Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Investor Presentation (March 2021)
40 slides from Purple Biotech's investor presentation, March 2021
Slide 1: Corporate Presentation
CORPORATE PRESENTATION NASDAQ/TASE: PPBT March 2021
Slide 2: Forward-looking Statements and Safe Harbor
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 forward-look
Slide 3: Our Transformation into Oncology
Our Transformation into Oncology CONSENSI® NT219 – Phase Acquisition of NDA approval & Acquisition of 1/2 initiation, TyrNovo/ China FameWave/ CONSENSI® US NT219 partnership CM24 launch Oncology Pivot 2017 2018 2019 2020 2011 2013 2015 2017 Established TASE CONSENSI® CONSENSI® listing Phase III NDA
Slide 4: Business Highlights
Business Highlights CM24 - First-in-class α-CEACAM1 mAb, validating Strong balance sheet and clinical collaboration with Bristol Myers Squibb cash position Purple Biotech (NASDAQ/TASE: PPBT) NT219 - First-in-class, small molecule, dual ADSs outstanding: 17.5M inhibitor of IRS 1/2 and STAT3 $61M cash
Slide 5: Advancing Clinical-stage Novel Oncology Therapies
Advancing Clinical-stage Novel Oncology Therapies Program Indication Preclinical Phase 1 Phase 2 Phase 3 Partner Value Drivers Solid tumors (monotherapy) (Completed) Solid tumors (combination with Expansion arms on CM24 nivolumab) RP2D: Initiation Q4:21 (CEACAM-1) NSCLC (combination with nivolumab)
Slide 6: Experienced Leadership
Experienced Leadership Isaac Israel Eric K. Rowinsky, MD Chief Executive Officer Chairman of the Board Former CEO of BeeContact Ltd. Former CMO at ImClone, Stemline, (TASE:BCNT). NextGen Biomed Board member at Biogen Inc. (TASE: NXGN) Gil Efron Hadas Reuveni, Ph.D Deputy CEO and Chief Financial Vice
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
CEACAM1* Plays a Key Role in Cancer Biology 01 | ADHESION 02 | IMMUNE CELLS/ 03 | IMMUNO- IMMUNE EXCLUSION ONCOLOGY Horst, 2011 Tsuzuki, 2020 Blumberg, 2015 “CEACAM1 creates a pro-angiogenic “Immune‐checkpoint molecules on “CEACAM1 regulates tumor microenvironment that regulatory T‐cells as a potent
Slide 9: CM24 MOA | Immuno-oncology
CM24 MOA | Immuno-oncology Tumor Tumor cell or pAPC CEACAM1 MHC CEACAM1 CEACAM5 CD45/148 PtdSer TCR Gal-9 CD4/8 CEACAM1 TIM3 CEACAM1 CEACAM1 CD8+T & NK Cells TCR Signaling Activation T cell enhanced cytotoxic activity & cytokine production 9 Markel et al, J Immunol 2002, 2006; Immunology, 2008; Canc
Slide 10: CM24 MOA | Adhesion
CM24 MOA | Adhesion Neutrophil extracellular trap-associated CEACAM1 as a putative therapeutic target to prevent metastatic progression: Primary Tumor Metastasizing CEACAM1 creates a pro-angiogenic tumor microenvironment that supports tumor vessel CM24 maturation. CM24 is proposed to attenuate/block
Slide 11: Anti-cancer Effect Following Treatment
Anti-cancer Effect Following Treatment Preclinical Data With CM24 + TIL and CM24 + α-PD1 TIL + IgG TIL + CM24 Naïve • Xenograft, lung lesion, Mel 526 (IV) Combination index (CI) = 0.15 • Tumor burden was monitored 26 days post last CM24 treatment < 1 synergy Significant benefits as both single age
Slide 12: CM24 Phase 1 Monotherapy Trial
CM24 Phase 1 Monotherapy Trial # pts • Open-label, multi-dose escalation 27 patients: 0.01mg/kg 1 monotherapy study to assess safety and tolerability Colorectal 11 0.03mg/kg 1 • Heavily pre-treated patients with a median Melanoma 7 of 4 prior regimens (range 2-8) Overall, Ovarian 4 0.1 mg/kg 3 treat
Slide 13: PK/PD Modeling Provides Dosage & Schedule Guidance
PK/PD Modeling Provides Dosage & Schedule Guidance Simulated TMDD1 saturation at Ctrough Predictions with with Q2W regimen Q3W regimen • Consistent with observed PK showing high clearance at doses • Modeling with increased interval between doses <10 mg/kg, plot shows low TMDD saturation at low doses
Slide 14: Large Market Opportunity in NSCLC & Pancreatic Cancer
Large Market Opportunity in NSCLC & Pancreatic Cancer • NSCLC accounts for ~200K new cases/year in the • Pancreatic Cancer accounts for ~60K new cases/year US; with a 5-year relative survival rate of 23%2 in the US; with a 5-year relative survival rate of 10%2 • Immunotherapy is now recommended as f
Slide 15: CM24 Phase 1/2 Combination Study Design
CM24 Phase 1/2 Combination Study Design A Phase 1/2 open label multi center Primary endpoints: Measurement of CEACAM1 based study of CM24 in combination with: Phase 1: Evaluate the safety, PK and the bio-marker. • Nivolumab in selected cancer indications MTD/RP2 dose Exploring further studies in oth
Slide 16: Advancing First-in-Class Oncology Therapies: NT219
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
NT219 - Dual Inhibitor of IRS1/2 & STAT3 IRS1/2 • Scaffold proteins, mediating mitogenic, metastatic, angiogenic and anti- apoptotic signals from IGF1R, IR, IL4R and other oncogenes, overexpressed in multiple tumor types STAT3 • Regulates major survival pathways • Well-established transcription such
Slide 18: Novel MOA: IRS Degradation By NT219
Novel MOA: IRS Degradation By NT219 Blocking IGF1R-AKT Pathway1 1 Binding to IRS 2 Ser-phosphorylation 3 Degradation IGF1 IGF1R IGF1 IGF1 IGF1 IGF1R IGF1R IGF1R IRS NT pS PI3K IRS IRS pS AKT AKT AKT AKT SURVIVAL APOPTOSIS APOPTOSIS APOPTOSIS Covalent binding to IRS1/2 leads to the Serine phosphoryla
Slide 19: NT219 Efficacy as Monotherapy
NT219 Efficacy as Monotherapy Animal model Head & Neck Cancer (SCC-9) NSG™, PBMCs- injected1 Drugs α-PD1 Cetuximab (Erbitux®) NT219 20mg/kg NT219 60mg/kg 1 NSG mice were injected SC with SCC-9 cells. PBMCs (18*106 cells per mouse) administered 4 weeks prior to first treatment. NT219, α-PD1, and cetu
Slide 20: STAT3 and IRS are Essential in Therapeutic Resistance
STAT3 and IRS are Essential in Therapeutic Resistance Blocking survival pathways Proof of Concept: PDX model of Head and Neck Cancer Erlotinib DRUG Control (n=6) EGFR Erlotinib (n=8) ONCOPROTEIN Erlotinib+NT219 (n=6) Erlotinib+Ruxolitinib (n=6) NT219 MEK NT219 Ruxolitinib Buparlisib Erlotinib+Buparl
Slide 21: NT219 + Targeted Therapies
NT219 + Targeted * Therapies Tumor Volume (mm3) 2,000 1,500 Established Efficacy 1,000 in PDX Models 500 0 Control NT219 Osimertinib Osimertinib+NT219 NSCLC Osimertinib 5 mg/kg, NT219 65 mg/kg, mean tumor volume at the end point, 3 mice/group; Exon 19 deletion EGFR and T790M, biopsy of bone marrow m
Slide 22: NT219 + α-PD1 Re-sensitizes to Refractory α-PD1 Tumors
NT219 + α-PD1 Re-sensitizes to 1200 Control (n=3) Refractory α-PD1 1000 NT219 (n=3) Keytruda (n=3) Tumors Keytruda + NT219 (n=3) Tumor volume (mm3) 800 PDX Model 600 Humanized PDX of Esophagus Cancer (refractory 400 to pembrolizumab) 200 Drug Pembrolizumab 0 (Keytruda®) 0 5 10 15 20 Days following t
Slide 23: First Market Opportunity
First Market Opportunity Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) Targeting the unmet medical need • 1L Standard of care has shifted from chemotherapy towards immuno- oncology + chemotherapy • Only < 20% of R/M SCCHN patients respond to α-PD1s • 175k new cases/year ar
Slide 24: NT219 Monotherapy and Combination Phase 1/2 Study Design
NT219 Monotherapy and Combination Phase 1/2 Study Design Study title Endpoints A phase 1/2 study with open-label, dose escalation phase Primary endpoints: followed by single-arm expansion to assess the safety, Safety, pharmacokinetics and to determine the MTD tolerability, PK, PD and efficacy of NT2
Slide 25: Business Highlights
Business Highlights CM24 - First-in-class α-CEACAM1 mAb, validating Strong balance sheet and clinical collaboration with Bristol Myers Squibb cash position Purple Biotech (NASDAQ/TASE: PPBT) NT219 - First-in-class, small molecule, dual ADSs outstanding: 17.5M inhibitor of IRS 1/2 and STAT3 $61M cash
Slide 26: We are committed
We are committed to providing cancer patients with first-in-class therapies to OVERCOME tumor drug resistance, ENHANCE treatment response and SLOW tumor progression 26
Slide 27: Thank You
THANK YOU Contact Us: ir@purple-biotech.com
Slide 28: Appendix A - CM24
Appendix A - CM24
Slide 29: Inhibition of Melanoma Growth Following CM24 and CM24 + TIL Treatment
Inhibition of Melanoma Growth Following CM24 and CM24 + TIL Treatment CM24 activity is Demonstrated as Single Agent and in Combination with TILS *P<0.05 TGI 45% *P<0.05 TGI 71% 29
Slide 30: Phase 1 PK Data
PHASE 1 PK DATA Target saturation was not reached with doses up to 10mg/kg 0.1 mg/kg 0.3 mg/kg 1 mg/kg 3 mg/kg 10 mg/kg Slower clearance with increasing dose Higher half-life with increasing dose 30
Slide 31: Appendix B - NT219
Appendix B - NT219
Slide 32: Selected Publications
Selected Publications Michael Alexander Karin Levitzki Menashe Michael Bar-Eli Cox 32
Slide 33: NT219 Suppresses β-Catenin activity in CRC Cells
NT219 | Suppresses β-Catenin activity in CRC Cells Silencing IRS2 inhibits NT219 downregulates IRS2 and suppresses the b-catenin activity CRC Cell Viability (72hr) b-catenin activity DMEM β-catenin luciferase activity 1.5 *** iAKT DMEM (Relative to SH-NS DMEM) *** β-catenin luciferase activity 1.5 (
Slide 34: NT219 | Pancreatic Cancer in Combination with Gemcitabine
NT219 | Pancreatic Cancer Highly effective anti cancer activity exhibited by NT219 in combination with Gemcitabine in Combination with Gemcitabine PDX model Pancreatic Cancer Drug Gemcitabine (Gemzar®) 34
Slide 35: RNA Sequencing | Analysis of Tumors Following Treatment
RNA Sequencing | Reduced expression of IRS1, Ki67, FOXM1 & TGFb is exhibited by pancreatic Analysis of Tumors cancer treated with NT219 alone and in combination with gemcitabine Following Treatment PDX model Pancreatic Cancer Drug Gemcitabine (Gemzar®) 35
Slide 36: Appendix C - CONSENSI
Appendix C - CONSENSI®
Slide 37: CONSENSI | From IND to the U.S. Market
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 Fixed dose combination of Celecoxib, Amlo
Slide 38: CONSENSI Phase III Trial Results
CONSENSI® Phase III Trial Results • Primary efficacy endpoint was successfully achieved (P=0.001) Blood Pressure Reduction of Consensi® vs. Amlodipine and Celecoxib* • Demonstrated 2.5x better blood pressure reduction than FDA requirement (50% of amlodipine arm) • Demonstrated consistent reduction i
Slide 39: Purple Biotech Commercial Drug: CONSENSI
Purple Biotech Commercial Drug: CONSENSI® 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 Fixed dose combination of Celecoxib,
Slide 40: CONSENSI U.S. Target Markets
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* ARTHRITIS PREVALENCE* HYPERTENSION PREVALENCE** • More than 50 mi