Business Wire

SAB Biotherapeutics Announces First Patient Dosed in Phase 1b Clinical Trial of SAB-185 for the Treatment of COVID-19

Share

SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company developing a novel immunotherapy platform to produce targeted polyclonal antibodies, today announced the dosing of the first patient in its Phase 1b clinical trial evaluating the safety and pharmacological activity of SAB-185, a COVID-19 therapeutic. SAB-185, developed from SAB’s novel technology platform that leverages the native human immune response to offer a differentiated high-potency therapeutic option that potentially addresses virus mutations, is currently being tested in an ongoing Phase 1 trial in healthy volunteers for the treatment of COVID-19.

“We believe that SAB-185 has the potential to be a differentiated treatment option that provides a highly-specific match against the complexity, diversity, and mutations of SARS-CoV-2. Dosing the first patient in this study marks a major milestone for us as we continue to advance our robust COVID-19 program and represents a step forward in the fight against the ongoing global health crisis,” said Eddie J. Sullivan, PhD, co-founder, president and CEO of SAB Biotherapeutics. “The speed with which we have advanced our program reflects our deep understanding of human polyclonal antibodies, the pressing need for treatment options, and the commitment of our team to develop a novel class of immunotherapies that is designed to establish a responsive model for health crises. We look forward to continuing to progress our COVID-19 program, and developing rapid response capabilities to new and emerging diseases.”

SAB-185, a human polyclonal antibody therapeutic that potently neutralizes live SARS-CoV-2 at titers higher than convalescent plasma, was developed from SAB’s proprietary DiversitAb™ platform, which harnesses the native human immune response to produce human polyclonal antibodies. SAB’s novel approach, which leverages genetically engineered cattle to produce fully human antibodies, enables a scalable and reliable production of targeted, high potency neutralizing antibody product. This approach has expedited the rapid development of this novel immunotherapy for COVID-19 deploying the same natural immune response to fight the disease as recovered patients, but with a much higher concentration of targeted antibodies.

The Phase 1b clinical trial is a randomized, double-blind, ascending dose study of SAB-185 administered intravenously in 21 patients with mild or moderate COVID-19. The primary endpoint of the study is safety. The secondary endpoints include an evaluation of the course of mild and moderate COVID-19 in ambulatory patients. Data from both the Phase 1 and Phase 1b studies will be used to inform the dosing and design of subsequent Phase 2 safety and efficacy studies. The Phase 1b trial is planned to be conducted at multiple sites including Sanford Health in Sioux Falls, South Dakota.

"We are excited to participate in this clinical trial to investigate the safety of SAB-185, a novel, first-of-its-kind human polyclonal antibody therapeutic candidate for COVID-19,” said David A. Pearce, PhD, president of innovation and research at Sanford Health.

“Our goal is to advance the science around COVID-19 so physicians can be better prepared to treat this novel coronavirus in the future,” said Dr. Susan Hoover, principal investigator and an infectious disease physician at Sanford Health. “This therapeutic would be an early-stage treatment that could potentially improve our patients' outcomes and even keep them out of the hospital.”

Direct support for the Phase 1 and Phase 1b clinical trials of SAB-185 is provided by the U.S. Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) on behalf of the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA).  For more information on the Phase 1b trial, please visit https://clinicaltrials.gov (Identifier: NCT04469179).

About SAB-185

SAB-185 is a fully-human, specifically targeted and broadly neutralizing polyclonal antibody therapeutic candidate for COVID-19. The therapeutic was developed from SAB’s novel proprietary DiversitAb™ Rapid Response Antibody Program in collaboration with the USG. CSL Behring is engaged for clinical manufacturing for the definitive trials. SAB filed the Investigational New Drug (IND) application and produced the initial clinical doses in just 98 days from program initiation. The novel therapeutic, generated from a subunit of the SARS-CoV-2 Wuhan strain, has shown neutralization of both the Munich and Washington strains in preclinical studies. Preclinical data has also demonstrated SAB-185 to be more potent than human-derived convalescent immunoglobulin G (IgG).

About SAB Biotherapeutics, Inc.

SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. Utilizing some of the most complex genetic engineering and antibody science in the world, SAB has developed a unique platform that can rapidly produce natural, specifically-targeted, high-potency, human polyclonal immunotherapies at commercial scale. SAB-185, a fully-human polyclonal antibody therapeutic candidate for COVID-19, is being developed with initial funding supported by the Biomedical Advanced Research Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services and the Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO - CBRND) Joint Project Lead for Enabling Biotechnologies (JPL-EB). In addition to COVID-19, the company’s pipeline also includes programs in Type 1 diabetes, organ transplant and influenza. For more information visit: www.sabbiotherapeutics.com or follow @SABBantibody on Twitter.

Contact information

Melissa Ullerich
Tel: 605-695-8350
mullerich@sabbiotherapeutics.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Topcon Announces eyeRISE 2021 Virtual Symposia & Expo18.1.2021 07:00:00 CETPress release

Topcon Healthcare, a leading provider of medical devices and software solutions for the global eye care community, announced today that it will host a two-day virtual symposia and expo entitled eyeRISE on February 9-10, 2021. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210117005025/en/ eyeRISE, or Eye Research Innovation Symposia & Expo, is a new, multi-disciplinary virtual congress showcasing the latest innovations in eye care. It will feature three solutions-focused tracks, delivering clinical and practical education through symposia, roundtable discussions and interactive workshops. (Graphic: Business Wire) eyeRISE, or Eye Research Innovation Symposia & Expo, is a new, multi-disciplinary virtual congress showcasing the latest innovations in eye care. It will feature three solutions-focused tracks, delivering clinical and practical education through symposia, roundtable discussions and interactive workshops. The two-day

Servier announce updated overall survival results of exploratory TASCO1 phase II study of LONSURF ® + bevacizumab in a first-line setting for patients with unresectable mCRC non-eligible for intensive therapy16.1.2021 22:15:00 CETPress release

Servier announced today updated results from the exploratory phase II TASCO1 study evaluating LONSURF® (trifluridine/tipiracil) + bevacizumab and capecitabine + bevacizumab (C-B) in a first-line setting for patients with unresectable metastatic colorectal cancer (mCRC) who are non-eligible for intensive therapy.1 The data were announced today during an oral presentation at the 2021 ASCO Gastrointestinal Cancers Symposium (ASCO-GI). Patients with mCRC who are not eligible for chemotherapy face a large unmet need, with fewer treatment options available to them and lower survival rates. Colorectal cancer (CRC) makes up 9.7% of total global cancer cases, with almost 1.4 million new cases of CRC each year.2 In Europe, CRC is the second most common cause of death due to cancer, and those with a metastatic disease have a 5-year survival rate of just 11%.3 “For patients with metastatic colorectal cancer, those non-eligible for standard combination therapy have few options left and we are conti

H.I.G. Realty Invests in Production Studios & Content Hub in Madrid15.1.2021 09:00:00 CETPress release

H.I.G. Capital, LLC ("H.I.G."), a leading global alternative investment firm with $43 billion of equity capital under management, announced today that one of its affiliates has invested in Madrid Content City, an approximately 140,000 square meter hub with state of the art audio-visual facilities, including production studios, production & post-production technical facilities, and a university focused on media studies. H.I.G. continues to add to its sizeable portfolio of real estate assets across Europe, consisting of both equity as well as debt investments, with a particular focus on its target market of value-added small and midcap opportunities. Riccardo Dallolio, Managing Director and Head of H.I.G. Europe Realty Partners, commented: “Madrid Content City will benefit from strong secular tailwinds underpinned by the boom in content production. The state-of-the-art studios and related facilities, the exceptional multinational tenant line-up with long term leases, and its critical mas

Eurofins, the global leader in analytical testing, expands worldwide face mask testing & certification capabilities15.1.2021 07:30:00 CETPress release

Since the start of the pandemic Eurofins (Paris:ERF) has tested thousands of models of surgical and hygienic masks and provided best-in-class speed and certification for PPEs globally, enabling these critical products to get market as fast as possible. Eurofins has developed global leading testing capabilities and certification services in the North America, Europe and Asia ensuring that PPE manufacturers are able to provide the indispensable support needed in the fight against the coronavirus. As of today, Eurofins is one of the few GLP certified and ISO/IEC 17025 accredited laboratory networks to fully cover all testing requirements for surgical/medical and hygienic masks by the FDA, EU regulations and many international and country-specific directives and guidelines such as CEN, CE Marking, ISO, ASTM or OECD. Our robust portfolio for masks includes globally accepted, safety and performance testing, virucidal, bacterial filtration, particle filtration, differential pressure, biocompa

TOXINS 2021: New analyses of pivotal Phase III trial data highlight long duration of response for Dysport ® (abobotulinumtoxinA) in five therapeutic indications15.1.2021 07:00:00 CETPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced results from new analyses of pivotal Phase III clinical trial data to assess treatment intervals over repeat cycles of Dysport® (abobotulinumtoxinA [aboBoNT-A]) in five patient populations. AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations is being shared during the TOXINS 2021 conference, which is taking place virtually between 16-17 January 2020 and is organized by the International Neurotoxin Association.1-28 Ipsen is sharing 26 abstracts during the congress, with data including updates from the recently published surveys into the experience of patients and caregivers, data from the Phase IV ULIS-III trial, and ten abstracts focused on basic science research into neurotoxins.1-27 Spasticity is one of the most common and disabling conditions associated with many neurological conditions in adults and is characterized by velocity-dependent muscle hypertonia. Spasticity can lead to disabilit

Velodyne Lidar Commends NHTSA Plan to Update NCAP14.1.2021 21:58:00 CETPress release

Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today commended the U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA) plan to update to its New Car Assessment Program (NCAP). The NHTSA proposal would add four advanced driver assistance system (ADAS) capabilities to the NCAP, keeping pace with evolving safety technologies and providing much-needed information to consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210114005992/en/ Images show vehicle with lidar-based PAEB stopping before adult target @ 50% overlap (above) and vehicle with camera and radar-based PAEB crashing into adult target (below). (Photo: Velodyne Lidar, Inc.) NCAP is the U.S. Government’s premier consumer information program for evaluating vehicle safety performance. The NHTSA proposal to add ADAS technologies to the NCAP includes pedestrian automatic emergency braking, lane keeping support, blind spot warning and

Snow Software Recognized as a 2020 Gartner Peer Insights Customers’ Choice for Software Asset Management14.1.2021 20:39:00 CETPress release

Snow Software, the global leader in technology intelligence, today announced that the company was named a December 2020 Gartner Peer Insights Customers’ Choice for Software Asset Management (SAM) Tools. Gartner defines software asset management tools as technology that “automates many of the tasks required to maintain compliance with software licenses, thereby controlling software spending.” This is the fourth Gartner Peer Insights Customers’ Choice announcement for SAM, and Snow has earned the distinction all four times. Based solely on feedback from verified customers, Gartner Peer Insights Customers’ Choice reflects reviews and ratings published within the last 12 months. Snow received 100 reviews – the most of any vendor in the market – with an overall rating of 4.6 out of 5 as of January 12, 2021. Earlier this year, Snow was recognized as a Leader in Gartner’s 2020 Magic Quadrant for Software Asset Management Tools1 and received the highest scores in three out of four use cases in

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom