SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage
biopharmaceutical company with a novel immunotherapy platform that
produces specifically targeted, high-potency, fully-human,
multi-epitope binding immunoglobulin IgG1 (polyclonal) antibodies
without the need for human donors, today announced positive
top-line results from the Phase 3 National Institutes of Health’s
(NIH) ACTIV-2 clinical trial that assessed SAB-185 in
non-hospitalized people with COVID-19 who were at high risk for
severe outcomes.
Trial data show that SAB-185 demonstrated benefit in sustained
symptom resolution in study participants with COVID-19 caused by
Omicron as compared to participants who received a monoclonal
antibody combination, REGEN-COV®(casirivimab and imdevimab).
Specifically, 66% of participants treated with SAB-185 reached full
symptom resolution for at least 4 consecutive days by Day 28, while
only 50% of participants on REGEN-COV® met this endpoint (p=0.010;
Figure 1, Table 1), and the median time to symptom resolution for
at least 4 consecutive days was 7 days shorter for SAB-185. Also,
the median time to symptom resolution for at least 2 consecutive
days was 6 days shorter for SAB-185, as compared to those who were
treated with REGEN-COV® (p=0.021; Figure 2, Table 1). In the
non-Omicron population, the median time to symptom resolution for
at least 4 consecutive days was 7 days shorter for SAB-185, and the
median time to symptom resolution for at least 2 consecutive days
was 4 days shorter for SAB-185 than REGEN-COV®, though neither of
these analyses met statistical significance.
Figure
1: Symptom Resolution Over 4 Consecutive Days |
Figure
2: Symptom Resolution Over 2 Consecutive Days |
|
|
Source: NIH
Table 1: Symptom Resolution for at least
2 days and 4 days
Source: NIH
The primary endpoint of the study was the composite of all-cause
hospitalizations and deaths. Following the emergence of the Omicron
variant in late 2021, the number of these clinical events dropped
significantly. An interim review conducted by the study’s Data and
Safety Monitoring Board determined that there would not be enough
clinical events in this study, with the number of participants
specified in the protocol, to arrive at a conclusive result, and
the trial was halted. These data were analyzed and showed the
primary endpoint was considered inconclusive for both
non-inferiority or superiority in non-Omicron and Omicron patients
due to the small number of hospitalizations and deaths.
Additionally, grade 3 or higher treatment emergent adverse event
rates were similar between SAB-185 and REGEN-COV® arms.
“The ACTIV-2 data is further validation of the potential of
SAB’s platform,” said Eddie J. Sullivan, Ph.D., co-founder,
President, and Chief Executive Officer of SAB Biotherapeutics. “It
shows that the DiversitAb™ platform can open the door to treatments
that are potentially more effective and potent and which remain
efficacious over longer periods of time versus monoclonal
antibodies. This is not surprising, as SAB-185 has been shown to
have pseudovirus neutralizing activity1,2 and protection in animal
models ranging from Alpha to Omicron variants3.”
Alexandra Kropotova, MD, Chief Medical Officer of SAB
Biotherapeutics, said: “In context, these Phase 3 data demonstrate
the potential both therapeutic benefits of our fully human
multi-epitope binding immunoglobulin antibody therapies as well as
their potential to be the modality of choice for COVID-19 and
future public health emergencies caused by rapidly mutating viral
and bacterial pathogens. This aligns with the FDA’s positive
assessment of SAB’s anti-influenza A and B countermeasure. SAB-176
was granted a Fast Track and Breakthrough Therapy designation to
treat high risk patients – similar to those at risk for
SARS-CoV-2.”
1. https://doi.org/10.1101/2021.08.09.454215
2. https://doi.org/10.1101/2021.02.06.430072
3. https://doi.org/10.1101/2021.07.26.453840
Earlier this month, SAB announced that the FDA had granted both
Fast Track designation and Breakthrough Therapy designation to
SAB-176, an investigational therapeutic for Type A and Type B
influenza illness in high-risk patients, including those who have
anti-viral resistant strains. SAB-176 is the first fully-human
broadly neutralizing immunoglobulin antibody therapeutic intended
to prevent or reduce severe outcomes of Type A and Type B influenza
infection in patients at high risk for severe complications,
including in patients who are immunocompromised. The Breakthrough
Therapy designation was granted to SAB-176 for post-exposure
prophylaxis for Type A and Type B influenza illness in high-risk
patients, including those who have anti-viral resistant
strains.
SAB’s DiversitAb™ platform is a first-of-its-kind technology
capable of producing large amounts of fully-human, high-titer,
high-avidity multi-epitope binding antibodies across multiple
targets without the need for human donors. SAB is leveraging its
proprietary platform to discover and develop product candidates
with the potential to be first-in-class or best-in-class against
complex targets to treat or prevent diseases with significant unmet
medical needs. These include infectious respiratory and
gastroenterological diseases, immune and autoimmune disorders, and
oncology.
Direct support for the development of SAB-185 was 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 by the Biomedical Advanced Research and Development
Authority (BARDA), part of the Department of Health and Human
Services (HHS) Office of the Assistant Secretary for Preparedness
and Response, under contract number MCDC 2019-448. The Phase 3
clinical trial was sponsored and funded by the National Institutes
of Health (NIH) and further information on the trial can be found
here.
More information on the SAB-185 COVID therapeutic candidate can
be found at: https://www.sab.bio/sab-185/
More information on the SAB-176 influenza therapeutic candidate
can be found at: https://www.sab.bio/sab-176/
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics, Inc. (SAB) is a clinical-stage
biopharmaceutical company focused on the development of powerful
and proprietary immunotherapeutic polyclonal human antibodies to
treat and prevent infectious diseases and immune and autoimmune
disorders. Our development programs include infectious diseases
resulting from outbreaks and pandemics, as well as immunological,
gastroenterological, and respiratory diseases that have significant
mortality and health impacts on immune compromised patients. SAB
has applied advanced genetic engineering and antibody science to
develop Transchromosomic (Tc) Bovine™. Our versatile DiversitAb
platform is applicable to a wide range of serious unmet needs in
human diseases. It produces natural, specifically targeted,
high-potency, fully-human polyclonal immunotherapies without the
need for human donors. SAB currently has multiple drug development
programs underway and collaborations with the US government and
global pharmaceutical companies. For more information on SAB,
visit: https://www.SAb.bio/ and follow SAB on Twitter and
LinkedIn.
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 and efficacy of
our influenza program, C. diff. program, type 1 diabetes program,
and other discovery programs, the results, including timing, of the
development of SAB-176, SAB-185, SAB-142 and SAB-195, including
SAB-176 Fast Track designation and the outcome of and potential
future government and other third-party collaborations or funded
programs.
These statements are based on the current expectations of SAB
and are not predictions of actual performance, and are not intended
to serve as, and must not be relied on, by any investor as a
guarantee, prediction, definitive statement, or an assurance, of
fact or probability. These statements are only current predictions
or expectations, and are subject to known and unknown risks,
uncertainties and other factors which may be beyond our control.
Actual events and circumstances are difficult or impossible to
predict, and these risks and uncertainties may cause our or our
industry’s results, performance, or achievements to be materially
different from those anticipated by these forward-looking
statements. A further description of risks and uncertainties can be
found in the sections captioned “Risk Factors” in our most recent
annual report on Form 10-K, subsequent quarterly reports on Form
10-Q, and other filings with or submissions to, the U.S. Securities
and Exchange Commission, which are available at
https://www.sec.gov/. Except as otherwise required by law, SAB
disclaims any intention or obligation to update or revise any
forward-looking statements, which speak only as of the date they
were made, whether as a result of new information, future events,
or circumstances or otherwise.
CONTACTS:
Investor Relations:
SABIR@westwicke.com
Media Relations:
SABPR@westwicke.com
Photos accompanying this announcement are available
athttps://www.globenewswire.com/NewsRoom/AttachmentNg/a095499a-435a-4029-863f-28c937c2590ahttps://www.globenewswire.com/NewsRoom/AttachmentNg/37d44902-3857-4c92-8aef-1fc6a3afc13fhttps://www.globenewswire.com/NewsRoom/AttachmentNg/195a698d-3430-4bd9-82a2-b6ba626265da
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