Biolinerx Ltd. · TASE:BLRX
Biolinerx — Investor Presentation (April 2018)
31 slides from Biolinerx's investor presentation, April 2018
Slide 1: Transforming science into medicine
Transforming science into medicine
Slide 2: Forward-looking statements
2 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
Slide 3: Committed to developing novel compounds in oncology and immunology
‘We are committed to developing novel compounds in oncology and immunology that will deliver life-changing innovations for patients.’ Philip Serlin, CEO
Slide 4: Who are we?
4 Who are we? NASDAQ: BLRX Oncology and immunology Significant pharma Attractive investment case focus collaborations Lead assets: Strong balance sheet BL-8040 $50 million (end Q4 2017) AGI-134 Significant upcoming milestones: Top line combination results from phase 2 COMBAT study in pancreatic canc
Slide 5: Main pipeline assets
5 Main pipeline assets REGULATORY PROJECT INDICATION PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVAL CANCER BL-8040 Stem-cell mobilization Consolidation AML Maintenance AML Gastric cancer Non-small cell lung cancer Pancreatic cancer Pancreatic cancer AGI-134 Solid tumors IMMUNOLOGY BL-9020 Type 1 diab
Slide 6: BL-8040 – Best-In-Class CXCR4 Antagonist for Multiple Oncology and Hematology Indications
BL-8040 – Best-In-Class CXCR4 Antagonist for Multiple Oncology and Hematology Indications For treatment of solid tumors, AML and indications requiring hematopoietic stem cell transplantation
Slide 7: BL-8040 – a best-in-class CXCR4 antagonist targeted at multiple indications
7 BL-8040 – a best-in-class CXCR4 antagonist targeted at multiple indications BL-8040 is a 14-amino acid synthetic cyclic peptide, high-affinity CXCR4 antagonist with long receptor occupancy (>48 hours) and extended CXCR4 inhibition
Slide 8: Stem-cell mobilization for patients undergoing bone-marrow transplantation
8 Stem-cell mobilization – for patients with hematological malignancies undergoing bone-marrow transplantation Patients with hematological malignancies often require HSC transplant after treatment to restore immune system Significant unmet medical need in SCM • Multiple apheresis sessions required •
Slide 9: Role of BL-8040 in stem-cell mobilization
9 Role of BL-8040 in stem-cell mobilization
Slide 10: BKTS001 Phase 1/2a study: Stem-cell mobilization in multiple myeloma
10 BKTS001 Phase 1/2a study: Stem-cell mobilization in multiple myeloma patients NCT01010880 (N=16) Multiple myeloma patients were treated with BL-8040 increases HSC mobilization in a dose-dependent manner increasing doses of BL-8040 on top of standard-of-care to assess mobilization of HSCs Conclusi
Slide 11: GENESIS Phase 3 study: Mobilization of HSCs in multiple myeloma
11 GENESIS Phase 3 study: Mobilization of HSCs for autologous transplant in multiple myeloma patients Initiated Q4 2017 - Phase 3 randomized, placebo-controlled, safety and efficacy study (n=177): NCT03246529 Study design Primary endpoint Part 1: Lead-in period - dose confirmation in up to 30 multip
Slide 12: BL-8040's potential role in AML treatment pathway
12 BL-8040’s potential role in AML treatment pathway – increasing leukemic cell exposure to anti-cancer therapies Malignant cells are harbored within protected niche of bone marrow (minimal residual disease), which impacts remission and survival rates BL-8040 mobilizes AML cells to the peripheral bl
Slide 13: Role of BL-8040 in AML
13 Role of BL-8040 in AML 1. Bensinger W et al. Bone Marrow Transplant 2009;43:181–195.
Slide 14: BL-8040.01 Phase 1/2a study in relapsed/refractory AML
14 BL-8040.01 Phase 1/2a study: Encouraging results in patients with relapsed/refractory AML Phase 1/2a dose escalation/expansion study (n=42): NCT01838395 Study design Comparison of the composite response rate Dose escalation (0.5 to 2.0 mg/kg) with expansion cohort at 1.5mg/kg (CR + CRi) of BL-804
Slide 15: BLAST Phase 2b study: Consolidation therapy for AML
15 BLAST Phase 2b study: Consolidation therapy for AML patients in first remission Phase 2b double-blind, multi-center placebo controlled study (n=194): NCT02502968 Treatment: Two or three cycles (age-based) of high-dose Ara-C in combination with either BL-8040 or placebo Endpoints BL-8040 potential
Slide 16: BATTLE Phase 1b/2 study: BL-8040 and atezolizumab in AML
16 BATTLE Phase 1b/2 study: Combination of BL-8040 and atezolizumab in AML patients with high risk of relapse Phase 1b/2 single arm, multi-center open-label study (n=60): NCT03154827 To evaluate the safety and efficacy of BL-8040 in combination with atezolizumab for maintenance treatment in AML pati
Slide 17: BL-8040 – addressing unmet needs in cancer immunotherapy
17 BL-8040 – addressing unmet needs in cancer immunotherapy Despite significant advances in cancer BL-8040 may address these needs by: immunotherapy, material needs remain: Improving efficacy of immunotherapy in Mobilization of immune cells to peripheral “cold” tumors, such as pancreatic cancer bloo
Slide 18: Role of BL-8040 in solid tumors
18 Role of BL-8040 in solid tumors
Slide 19: Data supporting role of BL-8040 in immunotherapy
19 Data supporting role of BL-8040 in immunotherapy Robust mobilization Tumor infiltration1 Microenvironment modification Pre-treatment Healthy volunteers were treated with BL-8040 CXCR4 antagonism selectively inhibits the or placebo migration of immunosuppressive cells Single administration of BL-8
Slide 20: BL-8040 – ongoing collaborations with global pharma companies
20 BL-8040 – ongoing collaborations with global pharma companies NCT02826484, NCT03193190, NCT03281369, NCT03154827 COMBAT Phase 2a study of BL-8040 + Four phase 1/2 studies planned of BL-8040 pembrolizumab (Keytruda®) + atezolizumab (TecentriqTM) Study in metastatic pancreatic cancer 3 studies in s
Slide 21: COMBAT Phase 2a study: Advanced pancreatic cancer
21 COMBAT Phase 2a study: Advanced pancreatic cancer Phase 2a open-label, multi-center study in combination with pembrolizumab (n=30): NCT02826484 To assess the safety and efficacy of BL-8040 in combination with pembrolizumab (Keytruda) in patients with advanced pancreatic cancer Endpoints Intermedi
Slide 22: MORPHEUS Phase 1b/2 study: Pancreatic, gastric and NSCLC
22 MORPHEUS Phase 1b/2 study: Pancreatic, gastric and NSCLC Phase 1b/2 open-label, multi-center, randomized study in combination with atezolizumab : NCT03193190, NCT03281369 Umbrella study to evaluate efficacy and safety of multiple immunotherapy-based treatment combinations in patients with locally
Slide 23: AGI-134 – Cancer Immunotherapy
AGI-134 – Cancer Immunotherapy Small molecule inducing hyper-acute, multi-arm immune response targeting tumor-specific neoantigens
Slide 24: AGI-134 – harnessing pre-existing immunity for patient-specific anti-tumor response
24 AGI-134 – harnessing pre-existing immunity to deliver a patient-specific anti-tumor response Tumors vary from patient to patient in their neoantigen load and identity AGI-134 is a universal drug that evokes a vaccine effect via a unique, hyper-acute, multi-arm mechanism that targets patient- spec
Slide 25: alpha-Gal and anti-Gal
25 alpha-Gal and anti-Gal The alpha-Gal epitope is abundantly synthesized on glycolipids of non-primates Due to constant exposure to this antigen (expressed by gut flora) humans develop and maintain high levels of anti-Gal Abs Xenotransplantation experiments in the 1980’s-90’s found that, when intro
Slide 26: AGI-134 MoA
AGI-134 MoA 1) Injected tumor Intratumoral injection of AGI-134 and coating of tumor cells ys a =\. Binding of anti-Gal antibodies 3A, Initial cell death and release of tumor-associated antigens Increased uptake by antigen presenting cells. and alteration of tumor microenvironment Tumor cell NK cell
Slide 27: Compelling pre-clinical data supports Phase 1 study expected mid-2018
27 Compelling pre-clinical data supports Phase 1 study expected to initiate in mid-2018 Intratumoral administration of AGI-134 induced regression of established melanoma primary tumors in GT KO mice Days post inoculation ASCO-SITC 2018 Abstract 68 / poster E4
Slide 28: AGI-134 exerts a potent durable abscopal effect and synergy with anti-PD1
28 AGI-134 exerts a potent durable abscopal effect and demonstrated synergy with anti-PD1 Single dose of AGI-134 into primary tumor protected mice from secondary tumor development for more than 90 days Combination of AGI-134 with immune checkpoint inhibitor (anti-PD-1) resulted in increased efficacy
Slide 29: Looking ahead
Looking ahead BIOLINEP>*<
Slide 30: Principal Milestones for 2017/2018
30 Principal Milestones for 2017/2018 BL-8040 (Allo SCM) BL-8040 (Panc., Gastric, BL-8040 (Auto SCM) BL-8040 (Pancreatic Cancer) AML) Lead-in results Phase 1/2 top-line results Phase 2 partial results Phase 1/2 initiation (Merck) (Genentech) BL-8040 (Allo SCM) BL-8040 (Multiple Phase 2 top-line Soli
Slide 31: Takeaways
31 Takeaways Focus on oncology and immunology (specifically immuno-oncology) 9 clinical studies ongoing or planned for the next 12-18 months Read-out from 3-4 Phase 2 studies over the next 12-18 months Phase 3 registrational study ongoing; read-out from lead-in period mid-2018 Significant collaborat