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
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
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
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
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
5:20 Taste of New England Welcome Reception in the Exhibit Hall with Poster Viewing
5:25 Meet the Plenary Keynotes
6:35 Find Your Table, Meet Your Moderator
6:40 Breakout Discussion Groups
7:30 Close of Day
Wednesday, June 19
7:00 am Registration Open and Morning Coffee
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
10:05 Poster Winner Announced
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
2:20 Booth Crawl and Dessert Break in the Exhibit Hall with Poster Viewing
2:25 Meet the Plenary Keynotes