Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Investor Presentation (November 2021)
37 slides from Purple Biotech's investor presentation, Nov 16, 2021
Slide 1: Corporate Presentation November 2021
NASDAQ/TASE: PPBT November 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: Business Highlights
3 Business Highlights Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT) CM24 - First - in - class α - CEACAM1 mAb , validating clinical collaboration with Bristol Myers Squibb NT219 - First - in - class, small molecule, dual inhibitor of IRS 1/2 and STAT3 $50.5M cash as of Se
Slide 4: Advancing Clinical-stage Novel Oncology Therapies
4 Advancing Clinical - stage Novel Oncology Therapies Program Indication Preclinical Phase 1 Phase 2 Phase 3 Partner Value Drivers CM24 (CEACAM - 1) S olid tumors (monotherapy) (Completed) Expansion arms on RP2D: Initiation Q4:21 Topline data: H2:21 S olid tumors (combination with nivolumab) NSCLC (
Slide 5: Experienced Leadership
5 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 President and Chief Financial Officer Former Deputy
Slide 6: Advancing First-in-Class Oncology Therapies: CM24, an α-CEACAM1 mAb
Advancing First - in - Class Oncology Therapies CM24 - an α - CEACAM1 mAb
Slide 7: CEACAM1 Plays a Key Role in Cancer Biology
7 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 CEACAM1 as a putative therapeutic target to prevent metastatic progression of col
Slide 8: CM24 MOA | Immuno-oncology
8 CM24 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 CEACAM1
Slide 9: CM24 MOA | Adhesion
9 CM 24 MOA | Adhesion Neutrophil extracellular trap - associated CEACAM1 as a putative therapeutic target to prevent metastatic progression: CEACAM1 creates a pro - angiogenic tumor microenvironment that supports tumor vessel maturation. CM24 is proposed to attenuate/block tumor growth and metastat
Slide 10: Significant benefits as both single agent and in combination with α-PD-1
10 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 CM24 treatment TIL + IgG TIL + CM 24 Naïv
Slide 11: CM24 Phase 1 Monotherapy Trial
11 • 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 12: PK/PD Modeling Provides Dosage & Schedule Guidance
12 PK/PD Modeling Provides Dosage & Schedule Guidance Simulated TMDD 1 saturation at Ctrough with Q 2 W regimen • Consistent with observed PK showing high clearance at doses < 10 mg/kg, plot shows low TMDD saturation at low doses • 10 mg/kg has a broad range of saturation, and > 10 mg/kg, Q 2 W dose
Slide 13: Large Market Opportunity in NSCLC & Pancreatic Cancer
13 13 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 14: CM24 Phase 1/2 Combination Study Design
14 CM 24 Phase 1 / 2 Combination Study Design (NCT 04731467 ) 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
Slide 15: 1st Cohort Analysis – Safety and Response
15 1 st Cohort Analysis – SAFETY and RESPONSE ϭϬ mg/kg Dose Level in combination with nivolumab • The administration of CM 24 at 10 mg/ kg q 2 wks in combination with nivolumab at 480 mg q 4 wks was well tolerated with no SAEs in patients with refractory PDAC • Three patients were enrolled into the
Slide 16: Advancing First-in-Class Oncology Therapies: NT219, a Small Molecule Dual Inhibitor of IRS1/2 and STAT3
Advancing First - in - Class Oncology Therapies NT 219 – A Small Molecule Dual Inhibitor of IRS 1 / 2 and STAT 3
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: By blocking both STAT3 and IRS pathways, NT219 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 Established 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 SCCHN metastasis, patient previously progressed on chemoradiation, several chemotherapies, and pe
Slide 22: NT219 + α-PD1 Re-sensitizes to Refractory α-PD1 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 Monotherapy and Combination Phase 1/2 Study Design
24 NT 219 Monotherapy and Combination Phase 1 / 2 Study Design ( NCT 04474470 ) Study title A phase 1 / 2 study with open - label, dose escalation phase followed by single - arm expansion to assess the safety, tolerability, PK, PD and efficacy of NT 219 , alone in adults with recurrent or metastatic
Slide 25: Interim Analysis – Safety and Response, 3 mg/kg Single Agent
25 Cancer Type Prior Lines of Therapy Treatment Duration(Weeks) Best Response* NT219 3mg/kg Pancreatic Cancer 3 8 PD GE Junction Cancer 4 22 PR Target lesion: Absent Non target lesion 1: Absent Non target lesion 2: Stable Breast Cancer 11 8 PD Interim Analysis – SAFETY and RESPONSE 3 mg/kg Dose Leve
Slide 26: Business Highlights
26 Business Highlights Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT) CM 24 - First - in - class α - CEACAM 1 mAb , validating clinical collaboration with Bristol Myers Squibb NT 219 - First - in - class, small molecule, dual inhibitor of IRS 1 / 2 and STAT 3 $ 50.5 M cash
Slide 27: Committed to providing cancer patients with first-in-class therapies
27 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 28: Thank You
THANK YOU Contact Us: ir@purple - biotech.com
Slide 29: Appendix A - CM24
Appendix A - CM 24
Slide 30: CM24 activity demonstrated as single agent and in combination with TILs
30 CM 24 activity is Demonstrated as Single Agent and in Combination with TILS Inhibition of Melanoma Growth Following CM24 and CM24 + TIL Treatment * P< 0.05 TGI 71 % * P< 0.05 TGI 45 %
Slide 31: Phase 1 PK Data
31 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 Predictions with Q 3 W regimen • Modeling with increased interval between doses demonstrates
Slide 32: Appendix B - NT219
Appendix B - NT 219
Slide 33: Selected Publications
33 Selected Publications Menashe Bar - Eli Michael Karin Michael Cox Alexander Levitzki
Slide 34: NT219 Suppresses β-Catenin Activity in CRC Cells and Inhibits CRC Brain Metastasis
34 AACR Annual Meeting, April 2021 , AACR Virtual Special Conference on Epigenetics and Metabolism, Oct 2020 , Ido Wolf, MD, Head of Oncology Division, Tel Aviv Sourasky Medical Center Colon cancer LS - 513 cells overexpressing IRS 2 demonstrate enhanced b - catenin activity. Targeted inhibition of
Slide 35: NT219 in Combination with Gemcitabine in Pancreatic Cancer
35 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 36: RNA Sequencing Analysis of Tumors Following Treatment
36 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 37: NT219 Demographics & Safety, 3 mg/kg Single Agent
37 Demographics of Patients treated with NT 219 3 mg/kg (n= 3 ) Median age (range) 74 (69 - 79) Male/Female, n (%) 2(66.6%)/1(33.3%) Race White n (%) 3 (100%) Prior Lines of Therapy 3 n (%) 1 (33.3%) 4, n (%) 1 (33.3%) 11, n (%) 1 (33.3%) Diagnosis, n Pancreatic Cancer 1 Gastroesophageal Junction Ca
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