Summit Day Two Agenda

8:00 am Morning Coffee & Networking

8:45 am Chair’s Opening Remarks

  • Ana Rossi Senior Medical Director, Global Medical Affairs Dermatology, Sanofi

Mapping Out the Evolving Regulatory Landscape

9:00 am Janus Kinase Inhibitors for Dermatologic Indications & Demonstrating Efficacy for Vitiligo

  • Kendall Marcus Director, Division of Dermatology & Dental Products, FDA

Synopsis

• Eaxming the role of Janus kinas inhibitors in treatment of patients with dermatologic diseases
• Demonstrating favorable risk/benefit of JAKi in development programs
• Reviewing the considerations for vitiligo product development

9:30 am Panel Discussion: Evaluate the Current Challenges, Approaches & Opportunities in Treating Inflammatory & Autoimmune Skin Conditions?

  • Ana Rossi Senior Medical Director, Global Medical Affairs Dermatology, Sanofi
  • Nathalie Wagner Head of Clinical Pharmacology, Galderma
  • Jim Lee Group Vice President, Head Inflammation & Autoimmunity, Incyte
  • Jasmina Jankicevic Dermatologist, Clinical Development & Medical Affairs, JJ Consulting
  • Paul Barclay Vice President, Global Program Head, Leo Pharma

Synopsis

• A year on from the DDD Summit in 2020: What have we learnt?
• How can drug developers cut to the real barriers, and debate what is truly required to break through to successful treatments for dermatological inflammatory conditions?
• Discussing barriers to progress and strategies to address these

10:00 am Reserved for Therapeutics Inc

10:30 am Morning Refreshments & Networking

Preclinical & Translational Development

Case-Studies on Emerging Preclinical Candidates & Approaches in Immuno-Inflammatory Derm- Related Conditions

11:00 am RPT193 – A potent, selective oral CCR4 Antagonist for the treatment of Atopic Dermatitis

Synopsis

• Exploring the role of Th2 cells in atopic dermatitis and the contribution of CCR4-mediated Th2 migration to the disease
• Introducing the RPT193, a novel oral CCR4 antagonist
• Describing preclinical efficacy of RPT193 in various Th2 driven allergic disease mouse models
• Description of the clinical development plan for RPT193

11:30 am Development of Therapies to Target Inflammation, Oxidative Stress & Fibrosis in Different Skin Diseases

  • Yiumo Chan Senior Director, Head of Medical Research, TWi Biotechnology

Synopsis

• Reviewing molecular mechanisms underlying skin diseases associated with chronic inflammation, oxidative stress and fibrosis
• Examining animal and in vitro models to explore the pathophysiological roles of inflammation, oxidative stress and fibrosis in skin diseases
• Discussing development of small molecule therapies to modulate these pathways in different common and rare skin diseases – application in clinical studies

12:00 pm New Pathway: Sensory Neurons Control Local Inflammation

  • Daniel Kaplan Professor of Dermatology & Immunology, University of Pittsburgh

Synopsis

• Examining inflammation in tissues is driven by cytokine circuits
• Exploring sensory neurons that provide both positive and negative regulation of cytokine circuits
• Targeting sensory neurons or neurotransmitters to control inflammation is an untapped area with large potential

Clinical Development

Recent Progress in JAK Inhibitors for the Treatment of Psoriasis, Atopic Dermatitis & Hidradenitis Suppurativa

11:00 am Bimekizumab in Moderate to Severe Plaque Psoriasis: A Model Informed Drug Development (MIDD) Journey from Discovery through Clinical Development Driving Key Decision Making and Optimized Posology

  • Merran Macpherson Quantitative Pharmacology PK-PD Lead, UCB
  • Ruth Oliver Vice President and Head of Quantitative Pharmacology and DMPK, UCB

Synopsis

• Examining the application of quantitative approaches to drug design
• Exploring early dose ranging and application of Bayesian approaches for decision making in a proof of concept
• Demonstrating the optimal dose ranging and maintenance dose interval evaluation using model-based approaches
• Design of phase 3: endpoint and time-point and H2H using population PK-PD modelling and clinical trial simulation.
• Impact on posology

11:30 am Topical JAK Inhibitors for the Treatment of Chronic Hand Eczema & other Complex Inflammatory Skin Disorders

  • Paul Barclay Vice President, Global Program Head, Leo Pharma

Synopsis

• Understanding the complex pathophysiology and disease burden of Chronic Hand Eczema
• Summarizing Phase 2 efficacy and safety of Delgocitinib, a topical pan-JAK inhibitor
• Exploring other potential dermatological conditions where JAK inhibitors are being evaluated

12:00 pm A Highly Selective JAK inhibitor SHR0302 for the Treatment of Patients with Moderate to Severe Atopic Dermatitis: A Successful Phase II Study

  • Min Irwin Chief Executive Officer, Reistone Biopharma

Synopsis

• Showcasing phase II study results
• Learnings from conducting dermatological trial in China
• Sharing experience on conducting big indication clinical study for a startup biotech

12:30 pm Lunch & Networking

Emerging Preclinical Candidates & Approaches


1:30 pm Antipruritic & Disease Modifying Activity of Novel Charged Sodium Channel Blockers in Inflammatory Skin Disease

  • Jim Ellis Chief Scientific Officer, Nocion Therapeutics

Synopsis

• Exploring how sensory nociceptors are increasingly implicated in the regulation of the immune response in inflammatory skin disease
• Developing charged sodium channel blockers (nocions) that selectively target nociceptors
• Learning how to use large pore channels that are open in response to inflammation to selectively enter into nociceptors where they block Nav1.7, 1.8 and 1.9 channels
• Showcasing how nocions inhibit itch and are disease modifying in a calcipotriol model of Atopic Dermatitis

2:00 pm SINTAX Medicines: Next generation Therapies for Skin Disease & Beyond

  • Douglas Maslin Senior Director, Immunology Clinical Lead, Evelo Biosciences

Synopsis

• Examining orally administered biologic medicines based on a new understanding of how immunity and inflammation are controlled
• Assessing how results demonstrate a potent pathway of systemic inflammatory control centered in the small intestine
• Discussing how the inflammatory control mechanisms of SINTAX down-regulate multiple inflammatory pathways including those which have been validated with targeted antibody therapies, but without the side effects seen with antibody therapeutics or broadly acting oral kinase inhibitors

2:30 pm De-risking Strategies for the Development of Dermatological Products

Synopsis

• Discussing various pre-clinical models for dermatological diseases
• Learning how to implement these models in the drug discovery process to identify and select new molecules for product development
• Examining the use of these models to de-risk clinical development

Recent Progress for the Treatment of Psoriasis, Atopic Dermatitis, Hidradenitis Suppurativa & Pruritus associated with Prurigo Nodularis

1:30 pm Targeting Complement Driven Neutrophil Activation in HS: Lessons Learned & Strategies Going Forward for Vilobelimab, a New First-in-class Anti-C5a Antibody

Synopsis

• Examining new research suggesting that a key role of neutrophils in HS draining tunnel development and disease progression
• Exploring vilobelimab that targets this mechanism and has demonstrated efficacy on reduction of all 3 inflammatory lesions but especially on draining tunnels
• Evaluating lessons learned from a failure to demonstrate efficacy on the currently established primary endpoint (HiSRC) in a phase II trial, which has recently resulted in high placebo response rates
• Developing a strategy moving forward with Vilobelimab: Lessons learned from regulatory interactions when there is a need for a new primary efficacy endpoint

2:00 pm Nalbuphine ER, an Oral Dual Acting Opioid being Developed for the Treatment of Pruritus associated with Prurigo Nodularis

Synopsis

• Examining the role of Nal ER in attenuating the itch scratch cycle by rebalancing the KOR and MOR pathways
• Evaluating efficacy and safety of Nal ER in the treatment of pruritus: Phase 2 results in prurigo nodularis and Phase 3 results in Uremic Pruritus
• Discussing ongoing Phase 2b/3 clinical study for Nal ER in prurigo nodularis and lifecycle management plans in pruritus

2:30 pm The Scientific Journey of Biologics in Psoriasis: From the First Advanced Therapies to the First Anti- IL-23 Therapy, TREMFYA

  • Lloyd Miller Vice President Immunodermatology, Janssen (Johnson & Johnson)

Synopsis

• Examining past 20 years + scientific research of the immunemediated pathways in psoriasis and how it’s led the way to more targeted and improved biologic therapeutics
• Exploring the first advanced biologics targeting TNF and how it has paved the way to understanding the key mechanistic role of IL-23-driven Th17 cells in psoriasis pathogenesis
• Discussing how these advances have led to development of TREMFYA, the first-in-class anti-IL-23 biologic therapy with remarkable and durable efficacy and safety over 5 years
• Understanding how the lessons learned in psoriasis have paved the way for accelerating the discovery of transformational therapies in other immune-mediated skin diseases, such as atopic dermatitis and hidradenitis suppurativa

3:00 pm Afternoon Refreshments & Networking

Innovation & Advancements in Developing Treatments for Cutaneous Skin Diseases

3:30 pm Innovation in Targeting Inflammation & Cancer

  • Arsalan Shabbir Senior Medical Director, Immunology & Inflammation Clinical Development, Regeneron Pharmaceuticals

Synopsis

• Discussing the role of PD1 in cutaneous skin cancers
• Presenting an overview of cemiplimab results in cutaneous skin cancers
• Examining the role of type 2 inflammation in atopic dermatitis and beyond

4:00 pm Autologous Gene Therapy for the Treatment of Dystrophic Epidermolysis Bullosa

Synopsis

• Outlining the scientific basis and mechanism of action for localized gene therapy for epidermolysis bullosa
• Describing meaningful clinical study endpoints and trial design to assess the safety and efficacy of the technology
• Identifying opportunities to advance gene therapy for cutaneous diseases

4:30 pm Filling Unmet Needs with Phyician Administered Treatments in Dermatology

Synopsis

• Assessing VP-102 in the treatment of Molluscum Contagiosum
• Discussing VP-102 in the treatment of HPV-induced skin diseases
• Examining the potential application of LTX-315 in Non-Melanoma Skin Cancer

5:15 pm Chair’s Closing Remarks

  • Ana Rossi Senior Medical Director, Global Medical Affairs Dermatology, Sanofi

5:30 pm End of Dermatology Drug Development Summit for Inflammatory Skin Diseases 2021