Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Investor Presentation (August 2021)
41 slides from Purple Biotech's investor presentation, August 2021
Slide 1: Corporate Presentation
CORPORATE PRESENTATION NASDAQ/TASE: PPBT August 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 CM24 – Phase NT219 partnership CM24 launch 1b/2 initiation Oncology Pivot 2017 2018 2019 2020 2021 2011 2013 2015 2017 Established TASE NASDAQ I
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 $53M 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 President & Chief Financial Officer
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 agent a
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 treatment
Slide 13: PK/PD Modeling Provides Dosage & Schedule Guidance
PK/PD Modeling Provides Dosage & Schedule Guidance Simulated TMDD1 saturation at Ctrough Consistent with observed PK showing high with Q2W regimen 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, Q2W dose is needed for
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 first l
Slide 15: CM24 Phase 1/2 Combination Study Design
CM24 Phase 1/2 Combination Study Design (NCT04731467) 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 st
Slide 16: Advancing First-in-Class Oncology Therapies: NT219
Advancing First-in-Class Oncology Therapies NT219 – A Small Molecule 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 NT219 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 Covalent binding to IRS1/2 leads to the Serine phosphorylation prevents IRS1/2
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
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 < 20% of R/M SCCHN patients respond to α-PD1s 175k new cases/year are expected
Slide 24: NT219 Monotherapy and Combination Phase 1/2 Study Design
NT219 Monotherapy and Combination Phase 1/2 Study Design (NCT04474470) 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 e
Slide 25: Interim Analysis – Safety and Response
Interim Analysis – SAFETY and RESPONSE 3 mg/kg Dose Level as a Single Agent Response Analysis Prior NT219 has been found to be well-tolerated with Cancer Lines of Treatment Best Response* Type Duration(Weeks) minimal adverse events Therapy Pancreatic 3 8 PD In a patient with refractory GE junction d
Slide 26: 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 $53M cash
Slide 27: 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 27
Slide 28: Thank You
THANK YOU Contact Us: ir@purple-biotech.com
Slide 29: Appendix A - CM24
Appendix A - CM24
Slide 30: 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% 30
Slide 31: Phase 1 PK Data
PHASE 1 PK DATA Target saturation was not reached with doses up to 10mg/kg Predictions with Q3W regimen 0.1 mg/kg 0.3 mg/kg 1 mg/kg 3 mg/kg 10 mg/kg Modeling with increased interval between Slower clearance with increasing dose doses demonstrates lower TMDD at 10mg/kg Higher half-life with increasin
Slide 32: Appendix B - NT219
Appendix B - NT219
Slide 33: Selected Publications
Selected Publications Michael Alexander Karin Levitzki Menashe Michael Bar-Eli Cox 33
Slide 34: NT219 Suppresses β-Catenin Activity in CRC Cells
NT219 | Suppresses β-Catenin activity in CRC Cells and Inhibited CRC Brain Metastasis In Vitro In Vivo 5-FU Silencing IRS2 inhibits NT219 downregulates IRS2 and suppresses the b-catenin activity CRC Cell Viability (72hr) b-catenin activity NT219 - + NT219 + 5-FU IRS2 Active β-Catenin β-actin NT219 c
Slide 35: 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®) 35
Slide 36: 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®) 36
Slide 37: NT219 Demographics & Safety
37 NT219 – DEMOGRAPHICS & SAFETY 3 mg/kg Dose Level as a Single Agent Patients Demographics Summary of Adverse Events Adverse Event Grade 1 Grade 2 Grade 3 Demographics of Patients treated with NT219 3mg/kg (n=3) Description n (#Events) n (#Events) n (#Events) Median age (range) 74 (69-79) Abdominal
Slide 38: Appendix C - CONSENSI
Appendix C - CONSENSI®
Slide 39: 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 40: 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 in all
Slide 41: 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* HYPERTENSIONPREVALENCE** More than 50 milli