DAY TWO - Thursday October 3

8:30 am Morning Coffee & Light Breakfast

8:50 am Chairs Opening Remarks

  • Mansoor Amiji University Distinguished Professor, Northeastern University

Deep Diving into Delivery Platforms for RNA-Based Vaccines & Gene Therapy Applications for Accelerated Translation Through the Clinic & Towards Patients in Need

9:00 am Discovery of Novel Ionizable Lipids for the Intramuscular Delivery of mRNA Vaccines

Synopsis

  • Providing an overview on LNP-based mRNA delivery system for the development of mRNA vaccine platform
  • Design and synthesis of novel ionizable lipids for the efficient delivery of mRNA vaccines
  • Focusing on building Structure Activity Relationship (SAR) of novel ionizable lipids with improved immunogenicity and reduced reactogenicity towards the development of effective mRNA vaccines

9:30 am LNP & Polymer Delivery of Self-Replicating RNA: Unlocking the Potential of Low Dose RNA Vaccines & Gene Therapy

  • Andrew Geall Co-founder & Chief Development Officer, Replicate Bioscience

Synopsis

  • LNP delivery of self-replicating RNA rabies vaccine elicits protective immunity in a majority of healthy participants down to 0.1 microgram (mcg) doses in a prime-boost schedule
  • There were no severe adverse events reported across all doses tested (0.1, 1 and 10 mcg), which supports a massive increase in the therapeutic index achievable with RNA technology in humans
  • Revealing preliminary data on polymer delivery of srRNA for gene therapy applications will be presented

10:00 am In Vivo Genome Editing: Translating Science from Bench to Bedside

Synopsis

  • Describing our expertise in metagenomics discovery and protein engineering with the help of High-Throughput Evolution Platform for Discovery and Optimization of Novel Editors (HEPDONE) system
  • Introduce our proprietary LNP mediated delivery systems targeting both liver and HSCs in the bone marrow
  • Recent clinical trial readouts from our multiple ongoing in vivo genome editing programs in China will be discussed

10:30 am mRNA LNP Process Science & Engineering: First Steps Towards a Novel Modality

Synopsis

Details to be revealed

11:00 am Morning Networking Break

Illuminating Conjugated Delivery Platforms for Targeted Delivery of RNA Therapeutics to the Liver & Beyond to Enable Cell Selectivity

12:00 pm Unlocking the Full Potential of RNAi with LEADTM (Ligand & Enhancer Assisted Delivery)

Synopsis

  • Delivery is the biggest hurdle to harnessing RNAi potential as a new drug modality
  • GalNAc conjugate technologies have revolutionized RNAi for liver targets. Extrahepatic delivery is the new frontier for RNA
  • Sanegene’s LEAD™ technology focusing on conjugate approach effectively delivers RNAi to specific tissues or cells of therapeutic relevance

12:30 pm Deep Learning-Based Design of Cell-Targeting Ligands Enables Cell- Specific, Functional SiRNA Delivery in Multiple Extrahepatic Tissues

Synopsis

  • Receptor-mediated endocytosis drives cell tropism across RNA modalities
  • Deep learning-based design of ligands targeting endocytosing receptors enables rapid in vivo testing of receptors for their capacity to mediate functional siRNA delivery
  • This platform – Connexa – has led to the discovery of multiple receptors capable of mediating in vivo functional siRNA delivery in extrahepatic tissues

1:00 pm Mergo®: A Scalable & Programmable Conjugation-Based Delivery System for Short Oligonucleotides

Synopsis

  • Sixfold is overcoming the RNA delivery challenge by systematically screening a large nd diverse conjugate space
  • The unique Mergo® system uses modified RNA tags that allow rapid in vivo evaluation of novel modifications that alter biodistribution and cell uptake, and mimic how RNA is naturally shuttled between cells
  • Sixfold will further present how the novel unbiased in vivo screening approach they have developed supports computational-based conjugate optimization

1:30 pm Lunch & Networking

Examining Novel Routes of Administration for More Selective Delivery to Treat Diseases Outside of the Liver

2:30 pm Roundtable Discussion – Taking Advantage of Administration Routes for Enabling Successful Extra Hepatic Delivery to Widen the Landscape of Treatable Targets

  • Laura Rotolo Formulation Chemist, Winship Cancer Institute of Emory University

Synopsis

  • Systemic delivery has only been achieved with lipid nanoparticles so far, what learnings can be taken from this and incorporated into new delivery platforms?
  • How is targeted delivery being achieved through direct delivery, such as inhalation for lung targets and direct injections for brain targets?
  • Discussing how to alter the physical characteristics of the delivery vehicle to ensure success via the chosen administration route

3:30 pm Afternoon Break & Networking

Achieving Extra Hepatic Delivery Through Novel & Innovative Platform Designs Enabling Treatment of a Wider Landscape of Diseases

4:00 pm Lipid Nanoparticle Mediated Oral Nucleic Acid Delivery to Enable Extra- Hepatic Delivery

Synopsis

• Need for Oral Delivery of Nucleic Acids

• Formulation approaches for LNPs for oral delivery

• Versatility of platform formulation that could be used for siRNA, miRNA and mRNA

4:30 pm Optimization of Fusogenix Proteolipid Vehicles for Extra-Hepatic Delivery of mRNA

  • Arun Raturi Chief Scientific Officer, Entos Pharmaceuticals

Synopsis

• Using the Fusogenix PLV technology as a nucleic acid delivery system

• Delivery of different cargos with a focus on mRNA and decreased toxicity

• mRNA encapsulated PLV delivery targeted to extra-hepatic tissues such as lung, eye, and muscle

5:00 pm Leveraging Innovative Lipid Nanoparticle Strategies for Advancing Delivery of mRNA in Epigenomic Therapeutics

  • Russell Johnson Vice President - Drug Delivery & Formulation, Omega Therapeutics, Inc.

Synopsis

• Illustrating strategies for delivering to specific epigenomic targets supported by preclinical to clinical data

• Expanding mRNA delivery to pulmonary tissue through nebulization and inhalation

• Showcasing preclinical data demonstrating successful target engagement for treatment of respiratory diseases

5:30 pm Chair’s Closing Remarks

5:45 pm End of the 3rd Non-Viral RNA Delivery Systems Summit 2024