Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — BiondVax Pharmaceuticals — RAFT meeting 2022
28 slides from Scinai Immunotherapeutics's conference presentation, Nov 8, 2022
Slide 1: RAFT meeting, 6-9 November 2022
1 RAFT meeting | 6 - 9 NOVEMBER 2022 Dalit Weinstein - Fischer
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: Collaboration with Max Planck & UMG
3 C OLLABORATION WITH M AX P LANCK & 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 Capabili
Slide 4: The science of nanosized antibodies
4 T HE SCIENCE OF NANOSIZED ANTIBODIES ( N ANO A BS ) * Nanobody is a trademark by ABLYNX N. V., a wholly owned subsidiary of Sanofi. BiondVax has no affiliation with and is not endorsed by Sanofi. HUMAN ANTIBODY ALPACA - DERIVED NANOAB Alpaca - derived nanosized antibodies (NanoAbs) are also known
Slide 5: A glance into the complexity of producing a strong VHH
5 A GLANCE INTO THE COMPLEXITY OF PRODUCING A STRONG N ANO A BS VHH Neutralization test GOOD RESULTS Relevant Lead in E.coli Relevant Lead in P. Pastoris Efficiency test Clone production and selection
Slide 6: Why are NanoAbs bio-better
6 W HY N ANO A BS ARE BIO - BETTER ‣ Choice from 10 8 library ‣ Extreme affinities ‣ Neutralizing receptor binding ‣ Extreme thermostability ‣ Rapid development ‣ Affordable production ‣ Flexible engineering to meet PK requirementsAR0
Slide 7: De-risked NanoAb target choice, favorable path to market
7 D E - RISKED N ANO A B TARGET CHOICE – FAVORABLE PATH TO MARKET MOLECULAR TARGET MECHANISM OF ACTION COMPOSITION OF MATTER COMMERCIAL ض ض + TBD Validated by existing mAb therapies Well understood Assessing safety & efficacy of alpaca - derived NanoAbs Solid demand for available mAb therapies VALID
Slide 8: Shorter R&D and regulatory pathways, validated existing mAb treatment targets
8 Shorter R&D and regulatory pathways V ALIDATED EXISTING M A B TREATMENT SUPPORT N ANO A BS TARGETS CHOICE - sars - anti products/ - antibody - 2 - cov - sars - anti therapies/ gov/ nih. treatmentguidelines. 19 covid www. https:// : Rxs COVID mAbs – More info / antibodies - monoclonal - 2 - cov Ast
Slide 9: Creating an innovative pipeline
9 C REATING AN INNOVATIVE N ANO A BS 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
Slide 10: COVID market continues to grow
10 C OVID - 19 MARKET CONTINUES TO GROW -- AUTHORED BY THE SCIENTIFIC LEADS OF OUR MAX PLANCK COLLABORATION ( 3 ) Initial waves Jan 2020 Jun Jan 2021 Jun Jan 2022 1 . New England Journal of Medicine. https://www.nejm.org/doi/full/ 10.1056 /NEJMp 2118468 . | 2 . WHO “ SARS - CoV - 2 is unlikely to be
Slide 11: Inhaled NanoAb for COVID treatment
11 I NHALED N ANO A BS FOR C OVID TREATMENT
Slide 12: Targeting SARS-CoV-2 with NanoAb
12 To date, there are limited therapeutic options to treat mild to moderate COVID - 19 • Our NanoAb is engineered to act against the SARS - CoV - 2 receptor binding domain (RBD) • By blocking the surface spike protein/RBD, the virus is neutralized • NanoAbs show high affinity and thermostability • T
Slide 13: Extreme virus-neutralizing potency explained by X-ray structure
13 E XTREME VIRUS - NEUTRALIZING POTENCY EXPLAINED BY X - RAY STRUCTURE NanoAb RBD (surface representation) NanoAb RBD cartoon surface NanoAb RBD & ACE2 Frontal clashes with RBD - bound ACE 2
Slide 14: Extreme cross-strain potency of the NanoAb
14 E XTREME CROSS - STRAIN POTENCY OF THE N ANO A BS 72 h Infection + NanoAb NanoAb Concentration I NFECTION AND TREATMENT OF V ERO CELLS N EUTRALIZATION AT P ICOMOLAR RANGE W IDE COVERAGE
Slide 15: COVID-19 treatment protected hamsters
15 96 % 75 % 84 % 87 % 50 60 70 80 90 100 110 Weight (%) *p= 0.003 *p= 0.005 Uninfected Infected VHH5 intranasal VHH 5 intraperitoneal C OVID - 19 N ANO A BS TREATMENT PROTECTED HAMSTERS % weight loss 6 days post infection, following NanoAb therapy Male Golden Syrian hamsters ( Mesocricetus auratus
Slide 16: BiondVax's project and results
16 B IOND V AX ’ S PROJECT AND RESULTS
Slide 17: BiondVax's GMP manufacturing and R&D facility
17 B IOND V AX ’ S GMP M ANUFACTURING AND R&D F ACILITY • Equipped to produce recombinant protein products such as NanoAb • Single - use equipment enables: - Adaptable manufacturing processes for the entire NanoAb pipeline - Quicker lead times - Faster time - to - market for new products • Designed
Slide 18: Large-scale production in Pichia pastoris
18 L ARGE - S CALE PRODUCTION IN P ICHIA P ASTORIS • Fed - Batch fermentation: up to 10 gr/L culture (pending on P.P strain) • Kg yields in a standard 1000 L fermenter NanoAb 10 15 20 25 30 40 50 60 70 85 100 kDa 0.5 µl Supernatant
Slide 19: Production process flow
19 - 70 C O.N growth Centrifuge Supernatant Carbon Source Glycerol/Methanol 120 hr process U PSTREAM D OWNSTREAM Clarification 1 d Chromatography 2 d Buffer exchange & concentration 1d Filtration 1 d P RODUCTION PROCESS FLOW
Slide 20: Accumulation throughout the fermentation, low HCP content
20 N ANO A BS ACCUMULATION THROUGHOUT THE FERMENTATION – L OW HCP CONTENT IPC - SDS Page assay 95 h post induction 98 h post induction 115 h post induction Size Marker Size Marker NanoAb
Slide 21: Straightforward DSP, optimized purification process
21 S TRAIGHT FORWARD DSP O PTIMIZED PURIFICATION PROCESS WITH ~ 75 % EFFICIENCY Filtration Clarification Chromatography Formulation Size removal of large particles, impurities, aggregates, etc.) Size removal of small impurities, media components, etc. and buffer exchange Purification according to VH
Slide 22: High purity of final product
22 This communication is not a prospectus or offer of securities for subscription or sale in any jurisdiction. 2 2 H IGH PURITY OF FINAL PRODUCT Harvest (pool) Main peak Impurities Final protein RP - HPLC R ESULTS • Downstream process efficiency ~ 75 % • Purity (HPLC - RP) ~ 98 %
Slide 23: Stability study, activity unaffected after 60 days at 25C
23 S TABILITY STUDY – T HE ACTIVITY OF OUR N ANO A BS IS UNAFFECTED FOLLOWING 60 DAYS AT 25 C
Slide 24: Inhaled route of administration & considerations of device choice
24 I NHALED ROUTE OF ADMINISTRATION & CONSIDERATIONS OF DEVICE CHOICE
Slide 25: Not all inhaler technologies suit biological molecules
25 N OT ALL INHALER TECHNOLOGIES SUIT BIOLOGICAL MOLECULES • S UITABLE FOR L ARGE BIOLOGICAL MOLECULES ( PROTEINS ) • L OW PRESSURE • R EDUCE SHEAR FORCE • T YPE OF MIST PLUME GENERATED BY THE DEVICE • A DJUSTED FORMULATION DEVELOPMENT TO KEEP STABILITY AT HIGH CONCENTRATIONS • S INGLE - USE INHALER
Slide 26: Summary
SUMMARY BiondVax) Pharmaceuticals Led
Slide 27: Key messages
27 K EY M ESSAGES : • D EVELOP SELF INHALED N ANO A BS TREATMENT FOR COVID - 19 • F IRST I N H UMAN CLINICAL TRIAL PLANNED FOR Q 3 2023 • P ICHIA P ASTORIS EXPRESSION SYSTEM • T ECHNOLOGY PLATFORM FOR ADDITIONAL N ANO A BS TARGETING OTHER DISEASES SUCH AS A STHMA AND PSORIASIS • CUTTING - EDGE TECH
Slide 28: Thank you
28 T HANK YOU BIONDVAX.COM Contact: Dalit Weinstein Fischer, VP TRD dalit@biondvax.com