Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Investor Presentation (January 2021)
40 slides from Purple Biotech's investor presentation, Jan 6, 2021
Slide 1: January 2021 Corporate Presentation
NASDAQ/TASE: PPBT JANUARY 2021 CORPORATE PRESENTATION
Slide 2: Forward-looking Statements and Safe Harbor
2 Forward - looking Statements and Safe Harbor Certain statements in this presentation that are forward - looking and not statements of historical fact are forward - looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 . Such for
Slide 3: Our Transformation into Oncology
3 Our Transformation into Oncology Acquisition of TyrNovo/ NT 219 CONSENSI® NDA approval & China partnership Acquisition of FameWave/ CM 24 NT 219 – Phase 1 / 2 initiation, CONSENSI® US launch Established TASE listing CONSENSI® Phase III positive results & NASDAQ IPO CONSENSI® NDA submission 2011 20
Slide 4: Advancing Clinical-stage Novel Oncology Therapies
4 Advancing Clinical - stage Novel Oncology Therapies Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT) CM 24 - First - in - class α - CEACAM 1 mAb, Validating clinical collaboration with NT 219 - First - in - class, small molecule, dual inhibitor of IRS 1 / 2 and STAT 3 H 2:
Slide 5: Expanding Pipeline
5 Expanding Pipeline Multiple data read - outs expected in the next 12 months Program Indication Preclinical Phase 1 Phase 2 Phase 3 Partner Value Drivers CM24 (CEACAM - 1) S olid tumors (monotherapy) (Completed) Expansion arms on RP 2 D: Initiation Q 4:21 Topline data: H 2:21 S olid tumors (combina
Slide 6: Experienced Leadership
6 Experienced Leadership Isaac Israel Chief Executive Officer Former CEO of BeeContact Ltd. (TASE:BCNT). NextGen Biomed (TASE: NXGN) Eric K. Rowinsky , MD Chairman of the Board Former CMO at ImClone, Stemline , Board member at Biogen Inc. Gil Efron Deputy CEO and Chief Financial Officer Former Deput
Slide 7: Advancing First-in-Class Oncology Therapies: CM24
Advancing First - in - Class Oncology Therapies CM24 - an α - CEACAM1 mAb
Slide 8: CEACAM1 Plays a Key Role in Cancer Biology
8 CEACAM 1 Ύ Plays a Key Role in Cancer Biology 01 | ADHESION Horst, 2011 “ CEACAM1 creates a pro - angiogenic tumor microenvironment that supports tumor vessel maturation ” “ Neutrophil extracellular trap - associated CEACAM 1 as a putative therapeutic target to prevent metastatic progression of co
Slide 9: CM24 MOA: Immuno-oncology
9 CM 24 MOA | Immuno - oncology Markel et al, J Immunol 2002 , 2006 ; Immunology, 2008 ; Cancer Immunol Immunother 2010 ; Ortenberg et al, Mol Cancer Ther 2012 ; Zhou, 2009 ; Li, 2013 ; Huang, 2015 ; Acharya N, et al. J Immunotherapy Canc 8 :e 911 - 22 , 2020 . Tumor CD8+T & NK Cells CEACAM 1 CEACAM
Slide 10: CM24 MOA: Adhesion
10 CM 24 MOA | Adhesion Neutrophil extracellular trap - associated CEACAM1 as a putative therapeutic target to prevent metastatic progression: CEACAM 1 creates a pro - angiogenic tumor microenvironment that supports tumor vessel maturation. CM 24 is proposed to attenuate/block tumor growth and metas
Slide 11: Significant benefits as single agent and in combination with anti-PD-1
11 Significant benefits as both single agent and in combination with α - PD - 1 Anti - cancer Effect Following Treatment Preclinical Data With CM24 + TIL and CM24 + α - PD1 • Xenograft, lung lesion, Mel 526 (IV) • Tumor burden was monitored 26 days post last CM 24 treatment TIL + IgG TIL + CM 24 Naï
Slide 12: CM24 Phase 1 Monotherapy Trial
12 • Open - label, multi - dose escalation monotherapy study to assess safety and tolerability • Heavily pre - treated patients with a median of 4 prior regimens (range 2 - 8 ) Overall, treatment was well tolerated • Most of the responding patients were treated with the highest dose levels of 3 mg/k
Slide 13: PK/PD Modeling Provides Dosage & Schedule Guidance
13 Nivolumab (OPDIVO®) administered Q 2 W or Q 4 W, representing good clinical and commercial fit for CM 24 PK/PD Modeling Provides Dosage & Schedule Guidance Simulated TMDD 1 saturation at Ctrough with Q 2 W regimen Predictions with Q 3 W regimen • Modeling with increased interval between doses dem
Slide 14: Large Market Opportunity in NSCLC & Pancreatic Cancer
14 14 Large Market Opportunity in NSCLC & Pancreatic Cancer • CEACAM 1 expression correlates with poor prognosis in NSCLC and Pancreatic cancer 1 • Preclinical data support significant synergy • Receptor saturation with CM 24 is better achieved with a Q 2 W regimen, aligning with the nivolumab regim
Slide 15: CM24 Phase 1/2 Combination Study Design
15 CM 24 Phase 1 / 2 Combination Study Design A Phase 1 / 2 open label multi center study of CM 24 in combination with: • Nivolumab in selected cancer indications (Phase 1 ) and NSCLC (Phase 2 ) • Nivolumab and nab - paclitaxel in pancreatic cancer (Phase 2 ) Primary endpoints: Phase 1 : Evaluate th
Slide 16: NT219 – A Dual Inhibitor of IRS1/2 and STAT3
Advancing First - in - Class Oncology Therapies NT219 – A Dual Inhibitor of IRS 1/2 and STAT3
Slide 17: NT219 Dual Inhibitor of IRS1/2 & STAT3
17 NT 219 - Dual Inhibitor of IRS 1 / 2 & STAT 3 NT 219 IRS 1 / 2 • Scaffold proteins, mediating mitogenic, metastatic, angiogenic and anti - apoptotic signals from IGF 1 R, IR, IL 4 R and other oncogenes, overexpressed in multiple tumor types • Regulates major survival pathways such as the PI 3 K/A
Slide 18: Novel MOA: IRS Degradation By NT219
18 Novel MOA: IRS Degradation By NT 219 Blocking IGF 1 R - AKT Pathway 1 Binding to IRS 1 1 Reuveni et al. Cancer Res 2013 Ser - phosphorylation 2 Degradation 3 Covalent binding to IRS 1 / 2 leads to the dissociation of IRS 1 / 2 from IGF 1 R Serine phosphorylation prevents re - binding of IRS 1 / 2
Slide 19: NT219 Efficacy as Monotherapy
19 NT 219 Efficacy as Monotherapy Animal model Head & Neck Cancer (SCC - 9 ) NSG Ρ , PBMCs - injected 1 Drugs α - PD 1 Cetuximab (Erbitux®) NT 219 20 mg/kg NT 219 60 mg/kg 1 NSG mice were injected SC with SCC - 9 cells. PBMCs ( 18 * 10 6 cells per mouse) administered 4 weeks prior to first treatment
Slide 20: Blocking both STAT3 and IRS prevents tumor resistance
20 By blocking both STAT 3 and IRS pathways, NT 219 prevents tumor resistance and re - sensitizes tumors to anti - cancer therapies STAT 3 and IRS are Essential in Therapeutic Resistance STAT 3 IRS EGFR MEK Tumor Regression ERK PI 3 K AKT Tumor Survival Tumor Survival Buparlisib Ruxolitinib Erlotini
Slide 21: NT219 + Targeted Therapies Efficacy in PDX Models
21 NT 219 + Targeted Therapies Established Efficacy in PDX Models NSCLC Exon 19 deletion EGFR and T 790 M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib R/M HNSCC metastasis, patient previously progressed on chemoradiation, several chemotherapies, and pe
Slide 22: NT219 + Anti-PD1 Re-sensitizes Refractory Tumors
22 NT 219 + α - PD 1 Re - sensitizes to Refractory α - PD 1 Tumors PDX Model Humanized PDX of Esophagus Cancer (refractory to pembrolizumab) Drug Pembrolizumab (Keytruda®) * Double autologous model - Tumors & PBMCs are from the same patient (#RA 236 ) | Keytruda - 6 mg/kg IP, NT 219 - 60 mg/kg IV 0
Slide 23: First Market Opportunity: Recurrent or Metastatic SCCHN
23 23 First Market Opportunity Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) Global Data 2018 : Head and Neck Squamous Cell Carcinoma: Opportunity Analysis and Forecasts to 2026 ; Internal best current estimates of patient numbers based on external research, 5 major global
Slide 24: NT219 Phase 1/2 Study Design
24 2020 2021 2022 2023 Dose Escalation NT 219 q 1 w 18 ≤ n ≤ 30 Expansion NT 219 q 1 w @ RP 2 D n= 11 + 18 (Simon 2 stage design) Dose Escalation NT 219 q 1 w + cetuximab q 1 w 9 ≤ n ≤ 18 NT 219 + cetuximab in subjects with R/M head and neck cancer 1 Expansion NT 219 q 1 w + cetuximab q 1 w n= 11 +
Slide 25: Advancing Clinical-stage Novel Oncology Therapies
25 Advancing Clinical - stage Novel Oncology Therapies Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT) CM 24 - First - in - class α - CEACAM 1 mAb , Validating clinical collaboration with NT 219 - First - in - class, small molecule, dual inhibitor of IRS 1 / 2 and STAT 3 H
Slide 26: Committed to providing cancer patients first-in-class therapies
26 We are committed to providing cancer patients with first - in - class therapies to OVERCOME tumor drug resistance, ENHANCE treatment response and SLOW tumor progression
Slide 27: Thank You
THANK YOU Contact Us: ir@purple - biotech.com
Slide 28: Appendix A - CM24
Appendix A - CM 24
Slide 29: CM24 Activity as Single Agent and with TILs
29 CM 24 activity is Demonstrated as Single Agent and in Combination with TILS Inhibition of Melanoma Growth Following CM 24 and CM 24 + TIL Treatment * P< 0.05 TGI 71 % * P< 0.05 TGI 45 %
Slide 30: Phase 1 PK Data
30 PHASE 1 PK DATA Target saturation was not reached with doses up to 10 mg/kg Slower clearance with increasing dose Higher half - life with increasing dose 0.1 mg/ kg 0.3 mg/ kg 1 mg/ kg 3 mg/ kg 10 mg/ kg
Slide 31: Appendix B - NT219
Appendix B - NT 219
Slide 32: Selected Publications
32 Selected Publications Menashe Bar - Eli Michael Karin Michael Cox Alexander Levitzki
Slide 33: NT219 Suppresses β-Catenin Activity in CRC Cells
33 Ido Wolf, MD, Head of Oncology Division, Tel Aviv Sourasky Medical Center AACR Virtual Special Conference on Epigenetics and Metabolism, Oct 2020 Colon cancer LS - 513 cells overexpressing IRS 2 demonstrate enhanced b - catenin activity. Targeted inhibition of IRS 2 by NT 219 or IRS 2 - SH RNA, s
Slide 34: NT219 in Pancreatic Cancer in Combination with Gemcitabine
34 PDX model Pancreatic Cancer Drug Gemcitabine ( Gemzar ® ) NT 219 | Pancreatic Cancer in Combination with Gemcitabine Highly effective anti cancer activity exhibited by NT 219 in combination with Gemcitabine
Slide 35: RNA Sequencing Analysis of Tumors Following Treatment
35 PDX model Pancreatic Cancer Drug Gemcitabine ( Gemzar ®) RNA Sequencing | Analysis of Tumors Following Treatment Reduced expression of IRS 1 , Ki 67 , FOXM 1 & TGFb is exhibited by pancreatic cancer treated with NT 219 alone and in combination with gemcitabine
Slide 36: Appendix C - CONSENSI
Appendix C - CONSENSI®
Slide 37: CONSENSI: From IND to the U.S. Market
37 CONSENSI® | From IND to the U.S. Market CONSENSI ® is the only NSAID whose labeling indicates reduction of blood pressure and consequent risk reduction of heart attack, stroke and death Full U.S. Prescribing Information is available at http://www.consensi.com Celecoxib , a COX - 2 selective NSAID
Slide 38: CONSENSI Phase III Trial Results
38 • Primary efficacy endpoint was successfully achieved (P= 0.001 ) • Demonstrated 2.5 x better blood pressure reduction than FDA requirement ( 50 % of amlodipine arm) • Demonstrated consistent reduction in all measures of blood pressure • Observed beneficial renal functions: • Additional Phase III
Slide 39: Purple Biotech Commercial Drug: CONSENSI
39 Purple Biotech Commercial Drug: CONSENSI® Simultaneous treatment of osteoarthritic pain and hypertension Fixed dose combination of Celecoxib , a COX - 2 selective NSAID (the active ingredient in Pfizer ’ s Celebrex®) + Amlodipine, a blood pressure - lowering agent (a calcium channel blocker) (the
Slide 40: CONSENSI U.S. Target Markets
40 CONSENSI ® U.S. Target Markets CONSENSI® targets osteoarthritis (OA) patients currently treated with NSAIDs (celecoxib as well as others) who also suffer from existing or newly diagnosed hypertension OSTEOARTHRITIS 50 million patients* NSAIDs 60 % of all OA Rxs * Arthritis Foundation: http://www.
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