Cambridge Healthtech Institute’s 3rd Annual

Emerging Immuno-Oncology Targets and Modalities

Next-Generation Targets and Modalities for Cancer Immunotherapy and Combinations

June 19-20, 2019  


While cancer immunotherapy has made a giant leap in the past five years, the majority of therapies at advanced stages of development are clustered in a similar target space. The increased investment in immuno-oncology has created an urgent opportunity to discover and populate new target spaces and develop new modalities that either present new classes of immunotherapies or can be used in combination with existing products. Cambridge Healthtech Institute’s 3rd Annual Emerging Immuno-Oncology Targets and Modalities conference will cover the emerging target space, including immunomodulatory inhibitor and agonist targets, stromal and immune cell targets, and strategies for rational combination immunotherapy. Emerging modalities, including adoptive T cell therapy, oncolytic virus immunotherapy, personalized cancer vaccines, and next-gen engineered protein constructs will be discussed. Case studies of preclinical and translational approaches to the discovery and validation of new immuno-oncology targets and combinations will be presented.

Final Agenda

Tuesday, June 18

7:00 am Registration Open and Morning Coffee

NEXT-GENERATION CLINICAL TRIALS IN ONCOLOGY

8:00 Chairperson’s Remarks

Nikolas T. Weissmueller, PhD, Associate Director, Strategic Options & Assessment, Business Insights & Analytics, R&D, Bristol-Myers Squibb


8:10 KEYNOTE PRESENTATION: Harnessing the Power of the Immune System: Lessons Learned from the Pembrolizumab Story

Jonathan Cheng, MD, Vice President & Oncology Therapeutic Area Head, Merck

Drug development in oncology has seen a rush of clinical trials given the emergence of checkpoint inhibitors in the oncologist’s armamentarium and the continued promise of immunotherapy. This has led to unprecedented opportunities resulting in a plethora of clinical trials with various designs and approaches. The lessons learned from the development of pembrolizumab will be discussed, in particular learnings in how to register a new drug quickly, the potential uses of a biomarker, and how to approach combinations for future development.

8:40 Next Generation Clinical Trials in Oncology

Patricia LoRusso, MD, Associate Center Director, Innovative Medicine, Yale Cancer Center

9:10 ASCO TAPUR Study and Implementing Precision Medicine

Edward S. Kim, MD, Chair, Solid Tumor Oncology and Investigational Therapeutics,Levine Cancer Institute, Donald S. Kim Distinguished Chair for Cancer Research, Atrium Health

Emerging approach for disease treatment and prevention that takes into account

individual variability in genes, environment, and lifestyle for each person.

9:40 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

10:25 Implementing Patient-Specific Immunotherapy Using an Adaptive Clinical Study Design

Andrew Ferguson, PhD, Director, Clinical Science, Gritstone Oncology, Inc.

Development of patient-specific immunotherapies to generate neoantigen-specific T cells that control tumor growth requires unique study design considerations. These include the choice of immunotherapy platform, treatment setting to enable manufacturing of patient-specific therapies, dose selection, and combination treatments. Gritstone’s first clinical study uses an adaptive design for dose selection in combination with checkpoint blockade to provide an efficient assessment of the safety, immunogenicity, and clinical activity of patient-specific immunotherapy.

10:55 Value-Based Clinical Trials in Immuno-Oncology

Nikolas T. Weissmueller, PhD, Associate Director, Strategic Options & Assessment, Business Insights & Analytics, R&D, Bristol-Myers Squibb

The development of IO combination therapies requires making multiple complex design choices at speed. Throughout development, many key value drivers are uncertain, interconnected, and hinge on the broader market. A structured evaluation of the evidence and the strategic options can quantify value trade-offs and help generate clarity of action for the decision maker.

11:25 Sponsored Presentation (Opportunity Available)

11:55 Transition to Lunch

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:30 Session Break

ADVANCES IN PATIENT SELECTION

1:05 Chairperson’s Remarks

Bruno Gomes, DVM, PhD, Global Head of Biomarkers Oncology, Roche

1:10 Challenges and Opportunities for Biomarkers in Early Clinical Development

Bruno Gomes, DVM, PhD, Global Head of Biomarkers Oncology, Roche

The presentation will present the opportunities and challenges in developing impactful biomarker strategies for early clinical development of new immuno-oncology drugs. We will focus on the design of fit-for-purpose entry into human clinical trials, proof or dis-proof of mechanism of action and optimal biological dose finding.

1:40 Maximizing Specimen Assets in Immuno-Oncology Clinical Trials

Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories

Immuno-oncology clinical trials have shifted toward more innovative clinical trial designs such as; Basket, Umbrella, and Adaptive methodologies that create increased complexity and demands on supporting functions. These trial designs are frequently biomarker intensive and need to be managed with a specimen-centric perspective to maximize collected bio-specimen assets. Innovative bio-specimen management approaches are becoming an essential part of empowering clinicians and researchers to better understand the individualized connections between biomarkers and human disease.

2:10 Sponsored Presentation (Opportunity Available)

2:25 Refreshment Break in the Exhibit Hall with Poster Viewing

IO PLENARY SESSION: PARTNERING ECOSYSTEM

3:10 PANEL DISCUSSION: Partnering, Preclinical Strategies and Tools, IO Clinical Trials; Capital Invested in IO Relative to Other Oncology Areas

Moderator: Leigh Zawel, PhD, CSO, Cullinan Oncology

Panelists:

Michael Woo, Director, Head of Immuno-Oncology Search & Evaluation, External Innovation, EMD Serono, Inc.

Sybil Williams, PhD, Director, Biology Oncology Discovery, Merck

Paul Young, PhD, Executive Director, Business Development & Licensing, Merck

Jernej Godec, PhD, Associate, Apple Tree Partners

Stacey J. Adam, PhD, Director, Cancer Research Partnerships, Foundation for the National Institutes of Health

Peter Bergethon, Vice President, Quantitative Medicine & Clinical Technologies, Biogen

  • Has the IO bubble popped? Why have no other IO drugs emerged with PD1/PDL1-like efficacy?
  • What combination strategies are being explored to convert poorly PD1 responsive tumors to more responsive ones?
  • Are there new IO monotherapies or combos that appear promising?
  • Is patient stratification practical with IO therapies?
  • What partnering strategies are most effective?
  • What is a recent deal your firm signed that you’re excited about?

4:10 Transition to Keynote


4:20 PLENARY KEYNOTE SESSION View details

5:20 Welcome Reception in the Exhibit Hall with Poster Viewing

6:35 Find Your Table, Meet Your Moderator

6:40 Breakout Discussion Groups View details

7:30 Close of Day

Wednesday, June 19

7:00 am Registration Open and Morning Coffee

OPERATIONAL CHALLENGES AND SAFETY CONSIDERATIONS

8:00 Chairperson’s Remarks

Justin Fairchild, Executive Director, Clinical Development, Parker Institute for Cancer Immunotherapy

8:05 Digitalization of Clinical Trials in Immuno-Oncology

Jill Loftiss, Head, Clinical Operations & Oncology, MedImmune

It is becoming increasingly valuable to leverage digital technology in a clinical trial environment to differentiate therapy, provide rapid insights and provide patientcentric solutions. This talk will aim to discuss how to move beyond ongoing digital health “pilot-itis” and describe the ecosystem of functions and capabilities that are needed to scale the use of digital technologies in clinical operations

8:35 Characterization of the Safety Profile of Immune-Cancer Therapies in a Changing Environment

Céline Adessi, PhD, Senior Group Director, Product Development, Safety Science Oncology, Licensing and Early Development, F. Hoffmann-La Roche

The presentation will cover key aspects of the current paradigm shift in cancer therapy. The requirements of the characterization of the safety profile of immune therapies, particularly used in combination, are evolving. The emergent novel toxicities and the need of long term follow up of toxicities are impacting the dose finding process compare to conventional chemotherapies. In this context the benefit-risk balance evaluation will be addressed.

9:05 Sponsored Presentation (Opportunity Available)

9:35 Coffee Break in the Exhibit Hall with Poster Viewing

COMBINATION COLLABORATIONS

10:20 Oncology Immunotherapy Combinations: Relationships between Companies

Lena Frank, Executive Director, Alliance & Program Management, Eisai

With the huge number of oncology combination studies currently ongoing, many companies are still in the process of figuring out the best practices for these combination studies and resulting filings. The management for combination studies with a collaborator may require different thinking, especially in the areas of study conduct, regulatory interactions and submissions, and commercialization.

10:50 The Parker Institute’s Collaborative and Integrated Approach to Immuno-Oncology: Innovative Clinical Trials

Justin Fairchild, Executive Director, Clinical Development, Parker Institute for Cancer Immunotherapy

The Parker Institute for Cancer Immunotherapy’s mission is to accelerate the development of breakthrough immune therapies to turn cancer into a curable disease. Through collaborative partnerships in both industry and academia, innovative trial designs, and integration of clinical and correlative datasets, Parker is advancing the understanding of novel immuno-oncology combinations.

11:20 PANEL DISCUSSION: Combination Collaborations in Immuno-Oncology Clinical Trials

Moderator: Lena Frank, Executive Director, Alliance & Program Management, Eisai

Panelists: Speakers of the Day

  • How do combination collaborations require different thinking from a relationship that involves a single compound?
  • What potential strategies should be reviewed prior to entering into a combination collaboration?
  • What specific areas will potentially need new best practices as compared to monotherapy collaborations?

11:50 Transition to Lunch

12:00 pm Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:30 Transition to Plenary


12:50 PLENARY KEYNOTE SESSION View details

2:20 Dessert and Coffee Break in the Exhibit Hall with Poster Viewing