Business Wire

First Treatment for MERS Appears Safe in NIH Phase I Clinical Trial

Jaa

SAB Biotherapeutics, Inc. (SAB), a clinical-stage biopharmaceutical development company, announced its anti-MERS immunotherapy (SAB-301) appears safe in a Phase I Clinical Trial. Results of the study, sponsored, funded and conducted by National Institutes of Health (NIH) were published today in The Lancet Infectious Diseases .

Presently, there are no approved vaccines or treatments for Middle East respiratory syndrome (MERS)–a newly discovered, contagious and sometimes fatal respiratory illness, caused by a virus known as MERS coronavirus (MERS-CoV). Since the first confirmed case in Saudi Arabia in 2012, the illness has spread to 27 countries and more than 2,000 people, with a fatality rate approaching 40%, according to the World Health Organization.

“This is the first study to show the safety of a potential treatment for MERS,” said John H. Beigel, M.D., a medical affairs scientist affiliated with Leidos Biomedical Research, supporting the NIAID Division of Clinical Research, and lead investigator on the study. “SAB-301–an experimental treatment for MERS developed from cattle plasma–was safe, well tolerated by healthy volunteers and had the same half-life as human-derived antibodies.”

Using plasma collected from recovered patients has been a preferred and effective source of antibodies to combat the pathogens associated with recent global health concerns involving influenza, MERS, SARS and Ebola.

“Our novel immunotherapy platform goes back to nature with the use of human polyclonal antibodies–our own body’s army–to combat disease,” said Eddie J. Sullivan, PhD, SAB Biotherapeutics president and CEO. “The use of human convalescent plasma as a treatment has been proven effective, but short in supply. Conversely, about 10 of our animals could serve the current MERS need.”

SAB’s novel DiversitAb™ platform enables the rapid production of large amounts of targeted human polyclonal antibodies, leveraging transchromosomic cattle (Tc Bovine™) that have been genetically designed to produce human antibodies (immunoglobulin G) rather than bovine in response to an antigen. Animal antibodies have been made in rabbits, sheep and horses. However, SAB’s platform is the first to produce fully human antibodies in large animals.

“Our goal is to leverage our immunotherapy platform as a countermeasure against emerging infectious diseases,” added Sullivan. “We have the ability to develop antibody treatments against a variety of infectious diseases in a much faster timeframe, as few as three months, and in much greater volume than currently possible.”

To produce SAB-301, Tc Bovine were vaccinated with a MERS antigen provided by Novavax. Within a brief period of time, they produced significant amounts of fully human antibodies to combat the virus. Plasma was collected (in a similar manner as from human plasma donors), then purified to isolate the antibodies becoming the therapeutic treatment.

In the study, 28 volunteers were treated with SAB-301 and 10 with a placebo. Six groups of volunteers received different intravenous doses and were assessed six times over 90 days. Complaints were common among the treatment and placebo group including mild headache and cold symptoms.

Funding for the Phase I clinical manufacturing was provided by a $5.3 million contract from Biomedical Advanced Research and Development Authority (BARDA), including an allotment for Phase II. Pre-clinical data from studies conducted by global infectious disease experts at the Naval Medical Research Center, the University of Maryland, School of Medicine and NIH paved the way for the study.

With the trials in healthy candidates complete, Phase II trials are planned to evaluate the potency and dosing in patients suffering with MERS in endemic countries.

“We’re also advancing treatments for Ebola, influenza and Zika,” Sullivan said. “SAB is dedicated to partnering with government and other organizations to address current and future human health threats to ultimately save lives.”

About SAB Biotherapeutics, Inc.

SAB Biotherapeutics, Inc. (SAB), headquartered in Sioux Falls, S.D. is a clinical stage, biopharmaceutical company leading the science and manufacturing of antibody therapeutics. Utilizing some of the most advanced antibody science in the world, SAB is delivering the world’s first large-scale platform to create immunoglobulins. This natural production platform holds the potential for treatment of public health problems, rare conditions, long-term diseases and global pandemic threats.

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.

Contact information

SAB Biotherapeutics, Inc.
Melissa Ullerich, +1 605-695-8350
mullerich@sabbiotherapeutics.com
or
NIAID/NIH
Ken Pekoc, +1 301-402-1663
kpekoc@niaid.nih.gov

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

ERYTECH Announces Filing of 2017 “Document de Référence” and 2017 Annual Report on Form 20-F24.4.2018 23:30Tiedote

Regulatory News: ERYTECH Pharma (Euronext Paris: ERYP – Nasdaq: ERYP), the clinical-stage biopharmaceutical company developing innovative therapies for severe forms of cancer and orphan diseases based on its proprietary ERYCAPS platform, encapsulating therapeutic drug substances inside red blood cells, today announced that it had filed its 2017 “Document de Référence” for the year ended December 31, 2017, including the management report and the annual financial report with the “Autorité des Marchés Financiers (AMF)” and its Annual Report on Form 20-F for the year ended December 31, 2017 with the U.S. Securities and Exchange Commission (SEC). These documents can be accessed on the Investors section of the Company’s corporate website (www.erytech.com). In addition, the “Document de Référence” is also available on the AMF’s website (http://www.amf-france.org) and the Annual Report on Form 20-F is also available on the SEC’s website (www.sec.gov). Printed copies of these documents are also

Rimini Street Launches New Solutions that Further Extend the Life and Value of Enterprise Software as a Foundation for Innovation24.4.2018 19:00Tiedote

Rimini Street, Inc . (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced the first offerings in a family of solutions designed to provide improved competitive advantage to organizations with mature and valuable enterprise software investments that can be used as a foundation for innovation. Rimini Street’s new solutions can enable an organization to quickly and cost-effectively modernize their current enterprise software with the latest desired features and capabilities, future-proof their technical platforms against yet-unknown technology changes, and secure their systems against a constantly evolving threat environment. Rimini Street’s new solutions enable organizations to leverage their existing systems as a solid foundation for an innovative hybrid IT strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/

Novaliq to Present Scientific and Clinical Research During the 2018 Association for Research in Vision and Ophthalmology Meeting in Honolulu, HI24.4.2018 18:53Tiedote

Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced that four scientific posters will be presented at the 2018 Association for Research in Vision and Ophthalmology (ARVO) Meeting in Honolulu, HI (April 29-May 3). The variety of data to be presented reflects Novaliq’s dedication to science and clinical research. With the collection of posters, Novaliq will share clinical and pre-clinical data on its EyeSol® drug delivery technology and provide insights into the mode of action of its NOV03/NovaTears® water-free therapy for the treatment of dry eye disease (DED). Furthermore, Novaliq will present its first pre-clinical efficacy data in glaucoma. Scientific posters supported by Novaliq will include: “Influence of perfluorohexyloctane containing eye drops on tear film thickness in patients with mild to moderate dry eye disease.” Authors: Garhöfer G., Schm

PPG Reports Sustainability Progress, New 2025 Goals24.4.2018 16:07Tiedote

PPG (NYSE:PPG) today released its 2017 Corporate Sustainability Report, which details the company’s continued progress in strengthening its sustainable operations in 2017 and the launch of new, aggressive sustainability goals it aims to achieve by 2025. The report is available at sustainability.ppg.com. “PPG’s sustainability efforts go beyond product innovations to extend to our customers’ operations and the communities in which we operate,” said Mark Cancilla, PPG vice president, environment, health and safety. “We are encouraged by our progress in 2017 and excited about our new goals, which are representative of the challenges and opportunities of our current business portfolio.” The company achieved the following progress in 2017: 32 percent of sales from products that provide customers with a sustainable advantage, an increase of 60 percent since 2012. This includes the unveiling of multiple products that provide a sustainable solution, such as Sigma Air Pure, a revolutionary bio-b

WeQ Launches to Transform Mobile Ad Tech with Human Intelligence and Inclusivity24.4.2018 16:00Tiedote

WeQ, a mobile ad tech brand providing user acquisition and engagement services at a global scale, announced today its official launch. WeQ is driven by a forward-thinking, socio-economic movement striving to shift from an exclusive ‘I’ culture to a collaborative ‘We’ culture. Setting its sights on becoming a trusted leader in the mobile ad tech industry, WeQ combines innovative data-driven technology with the collective human intelligence of its accomplished team of mobile ad tech experts to empower companies to reach their goals. WeQ comes out of the gate armed with a strategic investment, having secured more than $50 million USD in internal funds and debt capital to accelerate an ambitious global growth path. The ad tech brand plans to use the funds as it undertakes an aggressive M&A strategy. Over the next 12-24 months, WeQ plans to acquire cutting-edge technologies from innovative ventures to expand its technological footprint and services, attract international talent, and enter n

Bioiberica Approves Its Combined Drug for Osteoarthritis in Five More European Countries24.4.2018 15:17Tiedote

Bioiberica's combination of chondroitin sulphate and glucosamine hydrochloride, a slow action drug to treat osteoarthritis symptoms, was approved as an ethical drug in France, Austria, Hungary, Poland, and Finland through a mutual recognition process from Spain. ‘This approval confirms that Drug Agencies from different countries attest to the effectiveness and safety of the combination of pharmaceutical grade chondroitin sulphate and glucosamine hydrochloride. This drug has proven to reduce pain and improve mobility in people affected by knee osteoarthritis which, due to its safety profile, could also be used as an alternative by those patients with cardiovascular or gastrointestinal problems who should not be prescribed anti-inflammatory drugs chronically’, stated Dr Juan Gispert, Bioiberica's R&D director. The principle study that guarantees its effectiveness is the MOVES clinical trial, published in the Annals of the Rheumatic Diseases, which concludes that the combination of chondr

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme