Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — Investor Presentation (February 2021)
26 slides from Scorpius's investor presentation, Feb 9, 2021
Slide 1: Heat Biologics Corporate Presentation
Heat Biologics NASDAQ: HTBX CORPORATE PRESENTATION FEBRUARY 2021 1
Slide 2: Forward Looking Statements
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‐
Slide 3: Snapshot of Heat Biologics (Nasdaq: HTBX)
Snapshot of Heat Biologics (Nasdaq: HTBX) • US‐based biopharmaceutical company developing potential first‐in‐class immunotherapy products • HS‐110, an “off‐the‐shelf” cell‐based immunotherapy product that has the potential to improve PD‐(L)1 therapy ‐ Ongoing Phase 2 program demonstrates positive su
Slide 4: Product Pipeline
Product Pipeline MOA Product Indication Preclinical Phase 1 Phase 2 Phase 3 (Modality) HS‐110 gp96 + CTAs NSCLC (Cell Therapy) HS‐130 OX40L Solid Tumors (Cell Therapy) COVID‐19 gp96 + Viral Antigens COVID‐19 Vaccine (Cell Therapy) PTX‐35 TNFRSF25 Solid Tumors (mAb) CTA = cancer testis antigen; NSCLC
Slide 5: Product Pipeline
Product Pipeline MOA Product Indication Preclinical Phase 1 Phase 2 Phase 3 (Modality) HS‐110 gp96 + CTAs NSCLC (Cell Therapy) HS‐130 OX40L Solid Tumors (Cell Therapy) COVID‐19 gp96 + Viral Antigens COVID‐19 Vaccine (Cell Therapy) PTX‐35 TNFRSF25 Solid Tumors (mAb) CTA = cancer testis antigen; NSCLC
Slide 6: HS-110 Overview
HS‐110 Overview • HS‐110 is a Phase 2 cell‐based immunotherapy administered in combination with PD‐ (L)1 therapy to improve clinical outcomes for NSCLC patients ‐ Allogeneic cells with engineered gp96 to present multiple cancer testis antigens ‐ Selectively activate CD8+ “killer” T cells ‐ gp96 can
Slide 7: Heat Biologics' gp96 Platform
Heat Biologics’ gp96 Platform Activating the Immune System • Function of heat shock protein gp96: ‐ Potent mucosal adaptive memory inducer ‐ Chaperones antigens (pathogens or tumor) to the immune system ‐ Activates B cell response and drives antigen‐specific CD4+ and CD8+ T cell activation • platfor
Slide 8: Heat Biologics' gp96 Platform
Heat Biologics’ gp96 Platform Activating the Immune System • Function of heat shock protein gp96: ‐ Potent mucosal adaptive memory inducer ‐ Chaperones antigens (pathogens or tumor) to the immune system ‐ Activates B cell response and drives antigen‐specific CD4+ and CD8+ T cell activation • Key fea
Slide 9: Synergy of HS-110 with PD-1 Inhibitor
Synergy of HS‐110 with PD‐1 Inhibitor B16F10 Syngeneic Mouse Melanoma Model • B16F10 mouse model is a very aggressive tumor model and is resistant to anti‐PD1 treatment • Synergistic anti‐tumor‐growth activity of mouse HS‐110 Tumor Size (mm2) with anti‐PD1 was demonstrated as compared to either agen
Slide 10: HS-110 Trial Schema
HS‐110 Trial Schema Cohorts A and B Patients receive weekly HS‐110 (1 x 107 cells) intradermally for 18 weeks via 5 simultaneous injections of 0.1ml each, and biweekly nivolumab 240 mg IV until disease progression or unacceptable toxicity. 10
Slide 11: Clinical Proof-of-Concept Achieved
Clinical Proof‐of‐Concept Achieved HS‐110 in Combination with Nivolumab Cohort A: 2+ line Checkpoint Inhibitor (CPI) naïve patients • HS‐110 in combination with nivolumab compares favorably with published data§ • Two 2+ line NSCLC settings are under evaluation: ‐ 2+ line Checkpoint Inhibitor (CPI) n
Slide 12: Overall Survival (%) Cohort A
Cohort A: CPI naïve pts treated by HS‐110 + Nivolumab at >2L Overall Survival (OS) Overall Survival (%) Δ Heat Biologics Cohort A interim results as of November 2020 data cut. Median follow‐up time = 19.45 months. * Borghaei et al 2021. J Clin Oncol § Please note Heat Biologics’ trial did not have a
Slide 13: Overall Survival (%) Cohort B
Cohort B: CPI progressors treated by HS‐110 + Nivolumab at >2L Overall Survival (OS) Overall Survival (%) Δ Heat Biologics Cohort B interim results as of November 2020 data cut. Median follow‐ up time = 11.94 months. † Constatini et al 2018 ERJ Open Research ‡ Schvartsman et al 2017 Lung Cancer. § P
Slide 14: Product Pipeline
Product Pipeline MOA Product Indication Preclinical Phase 1 Phase 2 Phase 3 (Modality) HS‐110 gp96 + CTAs NSCLC (Cell Therapy) HS‐130 OX40L Solid Tumors (Cell Therapy) COVID‐19 gp96 + Viral Antigens COVID‐19 Vaccine (Cell Therapy) PTX‐35 TNFRSF25 Solid Tumors (mAb) CTA = cancer testis antigen; NSCLC
Slide 15: HS-130 Overview
HS‐130 Overview • HS‐130 is the first allogeneic, off‐the‐shelf, cell therapy approach utilizing OX40‐ mediated co‐stimulation to enhance activation of dormant immune signal ‐ Leverage HS‐110 clinical experience and manufacturing know‐how ‐ Addition of OX40L fusion protein to extend and expand T cel
Slide 16: Product Pipeline
Product Pipeline MOA Product Indication Preclinical Phase 1 Phase 2 Phase 3 (Modality) HS‐110 gp96 + CTAs NSCLC (Cell Therapy) HS‐130 OX40L Solid Tumors (Cell Therapy) COVID‐19 gp96 + Viral Antigens COVID‐19 Vaccine (Cell Therapy) PTX‐35 TNFRSF25 Solid Tumors (mAb) CTA = cancer testis antigen; NSCLC
Slide 17: gp96 Platform for Infectious Disease
gp96 Platform for Infectious Disease • gp96 platform demonstrated activity in animal models in multiple Induction of Humoral Immune Response infectious diseases by gp96SIVIg Vaccines ‐ Significant mucosal protection against simian immunodeficiency virus (SIV) in non‐ human primates Env‐spec IgG & Ig
Slide 18: Key Differentiation of gp96 Platform
Key Differentiation of gp96 Platform gp96 PLATFORM* • Heat’s gp96 platform‐based products evaluated in 250+ patients to date NO ANTI‐VECTOR IMMUNITY ‐ HS‐110 (Phase 2) demonstrated favorable safety profile and clinical activity in NO VIRAL ACTIVATION combination with PD‐1 inhibitors for treatmen
Slide 19: Heat Biologics' COVID-19 Vaccine Program
Heat Biologics’ COVID‐19 Vaccine Program • Leverages our proprietary gp96 platform to activate the immune system • Designed to elicit long‐lasting immune response against SARS‐CoV‐2 virus • We plan to collaborate with companies, researchers, government agencies and funding organizations to accelerat
Slide 20: Heat Biologics COVID-19 Vaccine Program
Heat Biologics COVID‐19 Vaccine Program Summary of Preclinical Data To Date Heat Biologic COVID‐19 Vaccine Design • Heat Biologics’ COVID‐19 vaccine utilizes gp96 Endogenous gp96 TM KDEL technology and incorporates full length Spike protein N- -C Secretory form gp96-Ig Transfect • Preclinical data d
Slide 21: Product Pipeline
Product Pipeline MOA Product Indication Preclinical Phase 1 Phase 2 Phase 3 (Modality) HS‐110 gp96 + CTAs NSCLC (Cell Therapy) HS‐130 OX40L Solid Tumors (Cell Therapy) COVID‐19 gp96 + Viral Antigens COVID‐19 Vaccine (Cell Therapy) PTX‐35 TNFRSF25 Solid Tumors (mAb) CTA = cancer testis antigen; NSCLC
Slide 22: PTX-35 Overview
PTX‐35 Overview • Potential first‐in‐class T cell co‐stimulator targeting TNFRSF25, with preferential specificity to expand antigen‐specific “memory” CD8+ T cells ‐ Phase 1 trial in solid tumors currently enrolling • Broad market potential ‐ Activity demonstrated in multiple preclinical in vivo colo
Slide 23: Synergy between anti-PD-(L)1 and TNFRSF25 Agonism
Synergy between anti‐PD‐(L)1 and TNFRSF25 Agonism In Combination with Antigen‐driven Immunotherapy Antigen-driven tumor cell killing augmented by PTX-35- costimulation Checkpoint blockade reverses immune suppression but sometimes this is not enough TNFRSF25 agonism by PTX- 35 may provide additional
Slide 24: PTX-35 Demonstrated Anti-Tumor Activities
PTX‐35 Demonstrated Anti‐Tumor Activities Synergy with Checkpoint Inhibition and Antigen‐driven Immunotherapies • Tumor growth inhibition (therapeutic setting) ‐ Antigen is required for synergy between PTX‐35 and anti‐PD‐1 inhibitor 24
Slide 25: PTX-35: Key Nonclinical Data in Oncology
PTX‐35: Key Nonclinical Data in Oncology • Activity demonstrated in multiple tumor models and in combination with checkpoint blockade and antigen‐driven immunotherapies in mice ‐ PTX‐35 has nanomolar potency ‐ Agonist for TNFRSF25 for stimulating expansion of antigen‐experienced T effector cells ‐ I
Slide 26: Snapshot of Heat Biologics (Nasdaq: HTBX)
Snapshot of Heat Biologics (Nasdaq: HTBX) • US‐based biopharmaceutical company developing potential first‐in‐class immunotherapy products • HS‐110, an “off‐the‐shelf” cell‐based immunotherapy product that has the potential to improve PD‐(L)1 therapy ‐ Ongoing Phase 2 program demonstrates positive su
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