SAB Biotherapeutics Announces SAB-185 Receives Positive DSMB Review and Advances to Phase 3 in NIH-Sponsored ACTIV-2 Trial for Treatment of COVID-19
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.
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.
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 email@example.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.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Amedeo and AURA AERO Announce a Strategic Partnership Agreement and a Letter of Intent to Purchase 200 Electric Regional Aircraft (“ERA”)19.10.2021 19:21:00 CEST | Press release
AURA AERO has created a clean sheet design while integrating new technologies, as well as existing technologies such as fly by wire, and is driving digital efficiencies to build revolutionary momentum in creating an electrical aircraft. With its current prototype aircraft, INTEGRAL, AURA AERO is achieving design and production maturity at a fraction of the cost and will carry that to the commercially sized 19- seater, Electric Regional Aircraft named ‘ERA’. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019006068/en/ “Amedeo are delighted to have signed an LOI for 200 Electric Regional Aircraft ‘ERA,’ that draws the commercial aviation industry closer to achieving its goal of net-zero by 2050. We are very pleased to be partnered with AURA AERO in leading such an important climate supporting initiative for the future. For Amedeo, sustainable aviation is more than aspirational and we are committed and focused on partnership
JAB and BNP Paribas Cardif Announce Strategic Pet Healthcare Alliance19.10.2021 18:37:00 CEST | Press release
JAB and insurer BNP Paribas Cardif today announced a strategic alliance to deliver a range of pet insurance services throughout the UK, EMEA and Latin America, with a vision to offer additional pet healthcare services over time. As part of the agreement, JAB will hold a majority stake in a new holding company to which BNP Paribas Cardif will contribute Cardif Pinnacle, its subsidiary focused on the rapidly growing pet insurance sector. BNP Paribas Cardif will remain significantly involved in the pet healthcare activity, supporting the development of this alliance through a continued stake in the business. The transaction is expected to close in Q2 2022, subject to customary closing conditions, including applicable regulatory approvals. Cardif Pinnacle has built a leading pet insurance business providing solutions to partners and pet owners based on innovation and a scalable platform. The Company’s business proposition leverages digital services, artificial intelligence and continuous i
Leading South Korean Furniture Manufacturer Empowered to Focus on IT Modernization Goals After Switching to Rimini Street Support19.10.2021 18:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that ENEX, a leading furniture manufacturer in South Korea, has switched to Rimini Street Support for its mission-critical SAP system. As a result of switching support providers, ENEX was able to immediately reduce its annual support fees and redirect its internal IT personnel to focus on higher value business initiatives, including plans to update and modernize its IT infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019005188/en/ Leading South Korean Furniture Manufacturer Empowered to Focus on IT Modernization Goals After Switching to Rimini Street Support (Photo: Business Wire) Switching to Ultra-Responsive Support and Maintenance Helps Drive Digital Transformation Founded in 1971, ENEX is
ElectReon and Gotland Partners Announce First Fully Operational Electric Bus Utilizing Wireless Electric Road System in Sweden19.10.2021 17:38:00 CEST | Press release
ElectReon (TASE: ELWS.TA), the leading provider of in-road wireless electric vehicle charging technology for commercial, public service, and passenger vehicles, announced today the successful launch of the first fully operational bus utilizing the company’s wireless charging infrastructure in the city of Visby in Gotland, Sweden. Implemented by a consortium of partners, the Smartroad Gotland project began operations in early 2020 and is one of four Electric Road demonstration projects currently being funded by the Swedish Transport Administration, Trafikverket. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019005925/en/ The Smartroad Gotland project is the first fully operational bus utilizing wireless charging infrastructure in the city of Visby in Gotland, Sweden. (Photo: Business Wire) Having supported Electric Road Systems (“ERS”) R&D programs for over a decade, Sweden is a pioneer in pursuing multiple ERS demonstrat
Berkshire Hathaway Specialty Insurance Elevates Multinational Capabilities, Creating Global Network Across 170 Countries19.10.2021 15:30:00 CEST | Press release
Berkshire Hathaway Specialty Insurance (BHSI) today announced that it has expanded its global network to encompass owned offices and network partners that can provide BHSI customers with locally admitted insurance policies in 170 countries worldwide. “We are very pleased to welcome so many outstanding partners around the globe to the BHSI family,” said David Valzania, Head of Multinational, BHSI. “Each of these carriers share BHSI’s values, and align with our product offerings, focus on excellent customer service, and commitment to the CLAIMS IS OUR PRODUCT® philosophy.” BHSI undertook a rigorous search, evaluation and due diligence process to select the carrier partners best suited to represent the Berkshire Hathaway brand and our customers. Policies issued by network partners receive the backing of BHSI’s financial strength. “Our multinational capabilities have been growing rapidly. With our expanded network, we look forward to providing consistently world-class products and services
Andersen Global Continues Asia Expansion with One of Indonesia’s Largest Tax Firms19.10.2021 15:30:00 CEST | Press release
Andersen Global enters the Indonesian market with collaborating firm Soewito, Fajar & Partners, operating as TaxPrime, one of the largest tax firms in the country. TaxPrime was founded in 2012 by Senior Partner Soewito and Managing Partner Muhamad Fajar Putranto, who previously served as tax officers for Indonesia’s Directorate General of Taxes (DGT). With three offices, the Jakarta-based firm operates with nine Partners, three Senior Advisors and more than 170 professionals, focusing on multinational companies with full-service capabilities in tax and customs compliance, tax and customs advisory, transfer pricing, tax and customs dispute resolution, international tax and structuring transactions. “Our firm is committed to delivering best-in-class service, and we constantly aim to expand our expertise,” Fajar said. “Our collaboration with Andersen Global emphasizes our commitment to serving clients with global operations in a seamless manner, and we look forward to working with the lik
JAB Expands Pet Insurance Platform Through Acquisition of Figo Pet Insurance19.10.2021 15:00:00 CEST | Press release
JAB is pleased to announce that Independence Pet Holdings (formerly Iguana Capital), JAB’s U.S. pet insurance platform, has entered into a definitive agreement to acquire Figo, one of the leading U.S. providers of pet insurance. As part of the agreement, the shareholders of Figo will roll a portion of their proceeds into PetPartners, the consumer-facing portion of JAB’s pet insurance platform. The acquisition is expected to close by the end of the year. Since its founding in 2015, Figo has quickly established a strong pet insurance brand and leading InsurTech position in the United States. Its modern pet insurance experience includes a simple, easy-to-follow consumer journey coupled with its Pet Cloud app, a cloud-based platform that provides 24/7 access to live veterinarians, customer support, claims processing, digital pet record management, and a social network for pet parents, all of which has driven impressive company growth, earning Figo the title of “Top InsurTech Leader” by A.M