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DIA/FDA Oligonucleotide-Based Therapeutics Conference

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Session 3 Track 1: Clinical Development of Oligonucleotide Therapeutics for Viral and Kidney Diseases

Session Chair(s)

Laura Sepp-Lorenzino, PhD

Laura Sepp-Lorenzino, PhD

  • Chief Scientific Officer
  • Intellia Therapeutics, Inc., United States
Zheng Li Li, PhD

Zheng Li Li, PhD

  • Pharmacologist
  • FDA, United States
This session will provide updates on siRNAs in clinical development for chronic hepatitis and cancer. Liver-targeted silencers of Hepatitis B Virus are being developed in combination with viral life cycle inhibitors and immune enhancing therapies, with the goal of breaking tolerance and establishing a functional cure in chronic hepatitis B patients. Phase ½ mono and combination therapy data for two HBV silencers will be presented. The last talk will highlight the clinical experience with an extra-hepatic siRNA candidate being developed for renal cell carcinoma, targeting HIF2.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Compare and contrast various oligonucleotide modalities and their applications
  • Recognize clinical development considerations and trial designs for mono and combination therapies
  • Discuss data from most advanced oligonucleotide drug/candidates for liver and kidney disease targets

Speaker(s)

Daniel Cloutier, PharmD

Clinical Development of VIR-2218, a GalNAc-siRNA Targeting Hepatitis B, in Combination with Immune Enhancing Therapies

Daniel Cloutier, PharmD

  • Senior Director, Clinical Research, Clinical Lead, HBV Program
  • Vir Biotechnology, Inc., United States
Michael Biermer, MD

Short Interfering RNA JNJ-3989 Combination Therapy

Michael Biermer, MD

  • Senior Medical Director, Clinical Development
  • Janssen Pharmaceuticals, Belgium
James Hamilton Hamilton, MD, MBA

ARO-HIF2 for Treatment of Clear Cell Renal Cell Carcinoma Ph1b

James Hamilton Hamilton, MD, MBA

  • Senior Vice President, Discovery and Transitional Medicine
  • Arrowhead Pharmaceuticals, United States

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