Immuno-Oncology Xchange West Coast 2018

Immuno-Oncology

Time

Titles and Bullets

Facilitator

9:00am – 10:00am

The challenges of validating complex immune biomarkers for clinical trials

What are the most common I-O biomarkers implemented in clinical trials and what are the challenges/ considerations to validate them” fit for purpose”?
What level of oversight is needed for analyzing biospecimens and what are the required Trial Master File (TMF) documents?
How do we get the vendors to validate assays in disease representative, matrix specific, samples? How do we reduce vendor resistance to providing required TMF documents in appropriate submission ready format?

Iman Jilani

Director, Early Development & Translational Immuno-Oncology
Pfizer

12:00pm – 1:00pm

What are the differentiators between the various Antibody platforms?

Why do antibodies from animals dominate the commercial and clinical pipelines?
What drives the selection of an antibody technology?

Bjorn Hock

Vice President
Biologics Technologies & Development
Ferring

10:30am – 11:30am

Protein biomarkers for response to immunotherapy.

How to best identify predictive or early prognostic biomarkers of immune response in plasma?
How effective is using a proteome-wide approach to reveal immune system interaction with checkpoint inhibitors and the biology behind resistance?
Blood specific protein markers: does it offer great potential to overcome immune related adverse events (irAE) associated with immunotherapies?
Can we better understand the effects of mono versus combined treatment strategies based on early response plasma biomarkers?

Marijana Rucevic

Senior Principal Scientist, Immunotherapy
Olink Proteomics

12:00pm – 1:00pm

Developing predictive biomarkers for immunotherapies to identify mechanisms of resistance.

Summarise current in vitro and in vivo biomarkers currently being used in IO trials
Discuss the dynamics of IOT therapies, time to engagement, targeting of cancer cells, T-cells and other immunomodulating cells. When does T-cell influx occur? When does T-cell inhibition occur?
Is pseudo-progression an issue in IOT?
What are the top 3-5 biomarkers that should be used to help with evaluating of IOT therapy?

Ian Wilson

Chief Operating Officer
ImaginAB

3:20pm – 4:20pm

Protein and metabolite quantitation for identifying and validating predictive biomarkers of patient response to cancer therapies.

Where do discovery proteomics and phosphoproteomics fit in the drug development pipeline?
What is the value of targeted precise protein quantitation, with isoform and phosphorylation information, for biomarker identification?
How can we use pathway-driven proteomics and metabolomics panels to identify treatment targets and mechanisms of resistance?
How do quantitative approaches help to avoid validation pitfalls?
Can high-specificity diagnostic assays for protein drug targets complement IHC-based approaches?

Christoph Borchers

Chief Scientific Officer
MRM Proteomics

4:20pm – 5:20pm

Strategy of biomarker selection for predicting the efficacy of combining immunotherapy with targeted therapy.

Current potential biomarkers for checkpoint inhibitors
Mapping the MOA of the targeted therapy to the hallmarks of cancer
Assessment of in-scope technology platforms for biomarker discovery
Implementation of appropriate biomarker sample collection plans

Yu Liang

Director, Clinical Biomarkers
Calithera Biosciences

Translational Research

Time

Titles and Bullets

Facilitator

9:00am – 10:00am

How to select right translational models to quantitatively monitor and characterize I-O therapeutic agents

What are the best preclinical models for development of immuno-oncology therapeutics?
What is the role of murine models (syngeneic and humanized immune system) in the prosecution of immuno- oncology drug programs?
What preclinical data is needed to confidently move immuno-oncology therapeutics to the clinic?

Leslie Sharp

Vice President of Immuno-Oncology
BioAtla

10:30am – 11:30am

Technology for effective translational research.

Mechanism of action/proof of biology
Modeling clinical response (efficacy)
Deficiencies/strengths in existing models

Mark Paris

Director, Translational Applications
Mitra Biotech

12:00pm – 1:00pm

Evaluating human PD-1 targeting antibodies and PD1 refractory tumors in animal models.

What is the role of myeloid and stromal cells in PD-1 refractory disease in humans and animal models?
Can T cell exhaustion be reversed?
Which membrane or soluble factors should be targeted to overcome PD-1 refractory disease?
Can mouse models fully recapitulate PD-1 non-responsiveness in humans?

Wim Van Schooten

Chief Scientific Officer
TeneoBio

3:20pm – 4:20pm

The use of in vitro assays to accelerate cancer immunotherapy development and reduce the risk of unwanted immunogenicity.

Which tools do you use to select and optimize the best leads before going into (pre)clinical development?
Which in vitro assays best mimic in vivo situations, taking into account IO-specific factors like tumor micro-environment?
What are the biggest risk factors of development you want to rule out in your ultimate lead selection?

Sophie Pattijn

Founder & Chief Technology Officer
ImmunXperts

4:20pm – 5:20pm

Critical issues in translational development of cellular therapies

Transformative potential
Targets
Accessory modifications
Logistics

Matthew Spear

Chief Medical Officer
Poseida Therapeutics

Clinical Trials

Time

Titles and Bullets

Facilitator

9:00am – 10:00am

Clinical operations best practices for cell-based immuno-oncology trials

What is the role of clinical operations during the protocol development and planning stages?
How can clinical operations manage the unique logistical complexities of cell-based investigational product?
What project management tools are most critical for ensuring a successfully executed cellular therapy trial?

Joseph Shan

Head of Clinical and Regulatory Affairs
CytoSen Therapeutics

10:30am – 11:30am

Translational Research Topic: A multi-disciplinary information management system in translational research

Translational Research is a multi-disciplinary field involving basic research, clinical research and population research – Do you have systems in place to manage the complex workflow and data requirements of such an undertaking.
Does your enterprise have an integrated translational research data platform using common ontologies? If yes what are the most commonly used ontologies?
Do you use genomics data or any type of molecular pathology data as part of the translational research. If yes, is your phenotype data merged with your genotype data?
Do you have a visibility to your samples? Where are they stored or where they are in the workflow?
Do you have full provenance between the final experiment results to the stored samples and all the wet lab and informatics processes in between them?

Vasu Rangadass

President & Chief Executive Officer
L7 Informatics

12:00pm – 1:00pm

Highly complex early-phase studies with adaptive designs and multi-arm trials requires flexibility

What is the optimal design of trials to prove the efficacy of second generation I/O therapeutics?

What are the biomarker platforms of greatest interest?

What are the most interesting second generation targets?

What are the most interesting developments in cell based therapeutics?

What are the most interesting therapeutics designed to enhance antigen presentation?

Charles Theuer

CEO
Tracon Pharmaceuticals

3:20pm – 4:20pm

Translational Research Topic: Relevance of current animal models for translational drug discovery in immuno-oncology.

What are the advantages and limitations of syngeneic models
Utility of humanized models (PBMC engrafted versus CD34 HSC engrafted).
What are the next gen models for combination therapies: GEMMs.
What is more important: efficacy or PD to move a drug discovery program forward?

Jayant Thatte

General Manager
Crown Bioscience San Diego

Immunotherapies

Time

Titles and Bullets

Facilitator

9:00am – 10:00am

Cancer Immunotherapy: Where do we go next?

What changes occur in the immune system after immunotherapy and what can we learn from them?
How are we going to overcome resistance to immunotherapy (either intrinsic or extrinsic)?

Norman Greenberg

Chief Scientific Officer & Senior Vice President
Atreca

10:30am – 11:30am

*Immune Biomarkers Topic*: Understanding and predicting patient response to advanced immunotherapies through tissue analysis

How will the next generation of advanced immunotherapies drive the need for better tissue analysis?
What is the role for data-driven approaches in understanding and stratifying populations?
How will clinicians adopt advanced tissue-based diagnostics?

Joe Krueger

Chief Science Officer
Flagship Biosciences

12:00pm – 1:00pm

How to overcome immunosuppressive TME impairment of T-cells in the development of cancer immunotherapies.

What are the major mechanisms of suppression in TME for effective T cell activity against tumor cells and how to best target each mechanism?
What is the nature of T cell exhaustion in TME and how can they be reactivated?
How TME participate in resistance of PD1/PDL1 inhibitors and what are the solutions – rational design of combination therapy?
How TME suppression affect CAR-T or TCR-T’s efficacy in solid tumor and what are the most promising solutions?

Haining Huang

Vice President, Drug Discovery
ACEA Therapeutics

4:20pm – 5:20pm

Where do cancer vaccines fit in the current landscape of immunotherapies? How to move them from “promising” to “effective”?

Overview of cancer vaccines landscape; what are the technologies/assets reaching the clinic now?
Self-antigens strategies: can we break tolerance? What are the promises?
Neo-antigens: are they limited to personalized vaccines?
What are the key combinations to enable successful cancer vaccinations?

Sylvaine Cases

Vice President Oncology, Scientific Innovation
Janssen Pharma

Combination Therapies

Time

Titles and Bullets

Facilitator

9:00am – 10:00am

Determining whether IO-IO or IO-chemotherapy is more effective?

What is the distinction between IO-IO and IO-Chemotherapy?
What are some of the key published combination studies and what do they tell us?
Can we predict which patients will respond to combination therapy versus monotherapy?
What can pre-clinical models tell us about the relative effectiveness of combination therapies?

Gary Starling

AVP MRL Biologics & Vaccines Discovery
Merck

12:00pm – 1:00pm

Implementing rational combination strategies leveraging IO-IO, IO-Targeted and IO-chemo to bring durable responses and/or “cures”

Multiple new therapeutic options for exploratory trials, excitement for “new” therapies; how do we prioritize?
Best approaches to combine small molecules & biologics
Methods to understand and tackle resistance and implement upfront combination strategies
Implement better patient selection strategies and improve biomarker read-out across broader clinical sites?
Challenges & opportunities of novel-novel combinations?

Shailaja Kasibhatla

Director, Translational Development
Celgene

3:20pm – 4:20pm

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

Director, Translational Applications
Mitra Biotech

4:20pm – 5:20pm

Implementing strategies to tackle resistance to anti-PD-1/PD-L1 therapies.

Are there any common underlying mechanisms for anti-PD-1/PD-L-1 resistance across cancer indications?
Are the mechanisms for primary resistance to anti-PD-1/PD-L1 similar or different from those seen in acquired refractory tumors?
Is combination therapy the preferred strategy to tackle anti-PD-1/PD-L1 resistance?

Xiadong Yang

President & CEO
Apexigen

Immuno-Oncology Xchange West Coast 2018

Immuno-Oncology

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