News Article | July 12, 2017
BELLEVUE, Wash. & BOSTON & SEOUL--(BUSINESS WIRE)--Intellectual Ventures’ Global Good Fund and GE (NYSE:GE), have signed a licensing agreement with the diagnostics technology company Access Bio (KOSDAQ:950130) to manufacture and distribute innovative diagnostic technologies that will help global health workers to more rapidly identify asymptomatic malaria in low-resource regions around the world. Identifying these low-level infections is considered critical to directing efforts towards malaria elimination. “Significantly enhancing the sensitivity of malaria rapid diagnostic tests (RDTs) addresses gaps in rapid diagnostics that will bring us closer to eliminating the deadly disease in more and more regions around the world,” said Maurizio Vecchione, Executive Vice President of Global Good & Research. “GE and Global Good have a shared commitment, along with Access Bio – as a commercialization partner – to enhance surveillance by public health teams to identify very low level malaria infections and realize the goal of eventually eradicating malaria entirely,” he said. The new diagnostics technologies for malaria detection were co-developed by a team of scientists and engineers at GE’s Global Research Center in Upstate New York and Global Good. GE Ventures, GE’s strategic arm to accelerate innovation and growth with partners, drove the commercialization model for the technology and the licensing agreement between GE, Global Good and Access Bio. “The combination of RDTs and serology tests will fill an important gap in the tool-set for the eradication of malaria,” said Joseph Suriano, Technical Discipline Leader at GE Global Research, leading GE’s involvement in the program. “By being able to see if a population has been recently exposed to the malaria parasite with serology tests, we can then efficiently target the use of more rapid, highly sensitive tests and other anti-malarial interventions to act before outbreaks occur.” The agreement covers a highly-sensitive diagnostic test that identifies key proteins present in malaria, as well as Plasmodium lactate dehydrogenase (pLDH) RDT to detect malarial parasites. The agreement also includes technology to create malaria serology tests for Plasmodium antibodies which can measure a population’s past exposure to the disease. “With our commercialization experience and mass production facilities, Access Bio will be able to fully accommodate the commercialization of the highly sensitive RDTs at affordable prices. These tests will be the next generation of diagnostic testing and a big step towards the eradication of malaria,” said Young Ho Choi, Chief Executive Officer of Access Bio. According to the WHO, the volume of malaria RDT sales reported by manufacturers increased by almost 7 times from 2008 to 2014. The WHO also reports that nearly half of the world’s population is at risk of malaria, and in 2015 alone, there were 429,000 deaths globally due to the disease; many of those deaths occur in the developing world, with 92% of those deaths taking place in Sub-Saharan Africa. The WHO "Global Technical Strategy for Malaria 2016-2030", a new 15-year framework for malaria control in all endemic countries, sets ambitious but achievable targets for 2030, including the elimination of malaria in at least 35 countries. Providing these new tests to these countries could enhance program effectiveness and empower local health systems to manage elimination programs more effectively. Global Good is a collaboration between Intellectual Ventures and Bill Gates to invent technology that improves life in low- and middle-income countries. With support from a coalition of NGO, government and business partners, we conceive, develop and deploy inventions for the poorest parts of the world. Global Good combines Intellectual Ventures’ unique invention prowess with the expertise of leading humanitarian organizations, forward-looking governments, and commercial partners that share our vision. Together, we invent, develop, and deploy commercially-viable technologies that improve life in developing countries. www.globalgood.com GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. GE is organized around a global exchange of knowledge, the "GE Store," through which each business shares and accesses the same technology, markets, structure and intellect. Each invention further fuels innovation and application across our industrial sectors. With people, services, technology and scale, GE delivers better outcomes for customers by speaking the language of industry. www.ge.com Access Bio (KOSDAQ:950130) is dedicated to the prevention and early diagnosis of infectious diseases through research, development, and manufacturing of in vitro rapid diagnostic tests, biosensors and molecular diagnostic products. The company’s in vitro diagnostic test platform includes immunochemical, biochemical and molecular products. Headquartered in Somerset, New Jersey, Access Bio serves its global customer base from manufacturing sites located in the US, Ethiopia and South Korea. In fiscal year 2015, the company reported $31.4 million of revenues, largely from sales of its industry-leading malaria RDT products. The company is in the early stages of commercializing a number of additional diagnostic kits that leverage its existing expertise and manufacturing capacity. For additional information about the company, please visit www.accessbio.net.
News Article | July 13, 2017
BELLEVUE, Wash. & BOSTON & SEOUL--(BUSINESS WIRE)--Le Fonds de Global Good d’Intellectual Ventures et GE (NYSE : GE) ont signé un accord de licence avec la société de technologie de diagnostic Access Bio (KOSDAQ: 950130) pour fabriquer et distribuer des technologies de diagnostic innovantes qui aideront les agents de santé internationaux à identifier plus rapidement le paludisme asymptomatique dans les régions à faible ressources dans le monde. L'identification de ces infections à bas niveau est considérée comme fondamentale pour diriger les efforts visant à éliminer le paludisme. « L’amélioration significative de la sensibilité des tests de diagnostic rapide du paludisme (TDRs) traite des déficiences dans le diagnostic rapide qui nous rapprochera de l'élimination de la maladie mortelle dans de plus de régions dans le monde », a déclaré Maurizio Vecchione, Vice-Président Exécutif de Global Good & Research. «GE et Global Good partage avec Access Bio- en tant que partenaire de la commercialisation-, l’engagement d'améliorer la surveillance des équipes de santé publique, afin d'identifier les infections à faible niveau du paludisme et réaliser l'objectif d’éliminer éventuellement le paludisme », a-t-il déclaré. Les nouvelles technologies de diagnostic pour la détection du paludisme ont été développées conjointement par une équipe de scientifiques et d'ingénieurs au Centre Mondial de Recherche de GE à Upstate New York et Global Good. GE Ventures, le bras stratégique de GE ayant pour but d’accélérer l'innovation et la croissance avec les partenaires, a conduit le modèle de commercialisation pour la technologie et l'accord de licence entre GE, Global Good et Access Bio. « La combinaison de TDRs et de tests sérologiques comblera une déficience importante dans l'ensemble d'outils de l'éradication du paludisme », a déclaré Joseph Suriano, Responsable de la Discipline Technique chez GE Global Research, qui mène la participation de GE au programme. « En étant capable de voir si une population a récemment été exposée au parasite du paludisme à l’aide des tests sérologiques, nous pouvons alors cibler efficacement l'utilisation de tests plus rapides et très sensibles et d'autres interventions antipaludiques pour agir avant que les épidémies se produisent ». Selon l'OMS, le volume des ventes de TDRs du paludisme signalé par les fabricants a augmenté de près de 7 fois entre 2008 et 2014. L'OMS avertit également que près de la moitié de la population mondiale risque du paludisme et, en 2015 seulement, la maladie a causé 429 000 décès dans le monde entier ; un grand nombre de ces décès apparait dans le monde en développement, et 92% des décès ont lieu en Afrique subsaharienne. Global Good est une collaboration entre Intellectual Ventures et Bill Gates, visant à inventer une technologie qui améliore la vie dans les pays à revenu faible ou intermédiaire. Avec le soutien d'une coalition d'ONG, de gouvernements et de partenaires commerciaux, nous concevons, développons et déployons des inventions pour les régions les plus pauvres du monde. Global Good combine la prouesse unique de l'invention d’Intellectual Ventures avec l'expertise des principales organisations humanitaires, des gouvernements prospectifs et des partenaires commerciaux qui partagent notre vision. Ensemble, nous inventons, développons et déployons des technologies commercialement essentielles qui améliorent la vie dans les pays en développement. www.globalgood.com GE est la société industrielle numérique mondiale, qui transforme l'industrie à travers des machines et des solutions définies par des logiciels qui sont connectées, réactives et prédictives. GE est organisée autour d'un échange mondial de connaissances, le «GE Store », à travers lequel chaque entreprise partage et accède aux mêmes technologies, marchés, structures et intellects. Chaque invention contribue à l'innovation et à l'application dans nos secteurs industriels. Avec les personnes, les services, la technologie et l'échelle, GE offre de meilleurs résultats pour les clients en parlant la langue de l'industrie. www.ge.com Access Bio (KOSDAQ : 950130) est dédié à la prévention et au diagnostic précoce des maladies infectieuses à travers la recherche, le développement et la fabrication de tests diagnostiques rapides in vitro, de biosensors et de produits de diagnostic moléculaire. La plateforme de test de diagnostic in vitro de l'entreprise comprend des produits immunochimiques, biochimiques et moléculaires. Ayant son siège social à Somerset au New Jersey, Access Bio dessert sa clientèle mondiale à partir de sites de fabrication situés aux États-Unis, en Éthiopie et en Corée du Sud. Au cours de l'exercice 2015, la société a enregistré un chiffre d'affaires de 31.4 millions de dollars, en grande partie grâce aux ventes de ses produits de pointe de TDRs de paludisme. La société est dans les premiers phases de la commercialisation d'un certain nombre de kits de diagnostic supplémentaires qui tirent parti de l'expertise et de la capacité de fabrication existantes.
Tibbitts J.,Genentech |
Cavagnaro J.A.,Access BIO |
Haller C.A.,Amgen Inc. |
Marafino B.,Scientific and Management Consulting |
And 2 more authors.
Regulatory Toxicology and Pharmacology | Year: 2010
Recent advances in our understanding of disease biology, biomarkers, new therapeutic targets, and innovative modalities have each fueled a dramatic expansion in the development of novel human therapeutics. Many are biotechnology-derived biologics possessing high selectivity and affinity for their intended target; as such they often pose challenges in the development path to approval. One challenge is the selection of the first-in-human (FIH) dose. This process has come under increased scrutiny as a result of a FIH trial with a super-agonist monoclonal antibody (TGN1412), which resulted in significant injury to healthy volunteers. Regulatory agencies have responded with supplemental guidance for the development of novel therapeutics. The intent of this paper is to provide experience-based insight, with relevant examples, for those planning the first administration of novel biopharmaceuticals in humans. © 2010 Elsevier Inc.
Cavagnaro J.,Access BIO |
Silva Lima B.,University of Lisbon
European Journal of Pharmacology | Year: 2015
Abstract The utility of animal models of disease for assessing the safety of novel therapeutic modalities has become an increasingly important topic of discussion as research and development efforts focus on improving the predictive value of animal studies to support accelerated clinical development. Medicines are approved for marketing based upon a determination that their benefits outweigh foreseeable risks in specific indications, specific populations, and at specific dosages and regimens. No medicine is 100% safe. A medicine is less safe if the actual risks are greater than the predicted risks. The purpose of preclinical safety assessment is to understand the potential risks to aid clinical decision-making. Ideally preclinical studies should identify potential adverse effects and design clinical studies that will minimize their occurrence. Most regulatory documents delineate the utilization of conventional "normal" animal species to evaluate the safety risk of new medicines (i.e., new chemical entities and new biological entities). Animal models of human disease are commonly utilized to gain insight into the pathogenesis of disease and to evaluate efficacy but less frequently utilized in preclinical safety assessment. An understanding of the limitations of the animal disease models together with a better understanding of the disease and how toxicity may be impacted by the disease condition should allow for a better prediction of risk in the intended patient population. Importantly, regulatory authorities are becoming more willing to accept and even recommend data from experimental animal disease models that combine efficacy and safety to support clinical development. © 2015 Elsevier B.V.
Cavagnaro J.,Access BIO |
Berman C.,Berman Consulting |
Kornbrust D.,Preclinisight |
White T.,Exponent, Inc. |
And 2 more authors.
Nucleic Acid Therapeutics | Year: 2014
This white paper summarizes the current consensus of the Reproductive Subcommittee of the Oligonucleotide Safety Working Group on strategies to assess potential reproductive and/or developmental toxicities of therapeutic oligonucleotides (ONs). The unique product characteristics of ONs require considerations when planning developmental and reproductive toxicology studies, including (a) chemical characteristics, (b) assessment of intended and unintended mechanism of action, and (c) the optimal exposure, including dosing regimen. Because experience across the various classes of ONs as defined by their chemical backbone is relatively limited, best practices cannot be defined. Rather, points to consider are provided to help in the design of science-based reproductive safety evaluation programs based upon product attributes. © Copyright 2014, Mary Ann Liebert, Inc.
PubMed | Lilly Research Laboratories, Hoffmann-La Roche, Bayer AG, Access BIO and 9 more.
Type: Journal Article | Journal: Toxicologic pathology | Year: 2015
PEGylation (the covalent binding of one or more polyethylene glycol molecules to another molecule) is a technology frequently used to improve the half-life and other pharmaceutical or pharmacological properties of proteins, peptides, and aptamers. To date, 11 PEGylated biopharmaceuticals have been approved and there is indication that many more are in nonclinical or clinical development. Adverse effects seen with those in toxicology studies are mostly related to the active part of the drug molecule and not to polyethylene glycol (PEG). In 5 of the 11 approved and 10 of the 17 PEGylated biopharmaceuticals in a 2013 industry survey presented here, cellular vacuolation is histologically observed in toxicology studies in certain organs and tissues. No other effects attributed to PEG alone have been reported. Importantly, vacuolation, which occurs mainly in phagocytes, has not been linked with changes in organ function in these toxicology studies. This article was authored through collaborative efforts of industry toxicologists/nonclinical scientists to address the nonclinical safety of large PEG molecules (>10 kilo Dalton) in PEGylated biopharmaceuticals. The impact of the PEG molecule on overall nonclinical safety assessments of PEGylated biopharmaceuticals is discussed, and toxicological information from a 2013 industry survey on PEGylated biopharmaceuticals under development is summarized. Results will contribute to the database of toxicological information publicly available for PEG and PEGylated biopharmaceuticals.
PubMed | Access BIO and University of Lisbon
Type: | Journal: European journal of pharmacology | Year: 2015
The utility of animal models of disease for assessing the safety of novel therapeutic modalities has become an increasingly important topic of discussion as research and development efforts focus on improving the predictive value of animal studies to support accelerated clinical development. Medicines are approved for marketing based upon a determination that their benefits outweigh foreseeable risks in specific indications, specific populations, and at specific dosages and regimens. No medicine is 100% safe. A medicine is less safe if the actual risks are greater than the predicted risks. The purpose of preclinical safety assessment is to understand the potential risks to aid clinical decision-making. Ideally preclinical studies should identify potential adverse effects and design clinical studies that will minimize their occurrence. Most regulatory documents delineate the utilization of conventional normal animal species to evaluate the safety risk of new medicines (i.e., new chemical entities and new biological entities). Animal models of human disease are commonly utilized to gain insight into the pathogenesis of disease and to evaluate efficacy but less frequently utilized in preclinical safety assessment. An understanding of the limitations of the animal disease models together with a better understanding of the disease and how toxicity may be impacted by the disease condition should allow for a better prediction of risk in the intended patient population. Importantly, regulatory authorities are becoming more willing to accept and even recommend data from experimental animal disease models that combine efficacy and safety to support clinical development.
Lewis R.M.,Access Bio. |
Drug Information Journal | Year: 2010
On February 3-4, 2009, a DIA Workshop was held to review and discuss comparability challenges and issues for biotechnology-derived pharmaceuticals. The workshop was held in the Washington, DC, area and was attended by representatives from the FDA and biotech and pharmaceutical industries. The expectation was to develop a consensus on which data are necessary to provide assurance of comparability for manufacturing changes made to biotechnology products during different stages of development or postmarketing. Numerous case studies were reviewed and discussed to build on best practices and recognize successful approaches to comparability. Copyright © 2010 Drug Information Association, Inc. All rights reserved.
Kornbrust D.,Preclinsight |
Cavagnaro J.,Access Bio |
Levin A.,Miragen Therapeutics |
Foy J.,Celgene |
And 3 more authors.
Nucleic Acid Therapeutics | Year: 2013
This document summarizes the current consensus opinion of the Exaggerated Pharmacology (EP) Subcommittee of the Oligonucleotide Safety Working Group on the appropriate strategies to assess potential adverse effects caused by an "exaggerated" degree of the intended pharmacologic activity of an oligonucleotide (ON). The Subcommittee focused its discussions primarily on the ON subclasses that impact expression of "host" (i.e., human gene products - antisense, small interfering RNAs, and related ONs that target messenger RNA), with later and more limited discussions on aptamer, immunostimulatory, and microRNA subclasses. It is expected that many of these principles will be relevant to other subclasses but will need to be carefully considered as those development programs advance towards clinical trials. The recommendations may also serve as a frame of reference when designing Good Laboratory Practice safety studies with ONs, with regard to the study design elements that address assessment of EP. It is also hoped that these recommendations will establish a foundation for discussion with regulatory agencies on this subject. © Mary Ann Liebert, Inc.
PubMed | University of California at San Diego and Access Bio
Type: | Journal: Clinical lymphoma, myeloma & leukemia | Year: 2015
Receptor tyrosine kinase-like orphan receptor 1 (ROR1) is an oncoembryonic antigen. Because of its expression on the cell surface of leukemia cells from patients with chronic lymphocytic leukemia (CLL), but not on normal B-cells or other postpartum tissues, ROR1 is an attractive candidate for targeted therapies. UC-961 is a first-in-class humanized monoclonal antibody that binds the extracellular domain of ROR1. In this article we outline some of the preclinical studies leading to an investigational new drug designation, enabling clinical studies in patients with CLL.