Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Investor Presentation (June 2021)
42 slides from Purple Biotech's investor presentation, Jun 4, 2021
Slide 1: Corporate Presentation June 2021
NASDAQ/TASE: PPBT June 2021 CORPOR A TE PRESEN T A TION
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 Ou r T ransformatio n int o Oncology Established TASE listing N A S D A Q I PO CONSENSI® NDA submission 2 0 11 2 0 13 2 0 15 2017 Acquisition of CONSENSI® NDA approval & Acquisition of NT219 – Phase 1/2 initiation, TyrNovo/ China FameWave/ CONSENSI® US CM24 – Phase NT219 partnership CM24 launch 1b
Slide 4: Business Highlights
4 Busine s s Highlights S t ro n g b a l a n c e shee t a nd c a s h 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 H2:2
Slide 5: Advancing Clinical-stage Novel Oncology Therapies
5 Advancing Clinical - s t ag e Nove l Oncolog y Therapies Multiple data read - outs expected in the next 12 months Program Indication Preclinical P h as e 1 P h as e 2 P h as e 3 Partner V a l u e Drivers CM24 (CEACAM - 1) Solid tumors (monotherapy) (Completed) Expansion arms on RP2D: Initiation Q4
Slide 6: Experienced Leadership
6 Experienced Leadership I s a a c I s rae l Chief Executive Officer Former CEO of BeeContact Ltd . (TASE : BCNT) . NextGen Biomed (TASE : NXGN) E r i c K. Row i nsky , MD Chairman of the Board Former CMO at ImClone, Stemline, Board member at Biogen Inc. G i l E f r o n D e pu t y CE O a n d Chi e f
Slide 7: Advancing First-in-Class Oncology Therapies: CM24
Advancing Firs t - i n - Class On c ology Therapies CM24 - a n α - CEACAM1 mAb
Slide 8: CEACAM Plays a Key Role in Cancer Biology
8 CEACAM 1 * Plays a Key Role i n Cancer Bi o logy 01 | ADHE S ION 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 o
Slide 9: CM24 MOA | Immuno-oncology
9 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:e911 - 22, 2020. T u m or CD8+T & NK Cells C EA C A M 1 C E A CAM 1
Slide 10: CM24 MOA | Adhesion
10 CM24 MOA | Adhesion CEACAM1 creates a pro - angiogenic tumor microenvironment that supports tumor vessel maturation. CM24 is proposed to attenuate/block tumor growth and metastatic processes. Rayes RF, et al. Neutrophil Extracellular Trap - Associated CEACAM1 as a Putative Therapeutic Target to P
Slide 11: Significant benefits as both single agent and in combination with α-PD-1
11 Significant benefits as both single agent and in combination with α - PD - 1 Anti - can c er Ef f ect F ollowin g T rea tm e nt 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 +
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/kg
Slide 13: PK/PD Modeling Provides Dosage & Schedule Guidance
13 1 Target - mediated drug disposition. 2 OPDIVO® is a registered trademark of Bristol - Myers Squibb. Ctrough is the drug concentration reached by CM24 before the next dose is administered PK/PD Modeling Provides Dosage & Schedule Guidance Simulated TMDD 1 saturation at Ctrough with Q2W regimen •
Slide 14: Large Market Opportunity in NSCLC & Pancreatic Cancer
14 Large Market Op p ortunit y i n NS C L C & Pancreatic Cancer • CEACAM1 expression correlates with poor prognosis in NSCLC and Pancreatic cancer 1 • Preclinical data support significant synergy • Receptor saturation with CM24 is better achieved with a Q2W regimen, aligning with the nivolumab regim
Slide 15: CM24 Phase 1/2 Combination Study Design
15 C M 2 4 Phase 1 / 2 Combination Study Design ( N CT 0 4 7314 6 7 ) A Phase 1/2 open label multi center study of CM24 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: Pha
Slide 16: Advancing First-in-Class Oncology Therapies: NT219
Advancing Firs t - i n - Class On c ology Therapies N T 21 9 – A Small Molecule Dual Inhibi t o r o f IRS 1/2 and S T A T3
Slide 17: NT219 Dual Inhibitor of IRS1/2 & STAT3
17 NT 21 9 - Dual Inhibitor o f IR S 1 / 2 & S T A T 3 NT219 IRS1/2 • Scaffold proteins, mediating mitogenic, metastatic, angiogenic and anti - apoptotic signals from IGF1R, IR, IL4R and other oncogenes, overexpressed in multiple tumor types • Regulates major survival pathways such as the PI3K/AKT,
Slide 18: Novel MOA: IRS Degradation by NT219
18 Nove l MOA: IRS De g ra d atio n B y NT 219 Blockin g IG F 1 R - AKT Pathwa y 1 Binding to IRS 1 1 Reuveni et al. Cancer Res 2013 2 Ser - phosphorylation Degrad a ti on 3 Covalent binding to IRS1/2 leads to the dissociation of IRS1/2 from IGF1R Serine phosphorylation prevents re - binding of IRS1
Slide 19: NT219 Efficacy as Monotherapy
19 NT219 E f ficacy as Monotherapy Animal model Head & Neck Cancer (SCC - 9) NSG™, PBMCs - injected 1 Drugs α - PD1 Cetuximab (Erbitux®) NT219 20mg/kg NT219 60mg/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. NT219, α
Slide 20: Blocking STAT3 and IRS prevents tumor resistance
20 By blocking both STAT3 and IRS pathways, NT219 prevents tumor resistance and re - sensitizes tumors to anti - cancer therapies S T A T 3 and IRS ar e Essentia l in Therapeutic Resi s tance STA T3 I R S EG FR MEK Tumor Regres s ion E RK P I 3K AKT Tumor Survival Tumor Survival B uparlisib Ruxoliti
Slide 21: NT219 + Targeted Therapies Established Efficacy in PDX Models
Control NT219 Cetuximab Cetuximab+NT219 Treatments on days 0, 3 and 10, cetuximab - 1mg/mouse, 3 mice/group; PBMCs (1.4M cells/mouse) were injected on day 6 21 ** p<0.01, * p<0.02 based on one - way ANOVA with post hoc Tukey’s HSD test NT 21 9 + T ar g eted Therapies Establishe d Ef f icacy i n PDX
Slide 22: NT219 + α-PD1 Re-sensitizes Refractory Tumors
22 N T 21 9 + α - P D 1 Re - sensitize s to Refr a ctory α - P D 1 Tumors PDX Model Humanized PDX of Esophagus Cancer (refractory to pembrolizumab) Drug P e m b r ol i z umab (Keytruda®) * Double autologous model - Tumors & PBMCs are from the same patient (#RA236) | Keytruda - 6mg/kg IP, NT219 - 60m
Slide 23: First Market Opportunity: Recurrent or Metastatic SCCHN
23 Fir s t Market Op p ortunity 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 NT 21 9 Monothera p y and Combination Phase 1 / 2 Stu d y Design ( NCT 04 4 7 4 4 7 0 ) 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 NT219, alone in adults with recurrent or met
Slide 25: Interim Analysis – Safety and Response
25 Ca n cer Type Prior Lines of Th e r a p y Treatment D u ra t i o n ( W ee k s) Best Response* NT219 3mg/kg P a n c r e a tic Cancer 3 8 PD Target lesion : A b se n t PR GE J u n c tion Cancer 4 22 Non target lesion 1: Absent N o n t a r g e t lesion 2: Stable Breast C a n c er 11 8 PD Interim Ana
Slide 26: Business Highlights
26 Busine s s Highlights S t ro n g b a l a n c e shee t a nd c a s h 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 H2:
Slide 27: Committed to providing cancer patients first-in-class therapies
We are committed to p r ovid i n g cancer patients with fi r s t - in - class therapies to OVERCO M E tu m o r dru g resistance, ENHANCE treatment respons e an d S L OW tu m o r prog r ession
Slide 28: Thank You
TH A N K YOU Contact Us: ir@purple - biotech.com
Slide 29: Appendix A - CM24
App e ndi x A - C M 24
Slide 30: CM24 activity as Single Agent and in Combination with TILs
30 CM24 activity is Demonstrated as Single Agent and in Combination with TILS Inhibi t io n o f Melanoma Growth Followin g CM24 and CM24 + TIL T reatment *P<0.05 TG I 71% *P<0.05 TG I 4 5%
Slide 31: Phase 1 PK Data
31 PHASE 1 PK D A T A T arge t satura t io n was no t r eached with d o se s u p to 1 0 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 Q3W regimen • Modeling with increased interval between doses demon
Slide 32: Appendix B - NT219
App e ndi x B - N T 219
Slide 33: Selected Publications
33 Selected Pu b lic a ti o ns Menashe Bar - Eli Michael Karin Michael Cox Alexander Levitzki
Slide 34: NT219 Suppresses β-Catenin activity
Colon cancer LS - 513 cells overexpressing IRS2 demonstrate enhanced - catenin activity. Targeted inhibition of IRS2 by NT219 or IRS2 - SH RNA, suppresses the increased - catenin activity and inhibit LS - 513 cell viability. Combination of 5 - FU and NT219 significantly inhibited the growth of C
Slide 35: NT219 Pancreatic Cancer in Combination with Gemcitabine
35 PDX model Pancreatic Cancer Drug Gemcitabine (Gemzar ® ) NT 21 9 | Pancr e ati c Canc er i n Combinat i on wi t h G e mcitab i ne Highly effective anti cancer activity exhibited by NT219 in combination with Gemcitabine
Slide 36: RNA Sequencing Analysis of Tumors Following Treatment
36 PDX model Pancreatic Cancer Drug Gemcitabine (Gemzar®) RNA Sequencing | Analys i s o f T um o rs F o l lowing T r e atment Reduced expression of IRS1, Ki67, FOXM1 & TGFb is exhibited by pancreatic cancer treated with NT219 alone and in combination with gemcitabine
Slide 37: NT219 Demographics & Safety
37 Demographics of Patients treated with NT219 3mg/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 Gastroesophag e al J unction Can
Slide 38: Appendix C - CONSENSI
App e ndi x C - CON S EN S I®
Slide 39: CONSENSI: From IND to the U.S. Market
39 CONSE N SI® | F ro m IND to the U .S . Market Celecoxib , a COX - 2 selective NSAID (the active ingredient in Pfizer’s Celebrex®) + Amlodipine a blood pressure - lowering agent (a calcium channel blocker) (the active ingredient in Pfizer's Norvasc®) CONSENSI ® is the only NSAID whose labeling ind
Slide 40: CONSENSI Phase III Trial Results
40 • Primary efficacy endpoint was successfully achieved (P=0.001) • Demonstrated 2.5x 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/IV c
Slide 41: Purple Biotech Commercial Drug: CONSENSI
41 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 a
Slide 42: CONSENSI U.S. Target Markets
42 CON S ENS I ® U.S . T arge t 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* N S A I Ds 60 % of all O A Rxs * Arthritis Foundation: