Genetic Delivery of HIV mAb Workshop

Genetic Delivery of Monoclonal Antibodies for Prevention and Cure of HIV

June 14, 2018

Location

5601 Fishers Lane, Room 1D13, Rockville, Maryland

Objectives of the Meeting

  • To review current developments and identify challenges in the field of genetic delivery of monoclonal antibodies against HIV
  • To discuss strategies for achieving sustained therapeutic levels of monoclonal antibodies after gene delivery for prophylaxis and virologic remission of HIV

Sponsored by

National Institute of Allergy and Infectious Diseases

AGENDA

Thursday, June 14, 2018

7:30 am-8:30 am

Registration and Security Clearance

8:30 am-8:40 am

Opening Remarks and Meeting Goals
Michael Pensiero / Maria Chiuchiolo (Division of AIDS/NIAID)

8:40 am-10:40 am

Session 1: Challenges for Clinical Development of Adeno- Associated Vector (AAV) Antibody Delivery

Chair: James M. Wilson (University of Pennsylvania)

Session goals:

  • To review latest updates on AAV-HIV antibody clinical development
  • To explore regulatory challenges for antibody gene delivery
  • To discuss challenges, successes, and lessons learned from the gene therapy field

8:40 am-8:50 am

Introduction
James M. Wilson (University of Pennsylvania)

8:50 am-9:10 am

A Phase 1 Trial of AAV1 Vectored Immunoprophylaxis for HIV
Frances Priddy (International AIDS Vaccine Initiative)

9:10 am-9:30 am

Use of an AAV8 Vector for Transgene Delivery of VRC 07; An Overview of VRC 603
Joseph Casazza (Vaccine Research Center, NIAID)

9:30 am-9:50 am

Optimization of Venous Limb Perfusion with rAAV for Expression of Secreted Proteins from Muscle and Induction of Peripheral Treg Responses
Terence Flotte (University of Massachusetts Medical School)

9:50 am-10:10 am

Investigational AAV Gene Therapy for Potential Treatment of Hemophilia B
Daniel Takefman (Spark Therapeutics)

10:10 am-10:40 am

Panel Discussion
Invited Panelist: Suzanne Epstein (FDA/CBER)

10:40 am-11:00 am

Break

11:00 am-1:00 pm

Session 2: Viral Vectored Delivery of Monoclonal Antibodies in Pre-clinical Development– Strategies Moving Forward

Chair: Phil Johnson (Biotechnology Consultant)

Session goal:

  • To discuss new AAV-based antibody delivery strategies in pre- clinical development

11:00 am-11:10 am

Introduction
Phil Johnson (Biotechnology Consultant)

11:10 am-11:30 am

The Potential of AAV Vector for Long-Term Delivery
Ron Desrosiers (University of Miami)

11:30 am-11:50 am

Pre-Clinical Assessment of Vectored Immunoprophylaxis Against HIV in Humanized Mice
Alex Balazs (Ragon Institute)

11:50 am-12:10 pm

Properties of AAV-eCD4-Ig Useful for Prevention and Reservoir Reduction
Michael Farzan (The Scripps Research Institute)

12:10 pm-12:30 pm

The NHP/SIV Model for AAV-Mediated Protection Against HIV Infection
Mario Roederer (Vaccine Research Center, NIAID)

12:30pm-1:00pm

Panel Discussion
Invited Panelist: Mark A. Kay (Stanford University)

1:00 pm-2:00 pm

Lunch Break

2:00 pm-4:20 pm

Session 3: Non-viral Expression Platforms for Delivery of Monoclonal Antibodies

Chairs: Drew Weissman and David Weiner

Session goal:

  • To discuss DNA- and RNA-based antibody delivery platforms for HIV and other infectious diseases currently in pre-clinical development

2:00 pm-2:25 pm

Engineering Synthetic Plasmid DNA (DMAb) for In Vivo Antibody Delivery
David Weiner (The Wistar Institute)

2:25 pm-2:45 pm

Novel dMAbTM Platform Technology for the Delivery of DNA- Encoded Monoclonal Antibodies
Kate Broderick (Inovio Pharmaceuticals)

2:45 pm-3:10 pm

Nucleoside-Modified mRNA Therapeutic Delivery
Drew Weissman (University of Pennsylvania)

3:10 pm-3:30 pm

mRNA-Encoded Antibodies for Passive Immunization
Frédéric Chevessier-Tünnesen (CureVac AG)

3:30 pm-3:50 pm

mRNA Delivery of Therapeutic Antibodies: HIV and Chikungunya
Elisabeth Narayanan (Moderna Therapeutics)

3:50 pm-4:20 pm

Panel Discussion
Invited Panelists:
Ruxandra Draghia (Merck, Global Vaccines) JoAnn Suzich (MedImmune)

4:20 pm-4:30 pm

Closing Remarks
Michael Pensiero (NIAID/ Division of AIDS, NIAID)

4:30 pm

Adjourn

                                                                         

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