“Investigational COVID-19 vaccine well-tolerated and generates immune response in older adults - National Institutes of Health” plus 4 more

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• Investigational COVID-19 vaccine well-tolerated and generates immune response in older adults - National Institutes of Health
• West Nile Virus Detected In Dead Bird For First Time In County This Year - SFGate
• OpGen Announces Award of German Government Grant Funding to its Subsidiary Curetis and Collaborators - BioSpace
• Experimental infection of domestic dogs and cats with SARS-CoV-2: Pathogenesis, transmission, and response to reexposure in cats - pnas.org
• Secura Bio Completes Acquisition of Global Rights to Oncology Drug Copiktra - BioSpace

Investigational COVID-19 vaccine well-tolerated and generates immune response in older adults - National Institutes of Health Posted: 29 Sep 2020 01:24 PM PDT Media Advisory Tuesday, September 29, 2020 What A Phase 1 trial of an investigational mRNA vaccine to prevent SARS-CoV-2 infection has shown that the vaccine is well-tolerated and generates a strong immune response in older adults. A report published today in the New England Journal of Medicine describes the findings from the study, which was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19 disease. The experimental vaccine, mRNA-1273, was co-developed by researchers at NIAID and Moderna, Inc. of Cambridge, Massachusetts. The Phase 1 trial began on March 16, 2020, and was expanded to enroll older adults about one month later. Older adults are more vulnerable to complications of COVID-19 and are an important population for vaccination. Understanding how the vaccine affects older adults is a critical part of measuring its safety and efficacy. The trial was conducted at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, Emory University in Atlanta, and NIAID's Vaccine Research Center (VRC) clinic at the NIH Clinical Center in Bethesda, Maryland. Julie Ledgerwood, D.O., deputy director and chief medical officer at the VRC, oversaw the study at the NIH site. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate for this trial. This trial is supported by the Infectious Diseases Clinical Research Consortium (IDCRC) through NIAID. In its expansion to include older adults, the trial enrolled 40 healthy volunteers: 20 adults ages 56 to 70 years, and 20 adults ages 71 years and older. Ten volunteers in each age group received a lower dose of the vaccine (25 µg), and 10 volunteers in each age group received a higher dose (100 µg). After approximately one month, volunteers then received a second dose of the same vaccine at the same dosage. Throughout the study, volunteers attended clinic visits to track their responses to the vaccine and assess safety. Overall, the researchers found that the investigational vaccine was well-tolerated in this older age group. Although some volunteers experienced some transient adverse effects, including fever and fatigue after vaccination, the researchers found that they also exhibited a good immune response to the vaccine: the blood of vaccinated volunteers contained robust binding and neutralizing antibodies against SARS-CoV-2. Importantly, the immune response to the vaccine seen in older volunteers was comparable to that seen in younger age groups. The study will continue to follow the older volunteers for approximately a year after second vaccination to monitor the long-term effects of the vaccine. According to the researchers, these Phase 1 trial results further support testing of the investigational vaccine in older adults in an ongoing large Phase 3 trial. For more details on the trial, please see NIAID's March 16 press release, NIAID's March 27 statement, or visit ClinicalTrials.gov and search identifier NCT04283461. Article Anderson et al. Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults. New England Journal of Medicine DOI: 10.1056/NEJMoa2028436 (2020). Who Dr. John Beigel, associate director for Clinical Research in NIAID's Division of Microbiology and Infectious Diseases, and Dr. Barney Graham, deputy director of NIAID's Vaccine Research Center, are available for comment. 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 www.nih.gov. NIH…Turning Discovery Into Health® ###

West Nile Virus Detected In Dead Bird For First Time In County This Year - SFGate Posted: 30 Sep 2020 11:20 AM PDT San Mateo County's Mosquito and Vector Control District has detected West Nile virus in a dead bird for the first time this year. The bird -- an American crow -- was collected in South San Francisco earlier this week, the vector control district said Wednesday. It is the first case of the virus found in San Mateo County since 2018. Though reports of dead birds indicate presence of the virus, the risk to humans remains low. West Nile virus primarily affects birds, but humans, horses and other animals can get infected if bitten by an infected mosquito, which are vectors for the virus. The virus cannot be spread person to person. The county's vector control district encouraged people to report fresh bird carcasses to the California West Nile Virus Hotline at www.westnile.ca.gov or by calling (877) WNV-BIRD. People can reduce the risk of infection by preventing mosquito breeding and avoiding mosquito bites. Since mosquitoes lay their eggs on standing water, the district recommends draining and eliminating sources of standing water on properties -- including flower pots, old car tires, clogged gutters and pet bowls. People should also wear clothing and mosquito repellent if outside during early morning and evening hours, as these are times the mosquitoes that transmit the virus tend to bite. Doors and windows should have tight-fitting screens to keep mosquitoes out. Mosquito repellent containing ingredients such as DEET, picaradin, oil of lemon eucalyptus, or IR3535 can prevent mosquito bites. The district will continue to treat mosquito breeding sources and collect mosquitoes for testing in areas where dead birds are found. For assistance with a mosquito problem, people can contact the district at (650) 344-8592 or visit www.smcmvcd.org for more information. West Nile virus has also been found in Contra Costa and Santa Clara counties this year. Copyright © 2020 by Bay City News, Inc. Republication, Rebroadcast or any other Reuse without the express written consent of Bay City News, Inc. is prohibited.

OpGen Announces Award of German Government Grant Funding to its Subsidiary Curetis and Collaborators - BioSpace Posted: 30 Sep 2020 04:48 AM PDT Project: AI based Assay Development for carbapenem-resistance based on porin loss and efflux pump overexpression in Gram-negative bacteria Project is part of the Research Campus InfectoGnostics and includes project partners at the University Hospital Jena, Institute for Infectious Diseases and Infection Control GAITHERSBURG, Md., and HOLZGERLINGEN, Germany, Sept. 30, 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 at the Research Campus InfectoGnostics. The project is coordinated by Jena University Hospital and designed to use artificial intelligence (AI) based assay development for carbapenem-resistance based on porin loss and efflux pump overexpression in Gram-negative bacteria. Specifically, the project expected to start in September 2020 and run until August 2025 with overall funding of more than 350 thousand Euros provided by Federal German Ministry of Education and Research (Bundesministerium für Bildung und Forschung BMBF) to Curetis alone, is aimed to make novel molecular diagnostics available for relevant resistance mechanisms against Carbapenems. Furthermore, the project aims to address resistance mechanisms in difficult-to-treat Gram-negative pathogens such as Enterobacteria, Pseudomonas and Acinetobacter. Curetis' role during the collaborative research project is to provide research on innovative detection methods for carbapenem resistance based on porin loss and efflux pump overexpression. Dr. Gerd Luedke, Director Innovation, Technology and IP at Curetis GmbH commented, "Carbapenems are last-resort antibiotics for treatment of patients infected with Gram-negative bacteria that show resistance against Cephalosporins. Resistance is often conferred by mechanisms such as porin loss or efflux pump overexpression, not adequately covered by current diagnostics. We are therefore excited to contribute novel approaches to the fight against antimicrobial resistance in such hospital superbugs." Dr. Oliwia Makarewicz, scientist with the Institute for Infectious Diseases and Infection Control at Jena University Hospital and leader of the project, emphasizes its interdisciplinary character, "Here, we combine molecular genetics, bioinformatics and AI based methods. That innovative approach will foster the outcome of the project as well as the scientific career options of the young researchers working within." Prof. Dr. Juergen Popp, Speaker of the InfectoGnostics Managing Board, added "We are pleased to start this new collaboration with Curetis, one of the leaders in rapid, cartridge-based multiplex PCR testing. This project will be a good example of direct co-working between academia, clinical medicine and industry to address medical needs through improved diagnostics with regard to antimicrobial resistances."    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 receipt of a grant from the German government by Curetis GmbH. 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.com Press Contact: Matthew Bretzius FischTank Marketing and PR matt@fischtankpr.com Investor Contact: Megan Paul Edison Group mpaul@edisongroup.com

Experimental infection of domestic dogs and cats with SARS-CoV-2: Pathogenesis, transmission, and response to reexposure in cats - pnas.org Posted: 29 Sep 2020 09:41 AM PDT New Research In Physical Sciences Featured Portals Articles by Topic Social Sciences Featured Portals Articles by Topic Biological Sciences Featured Portals Articles by Topic

Secura Bio Completes Acquisition of Global Rights to Oncology Drug Copiktra - BioSpace Posted: 30 Sep 2020 06:46 AM PDT LAS VEGAS, Sept. 30, 2020 /PRNewswire/ -- Secura Bio, Inc. (SBI) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announced that it has completed the acquisition of the global rights to Copiktra® (duvelisib) for all oncology indications from Verastem, Inc.  Secura Bio's hematological oncology portfolio now includes Copiktra and Farydak® (panobinostat), an HDAC inhibitor. Copiktra is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and gamma involved in the signaling that leads to malignant B-cells proliferation and cancer. Copiktra is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Copiktra is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status and Orphan Drug Designation and is being investigated in combination with other agents through company and investigator-sponsored studies.  A European Marketing Authorization Application for Copiktra was submitted in November 2019 to the European Medicines Agency (EMA) seeking approval for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory follicular lymphoma (FL). Secura Bio will aggressively support the development of Copiktra in the treatment of T-cell lymphomas for which the PI3K inhibition-based mode of action is highly relevant, and explore new therapeutic opportunities for which the combination of PI3K and HDAC inhibitors (such as Secura Bio's other approved product - Farydak) may provide superior clinical outcomes. "Completing the Copiktra acquisition represents a major step in building our worldwide oncology portfolio" said Joseph M. Limber, President and CEO of Secura Bio.  "We are very excited about the near-term prospects for Copiktra in Peripheral T- cell lymphoma; the PRIMO study which is expected to complete dosing in the first half of 2021 may provide the substantive clinical data required for guidelines and potentially a label expansion.  Copiktra compliments Farydak extremely well from both a commercial perspective and potentially a clinical perspective regarding opportunities in T- cell lymphomas.  Secura Bio now has two meaningful oncology drugs with novel modes of action that provide the potential to build a very broad portfolio of indications in B-Cell and T-Cell lymphomas."  The transaction was partially financed with a $70 million debt and convertible debt financing led by Athyrium Capital Management, LP (www.athyrium.com), a leading healthcare focused investment firm, and the Secura Bio Executive Team.  About Secura Bio, Inc. Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide commercialization of significant oncology therapies for physicians and their patients.  For more information on Secura Bio, please visit www.securabio.com About Athyrium Capital Management Athyrium is a specialized asset management company formed in 2008 to focus on investment opportunities in the global healthcare sector. Athyrium advises funds with over $3.7 billion in committed capital. The Athyrium team has substantial investment experience across a wide range of asset classes including public equity, private equity, fixed income, royalties, and other structured securities. Athyrium invests across all healthcare verticals including biopharma, medical devices and products, healthcare focused services, and healthcare information technology. The team partners with management teams to implement creative financing solutions to companies' capital needs. About COPIKTRA (duvelisib) COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells, in the United States. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.  COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed and has accelerated approval for refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status in the United States, and is being investigated in combination with other agents through investigator-sponsored studies.  For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov. SELECT IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA This does not include all information needed to use COPIKTRA (duvelisib) safety and effectively. See full Prescribing Information. WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full Prescribing Information for complete boxed warning Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected. Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA. Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA. Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA. INDICATIONS AND USAGE COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval based on overall response rate and continued approval may be contingent upon confirmatory trials. WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor hepatic function. Neutropenia: Monitor blood counts. Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at 1-877-7RXVSTM (1-877-779-8786). DRUG INTERACTIONS CYP3A inducers: Avoid co-administration with strong CYP3A inducers. CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors. CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates. USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. About Peripheral T-Cell Lymphoma Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"1 which circulate with the lymphatic system. PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older. Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin. There is currently no established standard of care for patients with relapsed or refractory disease. View original content:http://www.prnewswire.com/news-releases/secura-bio-completes-acquisition-of-global-rights-to-oncology-drug-copiktra-301141959.html SOURCE Secura Bio, Inc.

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