Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — BiondVax Pharmaceuticals — Investor Presentation (May 2022)
22 slides from Scinai Immunotherapeutics's investor presentation, May 13, 2022
Slide 1: BiondVax Pharmaceuticals Ltd. - May 12, 2022
BiondVax) Pharmaceuticals Ltd. BioMed| May 12, 2022
Slide 2: Forward-looking statements disclaimer
2 This communication is not a prospectus or offer of securities for subscription or sale in any jurisdiction. This communication contains forward - looking statements within the meaning of the Private Litigation Reform Act of 1995 . Words such as “ expect, ” “ believe, ” “ intend, ” “ plan, ” “ cont
Slide 3: Agenda
3 Tammy Ben Yedidia, PhD BiondVax CSO & clinical management 3 A GENDA The Science of NanoAbs BiondVax’s 1 st product under development NanoAb pipeline potential Q&A
Slide 4: Establishing BiondVax's own NanoAb platform
4 Pipeline development • Research collaboration agreement with Max - Planck - Gesellschaft and Universitätsmedizin Göttingen (UMG) for generation of innovative NanoAbs for BiondVax ’ s drug development pipeline • COVID - 19 NanoAb development • Tech Transfer ongoing, equipment acquired, manufacturin
Slide 5: Collaboration with Max Planck & UMG
5 COLLABORATION WITH MAX PLANCK & UMG • World - class science & access to leading scientists • NanoAb platform for development of promising potent therapeutics • Patents covering NanoAbs & their manufacturing • R&D knowledge, capabilities • Biosafety level 3 lab BIONDVAX MAX PLANCK & UMG Capabilitie
Slide 6: Targeting SARS-CoV-2 with NanoAbs
Targeting SARS - CoV - 2 with NanoAbs Severe acute respiratory syndrome coronavirus 2 (SARS - CoV - 2 ) is a novel coronavirus responsible for causing the coronavirus disease 2019 (COVID - 19 ) pandemic To date, there are limited therapeutic options to treat mild to moderate COVID - 19 • COVID - 19
Slide 7: NanoAb vs conventional antibody and libraries
VL 1 CL 1 VH 1 CH 1 CH 2 CH 3 CH 2 CH 3 VH 1 VH 1 Conventional Antibody (IgG) 150kD NanoAb 15kD Hybridoma clones Bacteriophages ~ 10 3 ~10 8 (100 million ) Huge NanoAb ‘ s libraries Strongest binders
Slide 8: Highly thermostable NanoAbs
8 Highly thermostable nanoAbs For any clinical application, antibodies need to be stable enough to survive the lengthy process of production, purification as well as storage . Best predictor for being developable: thermostability.
Slide 9: Our 1st Product: Inhaled NanoAbs for COVID-19
Our 1 st Product: Inhaled NanoAbs for COVID - 19 • VHHs also known as nanobodies* are single - domain antibodies characterized by a single peptide chain for antigen binding (originally identified in camelids) * NANOBODY is a registered trademark of Ablynx N.V./Sanofi • Indication: for the treatment
Slide 10: Extreme cross-strain neutralization
Extreme Cross - strain Neutralization • Infection and treatment of Vero cells • Neutralization at PicoMolar range • Wide coverage 72 h Infection + NanoAb NanoAb Concentration
Slide 11: NanoAbs protected hamsters
NanoAbs protected hamsters from COVID - 19
Slide 12: Large-scale production in Pichia pastoris
L arge - Scale production in Pichia pastoris Batch fermentation: up to 9 g per liter culture → kg yields in a standard 1000 liter fermenter NanoAb 10 15 20 25 30 40 50 60 70 85 10 0 kDa 0.5 µl Supernatant
Slide 13: Advantages of NanoAbs
13 Advantages of NanoAbs ‣ Choice from 10 8 library ‣ Extreme affinities ‣ Neutralizing receptor binding ‣ Extreme thermostability ‣ Rapid development ‣ Affordable production
Slide 14: Market continues to grow
14 COVID - 19 MARKET CONTINUES TO GROW -- AUTHORED BY THE SCIENTIFIC LEADS OF OUR MAX PLANCK COLLABORATION ( 3 ) 4 M cases 2 M Initial waves Jan 2020 Jun Jan 2021 Jun Jan 2022 1 . New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMp2118468 . | 2. WHO “ SARS - CoV - 2 is unlik
Slide 15: Successful neutralization upon inhalation
15 S UCCESSFUL N EUTRALIZATION UPON INHALATION 1. Technology transfer successful: we produced the NanoAb in Pichia passed it through an inhaler and showed neutralization 2. Max - Planck selected a NanoAb that covers Omicron, this will be used in our First - in - human trial in 2023 S UCCESSFUL N EUT
Slide 16: Plans towards first-in-human
16 PLAN S TOWARDS FIH 1. Large - Scale controlled production of the NanoAbs in Pichia pastoris 2. Show efficacy in a therapeutic model: – Infection of hamsters – 5 days therapy by inhalation – Evaluation of efficacy by • Weight monitoring • Viral load determination • Lung histopathology (toxicology
Slide 17: Creating an innovative NanoAb pipeline
17 CREATING AN INNOVATIVE NANOAB PIPELINE Extending from a promising COVID - 19 therapeutic … • Validated targets of existing mAb treatments • Short time to value generation, lower risk than mAbs • Large markets growing at attractive CAGRs COVID 19 Lead candidate demonstrating strong competitive edg
Slide 18: Key messages
18 K EY M ESSAGES : • B IOND V AX IS ADVANCING & HIRING • D EVELOPING N ANO A BS FOR COVID - 19 TREATMENT & BUILDING OUR OWN PIPELINE • A FFORDABLE PRODUCTION AT OUR OWN MANUFACTURING FACILITY • S UCCESSFUL TECH TRANSFER • O MICRON COVERAGE
Slide 19: Thank you
19 T HANK YOU BIONDVAX.COM Contact: Tammy Ben - Yedidia, CSO & Clinical management benyedidia@biondvax.com +972.8.930.2529
Slide 20: BiondVax's GMP Manufacturing and R&D Facility
BiondVax ’ s GMP Manufacturing and R&D Facility • Equipped to produce recombinant protein products such as NanoAb • Single - use equipment enables: - Adaptable manufacturing processes for entire NanoAb pipeline - Quicker lead times - Faster time - to - market for new products • Designed to meet FDA
Slide 21: Extreme anti-viral potency of NanoAbs
Extreme anti - viral potency of COVID - 19 NanoAbs Infection, fluorescence imaging
Slide 22: Virus-neutralizing potency explained by X-ray structure
Extreme virus - neutralizing potency explained by X - ray structure NanoAb RBD (surface representation) NanoAb RBD cartoon surface NanoAb RBD & ACE 2 Frontal clashes with RBD - bound ACE 2
BiondVax Pharmaceuticals — Investor Presentation (May 2022) on 6ix