral therapy, according to a study published in the New England Journal of Medicine by researchers at the University of Alabama at Birmingham, the National Institutes of Health and the University of Pennsylvania Penn Center for AIDS Research. "Monoclonal antibodies are revolutionizing our approach to many diseases in oncology and rheumatolgy," said Edgar T. Overton, M.D., co-director of the UAB Alabama Vaccine Research Clinic. "In this study, we tested whether a broadly neutralizing antibody against HIV could stop replicating virus. While a single antibody only modestly delayed viral rebound, we demonstrated that this strategy can be improved and potentially lead us to effective therapeutic HIV vaccine strategies. We are excited to pursue this approach in our ongoing efforts to end the HIV epidemic." Two clinical trials were conducted under the National Institutes of Health and the AIDS Clinical Trials Group in 24 HIV-1 infected individuals undergoing analytical treatment interruption, which measures changes in immunological response. The open-label trial in which both the researchers and participants were aware of the administered treatment showed that markers of of HIV virus replication were surpressed for at least four weeks after the VRC01 was administered and HIV treatment was stopped, but all participants failed to maintain durable viral suppression in the absence of antiretroviral therapy. Further studies looking at more potent antibodies and combinations of bNAbs like VRC01 will likely be required to achieve sustained remission of the virus in HIV-1 infected individuals after halting ART. "We are excited to be on the forefront of the global efforts to end AIDS," Overton said.

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