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News Article | February 22, 2017
Site: globenewswire.com

SEATTLE and SOUTH SAN FRANCISCO, Calif., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its investigational intratumoral therapy, G100, for the treatment of follicular non-Hodgkin’s lymphoma.  Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to products that treat rare diseases. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity for the first marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees. G100 is a product candidate from Immune Design's GLAAS® discovery platform. It contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl Lipid A (GLA), and is the lead product candidate in Immune Design’s Antigen Agnostic approach. It leverages the activation of both innate and adaptive immunity, including Dendritic Cells, in the tumor microenvironment to create an immune response against the tumor's preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate tumor-infiltrating lymphocytes, macrophages and dendritic cells, and promote antigen-presentation and the recruitment of T cells to the tumor.  The ensuing induction of local and systemic immune responses has been shown to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control in preclinical studies. G100 was evaluated in a Phase 1 study in Merkel cell carcinoma patients and produced a 50% overall response rate per protocol and a favorable safety profile. Currently, G100 is being evaluated as both a monotherapy (with local radiation) and in combination with Merck’s anti-PD-1 agent, pembrolizumab, pursuant to a clinical collaboration with Merck, in a randomized Phase 1/2 trial in patients with follicular non-Hodgkin's lymphoma. CMB305, Immune Design’s prime-boost cancer immunotherapy product candidate, has previously been designated orphan drug status for soft tissue sarcoma by the FDA, and each of the two agents comprising CMB305 also have both U.S. and European Orphan drug designation for soft tissue sarcoma. Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body's immune system to fight disease. The company's technologies are engineered to activate the immune system's natural ability to generate and/or expand antigen-specific cytotoxic T cells, while also enhancing other immune effectors, to fight cancer and other chronic diseases.  CMB305 and G100, the primary foci of Immune Design's ongoing immuno-oncology clinical programs, are products of its two synergistic discovery platforms, ZVex® and GLAAS, the fundamental technologies of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute (IDRI), respectively.  Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Immune Design's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, scope and outcome of clinical trials for Immune Design's product candidates, the reporting of clinical data regarding Immune Design’s product candidates and the timing and likelihood of regulatory filings and approvals. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, and unexpected litigation or other disputes. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful. Orphan Drug Designation does not provide any assurance of regulatory approval or expedite regulatory review. Other factors that may cause Immune Design's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Immune Design assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


SEATTLE and SOUTH SAN FRANCISCO, Calif., March 01, 2017 (GLOBE NEWSWIRE) --  Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced that new preclinical data showing the broad anti-tumor activity on its “prime-pull” approach, as well as the ability of its ZVex vectors to activate dendritic cells potently, will be presented at the upcoming American Association for Cancer Research (AACR) 2017 Annual Meeting, being held from April 1-5, 2017 in Washington D.C. “These AACR data illustrate the significant local and systemic immune responses that the combination of ZVex vectors with G100 may generate. We observed complete eradication of large, established B16 tumors in animal models, which previously has been achieved only with complex regimens,” said Jan ter Meulen, MD, PhD, Chief Scientific Officer at Immune Design. “In addition, we will present additional data supporting the ability of ZVex vectors to generate potent activation of human dendritic cells.” Immune Design will present data showing the “Prime-Pull” concept that involves the (i) intradermal administration of the dendritic cell (DC)-targeting ZVex vector expressing a tumor-associated antigen and (ii) intratumoral injection of G100, a formulated, potent synthetic toll-like receptor-4 (TLR-4) agonist, in the difficult to treat B16 melanoma model. Antigen-specific CD8 T-cells are induced (“primed”) by a ZVex vector, and subsequent injection of G100 leads to pro-inflammatory changes in the tumor microenvironment (TME), which induces the trafficking of T-cells into the tumor (the “pull”). This inflamed TME and recruitment of ZVex-induced CD8 T cells eradicated large, established B16 tumors. Also importantly, treated mice rejected re-challenge with a tumor lacking the antigen used for immunization, indicating antigen spreading induced by the immunotherapeutic regimen. Immune Design is evaluating this immunotherapy approach in an ongoing Phase 1 trial in patients with soft tissue sarcoma who are receiving G100 and CMB305, its prime-boost approach that is being evaluated in multiple clinical trials as both a monotherapy and in combination with atezolizumab, Genentech’s anti-PD-L1 antibody. In addition, Immune Design will present separate data highlighting the ability of its ZVex vectors to induce potent, innate immune activation in human DCs. Company researchers studied the effect of human DC transduction with ZVex vectors by gene expression profiling. Human DCs transduced with ZVex vectors displayed statistically significant up-regulation of genes involved in antigen presentation and anti-viral defense pathways, highlighting that ZVex is sufficient to activate transduced DCs and facilitate antigen presentation to T cells. The details for the poster presentations are as follows: Large established B16 tumors in mice are eradicated by ZVex® (dendritic cell-targeting lentiviral vector) and G100 (TLR4 agonist) combination immunotherapy through increasing tumor-infiltrating effector T cells and inducing antigen spreading The poster presentation will be made available at Immune Design’s website on or after April 5, 2017. The poster presentation will be made available at Immune Design’s website on or after April 5, 2017. ZVex is Immune Design's discovery platform designed to activate and expand the immune system's natural ability to create tumor-specific cytotoxic T cells (CTLs) in vivo. ZVex uses a re-engineered virus to carry genetic information of a tumor antigen selectively to dendritic cells in the skin or lymph nodes. This ultimately results in the creation of CTLs designed to kill tumor cells bearing that same specific tumor antigen. ZVex is also designed to carry the genetic information for, and therefore potentially cause dendritic cells to express, multiple antigens and/or selected epitopes of interest (including neoantigens), as well as cytokines or other immunomodulatory molecules. G100 is a product candidate from Immune Design's GLAAS® discovery platform. It contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl Lipid A (GLA), and is the lead product candidate in Immune Design’s Antigen Agnostic approach. It leverages the activation of both innate and adaptive immunity, including Dendritic Cells, in the tumor microenvironment to create an immune response against the tumor's preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate tumor-infiltrating lymphocytes, macrophages and dendritic cells, and promote antigen-presentation and the recruitment of T cells to the tumor.  The ensuing induction of local and systemic immune responses has been shown to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control in preclinical studies. G100 was evaluated in a Phase 1 study in Merkel cell carcinoma patients and produced a 50% overall response rate per protocol and a favorable safety profile. Currently, G100 is being evaluated as both a monotherapy with local radiation and in combination with Merck’s anti-PD-1 agent, pembrolizumab, pursuant to a clinical collaboration with Merck, in a randomized Phase 1/2 trial in patients with follicular non-Hodgkin lymphoma. Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body's immune system to fight disease. The company's technologies are engineered to activate the immune system's natural ability to generate and/or expand antigen-specific cytotoxic T cells, while also enhancing other immune effectors, to fight cancer and other chronic diseases.  CMB305 and G100, the primary foci of Immune Design's ongoing immuno-oncology clinical programs, are products of its two synergistic discovery platforms, ZVex and GLAAS, the fundamental technologies of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute (IDRI), respectively.  Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Immune Design's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the timing of initiation, progress, scope and outcome of clinical trials for Immune Design's product candidates and the reporting of clinical data regarding Immune Design’s product candidates. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment and unexpected litigation or other disputes. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful. Other factors that may cause Immune Design's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Immune Design assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


News Article | November 3, 2016
Site: www.eurekalert.org

IDRI's drug discovery efforts continue to grow with a recently awarded $7.5 million in additional funding, plus an additional $7.5 million of in-kind services, for a total commitment of $15 million over the next five years from Eli Lilly and Company. The funding and in-kind services, which include Lilly scientists' time and engagement on projects as well as Lilly research and development resources and capabilities, will extend the work of the Lilly TB Drug Discovery Initiative. This marks the continuation of a long-standing partnership between IDRI and Eli Lilly, which started more than eight years ago with the founding of the Lilly Initiative, a unique public-private partnership that includes IDRI, Lilly and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), with a focus on the discovery of new anti-tuberculosis drugs. One of the world's deadliest diseases, tuberculosis kills almost 1.5 million each year and is a leading killer of people who are HIV infected. About one-third of the world's population is infected with the bacterium that causes TB, creating a potential reservoir of disease. There is an increasing threat from multi-drug resistant and extensively drug resistant strains, demonstrating the need to develop more effective, cheaper and faster-acting drugs - the prime focus of IDRI's TB Discovery Program, led by Tanya Parish Ph.D., Vice President of Drug Discovery. The new funding from Lilly extends the work that has occurred over the past eight years, with a focus on moving new chemical entities into lead optimization with the intent to have at least one preclinical drug candidate. "Being part of the Lilly Initiative has helped us move through the phases of the traditional drug development 'funnel,' from hit evaluation to formal hit assessment, then hits to leads followed by lead optimization," said Parish. The Lilly Initiative's initial funding helped set up the foundation of IDRI's Discovery Program - personnel, equipment and specialized lab facilities - followed by the screening of compounds provided by Lilly, which was unique at the time. "The partnership marked one of the first times a large pharmaceutical company opened its compound library to an outside entity," said Parish. "We began screening those compounds to find out if there was potential for TB drugs; to date, we've screened more than 500,000 compounds." From there, Parish's group moved into evaluation and the TB Drug Accelerator (TBDA) was started, which led to additional screening. The TBDA is a partnership of eight pharmaceutical companies, including Lilly, and four other institutions funded in part by the Bill & Melinda Gates Foundation that targets the discovery of new TB drugs by collaborating on early-stage drug discovery for tuberculosis. According to Parish, the Lilly initiative and the TBDA are important, productive and complementary programs that move TB drug discovery forward. "This partnership with Lilly has expanded over the years," said Parish. "Not only do they provide financial and scientific resources, but people as well. We work together as one team with common goals, using our individual areas of expertise; for Lilly that's proven success in the field of drug discovery and for IDRI it is in-depth knowledge of tuberculosis." Philip Hipskind, Ph.D., Distinguished Research Fellow and leader of the Lilly initiative, added, "Together with IDRI, the NIAID, and our other partners, we've made remarkable progress over the last eight years towards new therapies for tuberculosis, and we are delighted to extend our collaboration for five more years." As a non-profit global health organization, IDRI (Infectious Disease Research Institute) takes a comprehensive approach to combat infectious diseases, combining the high-quality science of a research organization with the product development capabilities of a biotech company to create new diagnostics, drugs and vaccines. IDRI combines passion for improving human health with the understanding that it is not just what our scientists know about disease, but what we do to change its course that will have the greatest impact. Founded in 1993, IDRI has 125 employees headquartered in Seattle with nearly 100 partners/collaborators around the world. For more information, visit http://www. .


News Article | February 15, 2017
Site: www.eurekalert.org

SEATTLE, WA, USA, and NES ZIONA, ISRAEL, Feb. 14, 2017: Zika remains a major public health threat, and its devastating neurological effects on newborns and infants are still being unraveled. More than ever, a vaccine is needed to protect against Zika virus, which is now considered on par with dangerous mosquito-borne viral diseases, like dengue, Japanese encephalitis or yellow fever. IDRI (Infectious Disease Research Institute) and NanoPass Technologies have signed a collaboration agreement to develop and test a new Zika vaccine based on a replicating viral RNA (rvRNA) construct administered intradermally using NanoPass's proprietary MicronJet600® microneedle device. According to Steve Reed, Ph.D., IDRI's President, CEO & Founder, "This co-development effort with NanoPass and their committed funding will allow us to expedite development of a Zika vaccine candidate through initial clinical testing. We are excited about this collaboration with NanoPass, a company we've partnered with for many years. The combination of IDRI's rvRNA, unique formulations and NanoPass's delivery device can provide a promising platform for the development of a Zika vaccine and potentially other prophylactic and therapeutic vaccines." This agreement builds on IDRI's work recently funded through a $491,000, two-year grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to rapidly develop a novel, safe and effective Zika vaccine by designing and formulating new RNA-based vaccine candidates. Dan Stinchcomb, Ph.D., IDRI's Chief Scientific Officer, said that delivery is the key to developing successful RNA vaccines. "IDRI has identified delivery formulations that boost the immune response induced by our Zika rvRNA vaccine," he said. "By pairing these with an innovative microneedle device for intradermal delivery, we believe we can improve the immunogenicity and efficacy of our Zika vaccine candidate." NanoPass's MicronJet600 microneedle device targets immune cells of the skin in a nearly painless, effective way by harnessing the skin's potent immune system to improve vaccines and/or to dramatically reduce the needed dose while achieving the same outcome. "The human skin is our first layer of defense against many infectious diseases," Stinchcomb said. "The skin contains specialized cells that can process and induce strong immune responses - that's why microneedles have the potential to be a great vaccine delivery system." Other vaccines and vaccine platforms, including seasonal and pandemic flu, and live attenuated varicella-zoster virus, have shown improved immunogenicity and significant dose-sparing using microneedle delivery. Yotam Levin, M.D., CEO of NanoPass, added, "We are thrilled to enter this collaboration with IDRI, which expands our scope and marks our entry into vaccine development. We believe a reliable injection into the skin is critical for successful activation of broad and effective immune responses, which should be explored for RNA vaccines as well. We have been working with IDRI for almost a decade on multiple global health vaccine programs, and it is time for us to take on greater commitments and collaborative efforts in Zika and beyond." About IDRI: As a nonprofit global health organization, IDRI (Infectious Disease Research Institute) takes a comprehensive approach to combat infectious diseases, combining the high-quality science of a research organization with the product development capabilities of a biotech company to create new diagnostics, drugs and vaccines. Founded in 1993, IDRI has 125 employees headquartered in Seattle with nearly 100 partners/collaborators around the world. For more information, visit http://www. . About NanoPass: NanoPass Technologies Ltd. is a pioneer in the development and commercialization of nearly painless intradermal delivery solutions for vaccines and drugs. Its flagship product, the 0.6mm MicronJet600 microneedle, is the first and only true (http://www. NOTE: Research described in this press release is supported by the National Institute of Allergy and Infectious Disease of the National Institutes of Health under award number 1R21AI128992-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.


SEATTLE and SOUTH SAN FRANCISCO, Calif., Dec. 05, 2016 (GLOBE NEWSWIRE) -- Immune Design, a clinical-stage immunotherapy company focused on oncology, today announced new data that highlight the broad product reach potential of both its Specific Antigen and Endogenous Antigen/Intratumoral immunization approaches. ZVexMulti offers the potential to create products that deliver multiple tumor antigens (conserved and/or neo-antigens) to dendritic cells (DCs) in vivo within the same product Immune Design recently presented preclinical data at SITC 2016 (Poster #195) showing that immunization with ZVexMulti (multi-genome ZVex) vectors expressing multiple antigens resulted in consistent induction of polyfunctional CD8 T cells against all delivered antigens, thereby overcoming the limitation of antigen competition. Moreover, immune responses were as high as, or higher than, those obtained by combining individually manufactured vectors, demonstrating the versatility and potency of ZVexMulti. Immune Design scientists have also investigated the potential for ZVexMulti to deliver multiple MHC Class I and II putative neo-antigens in the CT.26 colon carcinoma model. Immune Design believes that ZVexMulti has the potential to deliver a significantly large number of neo-antigens, thus obviating the need for a proprietary predictive algorithm tools. These experiments were performed outside of the previously announced collaboration with Gritstone Oncology, which the two parties have agreed to terminate. “These data collectively illustrate the range and flexibility of Immune Design’s product discovery platforms to target both conserved tumor antigens and neo-antigens,” said Jan ter Meulen, MD, PhD, Chief Scientific Officer at Immune Design. “These approaches offer the potential to reach a broad patient population, while addressing some of the current limitations of other immunization approaches.” G100 ASH data demonstrate eradication of lymphomas via synergy with local radiation At the 58th American Society of Hematology (ASH) Annual Meeting in San Diego, California, on Monday, December 5 at 6pm Pacific, Immune Design is presenting data (Abstract #4166, Session: 625, “Intratumoral G100 Rescues Radiation-Induced T Cell Depletion and Has Synergistic Anti-Tumor Effect with Local Irradiation in A20 Lymphoma”) showing the synergistic effects of the G100 product candidate in combination with local radiation therapy in eradicating lymphomas in preclinical models. These data further support Immune Design’s ongoing randomized Phase 2 study in patients with follicular non-Hodgkin’s lymphoma (NHL). The research, authored by Ramesh Rengan, Eric Ford and Jeffery L. Schwartz of the University of Washington Department of Radiation Oncology, and Hailing Lu, Jessica Hewitt, Frank Hsu and Jan ter Meulen of Immune Design, evaluated the immune response and therapeutic effects of intratumoral administration of G100 alone, local radiation alone and G100 and local radiation given in concomitant therapy in a preclinical model of lymphoma. Results of combination therapy demonstrated: "These findings highlight the potential beneficial effect that immunotherapy with G100 could provide when given with radiation by modulating the tumor microenvironment to generate a systemic, durable T-cell anti-tumor response," said Ramesh Rengan, M.D., Associate Professor, University of Washington Department of Radiation Oncology. "As shown in this model, G100 may hold potential as a treatment for lymphoma patients." ZVex is Immune Design's discovery platform, initially designed to deliver a single RNA tumor antigen selectively directly to the patient’s DCs to generate tumor antigen-specific polyclonal cytotoxic T cells (CTLs).  ZVex is an engineered recombinant viral vector that selectively targets DCs in vivo to deliver any RNA gene of interest. Further development of this platform has yielded ZVexMulti, enabling Immune Design to deliver multiple RNA tumor antigens within the same product candidate. G100 is a product candidate from Immune Design’s GLAASTM discovery platform. It is a synthetic small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl Lipid A (GLA), formulated in a stable and oil emulsion. G100 is one of the molecules utilized in Immune Design's intratumoral immune activation, or Endogenous Antigen, approach. It leverages the activation of the innate immune system, including DCs, in the tumor microenvironment to create a robust immune response against the tumor's preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate existing tumor-infiltrating lymphocytes and promote antigen-presentation and the recruitment of T cells to the tumor to affect clinical outcome, as well as convert immunosuppressive M2-type tumor associated macrophages to a pro-inflammatory, M1-type. Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body's immune system to fight disease. The company's technologies are engineered to activate the immune system's natural ability to generate and/or expand antigen-specific cytotoxic T cells, while also enhancing other immune effectors, to fight cancer and other chronic diseases.  CMB305 and G100, the primary focus of Immune Design's ongoing immuno-oncology clinical programs, are products of its two synergistic discovery platforms, ZVex® and GLAASTM, the fundamental technologies of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute (IDRI), respectively.  Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend", “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Immune Design's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the timing, progress, scope and outcome of preclinical studies and clinical trials, and the clinical application of Immune Design's product candidates and technology platforms. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, changes in expected or existing competition, changes in the regulatory environment and unexpected litigation or other disputes. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful. Other factors that may cause Immune Design's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Immune Design assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


O'Hagan D.T.,Novartis | Fox C.B.,IDRI
Expert Review of Vaccines | Year: 2015

Major advances in adjuvant development for human vaccines have been reported recently for a range of indications, including malaria, influenza and varicella zoster virus. Furthermore, there is an increased understanding of adjuvant mechanisms of action and a greater emphasis on the importance of formulation and characterization. This progress may signify a new golden age of vaccine adjuvant discovery and development. © Informa UK, Ltd..


O'Hagan D.T.,Novartis | Fox C.B.,IDRI
Vaccine | Year: 2015

Adjuvants are an essential component of modern vaccine development. Despite many decades of development, only a few types of adjuvants are currently included in vaccines approved for human use. In order to better understand the reasons that development of some adjuvants succeeded while many others failed, we discuss some of the common attributes of successful first generation adjuvants. Next, we evaluate current trends in the development of second generation adjuvants, including the potential advantages of rationally designed synthetic immune potentiators appropriately formulated. Finally, we discuss desirable attributes of next generation adjuvants. Throughout, we emphasize that the importance of formulation and analytical characterization in all aspects of vaccine adjuvant development is often underappreciated. We highlight the formulation factors that must be evaluated in order to optimize interactions between vaccine antigens, immune potentiators, and particulate formulations, and the resulting effects on safety, biological activity, manufacturability, and stability. © 2015 Elsevier Ltd.


The Modern Vaccines/Adjuvants Formulation meeting aims to fill a critical gap in current vaccine development efforts by bringing together formulation scientists and immunologists to emphasize the importance of rational formulation design in order to optimize vaccine and adjuvant bioactivity, safety, and manufacturability. Session 6 on Vaccine and Adjuvant Formulation and Production provided three examples of this theme, with speakers emphasizing the need for extensive physicochemical characterization of adjuvant-antigen interactions, the rational formulation design of a CD8+ T cellinducing adjuvant based on immunological principles, and the development and production of a rabies vaccine by a developing country manufacturer. Throughout the session, the practical importance of sound formulation and manufacturing design accompanied by analytical characterization was highlighted. © 2013 Landes Bioscience.


Fox C.B.,IDRI | Haensler J.,Sanofi S.A.
Expert Review of Vaccines | Year: 2013

With the exception of alum, emulsion-based vaccine adjuvants have been administered to far more people than any other adjuvant, especially since the 2009 H1N1 influenza pandemic. The number of clinical safety and immunogenicity evaluations of vaccines containing emulsion adjuvants has correspondingly mushroomed. In this review, the authors introduce emulsion adjuvant composition and history before detailing the most recent findings from clinical and postmarketing data regarding the effects of emulsion adjuvants on vaccine immunogenicity and safety, with emphasis on the most widely distributed emulsion adjuvants, MF59® and AS03. The authors also present a summary of other emulsion adjuvants in clinical development and indicate promising avenues for future emulsion-based adjuvant development. Overall, emulsion adjuvants have demonstrated potent adjuvant activity across a number of disease indications along with acceptable safety profiles. © 2013 Informa UK Ltd.


News Article | November 3, 2016
Site: www.prnewswire.com

SEATTLE, Nov. 3, 2016 /PRNewswire-USNewswire/ -- IDRI's drug discovery efforts continue to grow with a recently awarded $7.5 million in additional funding, plus an additional $7.5 million of in-kind services, for a total commitment of $15 million over the next five years from Eli Lilly...

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