Sab Biotherapeutics, Inc. · NASDAQ:SABS
Sab Biotherapeutics — Plasma Product Biotechnology Conference 2022
20 slides from Sab Biotherapeutics's conference presentation, Nov 7, 2022
Slide 1: Phase 2 Efficacy and Safety of Two Novel SAB Immunotherapies
© 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL Plasma Product Biotechnology Conference 2022 Christoph Bausch, PhD, Chief Operating Officer Phase 2 Efficacy and Safety of Two Novel SAB Immunotherapies Against Respiratory Disease Indications Associated with Highly Mutating Viruses SAB-185: A SA
Slide 2: Forward Looking Statements
Forward Looking Statements 2 The material in this presentation has been prepared by SAB Biotherapeutics, Inc. (SAB) and is general background information about SAB’s activities current as of the date of this presentation. This information is given in summary form and is not intended to be complete.
Slide 3: DiversitAb Platform is Clinically Validated Across Several Targets
DiversitAb™ Platform is Clinically Validated Across Several Targets Referenced Trials: Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants – Full Text View - ClinicalTrials.gov Study of SAB-176 in Healthy Adult Participants - Full Text View - ClinicalTrials.gov Safety, Tole
Slide 4: Robust Biologic Pipeline with Broad Polyclonal Therapeutic Reach
Robust Biologic Pipeline with Broad Polyclonal Therapeutic Reach © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 5: SAB-185 Anti-SARS-CoV2
Fev BIOTHERAPEUTICS SAB-185 Anti-SARS-CoV2
Slide 6: DiversitAb Rapid Discovery and Development Process for SAB-185
6 © 2022 SAB BIOTHERAPEUTICS, INC. DiversitAb™ Rapid Discovery and Development Process for SAB-185 Program Start Discovery & Initial Antibody Production Clinical Development Initial plasma collections Initial Antigen Development & Production (04Mar2020) Initial Manufacturing Began (25May2020) TcB Im
Slide 7: SAB-185 Neutralization Potential vs. the Munich Variant and Other Variants
SAB-185 Neutralization Potential vs. the Munich Variant (Spike D614G) and Other Variants © 2022 SAB BIOTHERAPEUTICS, INC. 7
Slide 8: SAB-185 Protects Recombinant hACE2 Hamsters from SARS CoV-2 Variants Including Omicron
SAB-185 Protects Recombinant hACE2 Hamsters from Mortality and/or Severe Morbidity from SARS CoV-2 Variants Including Omicron © 2022 SAB BIOTHERAPEUTICS, INC. 8 SAB-185 protection from mortality in hamsters challenged with six variant SARS CoV-2 isolates SAB-185 protection from weight loss in hamste
Slide 9: Addresses Escape Mutants: SAB-185 Superior to Monoclonal Antibody
Addresses Escape Mutants: SAB-185 Superior to Monoclonal Antibody 9 WASHINGTON UNIVERSITY SCHOOL OF MEDICINE–ST. LOUIS; 15 JAN 2021 Escape Mutants No Escape Mutants SAB-185 Targeted High-Potency Polyclonal Mixture Monoclonal Ab LOT 1 LOT 5 LOT 6 No Antibody 2H04 E484K E484A F486S © 2022 SAB BIOTHERA
Slide 10: Data from NIH ACTIV-2 Trial Confirms SAB-185 Met Virology Endpoints
Phase 2 Data from NIH ACTIV-2 Trial Confirms SAB-185 Met Virology Endpoints for Graduation to Phase 3 * The choice of 0.6 for this Bayesian probability indicates that there is a 3 to 2 odds of the agent being better than placebo by the desired amount (≥0.5 log10 /ml) for the outcome measure. INTERIM
Slide 11: SAB-176 Pan Influenza Therapeutic
SAB-176 Pan Influenza Therapeutic
Slide 12: Targeted Product Profile and Administration Routes
Targeted Product Profile and Administration Routes 12 © 2022 SAB BIOTHERAPEUTICS, INC. Treat high-risk influenza adult patients prior to the development of severe disease: Adults 65 years of age and older Immunocompromised due to a disease or medications (autoimmune, cancer, etc.) Patients with resp
Slide 13: Efficacy Against Mutational Drift
B/Florida/04/2006 Challenge strain SOURCE: NEXTFLU AT HTTPS://NEXTFLU.ORG/VIC/12Y/ Antibodies produced to B/Phuket/3073/2013 –like virus protected against B/Florida/04/2006 2006 2017 B/Phuket/3073/2013 Vaccination strain Highly-Mutational Influenza Virus BYAM PHYLOGENIC TREE 100% Protection at All D
Slide 14: SAB-176 Protects Against Multiple Influenza Strains
H1N1 H3N2 B-Vic B Yam Sample Started at 5mg/ml A/California/ 4/2009 (Pandemic Strain) A/Michigan/ 45/2015 A/Brisbane/02/2018 A/Guangdong-maonan/2019 A/Singapore/INIFMH-16-0019/2016 A/Kansas/14/2017 A/Hong Kong/45/2019 B/Maryland /15/2016 B/Colorado/ 06/2017 B/Washington/02/2019 B/Phuket/ 3073/2013 B
Slide 15: Trial Design and Methods
Trial Design and Methods 15 © 2022 SAB BIOTHERAPEUTICS, INC. Trial design: Randomized, Double-Blind, Placebo-Controlled Influenza Challenge Study Study sample size: 60 Healthy volunteers, 18-45 years of age Study flow: Participants were admitted into the hVIVO facility 2 days prior inoculation and w
Slide 16: Primary and Selected Secondary Outcome Measures
Primary and Selected Secondary Outcome Measures 16 © 2022 SAB BIOTHERAPEUTICS, INC. Primary Outcome Measure: Area under the viral load-time curve (VL-AUC) of Influenza A/California/2009 H1N1 virus as determined by qRT-PCR on nasal samples of SAB-176 when compared to placebo. [Time Frame: 8 Days ] Se
Slide 17: Emerging Safety Profile
Emerging Safety Profile 17 © 2022 SAB BIOTHERAPEUTICS, INC. Overall, the challenge virus inoculation and subsequent single IV infusion of SAB-176 were safe and well tolerated. There were no SAEs in this study, no AEs leading to early withdrawal from the study, and none of the AEs were of grade 3 or
Slide 18: SAB-176 Met the Primary Endpoint of Viral Load and Secondary Endpoint of Symptom Reduction
SAB-176 Met the Primary Endpoint of Viral Load and Secondary Endpoint of Symptom Reduction Achieved Statistically Significant (p = 0.026) Reduction in Viral Load Mean Viral Load by Nasal Samples qRT-qPCR by Day Relative to Viral Challenge 18 Mean Total Symptom Score by Day Relative to Viral Challeng
Slide 19: Kaplan-Meier Time to Resolution of Positive Viral Cultures
19 © 2022 SAB BIOTHERAPEUTICS, INC. Kaplan-Meier Time to Resolution of Positive Viral Cultures Following First Positive Culture Starting 2 Days After Intranasal Viral Challenge Shortened time of viral shedding, as measured by lack of culturable virus
Slide 20: Conclusions
20 © 2022 SAB BIOTHERAPEUTICS, INC. Conclusions SAB-176: A novel pan influenza polyclonal immunotherapeutic Demonstrates significant HAI titers to multiple Type A and B and pandemic influenza strains In response to pandemic H1N1 viral challenge met primary endpoint of reducing nasopharyngeal viral l
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