Immuno-Oncology Xchange
East Coast, Boston
May 17, 2022

Welcome to hubXchange’s East Coast Immuno-Oncology Xchange 2022, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in developing immuno-oncology therapies, through a series of roundtable discussions.
Discussion topics will cover Immune Biomarkers, Translational Research, Clinical Development, Combination Strategies and Next-Generation Therapies.
Take advantage of this unique highly interactive meeting format designed for maximum engagement and collaboration with your peers.

Please note this is an In-Person meeting with a hybrid option to join virtually.

VENUE DETAILS: Hilton Boston Woburn, 2 Forbes Road, Woburn MA 01801

Immune Biomarkers

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote: Immune Perspectives – Standing Back and Looking Forward

The immune system is possibly the most pleiotropic system constituting human biology. This coupled with the ever-increasing technological advancements in the field of immunology has generated a proverbial flood of knowledge relating to the immune systems involvement in almost of every aspect of human health and disease. Biopharmaceutical companies have harnessed the adaptability and power of the immune system to create multiple novel therapies that merely a decade ago would have been almost science fiction.

This presentation provides a perspective on the development of the field of immunology and also looks forward to opportunities that will generate further innovation.

Justin Devine

Chief Medical Officer, Synexa

Justin Devine co-founded Synexa Life Sciences in 2003 and is the current serving Chief Medical Officer of Synexa Life Sciences. Justin is a physician and has further degree qualifications in both immunology and pharmacology.

His primary focus is to understand and meet both the challenges and objectives in the drug development industry by designing biomarker strategies to bring real insight to the challenges of clinical development.

He is particularly passionate about improving the drug development process by bringing innovative approaches to early phase research, including new ideas in translational medicine, bioinformatics and artificial intelligence.

9:05 – 10:05am

Prognostic models: Integrated analysis of both spatial and multimarker information in the tumor microenvironment

Utility and risk of cell segmentation in image analysis
Hypothesis-generating vs hypothesis testing
Precision, Recall, and AUCROC
Regions of interest vs whole slide
Training and validation datasets

Michael Surace

Associate Director, Translational Medicine Oncology, AstraZeneca

Michael Surace, PhD, received a BS in Biology from James Madison University in 2004 before joining the Medical Automation Research Center in the Department of Pathology at the University of Virginia. He received his PhD from Virginia Tech in 2010. In 2015 he joined STCube Pharmaceuticals as a research scientist characterizing novel immune checkpoint inhibitor antibodies with multiplex immunofluorescesce and digital pathology image analysis to support mechanistic of action research. In 2017 he joined Medimmune/ AstraZeneca as a scientist developing and validating Multiplex IF panels. Since then he has continued developing mIF platform inside Translational Medicine Oncology, focusing on validation of panels, reproducibility across sites, and improving the image and data analysis pipelines for research and clinical trials to support the development of predictive and prognostic models incorporating multiple markers and spatial information.

10:10 – 10:40am

1-2-1 Meetings/Networking Break

10:40 – 11:10am

1-2-1 Meetings/Networking Break

11:10 – 11:20am

Morning Refreshments

11:20am – 12:20pm

Immuno-oncology biomarker discovery – Solutions for high-throughput & automation in screenings for gene and protein biomarkers?

How do you best screen and study the interplay between tumor and immune
response?
Importance of high-throughput assays for biomarker discovery, especially in pre-
clinical
Primary and secondary screening assays for Immune Biomarkers?

Stefan Jellbauer

Global Product Manager, Thermo Fisher Scientific

Stefan Jellbauer is a Global Product Manager at Thermo Fisher Scientific
supporting the high-throughput QuantiGene gene expression platform and Luminex
instruments. After 10 years in academic research, Stefan joined
Affymetrix/eBioscience, where he worked in the roles of Field Application Scientist and Technical Specialist with Affymetrix and Thermo Fisher Scientific. He continued his work in cancer diagnostic research with Farcast Biosciences as Technical liaison
supporting BioPharma business development for an ex-vivo human tumor platform. Stefan re-joined the QuantiGene team at Thermo Fisher Scientific as a Product Manager.
Stefan received his Ph.D. in Biology (Medical Microbiology/Immunology) from Ludwig Maximilian’s University of Munich (Germany), focusing on tumor vaccination. He completed his post-doctoral work at the University of California, Irvine studying mucosal
immunology and host-pathogen interactions.

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

Spotlight Presentation – Next-Generation Spatial Proteomic Advancements for Quantitative Analysis of the Tissue Microenvironment

Multiplexed Ion Beam Imaging (MIBI™) technology enables high-definition spatial proteomics that uniquely provides actionable analysis of the tissue microenvironment—delivering novel insights into disease state, mechanism of action, and patient response. Learn how MIBI and MIBI-enabled Spatial Proteomic Services deliver:

Identification and enumeration of cell populations
Quantification of protein expression at the single-cell level
Analysis of spatial interactions with unmatched depth

Tad Hewitt

Business Director, Ionpath

Tad Hewit is the Business Director for Spatial Proteomics Services at Ionpath. He has over 20 years of experience in translational research, both in the laboratory and in business roles. Tad’s business career has focused on bringing innovative translational research services to biopharma, and he has been involved with several technologies from their early stages—such as patient-derived xenograft (PDX) tumor models and multiplex tumor imaging— that have later become industry-standard tools. Tad has a BS in Biology from Hampden-Sydney College, an MS in Biotechnology, and an MBA from Johns Hopkins University.

1:55 – 2:55pm

Digital pathology workflows in a clinical setting

The current probability of success of a drug reaching the market from initial research is staggeringly low, only ~3%, how can workflows in digital pathology improve on these statistics? Will a multi-omics approach in clinical trials help?
What level of scientific validity do you believe is needed for a successful clinical trial? how good is the evidence today for the association between the biomarker and the clinical condition?
Can you discuss the practicalities and obstacles in implementing digital pathology workflows into a clinical setting, this would include antibody validation?
How can immunotherapy stakeholders work together so targeted treatment benefits can be seen by more patients-is the system broken?

Kirsty Maclean

Senior Director, Biomarker & Translational Strategy, Ultivue

Kirsty has 20 years of leadership experience addressing academic, clinical, biotechnology, clinical research organizations (CRO) and pharmaceutical industries through clinical/technical communication, sales support, and market intelligence. Most recently, Kirsty was instrumental in overseeing commercial applications for CodexDNA enabling rapid antibody development for vaccines and novel therapeutics using an automated cloning platform. Previously Kirsty held leadership roles in commercial development and scientific communications at Definiens (now part of AstraZeneca), Nanostring Technologies and ThermoFisher Scientific.

3:00 – 3:30pm

1-2-1 Meetings/Networking Break

3:30 – 4:00pm

1-2-1 Meetings/Networking Break

4:00 – 4:10pm

Afternoon Refreshments

4:10 – 4:40pm

Poster Session: Multi-omics approach and database generation for biomarker strategy in clinical trials

Decipher the complexity of the tumor biology
Get Insights from Tumor Microenvironment
Strengthen the biologic hypothesis supporting your clinical programs

Jacques Fieschi-Meric

Vice President R&D, Veracyte

Jacques Fieschi-Meric received his PhD in Immunology from the Aix-Marseille University completed by a postdoctoral fellowship at the Commissariat à L’Energie Atomique. He served as R&D group leader at Beckman-Coulter, then Head of Project Management at QIAGEN. Today he is VP in charge of R&D at Veracyte

5:45– 6:45pm

Canape/Drinks Reception

Translational Research

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote: Immune Perspectives – Standing Back and Looking Forward

This presentation provides a perspective on the development of the field of immunology and also looks forward to opportunities that will generate further innovation.

Justin Devine

Chief Medical Officer, Synexa

10:10 – 10:40am

1-2-1 Meetings/Networking Break

10:40 – 11:10am

1-2-1 Meetings/Networking Break

11:10 – 11:20am

Morning Refreshments

11:20am – 12:20pm

Early- stage characterization of immuno-oncology leads through in-vitro cell-based assays

From checkpoint inhibitors towards neoepitope vaccines, does one size fits it all?
Which functional assays; Types and Stages?
From early characterization towards clinical biomarkers
– Strengths & Limitations?
– Challenges?

Thibaut Lanss

Lead Scientist, ImmunXperts

Thibaut holds a Master’s degree in Biochemistry, Molecular and Cellular biology from the University of Liège. He received his PhD (2012-2016) at the GIGA research center in Liège, where he acquired a strong experience in the immunology field, working on dendritic cells and T cells interactions. During this period, he also developed an in-depth knowledge of flow cytometry. He joined ImmunXperts as a Senior Scientist at the beginning of 2017.

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

Spotlight Presentation – Next-Generation Spatial Proteomic Advancements for Quantitative Analysis of the Tissue Microenvironment

Identification and enumeration of cell populations
Quantification of protein expression at the single-cell level
Analysis of spatial interactions with unmatched depth

Tad Hewitt

Business Director, Ionpath

1:55 – 2:55pm

How to select the right translational screening model to monitor IO agents

What are the limitations with current translational strategies for assessing single vs. Combination efficacy with IO agents and how can we prioritize which combinations to test in the Clinic?
Pros and cons of complex invitro translational models e.g., organoids or PDE to screen IO agents and combinations
Are there any novel translational models that recapitulate I-O resistance mechanisms in clinic e.g., primary and acquired resistance to PD1/PDL1 blockade?

Niranjan Yanamandra

Scientific Director, GlaxoSnithKline

Niranjan Yanamandra, Ph.D, has 20+ years of experience in oncology/immuno-oncology in both academic and industrial settings and over 35 peer-reviewed publications. Niranjan is currently a Scientific Director in the Immuno-Oncology & Combinations Research Unit at GSK where he leads groups conducting biology and translational research on checkpoint axis inhibitors in the Immuno-Oncology pipeline and supported the progression of multiple programs into the clinic. Niranjan obtained his Ph.D. in Human Genetics and pursued his postdoctoral training in oncology and translational research at MD Anderson Cancer Center and Moffitt Cancer Center.

3:00 – 3:30pm

1-2-1 Meetings/Networking Break

3:30 – 4:00pm

1-2-1 Meetings/Networking Break

4:00 – 4:10pm

Afternoon Refreshments

4:10 – 4:40pm

Poster Session: How to select the right translational screening model to monitor IO agents

Introduction to InSituPlex® DNA-barcoding and antibody staining technology for multiplex fluorescence applications
How to make use of multi-parameter data within the TME – spatial mapping, dynamic range of expression, and co-localization of markers on individual cells
Case studies

Keith Wharton

Vice President, Medical Director, Ultivue

Keith is a board-certified human anatomic pathologist with diverse achievements in research, drug/diagnostic development, and clinical investigation. Leading Ultivue’s Pathology and Biomarker Analytics team, he brings expertise in investigative pathology, multiplex microscopy and imaging, and digital pathology to our customers striving to realize the promise of personalized medicine. Most recently he was Senior Medical Director of Leica Biosystems, and prior to that he led and supported R&D, toxicology, biomarker, and clinical study teams in multiple therapeutic areas at Biogen and Novartis Institutes for BioMedical Research.

He earned a BS in Chemical Engineering from the University of Arizona, and MD and PhD in Molecular Biology from UCLA, where he discovered the molecular basis of DNA recognition by bHLH-PAS transcription factors. Following internship and residency in Anatomic Pathology and fellowships in Autopsy Pathology and Developmental Biology at Stanford, his research lab at UT Southwestern established the Naked cuticle (Nkd) gene family as critical feedback regulators of Wnt/b-catenin signaling.

4:45 – 5:45pm

In vivo models for immunological MoA and biomarker strategies to predict patient response and aid patient selection

What is the predictive value of syngeneic models versus humanized mouse models for efficacy?
How translatable are predictive biomarkers identified in murine models?
Modelling cold tumors versus relapsed tumors

Aundrietta Duncan

Director, Non-Clinical Development, Salarius Pharmaceuticals

Aundrietta received her B.S. in Biology from Howard University and her PhD in Cancer Epigenetics from MD Anderson Cancer Center. With a passion for translational science, she has spent her career overseeing the translational development of diverse therapeutics including nano-particles, aptamers, and small molecules in development for oncology and neurological indications as well as infectious disease. As Director of Non-clinical Development at Salarius Pharmaceuticals, Aundrietta oversees all pre-clinical research of pipeline assets with the goal of expanding their utility by identifying the appropriate indications, patient populations, and biomarkers, and supporting regulatory submissions.

5:45– 6:45pm

Canape/Drinks Reception

Clinical Development

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote: Immune Perspectives – Standing Back and Looking Forward

This presentation provides a perspective on the development of the field of immunology and also looks forward to opportunities that will generate further innovation.

Justin Devine

Chief Medical Officer, Synexa

9:05 – 10:05am

Effective and efficient assessment of immunotherapy combinations in early-phase clinical studies

What are the optimal end points and designs for combination immunotherapy clinical trials
How should we identify hyperprogression patients early on?
How to optimize efficiency and minimize redundancy?
Complications of combining traditional immunotherapy with cell therapy?

Lulu Chu

Associate Director, Cell
Therapy Clinical Pharmacology,
Modeling & Bioinformatics,
Takeda

Lulu is currently an Associate Director at Takeda, leading cellular pharmacology and modeling activities in different allogeneic cell therapy programs. She holds a B.S. degree in Biomedical Engineering from University of Virginia and obtained her Ph.D. in Biomedical Engineering from the Johns Hopkins University. Upon PhD graduation, Lulu worked at AstraZeneca and Novartis in multiple therapeutic areas and is currently the Chair for Systems Pharmacology community in the American Society for Clinical Pharmacology and Therapeutics

10:10 – 10:40am

1-2-1 Meetings/Networking Break

10:40 – 11:10am

1-2-1 Meetings/Networking Break

11:10 – 11:20am

Morning Refreshments

11:20am – 12:20pm

Immune Biomarkers Topic: How biomarker databases can help Biopharma companies develop a successful biomarker strategy?

Designing the right content
Gaining insight from biomarker database
Setting up a biomarker strategy from early to late stage clinical trial

Catherine Gerbon

Marketing Director, Veracyte

Catherine Gerbon has 15+ years of experience in the field of oncology diagnostics. She started her career as Marketing Lead in Ipsogen, specialized in onco-hematology diagnostics. After 10 years, she joined the Personalized Healthcare Global Product Management team in Qiagen and worked on NGS portfolio for diagnostics applications. In 2015, she has been appointed as Marketing Director in HalioDx, and managed the commercialization of Immuno-oncology solutions for diagnostics applications like Immunoscore® as well as biomarker testing solutions for Biopharmas companies. She’s currently Strategic Marketing Director in Veracyte and manages the portfolio of services proposed to Biopharma companies.

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

Spotlight Presentation – Next-Generation Spatial Proteomic Advancements for Quantitative Analysis of the Tissue Microenvironment

Identification and enumeration of cell populations
Quantification of protein expression at the single-cell level
Analysis of spatial interactions with unmatched depth

Tad Hewitt

Business Director, Ionpath

1:55 – 2:55pm

Immune Biomarkers Topic: Exosomes: Saints and sinners’

Harnessing exosomes as highly pleotropic and valuable biomarkers in areas such as MoA and disease progression
Addressing the illicit anti-tumour properties of naïve-immune cell derived exosomes such as those from dendritic cells
Discussing how cancer cell derived exosomes have the opposite role and promote tumour growth and immune evasion
Measuring exosomes from liquid biopsies may provide valuable insight and serve as
prognostic biomarkers in the tumour microenvironment

Justin Devine

Chief Medical Officer, Synexa

3:00 – 3:30pm

1-2-1 Meetings/Networking Break

3:30 – 4:00pm

1-2-1 Meetings/Networking Break

4:00 – 4:10pm

Afternoon Refreshments

4:10 – 4:40pm

Poster Session: A high sensitivity, tumor-informed liquid biopsy platform, designed to detect minimal residual disease at part per million resolution

Tumor-informed liquid biopsy approaches have proven promising for detecting minimal residual disease (MRD) and recurrence of cancer following surgical resection or other therapy. However, current liquid biopsy MRD assays typically detect ctDNA in a range above 30 to 300 parts per million (PPM), leaving a significant fraction of MRD cases undetected, particularly soon after surgery and in early-stage cancers where ctDNA can be at very low levels. To address this, Personalis has developed NeXT Personal™, a tumor-informed liquid biopsy assay that achieves sensitivity down to 1 PPM, therefore enabling earlier detection of MRD and recurrence.

Erin Newburn

Senior Director, Field Applications Scientist, Personalis

Erin Newburn joined Personalis as a Field Applications Scientist in 2013 with over 13 years of research experience in the areas of molecular biology, genetics, and biotechnology. As the Sr. Director, Field Applications Scientist, Erin’s team has the responsibility of providing both pre- and post-sale technical support for the Personalis NeXT Platform including both the ImmunoID
NeXT and NeXT Personal solutions.
Erin completed her postdoctoral training at the National Institute of Mental Health (NIMH) investigating candidate susceptibility genes for major psychiatric illnesses. Erin received her Ph.D. from the Ohio State University in Integrated Biomedical Science as a Presidential Fellow.

5:45– 6:45pm

Canape/Drinks Reception

Combination Strategies

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote: Immune Perspectives – Standing Back and Looking Forward

This presentation provides a perspective on the development of the field of immunology and also looks forward to opportunities that will generate further innovation.

Justin Devine

Chief Medical Officer, Synexa

9:05 – 10:05am

Strategies for improving PD1-CTLA4 therapy tolerability

What concomitant therapy options are available to minimize or ameliorate immunotherapy toxicities?
Can the balance between toxicity and efficacy be managed by dose/schedule modifications?
Can we better predict which patients are more likely to have tolerability issues?
Other strategies to minimize toxicity through rational drug design of next generation immunotherapy?

Fiona Garner

Executive Director, Immuno-Oncology Clinical Development and
Translational Medicine,
Partner Therapeutics

Fiona Garner currently leads the Immuno-oncology Clinical Development and Translational Medicine group at Partner Therapeutics. She has extensive experience in oncology clinical development from first-in-human studies through registration and post-marketing studies. She has led clinical development programs at Constellation Pharma (pelabresib), Radius Health (elacestrant), Sanofi (isatuximab) and Novartis (erismodegib) which led to the approval of Erivedge®, Sarclisa®.

10:10 – 10:40am

1-2-1 Meetings/Networking Break

10:40 – 11:10am

1-2-1 Meetings/Networking Break

11:10 – 11:20am

Morning Refreshments

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

Spotlight Presentation – Next-Generation Spatial Proteomic Advancements for Quantitative Analysis of the Tissue Microenvironment

Identification and enumeration of cell populations
Quantification of protein expression at the single-cell level
Analysis of spatial interactions with unmatched depth

Tad Hewitt

Business Director, Ionpath

3:00 – 3:30pm

1-2-1 Meetings/Networking Break

3:30 – 4:00pm

1-2-1 Meetings/Networking Break

4:00 – 4:10pm

Afternoon Refreshments

4:45 – 5:45pm

Targeting exhausted cells – Ab -cellular therapy combinations

The T cell exhaustion mechanism of ICI therapy
Therapeutic strategy to overcome exhaustion.
How to maximize the therapeutic effects when Ab combined with cellular therapeutics

Kehao Zhao

Chief Scientific Officer, Elpis Biopharmaceuticals

Kehao Zhao, is the Co-founder and Chief Scientific Officer of Elpis Biopharmaceuticals. He and his company have developed proprietary mRNA Display technologies for antibody discovery and protein engineering. Through those technologies, he is leading a team to develop antibody and cellular immunotherapeutics that target and activate the immune response to eradicate tumors. Kehao was a senior investigator at Novartis Institutes for Biomedical Research leading antibody therapeutics platform and cancer epigenetics research. Previously, Kehao was a scientist at Procter & Gamble Pharmaceuticals. Kehao completed postdoctoral training in Gene Expression & Regulation at the Wistar institute and received his PhD from the Institute of Biophysics at the Chinese Academy of Sciences. Kehao has published over 30 scientific research papers.

5:45– 6:45pm

Canape/Drinks Reception

Next-Generation Therapies

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote: Immune Perspectives – Standing Back and Looking Forward

This presentation provides a perspective on the development of the field of immunology and also looks forward to opportunities that will generate further innovation.

Justin Devine

Chief Medical Officer, Synexa

9:05 – 10:05am

Utilising bi-specific and tri-specific killer cell engagers to improve NK cell therapeutic potential

What are key pharmacokinetic and pharmacodynamic properties for FIH dose determination of FIH of Bispecifics and Trispecifics?
How can model informed drug development aid in selecting bispecific and trispecific candidates?
Which preclinical models are the best predictors of clinical efficacy?
How well do nonclinical data translate to the clinical setting? Do binding affinity and selectivity translate to more efficacious BiKEs and TriKEs?

Angela James

Vice President, Head of Clinical Pharmacology, MacroGenics

Angela James is the Vice-Chair of Women in Bio and an accomplished scientist with expertise in drug development which she is currently applying in her role as Vice President, Head of Clinical Pharmacology, at MacroGenics Inc. Angela earned a B.A. in Biology from Rice University and a Ph.D. in Pharmaceutical Sciences with a research focus in Pharmacokinetic/Pharmacodynamic Modeling and Simulation from University of Maryland, Baltimore. She later received a M.S. in Pharmacometrics from University of Maryland, Baltimore.
As she gained experience as a Global Clinical Pharmacology Lead, her career trajectory led her to roles at Alcon/Novartis, Celgene and Astellas Pharma. As the Global Clinical Pharmacology Lead at Astellas Pharma, she designed and successfully lead the execution of the Clinical Pharmacology strategy, for the successful approval of XOSPATA® (gilteritinib) for the treatment of adult patients with relapsed or refractory AML with a FLT3 mutation. Prior to leaving Astella, Angela was a Global Development Project Leader and led cross-functional project teams to successfully execute on global strategies for the development of novel immuno-oncology agents including an innovative cancer vaccine.

10:10 – 10:40am

1-2-1 Meetings/Networking Break

10:40 – 11:10am

1-2-1 Meetings/Networking Break

11:10 – 11:20am

Morning Refreshments

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

Spotlight Presentation – Next-Generation Spatial Proteomic Advancements for Quantitative Analysis of the Tissue Microenvironment

Identification and enumeration of cell populations
Quantification of protein expression at the single-cell level
Analysis of spatial interactions with unmatched depth

Tad Hewitt

Business Director, Ionpath

3:00 – 3:30pm

1-2-1 Meetings/Networking Break

3:30 – 4:00pm

1-2-1 Meetings/Networking Break

4:00 – 4:10pm

Afternoon Refreshments

4:45 – 5:45pm

CAR therapy – applications in solid tumours and moving beyond autologous T cells for CAR products

CAR dosing considerations
CAR therapy challenges associated with solid tumors
CAR engineering beyond T-cells

Anwesha Chaudhury

Senior Principal Pharmacometrician, Novartis

Anwesha Chaudhury is currently a senior principal pharmacometrician at Novartis in Cambridge, MA. Prior to joining Novartis in 2018, she completed her postdoctoral training in Systems Biology at Harvard Medical School and Massachusetts General Hospital. She is trained as a Chemical Engineer, and completed her Ph.D. from Rutgers University after getting her Bachelors and Masters degrees from India. During her Ph.D. and postdoc, Anwesha has received several awards and fellowships including the prestigious Life Sciences Research Fellowship. Currently, Anwesha is supporting the early development pipeline of oncology drugs at Novartis, primarily focused on antibodies and cell therapy.

5:45– 6:45pm

Canape/Drinks Reception

Immuno-Oncology XchangeEast Coast, BostonMay 17, 2022

Immune Biomarkers

Partners

Immuno-Oncology Xchange
East Coast, Boston
May 17, 2022