Business Wire

SD-SAB-BIOTHERAPEUTICS

24.9.2021 13:02:05 CEST | Business Wire | Press release

Share
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.

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.

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Imagine Dragons to Perform at Abu Dhabi Grand Prix21.5.2026 17:51:00 CEST | Press release

Ethara, organiser of the Formula 1 Etihad Airways Abu Dhabi Grand Prix, have announced that one of the world’s biggest bands, Imagine Dragons, will headline the Saturday After-Race Concerts at the F1 Season Finale in Abu Dhabi. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521214839/en/ Imagine Dragons to perform at Formula 1 Etihad Airways Abu Dhabi Grand Prix (Photo: AETOSWire) The announcement is another landmark moment for the Abu Dhabi Grand Prix, whose thrilling Yasalam presented by e& fan entertainment offering has become synonymous with the F1 Championship finale in Abu Dhabi and is recognised as one of the most compelling sports and entertainment crossovers globally. The global chart-toppers join Lewis Capaldi and Zara Larsson, who are set to kick off a blockbuster line-up of performances on Yas Island on Thursday, 3 December, with more major international artists to be revealed. With their popular top hits, Ima

Carnegie Mellon University and Cleveland Clinic Develop AI System to Interpret Cardiac MRI Scans with Enhanced Accuracy21.5.2026 14:05:00 CEST | Press release

Trained on more than 13,000 patient studies, novel system significantly outperforms existing models by up to 35% A team of researchers from Carnegie Mellon University, in collaboration with Cleveland Clinic’s Cardiovascular Innovation Research Center, has developed an artificial intelligence (AI) system capable of interpreting some of the most complex heart scans in medicine, cardiac magnetic resonance imaging (MRI), without the need for manually labeled training data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521762286/en/ A team of researchers from Carnegie Mellon University, in collaboration with Cleveland Clinic’s Cardiovascular Innovation Research Center, has developed an artificial intelligence (AI) system capable of interpreting some of the most complex heart scans in medicine, cardiac magnetic resonance imaging (MRI), without the need for manually labeled training data. The novel system, called CMR-CLIP, is d

Otovo Hits 30,000 Customers in Under a Year, Tackling the Growing ‘Solar Service Crisis’21.5.2026 14:00:00 CEST | Press release

A growing wave of unsupported solar systems and rising electricity prices are creating strong demand for Otovo’s energy service platform Otovo ASA (“Otovo”), a leading global energy service provider for residential and commercial customers, today announced it has reached 30,000 customers across the U.S. and Europe. A total of 20,000 customers have enrolled in Otovo Care, the Company’s membership-based home and commercial energy service, which is powered by Otovo’s industry-leading AI platform, Endurance™. “Reaching 30,000 customers in less than year is proof positive that home and business owners value their power systems,” said William J. (John) Berger, CEO of Otovo. “The ‘solar service crisis’ that is leaving millions of orphaned energy systems without support is driving strong interest in our Otovo Care membership program. Every day your home or commercial power system is not working, you are throwing money away. Otovo’s rapid response service platform keeps you up and running, ensu

The Live Moment Effect: Genius Sports and MediaScience Study Finds Specific Moments in Live Sports Can Double Unaided Brand Recall21.5.2026 14:00:00 CEST | Press release

New research shows that brands aligned with emotionally heightened moments in live sports can improve ad effectiveness Genius Sports Limited (NYSE: GENI), a global leader in real-time sports data, today released new biometric research conducted with MediaScience showing that ads delivered immediately after emotionally heightened moments in live sports can double unaided brand recall. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521475265/en/ The Live Moment Effect report from Genius Sports and MediaScience. The study, The Live Moment Effect, finds that advertising effectiveness is significantly influenced by a viewer’s emotional state immediately before an ad is shown. In controlled biometric testing, ads shown after high-intensity sporting moments, such as near-scoring plays or crucial momentum shifts, delivered approximately double the unaided brand recall of baseline conditions. The Moment Before the Ad Matters The r

Merck Announces First Patient Dosed in Phase 3 Study for Investigational Antibody-Drug Conjugate in Colorectal Cancer21.5.2026 14:00:00 CEST | Press release

Precemtabart tocentecan (Precem-TcT) is investigated as a potential first-in-class anti-CEACAM5 ADC, for the treatment of metastatic CRC (mCRC) CEACAM5 is overexpressed in the majority of colorectal tumors (~90%), and requires no patient selection Significant unmet need remains for clinically meaningful innovation in colorectal cancer (CRC), the second leading cause of cancer death worldwide Not intended for Canada-, UK- or US-based media Merck, a leading science and technology company, today announced that the first patient has been dosed in the Phase 3 PROCEADE®-CRC-03 trial (NCT07549412). The study is evaluating precemtabart tocentecan (Precem‑TcT), a potential first‑in‑class investigational anti‑CEACAM5 antibody‑drug conjugate (ADC), for the treatment of metastatic colorectal cancer (mCRC). “Leveraging our novel payload‑linker technology, Precem‑TcT is the first CEACAM5‑targeted ADC in clinical studies with an exatecan payload, rationally designed for stability and enhanced cancer

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye