8:00 am Morning Coffee

OPTIMIZING CLINICAL TRIAL DESIGN FOR INNATE IMMUNOTHERAPY DRUG DEVELOPMENT

8:50 am Chair’s Opening Remarks

  • Coen Kuijl Assistant Professor, VU medisch centrum

9:00 am Consistency in Global Clinical Trials: The Impact of Common Human HAQ-STING in Health & Medicine

  • Lei Jin Assistant Professor - Medicine , University of Florida

Synopsis

  • Understand how the human STING gene is highly heterogeneous with significant population stratification
  • Explore how common human HAQ-STING replaced AQ-STING in non-Africans indicating a natural selection for HAQ-STING during the out-of-African migration
  • Delve into how HAQ and AQ STING regulates fatty acid metabolism independent of type I IFNs

9:30 am Optimizing Patient Selection & Standardizing the Dose, Scheduling & Response Analysis; Targeting TLR9 in High-Risk Resectable Melanoma & Neoadjuvant CMP-001 & Nivolumab

  • Diwakar Davar Assistant Professor - Phase, Therapeutics & Melanoma , University of Pittsburgh

Synopsis

  • Assessing the use of historical markers and the need for further exploration
  • Understanding the design, translation and execution in response assessments

10:00 am Morning Refreshments & Poster Session

OPTIMIZING YOUR PRR-BASED DRUG DELIVERY TECHNOLOGY

11:00 am Intratumoral Immunotherapies Currently Undergoing Development & Updated on Efficacy Data

Synopsis

  • Review of all intratumoral immunotherapies that have been approved or have shared efficacy and safety results from clinical development
  • Challenges for intratumoral immunotherapy development, best endpoint to target
  • Predictive biomarkers; how and when assess them

11:30 am Eradication of Established Tumors with Induction of Innate & Adaptive Immunological Memory in Multiple Preclinical Models with Systemically Administered Decoy Bacteria, a Multi-TLR Agonist Therapeutic Vaccine

Synopsis

  • Explore how attenuated and killed, non-pathogenic, Gram-negative (Decoy) bacteria can induce potent priming of innate and adaptive anti-tumor immunity
  • See how Decoy bacteria can produce single agent activity and safe tumoreradicating synergy with each of several different classes of immuno-oncology agents
  • Decoy bacteria can also produce safe, single agent activity against chronic viral infections, including HBV, in preclinical models

12:00 pm Lunch Break

ANALYSING & OPTIMIZING THE VARIOUS DRUG FORMAT OPTIONS

1:00 pm Site-Specific TLR7 Agonist Antibody-Drug Conjugates as Next Generation ADCs

Synopsis

  • Presenting on the site-specific TLR7a ADC developed by EuCODE platform with an expanded genetic code
  • Reviewing how protein medicinal chemistry enables fine-tuning of TLR7a ADC to balance potency and safety in preclinical studies
  • Demonstrating how Ambrx’s TLR7a ADCs elicit strong anti-tumor responses as single-agent as well as in combination therapies

1:30 pm Panel Discussion: What is the Best Modality & Delivery Approach to PRR-Pathway Targeting?

  • Adi Diab Associate Professor - Melanoma Medical Oncology , MD Anderson Cancer Center
  • Andrew Miller Co-founder & Vice President - Immunology & Operations , Apros Therapeutics
  • Michael J. Newman Founder & Chief Scientific Officer , Indaptus Therapeutics
  • Mingchao Kang Group Lead, Head Technology Platform , Ambrx
  • Mark Moody Chief Operating Officer, Activate Therapeutics

Synopsis

  • Discussing safety profiles, dosing and scheduling considerations, therapeutic window
  • Dissecting drug design approach for systemic and intratumoral
  • Understanding possible regulatory considerations
  • Mechanisms of action that are leading to strong efficacy
  • Enhancing administration and delivery of therapies for safe and effective clinical outcomes
  • Systemic delivery technologies vs intra-tumoral delivery technologies

2:00 pm Afternoon Refreshments

NEXT STEPS IN PRR COMBINATION INTERVENTIONS TO HEIGHTEN DRUG EFFECT & OVERCOME RESISTANCE – THE FUTURE?

2:30 pm Navigating & Assessing Combination with Checkpoint Inhibitors & Other Options

  • Adi Diab Associate Professor - Melanoma Medical Oncology , MD Anderson Cancer Center

Synopsis

  • Innate immune stimulating therapies and their contribution to T-cell-based immunotherapies
  • Orchestrating T-cell recruitment and infiltration at the tumor site by targeting the myeloid lineage component of the innate immune system

3:00 pm Nanomedicine Formulations for TLR Agonist Drug Combinations

  • Mark Moody Chief Operating Officer, Activate Therapeutics

Synopsis

  • Activate’s lipogel nanoparticles (LgNPs) can co-package combinations of TLR agonists and immune-oncology drugs to provide sustained delivery of these drugs to the tumor while reducing systemic exposure and associated toxicity
  • These LgNPs are phagocytized by macrophages and dendritic cells – delivering TLR agonists to the endosome where TLR targets reside
  • TLR-based combination therapies have been shown to be more effective than monotherapies, and Activate’s LgNP based therapies have the potential to improve patient outcomes

3:30 pm STING Modulators as Therapeutic Agents for Infection, Auto-Immune & Oncology Indications

  • Joshi Ramanjulu Senior Director & Head of Project Leader Group, Innate Immunity Research Unit & Senior Fellow , GlaxoSmithKline

4:00 pm STING Agonism for the Treatment of COVID-19

  • Fiachra Humphries Assistant Professor of Medicine, UMass Chan Medical School Department of Medicine

4:30 pm Chair’s Closing Remarks & Close of Summit

  • Jun Li Senior Research Fellow, Boehringer Ingelheim