SD-SAB-BIOTHERAPEUTICS
24.9.2021 13:02:05 CEST | Business Wire | Press release
SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced that an independent Data Safety Monitoring Board (DSMB) has completed its prespecified interim analysis data review of the safety and efficacy of SAB-185 in the Phase 2 portion of the ACTIV-2 trial and has recommended advancement to Phase 3. SAB-185 is a fully-human, specifically-targeted, broadly-neutralizing polyclonal antibody therapeutic candidate for the treatment of non-hospitalized patients with mild to moderate COVID-19. It is being assessed in the ACTIV-2 trial funded and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) in collaboration with the AIDS Clinical Trials Group. SAB-185 is advancing to the Phase 3 trial based on meeting pre-defined graduation criteria.
“Advancement of SAB-185 to Phase 3 is a major milestone for our DiversitAb™ immunotherapy platform, which uniquely produces fully-human targeted polyclonal antibodies that have broad applicability to treating other infectious diseases and medical conditions,” said Eddie J. Sullivan, PhD, co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. “The recent publication of nonclinical data demonstrating SAB-185’s potent neutralization of multiple emerging SARS-CoV-2 variants provided additional evidence that SAB-185 has the potential to become a valuable therapy for mild to moderate COVID-19. We now look forward to the completion of the Phase 3 trial and if successful, the opportunity to make SAB-185 widely available to the many COVID-19 patients battling this persistent and evolving disease.”
Both the low and high doses of SAB-185 tested in Phase 2 met the pre-defined efficacy goal for advancement to Phase 3 and appeared safe at the interim analysis. NIAID and SAB researchers are finalizing the preferred dose to assess in Phase 3.
The Phase 3 portion of the ACTIV-2 trial is a randomized, unblinded, active comparator-controlled adaptive platform study that will assess the clinical safety and efficacy of SAB-185 compared to active control monoclonal antibody treatment in people with mild to moderate COVID-19 who are at higher risk for progression to hospitalization, enrolling approximately 600 participants to receive the investigational agent SAB-185 and 600 to receive an active comparator. The primary outcome measures of the Phase 3 trial will include safety and non-inferiority for the prevention of a composite endpoint of either hospitalization or death from any cause through study day 28.
For more information on the Phase 3 trial, please visit clinicaltrials.gov (Identifier: NCT04518410).
On June 22, 2021, SAB announced a planned merger with Big Cypress Acquisition Corp. (NASDAQ: BCYP). The transaction is expected to close in the fourth quarter of 2021.
About SAB-185
SAB-185 is a fully-human polyclonal antibody therapeutic entering a Phase 3 study for the treatment of non-hospitalized patients with mild to moderate COVID-19. It was developed in collaboration with the US government using SAB’s novel proprietary DiversitAb™ Rapid Response Antibody Program, as part of the Countermeasures Acceleration Group, formerly Operation Warp Speed. In nonclinical studies, the novel therapeutic candidate has shown potent neutralization of the Munich, Washington and other variant strains, including Delta and Lambda. Preclinical data has also indicated that SAB-185 is significantly more potent than human-derived convalescent immunoglobulin G (IgG).
Direct support for the development of SAB-185 is provided by the US 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) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (DHHS) Office of the Assistant Secretary for Preparedness and Response, under contract #MCDC 2019-448.
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. SAB has applied advanced genetic engineering and antibody science to develop transchromosomic (Tc) Bovine™ herds that produce fully-human antibodies targeted at specific diseases, including infectious diseases such as COVID-19 and influenza, immune system disorders including type 1 diabetes and organ transplantation, and cancer. SAB’s versatile DiversitAb™ platform is applicable to a wide range of serious unmet needs in human diseases. It produces natural, specifically targeted, high-potency, human polyclonal immunotherapies. SAB is currently advancing multiple clinical programs and has a number of collaborations with the US government and global pharmaceutical companies. For more information on SAB, visit: http://www.sabbiotherapeutics.com
and follow @SABBantibody on Twitter.
Forward-Looking Statements
Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, the development of SAB-185, and the proposed business combination between Big Cypress and SAB. These statements are based on the current expectations of SAB and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict, will differ from assumption and are beyond the control of SAB.
Additional Information and Where to Find It
In connection with the proposed business combination, Big Cypress has filed with the SEC a definitive proxy statement/prospectus. Big Cypress commenced mailing of the definitive proxy statement/prospectus to its stockholders on September 23, 2021. A proxy statement/prospectus will be sent to all Big Cypress stockholders as of the record date of September 17, 2021. This communication is not a substitute for the Registration Statement, the definitive proxy statement/final prospectus or any other document that Big Cypress will send to its stockholders in connection with the proposed business combination. Investors and security holders of Big Cypress are advised to read the proxy statement/prospectus in connection with Big Cypress’ solicitation of proxies for its special meeting of stockholders to be held to approve the proposed business combination (and related matters) because the proxy statement/prospectus contains important information about the proposed business combination and the parties to the proposed business combination. Stockholders will also be able to obtain copies of the proxy statement/prospectus, without charge at the SEC’s website http://www.sec.gov
or by directing a request to ir@bigcypressaccorp.com
.
Participants in the Solicitation
Big Cypress, SAB and their respective directors, executive officers, other members of management, and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of Big Cypress’ stockholders in connection with the proposed business combination. Investors and security holders may obtain more detailed information regarding the names and interests in the proposed business combination of Big Cypress’ directors and officers in Big Cypress’ filings with the SEC including the Registration Statement that has been submitted to the SEC by Big Cypress, once finalized, which will include the proxy statement of Big Cypress for the proposed business combination, and such information and names of SAB’s directors and executive officers also be in the Registration Statement submitted to the SEC by Big Cypress, which will include the proxy statement of Big Cypress for the proposed business combination.
Non-Solicitation
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Big Cypress or SAB, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210924005084/en/
Link:
About 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
Aster Guardians Global Nursing Award 2026 Names Agimol Pradeep From United Kingdom Winner of USD 250,000 Prize12.9.2026 21:27:00 CEST | Press release
From more than 134,000 registrations spanning 214 countries and economies, Nurse Agimol Pradeep from United Kingdom has been announced as the winner of the Aster Guardians Global Nursing Award 2026. A Senior Transplant Coordinator at King’s College Hospital and Honorary Senior Lecturer at the University of Salford, UK, she was recognised with USD 250,000 at a prestigious ceremony held in Kochi, India. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260912257725/en/ Nurse Agimol Pradeep - Aster Guardians Global Nursing Award 2026 Winner (Photo: AETOSWire) Since its launch in 2021, the Aster Guardians Global Nursing Award has grown into a global platform that celebrates nurses who are advancing the profession and creating meaningful change. The award was presented by Shri V. D. Satheesan, Hon’ble Chief Minister of Keralam, in presence of Dr. Azad Moopen and Alisha Moopen. The ceremony also featured a special message from Dr. Te
Last Night, a Star-studded Evening Celebrating Moncler’s Fifth Avenue Flagship Ushered in a New Chapter in the Brand’s Enduring Love Story With New York11.9.2026 23:01:00 CEST | Press release
Last night, on occasion of the opening of Moncler’s largest-ever global flagship on Fifth Avenue, special guests including Cher, Julia Roberts, Anne Hathaway, Serena Williams, Future, Spike Lee, Jessica Chastain, Adrien Brody, Odell Beckham Jr., Maria Sharapova, Colin Kaepernick, Adriana Lima, Mark Ronson, Shaun White, Helena Christensen, Penn Badgley, Gus Kenworthy, Jordan Clarkson, Coco Rocha, François Arnaud, Gavin Casalegno, Jacob Whiteduck-Lavoie, Sam Nivola, Evan Mock, Sammi Cheng, Princess Olympia of Greece, Hiroshi Fujiwara, Daniel Arsham, Edward Enninful, Tobe and Fat Nwigwe, Joaquín Furriel, Lucas Pinheiro Braathen, Nic von Rupp, Daniel Humm, Juliana Awad, Mickalene Thomas, Questlove, Michael Rainey Jr., Pete Davidson, and Francis Mallmann came together to mark a new chapter in the brand’s decades-long relationship with New York City. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260904757149/en/ MONCLER FIFTH AVE
Owkin to License K Pro and Multimodal Data to Servier to Advance Oncology Research11.9.2026 14:00:00 CEST | Press release
Owkin, the agentic AI company pioneering the first automated AI scientist to revolutionize drug discovery and development, today announced an agreement with Servier, an independent international pharmaceutical group governed by a foundation, to license K Pro, Owkin’s AI Scientist, together with multimodal patient data to advance the company’s oncology research. Under the agreement, Owkin will make multimodal patient data from its MOSAIC network accessible for analysis to Servier’s research teams, within K Pro. This agreement is the next chapter in Owkin and Servier’s collaboration, their previous work together being in patient subgroup identification, also in oncology. K Pro is Owkin’s AI scientist. It brings multimodal patient data and specialized biological agentic AI to drive smarter and faster decision-making to each step of the pharmaceutical value chain. K Pro utilizes specialized biological tools, leveraging a decade of knowledge gained through pharmaceutical partnerships and st
Mohammed bin Rashid Al Maktoum Global Water Award Accepts Entries Until 30 September 202611.9.2026 10:09:00 CEST | Press release
The Mohammed bin Rashid Al Maktoum Global Water Award continues to attract strong interest from innovators, researchers and institutions worldwide as it enters the final phase of its fifth cycle. Overseen by the UAE Water Aid Foundation (Suqia UAE) under the umbrella of the Mohammed bin Rashid Al Maktoum Global Initiatives and with a total prize value of USD 1 million, the award promotes the development of sustainable solutions that help tackle water scarcity and improve access to safe water, particularly in communities most affected by water shortages. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260911305420/en/ HE Saeed Mohammed Al Tayer, Chairman of the Board of Trustees of Suqia UAE (Photo: AETOSWire) Applicants are encouraged to submit comprehensive information about their submissions, thereby helping the judging panel evaluate the various stages and mechanisms of their innovation, including water production, treatme
SES Launches New Content Orchestration and Hybrid Delivery Platform11.9.2026 07:30:00 CEST | Press release
SES CORE enables media customers to manage, monitor and orchestrate content delivery through a single interface, increasing visibility, flexibility and signal reliability SES today announced the launch of SES CORE, the first-of-its-kind content orchestration and hybrid delivery platform, designed to enable broadcasters and media customers to manage, monitor, and enable transmission of content seamlessly via satellite, fiber, and IP. Built on infrastructure-neutral architecture, SES CORE provides a single user interface for content delivery. By bringing multiple distribution technologies into a unified orchestration layer, the platform enables customers to select the most effective content delivery path, guaranteeing service reliability and consistent delivery of high-quality content to global partners. Through SES CORE, customers gain real-time visibility into service status by monitoring active content feeds. The platform provides network performance insights, automates operational ta
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
