Sab Biotherapeutics, Inc. · NASDAQ:SABS
Sab Biotherapeutics — Plasma Product Biotechnology Conference 2022
36 slides from Sab Biotherapeutics's conference presentation, Nov 7, 2022
Slide 1: Plasma Fractionation and Downstream Processing of Human Polyclonal Antibodies from the DiversitAb Platform
Plasma Fractionation and Downstream Processing of Human Polyclonal Antibodies from the DiversitAb Platform © 2022 SAB BIOTHERAPEUTICS, INC. Plasma Product Biotechnology Conference 2022 Christoph Bausch, PhD, Chief Operating Officer EXHIBIT 99.1
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: Novel DiversitAb Platform for Developing Highly-Differentiated Immunotherapies
Novel DiversitAb™ Platform for Developing Highly-Differentiated Immunotherapies Vertical integration enables rapid, scalable development of multi-targeted products Robust, growing clinical-stage pipeline spanning multiple therapeutic areas Established proof-of-concept through US Government funded pr
Slide 4: pAbs Key Product Differentiators
pAbs Key Product Differentiators: Multi-target capability in a single therapeutic Natural multi-epitope targeted pAb selected and produced in vivo Ability to target multiple antigens to disease Specifically driven high-potency antibody titers and avidity Naturally activates cellular immunity Ability
Slide 5: A Natural Way to Produce Human Polyclonal Antibodies
Only transgenic animal that carries the entire human immunoglobulin (Ig) heavy and light (κ) chain loci. HAC is subject to mitosis along with the other 60 Tc Bovine chromsomes. HAC present in the Tc Bovine allows for the highest production of human antibody repertoire most similar to humans. Tc Bovi
Slide 6: Human Antibody Production in Bovine B-Cell
Human Antibody Production in Bovine B-Cell bIg Bovine chromosomes X X Bovine DNA-binding proteins Tc Bovine B-cells Remove species-incompatibility in protein-protein interaction Remove species-incompatibility in protein-DNA interaction HAC mRNA mRNA Human Bovine Chimeric IgM on B-Cell Receptor Fully
Slide 7: B-Cells Produce Anti-Target Fully-Human Polyclonal Antibodies
B-Cells Produce Anti-Target Fully-Human Polyclonal Antibodies Hyperimmunization Multiple immunizations drive titers to extremely high levels with exceptional avidity maturation and potency B-Cells Produce Human Antibodies Natural and somatic mutation drives very high-level B-cell clone avidity matur
Slide 8: First of its Kind DiversitAb Platform
First of its Kind DiversitAb™ Platform Advancing a new class of fully-human polyclonal Tc bovine-derived antibodies without the need for human serum ANTIGEN PATHOGEN TC BOVINE™ HYPERIMMUNIZATION HUMAN ANTIBODIES PURIFICATION TARGETED HIGH-POTENCY IMMUNOTHERAPY Reliable, controlled, consistent produc
Slide 9: Upstream Antibody Production
Upstream Antibody Production ANIMAL 1 V3 V4 V5+ D8 D11 D14 D8 D11 D14 D8 D11 D14 POOLED PLASMA PLASMA COLLECTIONS TITERS V1 V2 V3 V4 V5 V1 V2 V3 V4 V5 Procedures for Heterogeneity and Consistent Neutralizing Titers ANIMAL 2 V3 V4 V5+ D8 D11 D14 D8 D11 D14 D8 D11 D14 PLASMA COLLECTIONS 9 © 2022 SAB B
Slide 10: Downstream Manufacturing Process
Downstream Manufacturing Process Plasma selected to potency and impurity specifications Plasma thawed then pooled Caprylic Acid Fractionation & Clarification Chromatography Caprylic Acid: Precipitates bovine plasma proteins and HCP proteins pH adjustment Filter Aid – adheres insoluble proteins Depth
Slide 11: Manufacturing Step Process Overview
Manufacturing Step Process Overview SUITE 2 Chromatography/UF/Nanofiltration SUITE 1 Plasma Thaw / Pooling / Fractionation SUITE 3 Post Viral TFF SUITE 4 Fill/Finish © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 12: Scaled Infrastructure & Capacity: Laboratory & Manufacturing
Scaled Infrastructure & Capacity: Laboratory & Manufacturing Manufacturing Facility (200L) Manufacturing Facility (50L) 12 CET Lab Labeling Suite Fill Suite Cell Culture Lab 50L Suite © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 13: Scaled Infrastructure & Capacity: Tc Bovine & Plasma Production Facility
Scaled Infrastructure & Capacity: Tc Bovine & Plasma Production Facility 13
Slide 14: Adaptive & Cross Reactive to Mutating Strains
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 15: Anti-Influenza SAB-176 Neutralization Across 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 16: High Avidity: Driven By Hyperimmunization
High Avidity: Driven By Hyperimmunization SURENDER LAB; DIVISION OF VIRAL PRODUCTS, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) FDA 05 APR 2021 JOURNAL OF INFECTIOUS DISEASE (2022) SEP 4;226(4):655-663 SAB-185 (Anti-SARS-CoV2) avidity increases with affinity maturation driven by hyperimmuniz
Slide 17: High Avidity More Closely Linked to Patient Outcomes than Neutralizing Titers
High Avidity More Closely Linked to Patient Outcomes than Neutralizing Titers Neutralization Titers Demonstrate Discordance to Disease Severity & Outcome High Avidity Shows Direct Correlation to Patient Survival Neutralizing antibody titers and hACE2 receptor inhibition activity of COVID-19 patients
Slide 18: Oncology SAB-162E Exhibits High Binding Capability
Oncology SAB-162E (Human Anti-Human EGFR pAbs) Exhibits High Binding Capability 18 ELISA EGFR ELISA EGFRvIII H292 H1975 H1299 © 2022 SAB BIOTHERAPEUTICS, INC. C
Slide 19: SAB-162E Functional Properties for Addressing Complexity of Cancer
SAB-162E has Functional Properties for Addressing the Complexity of Cancer 19 SAB-162E inhibits cellular migration of NSCLC cells SAB-162E activates ADCC effector function © 2022 SAB BIOTHERAPEUTICS, INC. SAB-162E activates CDC effector function A B C
Slide 20: In vivo Efficacy Study for SAB-162E
in vivo Efficacy Study for SAB-162E (NOD/SCID mice) p=0.0004 p=0.0008 p=0.0016 * * * © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 21: In Vivo Efficacy Demonstrated Across a Broad Range of Targets
Consistent, Replicable Platform In Vivo Efficacy Demonstrated Across a Broad Range Targets TARGET EFFICACY MODEL(S) COLLABORATORS Anthrax 100% mouse (lethal) Food and Drug Administration Alphaviruses 100% 100% mouse (lethal aerosol) non-human primate (viral clearance) Naval Medical Research Center,
Slide 22: Tc Goats - Expanding The Human Immunotherapeutic Platform
Tc Goats™ - Expanding The Human Immunotherapeutic Platform for Personalized Medicine
Slide 23: Genetic Engineering Science Applied Across Multiple Species
Genetic Engineering Science Applied Across Multiple Species SAB Capra, LLC. is a wholly-owned subsidiary of SAB Biotherapeutics, Inc. Advancing novel antibody production platform leveraging transgenic goats Functionality of the HAC proven in a second species (ruminant ungulate) Generated H7N9-specif
Slide 24: Demonstrated Fully Human IgG in Tc Goat
Demonstrated Fully Human IgG in Tc Goat 24 Human IgG in Tc Capra Kids © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 25: Advancing the Tc Platform for Continued Advancement of Human Health
Advancing the Tc Platform for Continued Advancement of Human Health Developing targeted human polyclonal antibodies for use in personalized medicine Tc Goat platform production ready for producing diagnostics and testing reagent applications. Accommodating smaller volume markets, lower cost of devel
Slide 26: DiversitAb Proprietary Platform Technology
DiversitAb™ Proprietary Platform Technology © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 27: DiversitAb Development Process for Rapid High Titer & Avidity Maturation
Tc Bovine™ Vaccination Plasma Collection WEEK V1 V2 V3 V4 V5 PRIME–pDNA BOOST–RECOMBINANT PROTEIN V6 HUMAN POLYCLONAL ANTIBODIES TARGET 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 D8 D14 D11 D8 D14 D11 Pooling and Manufacturing D8 D14 D11 DiversitAb™ Development Process for Rapid High Titer & Avi
Slide 28: SAB-185: Specifically Targeted Human Immune Response
SAB-185: Specifically Targeted Human Immune Response Spike Glycoprotein Diversity of antibodies and uniquely combinatorial paratopes drives effector functions including antibody and complement dependent cellular cytotoxicity Multiple blocking and neutralizing antibody species bind to single epitope
Slide 29: Positioned for Personalized Medicine
High-dose therapy resulted in improved clinical parameters associated with reduced M. hominis burden following two subsequent infections JARED N SILVER, CAMERON D ASHBAUGH, JACOB J MILES, HUA WU, GREGORY T MARECKI, JOYCE K HWANG, JIN-AN JIAO, MARK ABRAMS, EDDIE J SULLIVAN, DUANE R WESEMANN, DEPLOYME
Slide 30: Highly-Potent: Exceeds Titers of Human Convalescent Plasma by 40X
Highly-Potent: Exceeds Titers of Human Convalescent Plasma by 40X WILLIAM B. KLIMSTRA. PH.D. DEPARTMENT OF IMMUNOLOGY ; MEMBER, CENTER FOR VACCINE RESEARCH; THE UNIVERSITY OF PITTSBURGH 160 <20 6400 40X HIGHER NEUTRALIZING TITERS HYPERIMMUNIZATION WITH WUHAN SPIKE PROTEIN 30 © 2021 SAB BIOTHERAPEUTI
Slide 31: High Potency and Broad Cross Protective Neutralization
© 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL High Potency and Broad Cross Protective Neutralization Dr. Victor Huber, University of South Dakota
Slide 32: One of Its Kind DiversitAb Platform
One of Its Kind DiversitAb™ Platform © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 33: Manufacturing Process: hIgG purification overview
Manufacturing Process hIgG purification overview Plasma Request & Pooling Caprylic Acid Fractionation Kappa Select Capture Affinity HC15 (Neg Affinity) Q-Seph (Polish) Captures BIgG HC molecules and enriches for hIgG Captures Kappa IgG (Reduces cIgG and bIgG impurities) Polishes and reduces IgA, IgM
Slide 34: Downstream Manufacturing Process
Downstream Manufacturing Process Vials labeled and boxed after QC tested, QA approves labels and then releases prior to distribution. Nanofiltration Dedicated Viral Clearance Step Final Formulation Concentrated and diafiltrated with Formulation Buffer Chromatography steps include two affinity and on
Slide 35: Downstream Manufacturing Process
Downstream Manufacturing Process Vials labeled and boxed prior to being approved and released Labels are created by Nanofiltration Dedicated Viral Reduction Step Final Formulation Concentrated and diafiltrated with Formulation Buffer Chromatography steps include two affinity and one ion exchange Cap
Slide 36: SAB-162E decreased mouse in vivo tumor growth and almost tripled survival time
SAB-162E decreased mouse in vivo tumor growth and almost tripled survival time 36 © 2022 SAB BIOTHERAPEUTICS, INC.
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