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

Galderma Receives U.S. FDA Approval for Differin® Epiduo® Acne Gel Prescription-to-OTC Switch22.5.2026 18:25:00 CEST | Press release

A unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin® and Epiduo® heritage Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) us

Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia22.5.2026 16:18:00 CEST | Press release

Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia, with an orphan medicinal product designation. This press release features multimedia. View the full releas

ICE Brent and ICE WTI Perpetual Futures to Launch on OKX22.5.2026 14:30:00 CEST | Press release

OKX, a blockchain technology and trading company serving more than 120 million customers globally,and Intercontinental Exchange (NYSE: ICE), one of the world's leading providers of financial market technology and data powering global capital markets including the New York Stock Exchange, today announced plans for OKX to launch perpetual futures based on ICE's Brent Crude and WTI Crude energy benchmarks. The products are expected to be available to trade on OKX’s platform in jurisdictions where OKX is licensed to offer perpetual futures products. The new OKX contracts represent a major step forward in expanding regulated access to global commodity markets through digital asset infrastructure. This first product collaboration between OKX and ICE comes after the companies established a strategic relationship in March 2026. ICE operates some of the world’s leading exchanges, clearing houses and market data services across energy, commodities, fixed income and equities markets. ICE’s future

Enhertu® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors22.5.2026 14:00:00 CEST | Press release

Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority

Future Health Challenge Awards USD 300,000 to Early Detection and Population Health Sensing Tools on Sidelines of World Health Assembly22.5.2026 13:45:00 CEST | Press release

Global teams recognised in the Future Health Challenge for solutions designed to detect health risks earlier and support faster health system decisions Future Health – A Global Initiative by Abu Dhabi and MIT Solve announce the winners of the inaugural Future Health ChallengeWinning solution equips frontline health workers in low-resource settings with mobile clinical decision-support tools, enabling earlier detection and more effective care deliveryTeams competed for a USD 200,000 grand prize and two USD 50,000 runner-up awards on the sidelines of the 79th World Health Assembly in GenevaWinners recognised for solutions advancing anticipatory, data-driven health systems Three global teams developing early detection and real-time population health monitoring solutions have secured a total of USD 300,000 on the sidelines of the 79th World Health Assembly. The winning solutions address critical challenges in early detection, continuous population insight and more timely decision making, s

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