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
the first patient has been dosed with SAB-185 in the Phase 3
ACTIV-2 COVID-19 trial.
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. The candidate is being assessed in the ACTIV-2 trial led
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 the second agent to graduate to Phase 3 and the first
polyclonal antibody therapeutic candidate in ACTIV-2, which is
evaluating multiple investigational agents to treat early
symptomatic COVID-19 in non-hospitalized individuals.
SAB-185 advanced from Phase 2 to the Phase 3 portion of the
ACTIV-2 trial based on meeting pre-defined graduation criteria. The
interim analysis demonstrated that both the lower and higher doses
of SAB-185 tested in Phase 2 met the pre-defined efficacy goal for
advancement to Phase 3 and appeared safe. SAB researchers in
consultation with NIAID have determined the lower dose of SAB-185
(3,840 Units/kg) will be assessed in Phase 3.
“We are delighted that the Phase 3 trial is underway, just days
after the decision by the independent Data Safety Monitoring Board
to advance SAB-185 to Phase 3,” said Eddie J. Sullivan, PhD,
co-Founder, President, and Chief Executive Officer of SAB
Biotherapeutics. “The joint decision with NIAID to evaluate the
lower dose of SAB-185 in the Phase 3 trial is a testament to the
potency of our human polyclonal antibody therapeutic candidate,
which has demonstrated neutralization of multiple emerging
SARS-CoV-2 variants in recently published nonclinical studies.”
The Phase 3 portion of the ACTIV-2 trial is a randomized,
unblinded, active comparator-controlled adaptive platform
non-inferiority study that is assessing 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. It is 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 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 ACTIV-2 trial, 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 has been 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211004005414/en/
Melissa Ullerich +1 605-679-4609
mullerich@sabbiotherapeutics.com
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