Adam Buckley

Transcription

1 S C I - B - VAC : T H I R D G E N E R AT I O N H BV VAC C I N E WO R L D VAC C I N E C O N G R ES S VBI Vaccines, Inc. 222 Third Street, Suite 2241 Cambridge, MA (617) NASDAQ: VBIV TSX: VBV Adam Buckley abuckley@vbivaccines.cm NASDAQ: VBIV TSX: VBV A P R I L

2 Cautinary Statement Regarding Frward-Lking Infrmatin Certain statements in this presentatin cntain frward-lking statements within the meaning f the Private Securities Litigatin Refrm Act f 1995 r frward-lking infrmatin under applicable Canadian securities legislatin (cllectively, frward-lking statements ) that may nt be based n histrical fact, but instead relate t future events, including, withut limitatin, statements cntaining the wrds believe, may, plan, will, estimate, cntinue, anticipate, intend, expect, gals and similar expressins. All statements ther than statements f histrical fact included in this presentatin are frward-lking statements. Such frward-lking statements are based n a number f assumptins, including, withut limitatin, assumptins regarding the successful develpment and/r cmmercializatin f the cmpany s prducts, such as the receipt f necessary regulatry apprvals; general ecnmic cnditins; that the cmpany s business is able t perate as anticipated withut interruptins; cmpetitive cnditins; and changes in applicable laws, rules and regulatins. Althugh management believes that the assumptins made and expectatins represented by such statements are reasnable, there can be n assurance that a frward-lking statement cntained herein will prve t be accurate. Actual results and develpments may differ materially frm thse expressed r implied by the frward-lking statements cntained herein, and, even if such actual results and develpments are realized r substantially realized, there can be n assurance that they will have the expected cnsequences r effects. Factrs which culd cause actual results t differ materially frm current expectatins include, withut limitatin: the failure t successfully develp r cmmercialize the cmpany s prducts; adverse changes in general ecnmic cnditins r applicable laws, rules and regulatins; and ther factrs detailed frm time t time in the cmpany s reprts filed with the U.S Securities and Exchange Cmmissin and the Canadian Securities Cmmissins. Given these risks, uncertainties and factrs, yu are cautined nt t place undue reliance n such frward-lking statements and infrmatin, which are qualified in their entirety by this cautinary statement and are made nly as f the date f this presentatin. All frward-lking statements and infrmatin made herein are based n the cmpany s current expectatins, and the cmpany undertakes n bligatin t revise r update such frward-lking statements and infrmatin t reflect subsequent events r circumstances, except as required by law. NASDAQ: VBIV TSX: VBV 2

3 Intrductin t Sci-B-Vac Sci-B-Vac is a 3 rd Generatin HBV Vaccine Expressing All Majr Surface Antigens f HBV A Better Viral Mimic, Leads t Imprved Ptency 1 st Generatin HBV Vaccines Inactivated HBV particles derived frm serum f infected individuals Native human glycsylatin Include HBsAg, Pre-S1, Pre-S2 Highly Ptent 2 nd Generatin HBV Vaccines Recmbinant HBV VLPs prduced in yeast Includes nly HBsAg with yeast glycsylatin Highly Ptent in children Less ptent in adults & immuncmprmised Sci-B-Vac Recmbinant HBV VLPs prduced in (CHO) cells Naturally mammalian glycsylated Include HBsAg, Pre-S1, Pre-S2 Highly Ptent in all studied ppulatins NASDAQ: VBIV TSX: VBV 3

4 Aging Chrts f Unvaccinated Adults Define Key Market Segments fr an Imprved HBV Vaccine Universal Pediatric Vaccinatin in 1990 s Still Leave Majrity f Adults Expsed (Adult Vaccinatin Rates in US & EU = 20 24%) Market Segment Otherwise Healthy Immun-Cmprmised Unvaccinated At-Risk Ppulatins Obese, Over-40, Smkers & HCW >94M in USA 4 >200M in EU 5 >375M in China Diabetics & Chrnic Renal Failure >20M in USA 1 >40M in EU 2 >50M in China 3 Key Prduct Attributes Superir Ptency & Earlier Sercnversin Superir Ptency 1) 2) 3) Yang, et al (2010), N Engl J Med, 362: ) 5) 6) Glbal Health Observatry Data NASDAQ: VBIV TSX: VBV 4

5 The Unmet Need: High-Risk Ppulatins f Nn-Respnders & Lw Respnders t Yeast-derived, Alum Adjuvanted, HBsAg Vaccinatin EXEMPLAR SEROPROTECTION RATES: Immun-cmprmised Patients with chrnic liver disease ~50% Chrnic renal failure, dialysis & diabetes 34-81% Pre-transplantatin candidates 28-36% Pst-transplantatin patients ~10% Otherwise Healthy ~50-85% Obese Over age 40 Smkers Travellers & HCW Surces: Yang et al, Scientific Reprts (2016) WHO NASDAQ: VBIV TSX: VBV 5

6 Key Attributes f Sci-B-Vac Opprtunity fr an Imprved HBV Vaccine in Adult Ppulatins Imprved Ptency vs 2 nd Generatin Vaccines Rapid Onset f Immunity Ptent in high-risk, nn-respnsive & immun-cmprmised ppulatins Safe, well-knwn adjuvant: Alum Hydrxide Exceptinal Safety Administered t ver 300,000 (apprx50% nenates) NASDAQ: VBIV TSX: VBV 6

7 Sci-B-Vac Evkes Rapid Immunity Recent Ph IV Study Shwed Over 90% Ser-Prtectin After 2-Dses in Adults Sci-B-Vac Phase IV Study in Israeli Adults (age 18-40, N=88) Serprtectin (>10 miu/ml) 100.0% 80.0% 91.9% 98.8% 60.0% 40.0% 56.8% 20.0% 0.0% 1 (P1Vd30) 2 (P2Vd30) 3 (P2Vd60) Mnth Clinical Study: SciB018 NASDAQ: VBIV TSX: VBV 7

8 Opprtunity fr Imprved Ptency vs 2 nd Generatin Vaccines in Adult Ppulatins Additinal Clinical Develpment t Define Benefits in Key Adult Ppulatins 100,000 10,000 Reciprcal GMT 1, Study : Sci-B-Vac Serprtectin and GMT vs Engerix-B (n = 524) in Adults Age (mean age = 43) % 5.4% 16.8 ( ) ( ) 99.2% 1876 ( ) 92.4% % 85.1% 1 mnth (P1Vd30) 7 mnth (P3Vd30) 12 mnth (P3Vd180) Engerix-B GMT (20ug dse) Engerix-B Serprtectin (20ug dse) ( ) ( ) 2203 ( ) Sci-B-Vac GMT (10ug dse) Sci-B-Vac Serprtectin (10ug dse) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Percent Serprtectin (>10 miu/ml) Clinical Study: NASDAQ: VBIV TSX: VBV 8

9 Older Adults are ne Ppulatin that may Benefit frm Sci-B-Vac : Superir Serprtectin Rates Stratificatin by Age f Study Demnstrates Significantly Imprved Ptency in Older Adults Serprtectin Stratified by Age Percent HBsAg Serprtectin 100.0% 95.0% 90.0% 85.0% 80.0% 75.0% 70.0% 65.0% 60.0% 55.0% 50.0% 86.0% p = % p < % 96.0% Engerix B <= 45 (n = 136) Engerix B > 45 (n = 115) Sci-B-Vac <= 45 (n = 118) Sci-B-Vac > 45 (n = 126) Engerix B <= 45 (n = 136) Engerix B > 45 (n = 115) Sci-B-Vac <= 45 (n = 118) Sci-B-Vac > 45 (n = 126) Study Reference: Phase III NASDAQ: VBIV TSX: VBV 9

10 Sci-B-Vac Offers Ptential fr Imprved Ptency in High-Risk Grups, Including Diabetics & CKD Sci-B-Vac Stimulates Serprective anti-hbsag Immunity in CKD Ppulatins That Had Nt Respnded t Duble-Dse f Engerix-B Efficacy f Sci-B-Vac in Nn-Respnders: Study f 16 Chrnic Kidney Disease Patients wh had nt respnded (<10 intl. units) t 4x40ug dses f Engerix-B Reciprcal GMT Dses 40ug Engerix B (schedule 0, 1, 2 & 6 mnths) Tw Dses 20ug Sci-B-Vac (at day 90, 8 wks pst 2nd vaccinatin) Three Dses 20ug Sci-B-Vac (at day 210, 30 days pst 3rd vaccinatin) Percent Serprtected (>10 miu/ml) GMT Sercnversin Study Reference: Pst-launch V01 NASDAQ: VBIV TSX: VBV 10

11 Data in Immun-cmprmised: End-Stage Renal Disease Investigatr Led (T. Weinstein, 2004) Study at Rabin Medical Center, Israel Evaluated Serprtectin Rate f Sci-B-Vac in 29 ESRD Subjects Ntinal Cmparisn Made t Histric Engerix-B Respnses in Same Department Sci-B-Vac Serprtectin (>10mIU/ml) in Israeli ESRD Patients vs Histric Cntrls % Serprtectin (>10mIU/ml) 100% 80% 60% 40% 20% 0% 3 x 20ug (n = 36) 3 x 10ug (n = 29) Data supprts further well-cntrlled study in Immuncmprmised/ESRD ppulatins Study Publicatin: T. Weinstein, Nephrn Clin Pract 2004;97:c67-c72 NASDAQ: VBIV TSX: VBV 11

12 Synpses f Existing Clinical Studies fr Sci-B-Vac 22 clinical trials cnducted t date 14 pen label clinical studies + extensin studies 5 bserver blind clinical studies 9 f the abve studies cnducted in adults, 7 f which will be used t supprt a phase 3 Clinical Trial Applicatin Mre than 95% f patients are prtected within 2 mnths after first vaccinatin Safe and well tlerated NASDAQ: VBIV TSX: VBV 12

13 VBI is Discussing Its Clinical Develpment Pririties with Regulatrs in Nrth America & Eurpe EMA Feb 2017: Received psitive EMA Scientific Advice regarding Sci-B-Vac Phase III clinical prgram Health Canada Feb 2017: Received psitive respnse frm Health Canada regarding Sci- B-Vac Phase III clinical prgram FDA Expecting feedback n prpsed clinical develpment plans in H NASDAQ: VBIV TSX: VBV 13

14 Prphylactic Sci-B-Vac Summary OPPORTUNITY FOR IMPROVED POTENCY IN ADULT & AT-RISK POPULATIONS Ptent & Rapid HBV Immunity Imprved ptency vs 2 nd generatin HBV vaccines Rapid nset f immunity Stimulatin f immunity in nn-respnders VBI is currently develping Sci-B-Vac fr prphylactic adult Indicatin in US/EU Histry f safety with ver 300,000 dses administered (all ppulatins) Established manufacturing prtcls at GMP cmmercial scale Integrated regulatry feedback n VBI s prpsed clinical develpment plan is expected frm Nrth American & Eurpean regulatrs in H NASDAQ: VBIV TSX: VBV 14

15 VBI Vaccines, Inc. 222 Third Street, Suite 2241 Cambridge, MA (617) Adam Buckley NASDAQ: VBIV TSX: VBV 15