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

Armis Named a Leader for Second Consecutive Year in 2026 Gartner® Magic Quadrant™ for CPS Protection Platforms4.3.2026 16:12:00 CET | Press release

Armis CentrixTM leveraged by global organizations to manage cyber risk across their entire attack surface Armis, the cyber exposure management & security company, today announced that it has been named a Leader in the 2026 Gartner Magic Quadrant for CPS Protection Platforms for the second consecutive year. “In an era of agentic AI, the security of our cyber-physical systems has become a strategic imperative for enterprises and governments globally; it is a pivotal pillar of global stability,” said Yevgeny Dibrov, CEO and Co-Founder of Armis. “We believe this back-to-back recognition from Gartner reflects our continued commitment to helping organizations secure the complex, critical world of CPS and reinforces the strength of our unified, proactive platform approach. Our innovation pipeline, which is aligned with our customers' needs, will continue to prioritize protecting critical environments to keep society safe and secure.” Armis was named a Leader in this report among the 13 vendor

Svante Acquires Carbon Dioxide Removal Project Developer, Carbon Alpha Corp.4.3.2026 16:00:00 CET | Press release

Svante acquires Carbon Alpha to accelerate commercial-scale carbon removal & expand its CCS/BECCS project development business in Western Canada. Acquisition adds the North Star BECCS Project, developed in partnership with the Meadow Lake Tribal Council, advancing the market for durable and verifiable CDR credits. The transaction strengthens Svante’s fully integrated carbon management platform, adding CO₂ storage expertise, a regional pipeline & a major geological storage hub. Svante Technologies Inc. (Svante), a leader in carbon management, and Calgary-based Carbon Alpha Corporation (Carbon Alpha) today announced that Svante has acquired Carbon Alpha and its related subsidiaries, including Carbon Alpha Development Corp. and its ownership interests in North Star Carbon Solutions Corp. and North Star Carbon Solutions Limited Partnership, a project developer for carbon capture and storage (CCS) in Western Canada. With this transaction, Carbon Alpha’s flagship North Star Bioenergy Carbon

Binarly Announces Leadership Transition as Enterprise Demand Accelerates for Supply-Chain Security4.3.2026 16:00:00 CET | Press release

Binarly, the industry leader in software and firmware supply‑chain security, today announced a leadership transition as the company enters its next phase of growth. Founder and current CEO Alex Matrosov has joined the company’s Board, and Gwenyth Castro has joined as Chief Executive Officer to scale global go-to-market and enterprise growth. Binarly developed its Transparency Platform on a unique, patented technology core designed to help the world’s largest enterprises identify and reduce third-party software risk across complex environments. The platform is trusted by organizations including Meta and Dell, among others. “We built Binarly to solve a problem the industry kept ignoring: you can’t secure what you can’t see,” said Alex Matrosov, Founder of Binarly. “Over the last five years, this team turned deep program analysis and vulnerability research into a platform trusted by some of the world’s most demanding enterprises. Now, as AI accelerates how software is built and shipped, t

Unleash Raises $35M Led by One Peak to Help Enterprises Ship AI-driven Software Faster, Safer, and Smarter4.3.2026 15:00:00 CET | Press release

Unleash, the open-source FeatureOps company, today announced a $35 million Series B financing led by One Peak, with participation from existing investors Spark Capital, Frontline Ventures, and Firstminute Capital. The new funding will be used to accelerate product innovation and global expansion as enterprises confront the opportunities and risks of AI-accelerated software delivery. AI has dramatically accelerated software development, creating a generational opportunity for anyone in an enterprise to turn ideas, prompts, and prototypes into applications. But AI has also outpaced the systems designed to control software delivery. DORA research shows that a 25% rise in AI adoption correlates with a 7% drop in software stability. Enterprises are shipping code 2-3x faster with AI, yet outages caused by uncontrolled feature rollouts and missing kill switches are costing businesses millions in lost revenue, prolonged customer downtime, and brand damage. FeatureOps is emerging as the missing

Capcom’s Resident Evil Requiem Surpasses 5 Million Units!4.3.2026 15:00:00 CET | Press release

– Worldwide acclaim contributed to strong sales – Capcom Co., Ltd. (TOKYO:9697) today announced that worldwide sales of Resident Evil Requiem, released on February 27, 2026, surpassed 5 million units. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260304446142/en/ Resident Evil Requiem Logo Resident Evil Requiem is the latest installment in the Resident Evil series, which celebrates its 30th anniversary this month. The title successfully elevated the essence of survival horror by heightening the interplay between intense fear and exhilarating action. Resident Evil Requiem was developed using RE ENGINE, Capcom’s proprietary game engine, which allowed the company to deliver visuals in photorealistic detail, including the characters’ skin, teary eyes, and flowing hair, as well as the translucency of light. In addition, the title offers a new game experience for a broad fanbase through multiple difficulty settings that accommoda

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