Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — Investor Presentation (May 2017)
35 slides from Scorpius's investor presentation, May 31, 2017
Slide 1: Heat Biologics
Heat Biologics NASDAQ:HTBX May 31, 2017
Slide 2: Forward-looking statements
This presentation includes statements that are, or may be deemed, ‘‘forward-looking statements’’ within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, includ
Slide 3: Investment Opportunity
Investment Opportunity 3 Favorable Safety Profile TECHNOLOGIES Multiple Platform Signals in lung cancer with CHECKPOINT Inhibitors POTENTIAL BEST-IN-CLASS Activation of Cancer Killing CD8+ T Cells ROBUST Pipeline of COMBINATION Therapies Turning COLD Tumors HOT
Slide 4: Mission
4 Mission Our Mission is to Activate CD8+ ”Killer” T cells to Turn “COLD” Tumors “HOT” Cold Hot Our goal is to combine with checkpoint inhibitors and other immunotherapies to dramatically increase their effectiveness
Slide 5: What are COLD and HOT tumors?
What are COLD and HOT tumors? 5 Turning COLD Tumors HOT Cold Hot COLD Tumors Tumors that have not been subject to robust CD8+ “Killer” T cell attackBiopsied tumors contain minimal CD8+ T cells HOT TumorsTumors that have been subject to robust CD8+ “Killer” T cell attack Biopsied tumors are loaded wi
Slide 6: Checkpoint inhibitors are dramatically changing the standard of care
Checkpoint inhibitors are dramatically changing the standard of care against a wide variety of cancers5 checkpoints approved to treat seven different cancers since 2014Additional checkpoints against new tumors expected later this yearCitibank, Goldman Sachs project checkpoints will be used to treat
Slide 7: The Problem with Checkpoints
7 The Problem with Checkpoints Survival Traditional Therapies Checkpoint Inhibitors Alone Checkpoint inhibitors dramatically increase survival in patients with HOT tumors, but are largely ineffective in patients with COLD tumors Potential for Checkpoint Inhibitors in Combination Therapies
Slide 8: Turning COLD tumors HOT
Turning COLD tumors HOT Focused on turning COLD tumors HOT to enhance the effectiveness of checkpoint therapy for the majority of patients who don’t respond to checkpoints alone Checkpoint Inhibitor Monotherapy Heat BiologicsCombination Therapy Cold Tumor Cold Tumor Hot Tumor Hot Tumor Current Respo
Slide 9: Checkpoint Combination Advantages
Activates CD8+ T cells, a critical component of effective anti-cancer immunityActivated T cells invade tumor siteSimple once-a-week intradermal injectionWell-tolerated with combinationsClinical and preclinical data supports activity with ImPACT and checkpoint inhibitors 9 Checkpoint Combination Adva
Slide 10: Combination Therapies
Combination Therapies 10 T Cell Activation ImPACT TherapyCell-Based Delivery of Multiple Antigens Activation of Patients’CD8+ “Killer” T Cells ComPACT TherapyCell-Based Delivery ofMultiple Antigens Activation of Patients’CD8+ “Killer” T Cells Co-Stimulation Pelican PTX-25Monoclonal AntibodyPelican P
Slide 11: ImPACT / ComPACT Therapies
PD1/PD-L1CTLA-4Lag-3TIM-3Plus Others Pelican PTX-25Monoclonal AntibodyPelican PTX-15Fusion Protein ImPACT / ComPACT Therapies 11 T Cell Activation ImPACT TherapyCell-Based Delivery of Multiple Antigens Activation of Patients’CD8+ “Killer” T Cells ComPACT TherapyCell-Based Delivery ofMultiple Antigen
Slide 12: ImPACT/ComPACT Manufacturing
ImPACT/ComPACT Manufacturing 12 Robust, Multi-Antigen T Cell Activation Compare Using Our Proprietary Technology Screen ID Cell Line with Most Antigen OverlapTransfect with Activation Technology Select Scale-Up for Manufacturing by CMO Scale-Up Collect CancerCell Line & Patient Tissue Samples Sample
Slide 13: ImPACT: Immune Pan-Antigen Cytotoxic Therapy
ImPACT: Immune Pan-Antigen Cytotoxic Therapy 13 ImPACT Cell Cancer Killing T-Cell ImPACT cells secrete antigens designed to specifically activate patient’s killer T-Cells T-Cells circulate to destroy patient’s tumor Cluster of five 0.1 mL intradermal injections Activated cells EXPRESS chaperoned ant
Slide 14: Heat Pipeline
Heat Pipeline 14 Heat Biologics Corporate Model Deck THERAPEUTIC VACCINES HS-110(viagenpumatucel-L) NSCLC Phase II ImPACT activation technology in combination with nivolumab and other checkpoint inhibitors TBA HS-120 NSCLC Preclinical ComPACT activation technology in combination with checkpoint inhi
Slide 15: HS-110 Phase 2 Lung Trial Design
Objective Evaluate objective response rate of HS-110 with a PD-1 checkpoint inhibitorCurrently 2nd line therapy or greater Patient Population Phase 1b expanded to Phase 2 in 1Q17 based upon efficacy Secondary Endpoints Safety and tolerability, immune response, overall survival and progression-free s
Slide 16: Activated Immune Response Correlates to Clinical Response
16 Activated Immune Response Correlates to Clinical Response Key Findings Source: HS-110 Ph 1b NSCLC data (left); HS-110 Ph 1b NSCLC data reported at World Lung Dec. 2016 (right) Immune response to HS-110 observed in all 5 patients who had reduced tumorsPatients with no immune response to HS-110 did
Slide 17: T Cell Tumor Infiltration
T Cell Tumor Infiltration 17 Clinical evidence that HS-110 is turning COLD tumors HOT“Killer” CD8+ T cells driven deep into tumors“Cold” tumors with no previous activation made highly active (”HOT”)Expression of PD-L1 increased with CD8+ T cell infiltration in some tumors T Cell Infiltration Observe
Slide 18: Positive Safety Signals
Positive Safety Signals Over 1,000 doses administered to ~200 patientsOnly one patient ended treatment due to a non-serious adverse reaction*No systemic use of steroids required to treat reactionsNo serious adverse reactions No additive toxicities 18 1,000+ Doses – No Serious Adverse Reactions Favor
Slide 19: ComPACT Platform Technology
ComPACT Platform Technology 19 gp96-Ig OX40L-Fc The first potential dual-acting immunotherapy designed to deliver T cell activation and costimulation in a single product – combination therapy without additive costs
Slide 20: ComPACT Outperforms OX40 Monoclonal Antibodies in Preclinical Models
ComPACT Outperforms OX40 Monoclonal Antibodies in Preclinical Models 20 ComPACT leads to ~50% complete tumor rejection as compared to ~16% with OX40 agonist antibody combinations
Slide 21: T Cell Co-Stimulation
T Cell Co-Stimulation 21 Heat Biologics Corporate Model Deck CO-STIMULATORS PTX-25 TBA Preclinical Humanized monoclonal antibody, functional agonist of human TNFRSF25 PTX-15 TBA Preclinical TL1A-Ig fusion protein, functional agonist of human TNFRSF25 Co-Stimulation Pelican PTX-25Monoclonal AntibodyP
Slide 22: Heat Biologics Acquires Pelican Therapeutics
22 Heat has acquired 80% controlling interest in PelicanPelican will operate as a subsidiary in TexasPTX-25 - potential best-in-class co-stimulator Pre-clinical synergy with Heat’s ImPACT and checkpoint therapy$15.2M CPRIT Grant to fund clinical development Heat Biologics Acquires Pelican Therapeuti
Slide 23: Emerging Target in T Cell Co-Stimulation
Emerging Target in T Cell Co-Stimulation 23 Many companies are pursuing co-stimulators with less specificity for CD8+ “memory” activation Only Pelican is targeting TNFRSF25, an emerging target in immuno-oncology Target Lead mAb Clinical Stage Companies Comments 4-1BB/4-1BBL Urelumab, PF-05082566 Pha
Slide 24: Potential Best-in-Class Co-Stimulator
24 Potential Best-in-Class Co-Stimulator PTX-25 is a potential best-in-class T cell co-stimulator specific to “killer” CD8+ “memory” T cellsPre-clinical studies show advantages over competing T cell co-stimulator programs based on CD8+ T cell specificity$15.2 million New Company Product Development
Slide 25: Pre-Clinical Data
Pre-Clinical Data 25 Untreated (N=6)B16.F10-ova Only Control (N=6)OX40(ab) (N=8)ImPACT (N=8)ImPACT & OX40(ab) (N=8)ComPACT/OX40L (N=9) Strong supporting pre-clinical data combining co-stimulators with Heat’s ImPACT/ComPACT therapies Source: Fromm et al. Society for Immunotherapy of Cancer Annual Mee
Slide 26: PTX-25 Comparative Pre-Clinical Anti-Tumor Activity
PTX-25 Comparative Pre-Clinical Anti-Tumor Activity 26 TNFRSF25 agonism with murine mAb shows increased survival compared to other co-stimulators Schreiber T. et al. SITC 2014 Comparative activity of OX40, GITR, 4-1BB and TNFRSF25 agonist mAbs in a long-established (9-day) B16-F10 melanoma model
Slide 27: Corporate Highlights
Corporate Highlights 27 As of May 26, 2017; As reported as of March 31, 2017 Market Cap$25M1 Cash & Equiv.$11.1M2 NasdaqHTBX Shares Outstanding35.6M Shares Price$0.701 Grant Funds$15.2M
Slide 28: Heat Biologics Highlights
Heat Biologics Highlights 28 Lower COG Compared to Personalized Therapies Phase II NSCLC Trial Innovative drugs designed to turn COLD tumors HOT Favorable Safety Profile TECHNOLOGIES Multiple Platform Signals in lung cancer with CHECKPOINT Inhibitors POTENTIAL BEST-IN-CLASS Activation of Cancer Kill
Slide 29: Turning COLD Tumors HOT
Cold Hot Turning COLD Tumors HOT
Slide 30: Appendix
Appendix 30
Slide 31: Introducing gp96
Introducing gp96 *Schild, H. & Rammensee, H. Gp-96 – The Immune System’s Swiss Army Knife. Nature Immunology 2, 100-101 (2000) “Molecular Warning System” Natural biological process to deliver proteins (antigens) & gp96 adjuvant to our immune systemGp96 “chaperones” newly-created proteins to the cell
Slide 32: ImPACT Therapy
ImPACT Therapy Heat Biologics ImPACT technology reprograms cancer cells to continuously secrete their own antigens bound to heat shock protein gp96 to seek out and destroy a variety of tumours Genetically modify tumor cells by “severing the leash” that binds the gp96 to the endoplasmic reticulum of
Slide 33: Expression of T cell Costimulators
Expression of T cell Costimulators Genomics Institute of the Novartis Research FoundationSu et al. PNAS 2004:101(16);6062-7 TNFRSF25 is preferentially expressed by human CD8+ T cells (red = high expression) Compared to other T cell costimulators, TNFRSF25 is preferentially expressed on CD8+ T cells
Slide 34: Preferential CD8+ T cell Induction with TNFRSF25
Preferential CD8+ T cell Induction with TNFRSF25 Pre-clinical studies with murine agonist antibody shows preferential CD8+ T cell Induction; differentiation from other T cell costimulators The frequency of antigen-specific memory CD4+ or memory CD8+ T cells were examined following treatment of mice
Slide 35: Highlights from Pelican Pre-clinical Studies
Highlights from Pelican Pre-clinical Studies mAb to TNFRSF25, drives the development of antigen-specific CD8+ T cells (this effect mimics TLIA, the natural monogamous ligand of TNFRSF25)mAb to TNFRSF25 results in costimulation and expansion of antigen-experienced memory T cells, both CD4+ and CD8+no