HTBX Corporate Milestones Below we list key milestones for Heat Biologics:
1 - Complete HS-110 Phase II NSCLC enrollment ? 2Q:19 2 - HS-130 (ComPACT) IND filing and FDA Clearance ? August 2019 3 - HS-110 interim data readout ? November 2019 4 - HS-110 Phase II interim readout ? 4Q:19 5 - PTX-35 IND clearance and first patient dosing ? 2Q:20 6 - Various coronavirus vaccine milestones ? 2Q:20 7 - ASCO Poster Presentation ? May 29, 2020 8 - Discussion with potential partners ? Ongoing 9 - Schedule End of Phase II Meeting with FDA ? 2H:20 10 - Complete HS-130 Phase I trial ? 4Q:20 11 - Develop Phase III / commercial manufacturing capacity for HS-110 2020
: HTBX - hier nur ein kleiner Teil ihrer Pipeline
?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.
gp96 Platform for Infectious Disease ? gp96 platform demonstrated efficacy in multiple infectious diseases - Significant mucosal protection against simian immunodeficiency virus (SIV) in monkey - Induction of Zika-specific CD8 T cells in mouse - No pathological changes in placenta or fetus - Elevation of malaria-specific CD8 T cells in mouse ? Multiple grants received to utilize gp96 platform for various infectious diseases - National Institute of Health (NIH) - Department of Defense (DoD) - Florida Department of Health ? Heat Biologics leverages the body of work done to date to develop our COVID-19 vaccine program 14 Reference:
Env-spec IgG & IgA Antigen Secreting Cells (per 10 6 PBMCs) Induction of Humoral Immune Response by gp96SIVIg Vaccines Key Differentiation of gp96 Platform ? Heat?s gp96 platform-based products evaluated in 300+ patients to date - HS-110 (Phase 2) demonstrated favorable safety profile and clinical efficacy in combination with PD-1 inhibitors for treatment of NSCLC ? Potential first-in-class for infectious disease - Based on human cells engineered to secrete gp96-bound viral antigens - Platform designed to be antigen-specific and pathogen-specific - Aim to trigger mucosal immunity by activating both B and T cell responses at the point of pathogen entry - Preclinical work using gp96 platform includes SIV/ HIV, malaria and zika ? Heat?s COVID-19 vaccine program focuses on multiple SARS-CoV-2 antigens - Target to utilize natural immune process to induce long-lasting memory responses 15 gp96 PLATFORM* NO ANTI-VECTOR IMMUNITY ? NO VIRAL ACTIVATION ? NO INTEGRATION OF FOREIGN DNA INTO HOST GENOME ACTIVATION OF T CELLS ? ACTIVATION OF B CELLS ? HIGH IMMUNOGENICITY ? INDUCTION OF MUCOSAL IMMUNITY ? LONG-TERM MEMORY RESPONSE ? *Target product profile for infectious disease Heat Biologics? COVID-19 Vaccine Program ? Leverages our proprietary gp96 platform to effectively deliver multiple SARS-CoV-2 antigens 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 accelerate our COVID-19 vaccine program