8:20 am Chair’s Opening Remarks

Catch me in the Clinic
Capturing the Right Patients at the Right Time… as Quickly as Possible

8:30 am Design of IPF Clinical Trials in the Era of Approved Therapies:

  • Fernando Martinez Chief, Division of Pulmonary & Critical Care Medicine, Weill Cornell Medicine
  • Robert Kaner Associate Professor of Clinical Medicine, Weill Cornell
  • Majd Mouded Medical Director, Clinical Development, Biogen
  • Ganesh Raghu Director, Interstitial Lung Disease/ Sarcoid, Pulmonary Fibrosis Program, University of Washington

Synopsis

• Debating clinical trial design for Phase 1-3
• Endpoints to assess improvement in quality of life
• How to determine proof of concept from a phase 2 trial
• How is best to judge efficacy in phase 3

9:15 am Think Tank Roundtable Discussions:

Synopsis

More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas. A valuable chance for attendee to unite around hot topics, debate best practice and share experience to identify solutions.

• In Vitro & In Vivo for Target Identification & Validation

• Proof of Concept: Phase 2 Design

• Novel Intermediate Outcomes Including Circulating Biomarkers & Biomarkers of Response

9:45 am Roundtable Feedback Panel

10:15 am Morning Break & Networking

Preclinical Stream

Clinical Stream

Cellular Senescence as a New Frontier & Pathological Feature for IPF

Investigating Further Than IPF

Challenges in Dissecting Protective from Disease-Driving Cell Senescence in IPF

11:00 am

Progressive Fibrosing ILD: An Extension of IPF?

11:00 am

• The accumulation and persistence of senescent cells is now a well-established feature of IPF
• The role of senescence in IPF is complicated because cell senescence can be organ protective via mitigation of tumor development, etc.
• Discussing strategies around distinguishing protective from disease-driving cell senescence

Cory Hogaboam, Professor of Medicine,
Cedars-Sinai Medical Center

• Sharing the concept of progressive fibrosing ILD in the context of IPF clinical trials
• Updates on ongoing clinical trials with anti-fibrotics in non-IPF lung disease

Kevin Flaherty, Division of Pulmonary & Critical Care Medicine,
University of Michigan

Mechanisms of DNA Damage Response in the Lungs In Vivo

11:30 am

SSc-ILD Related Outcomes: Path to Proof of Concept in IPF

11:30 am

• Discussing the current paradigm between exposure to genotoxic stress, subsequent cellular senescence and lung fibrosis
• Assessing the relevance of in vitro findings to the in vivo context
• Revealing results and discussing relevance to human pathology and their translational opportunities

Andrei Gudkov, Professor of Oncology,
Roswell Park Comprehensive Cancer Center

• SSc presents in skin and other tissues, including lung. Pre/post treatment skin biopsies can inform on target engagement in tissue
• Treating patients earlier in disease course may prevent progression to significant ILD
• Potential to get informative clinical outcomes in smaller, shorter trials than in IPF

Joe Arron, Senior Scientist & Senior Director, Immunology Discovery,
Genentech

12:00 pm Lunch & Networking

Preclinical Progress & Results

Next Generation miR-29 Mimics as a Therapy for Pulmonary Fibrosis

1:00 pm

• Developing second generation miR-29 mimics with targeting capability
• Understanding improved stability, retained miRNA activity and shown efficacy in vivo in bleomycin treated mice
• Reviewing clinical viability including systemic administration at viable doses unlike previous versions

Rusty Montgomery, Director, Research
Miragen Therapeutics

IDL-2965: A Selective, Highly Potent, Clinical Stage Integrin Antagonist for the Treatment of IPF & NASH

1:00 pm

• Discussing IDL-2965: an oral small-molecule integrin antagonist that potently inhibits αvβ1, αvβ3, and αvβ6
• Presenting IDL-2965 potent antifibrotic activity at low, once-daily, oral doses in multiple animal models of lung and liver fibrosis
• Sharing investigations of IDL-2965 in an adaptive, biomarker driven Phase 1/2a clinical program, allowing rapid progression from healthy volunteers to IPF and NASH patients

Karl Kossen, Senior Vice President of Translational Science,
Indalo Therapeutics

Targeting Lysyl Oxidase Like 2 (LOXL2) to Treat IPF

1:30 pm

• Scientific rationale for targeting LOXL2
• Presenting preclinical data supporting compound selection
• Sharing clinical data for LOXL2 inhibitors

Wolfgang Jarolimek, Head of Drug Discovery
Pharmaxis

Targeting the Collagen-Specific Chaperone, HSP47, with ND-L02-s0201, a Novel Lipid Nanoparticle Containing HSP47 siRNA, for the Treatment of Fibrotic Diseases

1:30 pm

• Outlining HSP47 as a compelling anti-fibrotic target
• Sharing of preclinical data supporting ND-L02-s0201 clinical development
• Overview of on-going Phase 2 randomized, double blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and biological activity of ND-L02-s0201 in subjects with Idiopathic Pulmonary Fibrosis

Sonya Zabludoff, Senior Director,
Nitto Denko

2:00 pm Afternoon Break & Networking

2:30 pm GLPG1205, a Potent & Selective Antagonist of GPR84, for the Treatment of IPF

Synopsis

• Rationale for targeting GPR84
• Presenting pre-clinical data supporting the potential of GLPG1205 to treat lung fibrosis

3:00 pm PLN-74809, an Oral Dual Inhibitor of Integrins αVβ6 & αVβ1, for the Treatment of Idiopathic Pulmonary Fibrosis

Synopsis

• PLN-74809 was shown to be orally bioavailable and well tolerated in a Phase 1a single and multiple ascending dose study, with a long half-life supporting oncedaily dosing
• PLN-74809 is undergoing Phase 1b evaluation to assess its inhibitory effects on TGF-β activation, as measured by pSMAD levels in alveolar macrophages, collected via bronchoalveolar lavage
• Phase 2a trials in IPF patients are planned for 2H19 and will include: PET imaging to assess target engagement of PLN-74809 on αVβ6 in lungs; a multinational dose-ranging safety, tolerability and PK study with exploratory endpoints including pulmonary function, biomarkers and imaging

3:30 pm Directional Approach in Clinical Trials

  • Elias Kouchakji Senior Vice President, Clinical Development,
    Drug Safety & Pharmacovigilance, FibroGen

Synopsis

• Additional data demonstrating improvement in quantitative lung fibrosis
• Showing positive result in patient reported outcomes
• Continuing phase 3 studies with patient reported outcomes

4:00 pm Chair’s Closing Remarks

  • Fernando Martinez Chief, Division of Pulmonary & Critical Care Medicine, Weill Cornell Medicine