US Immuno-Oncology Xchange 2018
FULL AGENDA

IMMUNE BIOMARKERS Track

Time
Topic Title and Bullets
Facilitator

09:00-10:00

Developing predictive biomarkers for immunotherapies to identify mechanisms of resistance
• Clinically relevant model systems assays to predict biomarkers of resistance and activity
• Patient selection biomarkers and stratification to enhance clinical benefit
• Understanding failure of response to PD1 treatment to enable viable combinations

Roopa Srinivasan,
Senior Director, Head of Translational Research, Immuno-Oncology R&D, GlaxoSmithKline

10:30-11:30

Can proteomics enable immuno-oncology biomarker discovery?
• The use of Thermal Proteome Profiling to map cellular pathways
• Direct and indirect target engagement quantification
• Predictive biomarker identification and validation

Michael Dabrowski,
Chief Executive Officer,
Pelago Bioscience

12:00-13:00

Bridging the knowledge gap between real-world adaptation of I-O treatments and reliable biomarkers to ensure safe and effective use of this therapy class
• Potential value of biomarkers for different purposes in I-O
• Proper identification and qualification of biomarkers in I-O
• Where is the gap, using PD-L1 as an example, and how can it be filled?

Abdel Halim,
Vice President, Translational Medicine,
Biomarkers & Diagnostics, Celldex Therapeutics

15:15-16:15

Identifying and validating predictive biomarkers for combined immunotherapy and targeted therapy
• How do targeted proteomic biomarkers of treatment efficacy tell us what genetics alone cannot?
• How can we develop fast high-specificity diagnostic assays for protein drug targets?
• How can we use multiplexed pathway-driven proteomics and metabolomics panels to identify treatment targets and mechanisms of resistance?
• How does reproducible protein quantitation, with isoform and phosphorylation information, help avoid validation pitfalls?
• How do we gain insight by going beyond cytokine levels?

Christoph Borchers,
Chief Scientific Officer,
MRM Proteomics

16:20-17:20

Challenges and opportunities for pharmacodynamic biomarkers in IO to help inform clinical dosing decisions
• How to tackle a 10x problem – identifying biomarkers for response
• Microbiome Yes / No, when and how
• Tumor-based markers: TILs, mutational load, T-cell repertoire
• Biomarkers for toxicity?
• Interaction tumor and microenvironment

Stefan Scherer,
Vice President, Head Early Development,
Strategy & Innovation,
Novartis

TRANSLATIONAL RESEARCH Track

Time
Topic Title and Bullets
Facilitator

9:00-10:00

How to select right translational models to quantitatively monitor and characterize IO therapeutic agents
• Is there a biased focus toward the improvement of patient selection schemes and is this helping or impeding our progress?
• No model is perfect: How do we apply “fit-for-purpose” validation of current models to immunotherapy drug development?
• Emerging immune biomarker technologies and the vision for quantification (from high throughput genomics to immune monitoring cytometry)

Maria Karasarides,
Executive Director, Immuno-Oncology,
Regeneron Pharmaceuticals

10:30-11:30

Technology for effective translational research
• Mechanism of action/proof of biology
• Modeling clinical response (efficacy)
• Deficiencies/strengths in existing models

Mark Paris,
Associate Director, Translational Applications,
Mitra Biotech

12:00-13:00

Evaluating the efficacy of human PD-1 targeting antibodies in humanised mouse models
• Which subsets of immune cells provide the best indicator of the mechanism of action in these model systems?
• How closely do the cell populations actually reflect and correlate to human immune cells?
• What do the next generation of mouse models look like?
• Which new IO targets are the leading candidates for development and validation by these models?
• How does the FDA and other regulatory agencies view the mouse model as part of a pre-clinical data package?

William Hearl,
President & Chief Executive Officer,
Immunomic Therapeutics

16:20-17:20

How to better predict anti-tumor efficacy and toxicity associated with immune cells genetically engineered with CARs and TCRs
• Are in vitro assays predictive of CAR/TCR efficacy and toxicity in patients?
• Are animal models useful in understanding CAR/TCR efficacy and toxicity?
• If in vitro and animal models are not predictive of T cell efficacy and safety, how does the field choose clinical candidates for their trials?

Ildiko Csiki,
Vice President, Clinical Development,
Immuno-Oncology, Inovio Pharmaceuticals

CLINICAL TRIALS Track

Time
Topic Title and Bullets
Facilitator

9:00-10:00

Developing new clinical endpoints for immuno-oncology studies
• How has our thinking of the mechanism of action of immune agents changed our thinking of clinical endpoints in general?
• What does the tail of the survival curves (PFS and OS) how we should define “clinical benefit?”
• What is the optimal study design with which to define a maximally tolerated or biologically effective dose?
• How can we leverage predictive biomarkers into our studies now?

Jeffrey Skolnik,
Vice President Clinical Development,
Inovio Pharmaceuticals

10:30-11:30

Using predictive analytics to accelerate the success of your clinical operations
• Why have true leading indicators of clinical trial performance not been routinely captured?
• How can you use predictive analytics to better select and manage clinical service vendors?
• What can you do to Increase investor, investigator, and internal confidence in your ability to meet deadlines and budgets?
• Where can you make changes that advance your ability to recruit and retain patients.
• Why is creating a data-driven clinical operations culture important, why you don’t have one, and how can you get one?

Peter Malamis,
Chief Executive Officer,
CRO Analytics

12:00-13:00

Highly complex early-phase studies with adaptive designs and multi-arm trials requires flexibility
• What are the appropriate statistical designs for early phase IO phase 1 studies?
• What are appropriate expansion rules and when should biopsies be mandated?
• What should change when combinations are to be tested rather than monotherapy?
• How do we advance IO agents in checkpoint-naive patients?

Teng Jin Ong,
Vice President,
Medical Affairs, Celgene

15:15-16:15

Determining patient selection and eligibility
• How can patient ineligibility rate be reduced by modification of entry criteria (prior IO therapy exposure, need for pathology samples, biomarker criteria)
• What can be done to make it easier for patients to participate (financial burden, lifestyle impact)?
• How to overcome physician nihilism (perceived barriers to study site referral, lack of trial knowledge)

Harish Dave,
Chief Medical Officer,
Accelovance Inc.

16:20-17:20

Can OS still be measured given crossovers in trials? What measures best represent OS?
• What role will PFS continue to play?
• Some CPIs have been conditionally approved based on ORR: can a similar strategy also be pursued in an earlier setting?
• Is there a need to validate some surrogate endpoints for OS to continue the development of immuno-oncology agents? What would be the most effective approach to do so? Would it still require to be indication specific?

Cristian Massachesi,
Vice President Asset Team Leader,
Immuno-Oncology,
Pfizer

IMMUNOTHERAPIES Track

Time
Topic Title and Bullets
Facilitator

09:00-10:00

Where do cancer vaccines fit in the current landscape of immunotherapies? How to  move them from “promising” to “effective”?
• Overcoming the challenges posed by immune evasion
• How to ensure continuous improvement in the algorithms for neoantigen vaccines?
• Can posttranslational modifications be used as a vaccine target
• Best approaches to identifying pharmacodynamics (PD) biomarkers to assess response
• How to best determine when and what combination therapy is best to administer along with the vaccine

Cori Gorman,
Vice President Precision Medicine
& Manufacturing,
Agenus Bio

12:00-13:00

Developing CAR-T technologies to overcome immune evading mechanisms of tumours
• What are the key tumor suppressive mechanisms that prevent CAR-T cell activity (e.g. immune checkpoints, cytokines, metabolism)?
• How to design CAR T cells to resist the TME?
• How to enhance CAR T cell activity and engage the host anti-tumor immune response?
• How can CAR T cells be used to solve the problem of tumor heterogeneity?
• What are the potential challenges with these approaches?

Charles Sentman,
Professor, Microbiology &
Immunology,
Dartmouth Medical School

15:15-16:15

Will bispecific antibodies dethrone monotherapy for treating cancer?
• Is redirecting T-cells with bispecific antibodies safer than CAR-T cell therapy?
• Is the complexity of bispecific antibodies hindering their development over conventional antibodies?
• Beyond CD3 bispecifics, what is the future for discovering new targets as we understand more about tumor biology?

Yasmina Abdiche,
Chief Scientific Officer,
Carterra

16:20-17:20

Addressing optimal timing and sequencing of immune checkpoint inhibition
• Does tumor burden impact response to immune checkpoint inhibitors (ICI)?
• Does the timing of radiation therapy relative to ICI matter? Chemotherapy?
• Will NeoAdj ICI improve outcomes in resectables tumors compared to adjuvant only?
• What is the optimal duration of ICI for stage 4, stage 3 unresectable and in the adjuvant setting?

Kevin Horgan,
Vice President, Global Medicine Leader – Immuno-Oncology,
AstraZeneca

COMBINATION THERAPIES Track

Time
Topic Title and Bullets
Facilitator

09:00-10:00

Next generation I-O combinations for cancer
• Is there a preferred agent capable of converting non-inflamed tumors into inflamed ones to synergize the activity of PD-1/ PD-L1 inhibtion?
• How much preclinical evaluation is needed for new IO-combos?
• How do we optimize trial design to evaluate optimal dose and schedule for combination agents, which may differ across distinct indications?
• Are we ready to test triple I-O combinations?
• What is the next I-O backbone agent to be tested beyond PD-1/PD-L1 blockade?

Andres Guiterrez,
Chief Medical Officer,
Oncolytics Biotech

10:30-11:30

Implementing strategies to tackle resistance to anti-PD-1/PD-L1 therapies
• Combination approaches to overcome primary resistance to PD-1/PD-L1
• Combination approaches to address acquired resistance to PD-1/PD-L1
• How should we define acquired resistance to PD-1/PD-L1?
• Should PD-1/PD-L1 therapies be part of the combination regimen in the acquired resistance setting?

Patrick Mayes,
Executive Director, Head of
Immuno-Oncology Antibody Research,
Incyte Corporation

12:00-13:00

How to prioritise which combinations to use during development
• As pre-clinical models in immune-oncology are poorly predictive of efficacy, what other measures should be used to determine appropriate combinations to develop?
• How important is the regulatory requirement to demonstrate the contribution of each component in a combination?
• Are data with combinations translatable across agents of the same class?
• How will one combination be measured against another if not directly compared?

Harry Raftopoulos,
Vice President, Translational Medicine
– Immuno-Oncology,
Bayer

15:15-16:15

Rational design of combination approaches
• Differential response versus amplification
• Patient stratification and or biomarker ID (molecular, preclinical modelling)
• Selecting/identifying complementary biology
• Methods for predicting response ahead of clinical testing

Mark Paris,
Associate Director, Translational Applications,
Mitra Biotech

16:20-17:20

Strategies to optimize combination therapy
• Triple combination approaches
• Prevention of IR-AEs in PD1 /CTLA4 inhibitor combination
• Prevention of IR-AEs and CIN in PD1/chemotherapy combination
• Oral IO agents with shorter half lives to better manage IR-AEs

Ramon Mohanlal,
Executive Vice President, Chief Medical Officer,
BeyondSpring Pharmaceuticals