Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — Investor Presentation (March 2016)
28 slides from Scorpius's investor presentation, Mar 16, 2016
Slide 1: Heat Biologics
Heat Biologics NASDAQ:HTBX March 2016
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes statements that are, or may be deemed, ‘‘forward-looking statements.’’ In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expec
Slide 3: Investment Opportunity
Investment Opportunity 3 Developing first new immunotherapy in non-muscle invasive bladder cancer (NMIBC) Platform technologies designed to activate CD8+ T cells against multiple tumor antigens Immuno-oncology company developing novel therapies to activate a patient’s immune system against cancer Co
Slide 4: Vision and Strategy
Vision and Strategy Addressing Three Distinct But Synergistic Mechanisms of Action to Optimize Cancer Immunotherapy 4 Activation of CD8+ “killer” T cells Co-stimulation to enhance immune response Overcome tumor defenses through combination therapies T Cell Costimulation Checkpoint Inhibition T Cell
Slide 5: Heat's Product Development
Heat’s Product Development 5 Cancer Cell Lines & Patient Samples Heat’s AntigenScreening & Selection Algorithm Transition to CMOto Mass Produce Select Cell Line with Most Antigen Overlap Transfect with Heat’s Technology Platform Technology Highlights Applies to multiple cancersDesigned to activate k
Slide 6: ImPACT Platform Technology
ImPACT Platform Technology 6 Intradermal injectedImPACT cells ImPACT cells secrete Gp96-Ig chaperone + tumor antigens (TAA) ImPACT Cells Gp96-Ig+TAA Selectively activate CD8+ T Cells CD8+ T-Cells Dendritic Cells CD8+ T cells circulate & eliminate tumor cells Tumor Cells CD8+ CD8+ CD8+ CD8+ 2 Dual an
Slide 7: Pipeline
Pipeline 7 Heat Biologics Corporate Model Deck Product Combination Indication Preclinical Mfg Phase 1 Phase 2 Phase 3 HS-410(vesigenurtacel-L) BCG; Monotherapy NMIBC HS-110(viagenpumatucel-L) nivolumab and other checkpoint inhibitors NSCLC HS-110 (viagenpumatucel-L) cyclophosphamide NSCLC Bladder Lu
Slide 8: Pipeline: HS-410 Fast Track Designation
Pipeline 8 Heat Biologics Corporate Model Deck HS-410 received fast track designation from U.S. FDA Product Combination Indication Preclinical Mfg Phase 1 Phase 2 Phase 3 HS-410(vesigenurtacel-L) BCG;Monotherapy NMIBC HS-110(viagenpumatucel-L) nivolumab and other checkpoint inhibitors NSCLC HS-110 (
Slide 9: Bladder Cancer – NMIBC Opportunity
Bladder Cancer – NMIBC Opportunity 9 1. American Cancer Society 2015 Statistics; 2. Park JC, et al. Clin Adv Hematol Oncol. 2014 Dec;12(12):838-45; 3. BCG is Bacillus Calmette-Guérin Large MarketOver 500,000 bladder cancer patients in U.S.174,000+ new cases and 16,000 deaths per year in U.S.1 High U
Slide 10: HS-410 Phase 1 NMIBC Trial Overview
HS-410 Phase 1 NMIBC Trial Overview Design Open-label, multicenter safety trialIntradermal injections of HS-410 after surgery and induction BCG10 patients enrolled SafetyImmune ResponseEfficacy Positive safety profileNo SAEs or vaccine-related treatment discontinuationsHS-410 shared 15+ tumor antige
Slide 11: High Degree of Overlap with Patient Tumor Antigens
High Degree of Overlapwith Patient Tumor Antigens 11 (-) < 5 Reads(+) > 5 Normalized Reads(++) > 25 Normalized Reads(+++) > 100 Normalized Reads HS-410 shared at least 15 tumor antigens with those expressed on the patients’ cancer cells Heat’s platforms target broad range of antigens Patient Samples
Slide 12: Post-treatment Induction of CD8+ TIL
Post-treatment Induction of CD8+ TIL 12 Before treatment there are few CD8+ (red) TIL in the disease-free patient (25-007, upper left), whereas TIL are abundant in the recurring patient (25-004, lower left)Following treatment with HS-410, there is robust induction of TIL in the disease-free patient,
Slide 13: Polyclonal TCR Expansion in Blood and Tumor Samples
Polyclonal TCRExpansion in Blood and Tumor Samples 13 Source: Heat’s HS-410 Phase 1 NMIBC trial results T cells that are expanding post-vaccine are those that were present at very low frequencies (or completely absent) in the pre-vaccine sample Blood Samples Post-Vaccine Post-Vaccine Pre-Vaccine Pre
Slide 14: Significant Correlation Between TIL Clonality and Clinical Outcome
Significant CorrelationBetween TIL Clonality and Clinical Outcome 14 HS-410 significantly increased TIL clonality in patientswho exhibited a positive clinical outcome (disease-free); P-value 0.0126 Data are consistent with HS-410 mechanism of action = Disease-free = Recurrent Disease Source: Heat’s
Slide 15: HS-410 Phase 2 NMIBC Trial Overview
HS-410 Ph 2 NMIBC Trial Overview 15 Topline data expected 4Q:16 Objective Evaluate safety and tolerability of HS-410 either alone or in combination with BCG Patient Population Patients with NMIBC (high-grade Ta; T1; CIS) after surgery Enrollment 16 U.S. sitesCompleted enrollment of 75 patients for r
Slide 16: HS-410 Ph 2 NMIBC Monotherapy 3-Month Interim Data
HS-410 Ph 2 NMIBC Monotherapy 3-Month Interim Data 16 Population Historical RR1 Monotherapy RR High-risk papillary only ~20% 1/6 (17%) CIS ~50% 0/1 (0%) Intermediate risk UNK (~<20%) N/A Composite ~30% 1/7 (14%) Source: 1) SWOG 8507 (Lamm 2000 J.Urol), EORTC 30906 (de Reijke 2005 J. Urol), EORTC 309
Slide 17: HS-410 Ph 2 NMIBC Monotherapy 3-Month Interim Data Images
HS-410 Ph 2 NMIBC Monotherapy 3-Month Interim Data Images of the bladder (above) showed changes that resemble lymphoid (T cell rich) structures, which we believe indicates that HS-410 leads to a localized immune response within the bladder Blue-light cystoscopy from patient treated with HS-410 Tumor
Slide 18: Pipeline
Pipeline 18 Heat Biologics Corporate Model Deck Product Combination Indication Preclinical Mfg Phase 1 Phase 2 Phase 3 HS-410(vesigenurtacel-L) BCG;Monotherapy NMIBC HS-110(viagenpumatucel-L) nivolumab and other checkpoint inhibitors NSCLC HS-110 (viagenpumatucel-L) cyclophosphamide NSCLC Bladder Lu
Slide 19: NSCLC Opportunity
NSCLC Opportunity 19 1. National Cancer Institute 2013 statistics; Graphic source: Teng et al., 2015 Can Res; Gettinger et al., 2015 JCO CD8+ (TIL+) patients may respond to anti-PD-(L)1 CD8- (TIL-) patients may not respond to anti-PD-(L)1 Approx. 50% PD-1 ORR Approx. 10% PD-1 ORR Estimated 45% NSCLC
Slide 20: HS-110 Ph 1b NSCLC DURGA Trial Overview
HS-110 Ph 1b NSCLC “DURGA” Trial Overview HS-110 weekly intradermally for 18 weeks; nivolumab i.v. every other week until progression One Year Topline Data Expected 4Q:16 Objective Evaluate safety and tolerability of HS-110 + a PD-1 checkpoint inhibitor Patient Population Potential to expand each co
Slide 21: ComPACT Platform Technology
ComPACT Platform Technology 21 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 22: ComPACT Outperforms OX40 Monoclonal Antibodies in Preclinical Models
ComPACT Outperforms OX40 Monoclonal Antibodies in Preclinical Models 22 ComPACT leads to ~50% complete tumor rejection as compared to ~16% with OX40 agonist antibody combinations
Slide 23: 2016 Development Milestones
2016 Development Milestones 23 Report DURGA interim immune response data (8 patients) HS-410 Bladder (NMIBC) HS-110 Lung (NSCLC) 1Q 2Q 3Q 4Q 2015 2016 Completed Report DURGA topline for nivolumab arm (8 patients)Report Ph 2 combo with cyclophosphamide data Report Ph 2 NMIBC data for combination armR
Slide 24: Summary: Value Proposition
Summary: Value Proposition Highlights:Clinical evidence of mechanism of actionFavorable safety profile to-datePan-antigen, T cell activationApplicable to multiple cancersReady-to-use; scalable, low cost manufacturingRetain worldwide commercialization rightsUpcoming Milestones:Randomized Ph 2 HS-410
Slide 25: Appendix
eat Biologics APPENDIX
Slide 26: HS-410 Injection Site Reactions Kinetics
Third Injection Site First Injection Site Second Injection Site HS-410 Injection Site Reactions Kinetics Follow Delayed-type Hypersensitivity Reaction; Consistent with Mechanism of Action 26 No visible reaction Week 1 Week 2 Week 3 No visible reaction 1 2 3 Week 1 Week 2 Week 3 Week 1 Week 2
Slide 27: Clinical and Immune Response
Clinical and Immune Response Disease Characteristics and Recurrence Status 27 Patient T-Class CIS Grade Disease Status Induction BCG Vaccine Doses Maintenance BCG 3-month Cysto 6-month Cysto Recurrence Status 12-001 T1 No High Newly Diagnosed 5 15 4 No 23-001 T1 Yes High Newly Diagnosed 6 15 3 No 23
Slide 28: Thank You
eat Biologics THANK YOU