Stronger treatments could cure Chagas disease - University of Georgia

Stronger treatments could cure Chagas disease - University of Georgia
OpGen Announces Award of German Government Grant Funding to its Subsidiary Curetis and Collaborators - GlobeNewswire
3P Bio to manufacture SpyBiotech vaccine - European Biotechnology News

Posted: 28 Oct 2020 11:14 AM PDT

Researchers in the University of Georgia's Center for Tropical and Emerging Global Diseases have found that a more intensive, less frequent drug regimen with currently available therapeutics could cure the infection that causes Chagas disease, a potentially life-threatening illness affecting up to 300,000 people in the United States.

Trypanosoma cruzi is a single-celled parasitic organism that causes Chagas disease. At least 6 million people are infected by T. cruzi, mostly in South America. Current drug therapies have been ineffective in completely clearing the infection and are associated with severe adverse side effects.

A single dose of benznidazole has been shown to be highly effective in killing more than 90% of parasites. However, after a CTEGD team found some of the parasites enter into a dormancy stage, the researchers hypothesized that an intermittent treatment schedule could be effective.

Current human trials are only looking at giving lower doses over a shorter time period, which is the exact opposite of what we show works." — Rick Tarleton

"In this system we can see what a single dose of drug does," said Rick Tarleton, Regents' Professor in UGA's department of cellular biology. "Does it make sense to give a drug twice daily when the remaining dormant parasites are insensitive to it?"

The investigators found that giving as little as two-and-a-half times the typical daily dose of benznidazole, once per week for 30 weeks, completely cleared the infection, whereas giving the standard daily dose once a week for a longer period did not.

"Current human trials are only looking at giving lower doses over a shorter time period, which is the exact opposite of what we show works," said Tarleton.

Since Tarleton's team worked with a mouse model, how this change in treatment regimen will translate in humans is yet unknown, as are any potential side effects of the higher doses. Adverse reactions already are a problem with current treatments; the hope is that side effects from a less frequent dosage would be more tolerable.

Significant challenge

Assessing the success of treatments in Chagas disease is a significant challenge. Tissue samples from infected organisms might not be representative of the entire organ or animal, since low numbers of persistent, dormant parasites can be difficult to detect. Therefore, Tarleton's group used light sheet fluorescence microscopy to view intact whole organs from infected mice.

"With light sheet fluorescence microscopy, you have a broad view of potentially any tissue in the mouse that allows for dependable assessment of parasite load and persistence," said Tarleton. "It gives you an incredible view of the infection."

Using this technology, they learned something new about the dormant parasites: Some were still susceptible to drug treatment. This provides hope that new drug therapies could be developed to target these parasites.

"Discovery of new drugs should continue," Tarleton said. "We still need better drugs."

Co-led by assistant research scientist Juan Bustamante and research professional Fernando Sanchez in Tarleton's research group, the study's findings appear in Science Translational Medicine.

OpGen Announces Award of German Government Grant Funding to its Subsidiary Curetis and Collaborators - GlobeNewswire

Posted: 28 Oct 2020 04:30 AM PDT

Project to look at rapid molecular diagnostics for travel related and enteric diseases in small animals
Veterinary applications to be developed on Unyvero A30 RQ platformCuretis to collaborate with Carpegen and Ludwig-Maximilians-University of Munich
GAITHERSBURG, Md. and HOLZGERLINGEN, Germany, Oct. 28, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, "OpGen"), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today the award of a German Federal Government grant to its subsidiary, Curetis GmbH, and collaborators Carpegen GmbH (Muenster, Germany) and the Clinic for Small Animal Internal Medicine of the LMU Ludwig-Maximilians- University (Munich, Germany).
The project which was originally initiated via the VetDx network in Berlin and Brandenburg is set to receive funding under the "Zentrales Innovationsprogramm Mittelstand" i.e., a central innovation program for medium sized growth companies in collaboration with academic institutions. The project will focus on travel related and enteric diseases in small animals which is an area of growing concern with increasing incidence rates. Several of these diseases are caused by potential zoonotic pathogens that could also be passed to humans, i.e. by looking at veterinary applications one might also help prevent human diseases in the future.Currently there is no comparable rapid, automated, cartridge-based sample to answer molecular diagnostic system that would target these diseases, which the collaboration partners believe will be needed to successfully address the unmet clinical need. The primary project objective is to develop such a molecular diagnostics platform for infectious diseases in small animals. The 3-year project starts on December 1^st, 2020. Under the grant project which has a volume of over half a million Euros, Curetis expects to receive EUR 152,000 in non-dilutive funding during this time.Specifically, the project will be targeting travel related and enteric diseases in small animals such as parasitic diseases and viral infectious diseases. Curetis' contribution will be focusing on the development and integration of sample preparation and assays onto the Unyvero A30 RQ platform, as well as integration of dried reagents into the diagnostic test cartridges that run on the system. Collaboration partner Carpegen will be focusing on the development of dried reagents and on joint sample preparation and assay development efforts together with the team at Curetis, while the academic partner LMU will be responsible for sample acquisition and prototype validation as well as for providing reference strains."We are excited to collaborate with Carpegen and LMU on this project which will help expand the use of our Unyvero A30 platform in development. Developing rapid veterinary diagnostics tests on such an automated platform will potentially open up future commercial and partnering opportunities" said Oliver Schacht, PhD, CEO of OpGen."We are really looking forward to participating in this exciting project which is the first project of Carpegen targeting the veterinary market" said Antje Roetger, PhD, CEO of Carpegen. "In addition, we are very pleased that we have the ongoing opportunity to work on a project involving OpGen's Unyvero A30 RQ platform since the first prototype of this promising platform was developed within an R&D project led by Carpegen.""We are very happy for the opportunity to contribute to a new point-of-care system in veterinary diagnostics. With an annual case load of more than 5,000 patients as a first opinion and referral clinic we experience every day the need for accurate and fast diagnosis of infectious diseases. We consider it our obligation to find solutions for our patients, the pet owners, and veterinarians working in private practices by developing economical and easy-to-use laboratory tests in collaboration with innovative industry partners." said Dr. Karin Weber, Head of Laboratory at the Clinic for Small Animal Internal Medicine.About LMU Munich
The Clinic for Small Animal Internal Medicine as part of the LMU Munich is a leading academic institution in the field of veterinary internal medicine for cats and dogs and strives to actively participate in the development of sustainable diagnostic systems for small animal medicine. With our professional expertise we ensure that the products align with market needs. As a university research group we would like to contribute significantly to the progress of point-of-care systems in veterinary medicine. As a university veterinary clinic we would like to improve the diagnostic possibilities in small animal medicine for the benefit of our animal patients.About Carpegen
Carpegen (Muenster, Germany) is a provider of high-quality molecular diagnostics. We focus on developing real-time PCR assays and point-of-care systems for the diagnosis of specific infections and the detection of genetic biomarkers. Carpegen has developed Carpegen® Perio Diagnostics, a powerful real-time PCR based system that sets new standards in dental diagnostics. A main objective of Carpegen's research program is to develop and out-license POC/PCR systems for diverse applications in medicine, as well as in food/beverage and environmental analytics. Since 2020, Carpegen offers sensitive and specific real-time PCR diagnostics for the detection of the coronavirus disease 2019 (COVID-19).About OpGen, Inc.
OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with its subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen's product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas® Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.For more information, please visit www.opgen.com.Forward-Looking Statements
This press release includes statements regarding the award of a grant from the German government to Curetis GmbH and development efforts in veterinary applications for the Unyvero A30 RQ platform. These statements and other statements regarding OpGen's products, their commercialization and launch, future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the success of our commercialization efforts, the impact of COVID-19 on the Company's operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, the realization of expected benefits of our business combination transaction with Curetis GmbH, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.OpGen Contact:
Oliver Schacht
CEO
InvestorRelations@opgen.comPress Contact:
Matthew Bretzius
FischTank Marketing and PR
matt@fischtankpr.com Investor Contact:
Megan Paul
Edison Group
mpaul@edisongroup.com

3P Bio to manufacture SpyBiotech vaccine - European Biotechnology News

Posted: 28 Oct 2020 02:48 AM PDT

British SpyBiotech has outsourced GMP manufacturing of its VLP vaccine platform to Navarra-based 3P Biopharmaceuticals.

Under the agreement, Navarra-based CDMO 3P Biopharmaceuticals will produce cGMP lots for Phase I testing of SpyBiotech's (Oxford) vaccine candidate against the human Cytomegalie virus (CMV) starting next year. SpyBiotech, which has developed a technology platform that allows to "glue" antigens stochiometrically to virus-like particles (VLPs), selected 3P Biopharmaceuticals in June 2019 to manufacture a cGMP batch of their VLP carrier with the goal of completing production in 2021. This carrier will be used to initially display antigens from CMV, but can be used for a huge number of different pathogens. A US partner, for instance, uses SpyBiotech's platform to couple SARS-CoV-2 antigens to ferritin VLPs. Thus, the vaccine platform can be used to target many infectious agents, but also cancer or chronic diseases.

The SpyCatcher/SpyTag is a platform technology that allows antigens to be displayed onto virus-like particles (VLPs) with a covalent, irreversible bond in a highly stable and effective way with specific orientation/epitope presentation and high density. The platform allows to split a protein from Streptococcus pyogenes into two parts: the SpyTag peptide that can be bound to antigens and its partner protein SpyCatcher that binds to the VLP. The two pieces of the original SpyTag/SpyCatcher protein then bind back together in a spontaneous conjugation forming an unbreakable covalent bond. This innovation can be used for an exceptionally broad range of applications in vaccine development and has established proof of concept data in viral, bacterial, parasitic diseases as well as chronic diseases and cancer.

3P Biopharmaceuticals has led process development and now will produce the first batches for clinical testing. Dámaso Molero, CEO of 3P Pharmaceuticals, said: "It is amazing being part of a project, which presents an opportunity to develop treatments for a broad range of diseases. We are helping to support manufacturing which we believe will open the door for pioneering vaccines which could offer hope for improving the lives of many people. That is extremely exciting."

Genevieve Labbe, Senior Scientist and GMP Project Manager for SpyBiotech commented: "It's critical to have a trusted partner in place for cell line and cGMP production. SpyBiotech is looking forward to advancing this product and we are delighted to be working with 3P Biopharmaceuticals, a leading CDMO."

The partnership is a validation of 3P Biopharmaceuticals' ability not only to develop and produce biologicals and cell therapy's GMP compliantly but also find process for highly innovative novel drug formats. Starting 13 years ago at CIMA Navarra, 3P Biopharmaceuticals has expanded its GMP and FDA-inspected production capacities and staff to over 250 experts and has grown up to one of the most trusted CDMOs in Europe.

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