Biolinerx Ltd. · TASE:BLRX
Biolinerx — Investor Presentation (June 2017)
39 slides from Biolinerx's investor presentation, Jun 12, 2017
Slide 1: Corporate Presentation June 2017
Corporate PresentationJune 2017
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains “forward-looking statements.” These statements include words like “may,” “expects,” “believes,” “plans,” “scheduled,” and “intends,” and describe opinions about future events. These forward-looking statements involve known and unknown risks and u
Slide 3: BioLineRx Snapshot
Drug development company focused on oncology & immunology:BL-8040 (CXCR4 antagonist) with robust clinical program in immuno-oncology, AML and bone marrow transplantationAGI-134 (alpha-Gal immunotherapy) activating a patient-specific, anti-tumor response to patient’s own cancer neo-antigensImmunology
Slide 4: Main Pipeline Assets
OTHER Main Pipeline Assets PROJECT INDICATION PARTNERS PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY APPROVAL CANCER IMMUNOLOGY Consolidation AML Maintenance AML Gastric cancer Non-small cell lung cancer Pancreatic cancer Pancreatic cancer Stem-cell mobilization Type 1 diabetes NASH Liver failure
Slide 5: BL-8040 Best-in-class CXCR4 antagonist for multiple oncology indications
BL-8040 Best-in-class CXCR4 antagonist for multiple oncology indications
Slide 6: BL-8040 Highlights
BL-8040 Highlights Best-in-class CXCR4 antagonistPlatform molecule with MOA relevant in multiple tumorsMost advanced compound targeting CXCR4Partnerships with leading companies and institutions (Genentech, Merck, MDACC)Multiple clinical studies ongoing or in final planning stagesMultiple studies und
Slide 7: BL-8040 Clinical Development Program
BL-8040 Clinical Development Program Pre-Clinical Phase 1 Phase 2 Phase 3 INDICATION STUDY ONGOING PLANNED AML Consolidation ACUTE MYELOID LEUKEMIA (AML) AML Maintenance (Atezolizumab) BLAST BATTLE H2/2017 initiation – Genentech collab Immunotherapy Combination Pancreatic (Pembrolizumab) COMBAT Merc
Slide 8: BL-8040 in Immuno-Oncology
Into Medicine Ss Transforming Science BL-8040 in Immuno-Oncology BIOLUING
Slide 9: BL-8040's MoA in Cancer Immunotherapy
BL-8040’s MoA in Cancer Immunotherapy Immunostimulant - BL-8040 is a powerful mobilizer of immune cells from the bone marrow and lymph nodes (T-cells, B-cells, immature dendritic-cells and NK-cells)Potentiator - BL-8040 increases infiltration of immune cells into tumors (exhibiting a synergistic eff
Slide 10: BL-8040 is a Powerful Mobilizer of Immune Cells
BL-8040 is a Powerful Mobilizer of Immune Cells(clinical data) BL-8040 CD56+/CD3- NK-cells CD3+ T-cells CD19+ B-cells Placebo Healthy volunteers were treated with BL-8040 or placeboSingle administration of BL-8040 triggered substantial mobilizationLong receptor occupancy results in prolonged effect
Slide 11: BL-8040 Increases T-Cell Infiltration into Tumors (mice model)
BL-8040 Increases T-Cell Infiltration into Tumors (mice model) Model: Orthotropic syngeneic tumors in pancreas of C57BL/6 male mice Treatment with BL-8040 for 10 consecutive days Treatment with BL-8040 induces accumulation of CD3+ T-cells in PDA tumors IHC: aCD3
Slide 12: BL-8040 Increases T-Cell Infiltration into Tumors (cont.)
BL-8040 Increases T-Cell Infiltration into Tumors (cont.) FACS analysis confirmed enrichment of immune cells within the tumor * Tumor sections were enzymatically digested and single cell suspensions were analyzed by FACS** Values in the table represent absolute cell count
Slide 13: BL-8040 Affects the Tumor Microenvironment
BL-8040 Affects the Tumor Microenvironment(CXCR4/SDF-1 Immuno-Suppressive Role in Cancer) SDF-1 expression is an independent predictor of poor survival in cancer patientsCXCR4/SDF-1 axis is key pathway mediating the attraction of immuno-suppressive cells (MDSCs, Tregs, pDCs) to the tumor environment
Slide 14: Immunotherapy Collaboration with Genentech
Immunotherapy Collaboration with Genentech Four phase 1b studies planned to investigate combination of BL-8040 with Genentech’s TecentriqTM (Atezolizumab - anti-PDL1 immune checkpoint inhibitor)Genentech to sponsor and conduct three phase 1b studies in multiple solid tumors BioLineRx to sponsor and
Slide 15: Immunotherapy Collaboration with Merck
Immunotherapy Collaboration with Merck Phase 2a study to examine combination of BL-8040 with Merck’s Keytruda® (anti-PD1 immune checkpoint inhibitor)Up to 30 patients with metastatic pancreatic adenocarcinomaOpen-label, single-arm trial with sites in the US, Israel and South KoreaStudy endpointsClin
Slide 16: BL-8040 in AML
Into Medicine Ss Transforming Science a BL-8040 in AML BIOLUING
Slide 17: BL-8040 Mechanism of Action in AML
* BL-8040 Mechanism of Action in AML Binds CXCR4 with high affinity (1-10 nM)Maintains extended inhibition of CXCR4 through long receptor occupancy (>24 hours)BL-8040 induces apoptosis of AML blasts by down-regulation of survival factorsBone-marrow clearance - eliminates minimal residual disease BL-
Slide 18: BL-8040 in AML – Background and Direction
* BL-8040 in AML – Background and Direction Company conducted successful proof-of-concept phase 2a study in relapsed/refractory AML (45 patients)Showed robust bone marrow clearance, induction of apoptosis and terminal differentiation of AML cells Excellent safety and tolerability BL-8040 in AML – Ba
Slide 19: AML – Clinical Development Status
AML – Clinical Development Status Results support accelerated development in AML space with potential for elimination of minimal residual disease (MRD)Consolidation AML phase 2b study ongoing194 patients, double-blind, placebo controlled at ~25 sites in GermanyEnrollment ongoing: potential interim r
Slide 20: BL-8040 in SC Mobilization
Into Medicine Ss Transforming Science BL-8040 in SC Mobilization BIOLUING
Slide 21: Stem Cell Mobilization for Autologous Transplantation
Stem Cell Mobilization for Autologous Transplantation G-CSF is current standard for autologous stem cell mobilization4-6 daily injections of G-CSF, plus 1-4 apheresis sessions required50-70% of patients are poor mobilizersFor poor mobilizers, 1-4 daily injections of Mozobil on top of G-CSF are requi
Slide 22: BL-8040 is Powerful Mobilizer of CD34+ Cells
BL-8040 is Powerful Mobilizer of CD34+ Cells Substantial HSC mobilization from BM to PB was recorded Consistent pattern of mobilization across all subjects treated with BL-8040 Time post BL-8040 (hr) BL-8040:
Slide 23: Single BL-8040 Administration Results in Robust Collection of Stem Cells
Single BL-8040 Administration Results in Robust Collection of Stem Cells Using Single Apheresis Subject # Whole blood processed (L) % CD34+ cells CD34+/KG (Donor weight) CD34+/KG (70kg recipient weight) 5001 9.8 0.75 4,091,848 5,091,429 5002 16.0 1.01 11,964,615 11,998,800 5003 16.6 0.85 13,667,866
Slide 24: CXCR4 Competitor Landscape
CXCR4 Competitor Landscape Compound(Company) Dev. Stage Molecule Type Indications (under development) AML SCM IO BL-8040 (BioLineRx) Phase 2 Peptide (sc) Auto/Allo SCM; AML (r/r, consolidation, maintenance);Solid tumors (gastric, pancreatic, NSCLC) Ph 2 Ph 3 ready Ph 1/2 (+Pembro/+Atezo) Mozobil (Ge
Slide 25: BL-8040 vs Mozobil and Ulocuplumab
BL-8040 Mozobil Ulocuplumab Affinity for CXCR4 1-10 nM 84 nM 5nM CXCR4 Binding site Extracellular domains in the CXCR4 receptor Trans-membrane regions in the CXCR4 receptor Extracellular domains in the CXCR4 receptor Molecule Type Peptide Small molecule Ab Plasma half-life 1-3 hr ~3-5 hr More than 2
Slide 26: BL-8040 Summary
BL-8040 Summary Most advanced antagonist of CXCR4, an exciting and validated targetRobust platform for multiple oncology indicationsImmunotherapyAMLStem-cell mobilization/transplantationSignificant efficacy demonstrated in numerous clinical studiesPartnerships with Genentech and Merck in immuno-onco
Slide 27: AGI-134 Alpha-Gal immunotherapy
AGI-134 Alpha-Gal immunotherapy, activating anti-tumor response to patient’s own neoantigens
Slide 28: AGI-134 Highlights
AGI-134 Highlights Unique mechanism harnessing naturally occurring immune machineryPromotes systemic anti-tumor response against patient’s own tumor antigensApplicable for large array of tumorsTargets primary tumor, as well as existing and potential future metastasesReduces immuno-suppressive nature
Slide 29: AGI-134 Mechanism of Action
AGI-134 Mechanism of ActionTransforming cold into hot tumors, targeting patient’s own neoantigens Coating of tumor cells by AGI-134 Tumor destruction Intra-tumoral injection of AGI-134 Binding of anti - a Gal antibodies Initial cell death Spillage of tumor-associated antigens Alteration of tumormicr
Slide 30: AGI-134: Key Efficacy Findings
AGI-134: Key Efficacy Findings In vitro and in vivo studies have validated the underlying steps of the MOASingle dose of AGI-134 demonstrated systemic effect by protecting mice from secondary tumor development for over 90 days Combination of AGI-134 with immune checkpoint inhibitor (PD-1) gave incre
Slide 31: AGI-134: Unique MOA Among Intratumoral Agents
AGI-134: Unique MOA Among Intratumoral Agents Oncolytic viruses PAMPs AGI-134 Injected tumor cells identified by naturally occurring pre-existing antibodies Antibody-bound tumor cells destroyed by activated complement and ADCC Tumor neoantigens release by spilling Antibody-activated complement syste
Slide 32: AGI-134 Summary
AGI-134 Summary Novel and demonstrated mechanism of action Technology potential Addresses wide range of poorly treated solid tumorsTransforms “cold” into “hot” tumorsTargets patient’s neoantigensStrong pre-clinical data, clear development pathway discussed with MHRA and FDANear-clinical stage, with
Slide 33: Corporate
Ss Transforming Science a Into Medicine Corporate BIOLUING
Slide 34: BioLineRx Management
BioLineRx Management Philip A. Serlin, CPA, MBA – Chief Executive OfficerServed as the Company’s CFO and COO from 2009 to 2016. Previously CFO and COO of Kayote Networks and CFO of Tescom Software Systems Testing. Background includes senior positions at Chiaro Networks and at Deloitte in Tel Aviv, a
Slide 35: Strategic Collaboration with Novartis
Strategic Collaboration with Novartis Novartis selected BLRX as its partner for asset identification and early developmentExclusive first look at all Israeli-based projects scouted by BioLineRxCo-develop selected projects through clinical proof-of-concept (POC)Unique collaboration provides lasting s
Slide 36: Financial Summary
Cash position$55 million as of April 30, 2017Existing financial resources fund operational requirements into 2019Capital structureTraded on NASDAQ and TASE (Symbol: BLRX)96 million shares outstanding; 104 million fully dilutedUS shareholders represent ~70% of investor base, including key life-scienc
Slide 37: Principal Expected Development Milestones in 2017/2018
Principal Expected Development Milestones in 2017/2018 2018 2017 BL-8040 (Autologous SCM) phase 3 initiation BL-8040 (Pancreatic Cancer) phase 2 partial results BL-8040 (Allogeneic SCM) phase 2 top-line results BL-8040 (AML Maintenance) phase 1b initiation BL-8040 (Multiple Solid Tumors) phase 1b in
Slide 38: Takeaways
Takeaways…… Focus on oncology and immunology (mainly immuno-oncology)9 clinical studies ongoing or planned for next 12-18 monthsRead-out from 3-4 phase 2 studies over next 12-18 monthsInitiation of phase 3 registrational study expected in H2 2017Significant collaborations with 3 of the leading globa
Slide 39: Thank You
Thank You