IMMUNO-ONCOLOGY XCHANGE
EUROPE 2022
Zurich, November 23

Welcome to hubXchange’s Europe 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.

VENUE DETAILS: Hilton Zurich Airport Hotel, Hohenbuehlstrasse 10 – 8152 Opfikon, Switzerland

Immune Biomarkers

Time

Titles and Bullets

Facilitator

8:00 – 8:30

Registration

8:30 – 9:00

Opening Address & Keynote Presentation:

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 is a medical doctor, immunologist and pharmacologist and a co-founder and CMO of Synexa. His primary focus is to understand our clients’ objectives in new drug development and to implement biomarker strategies that bring real insight to the challenges of clinical development and the immunological underpinning of health and disease.

9:05 – 10:05

Predictive biomarkers for IO treatment used in clinical practice now and in the future

In which cases is patient selection/testing necessary?
Which assays to use for which IO drug for which indication?
When to test for immune biomarkers?

Regula Deurloo

Medical Affairs Biomarker Leader in the Oncology Biomarker Development Group, gRED Translational Medicine, Roche

Regula has 14 years of experience in Pharma Development and is leading the Medical Affairs Biomarker Team in Basel since 2016. She is responsible for the implementation of the biomarker and CDx strategy specifically in the breast and GYN cancer disease area. In her work, she is bringing global biomarker leaders and biomarker scientists from Affiliates together and is collaborating with academic leaders. Regula has obtained her Ph.D. from ETH Zurich (Switzerland) where she worked in the Laboratory for Transplantation Immunology. She joined Roche in 2008.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings/Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Sponsor-led Roundtable Discussion

Advanced phenotyping of the tumour immune microenvironment

The development and validation process of an automated high throughput, high-plex multiplexed assay to derive meaningful biological insights
Comparison of multiplexed staining to standard IHC DAB staining
Considerations for reproducibility-single marker staining vs multiplexed staining

Angela Vasaturo

Associate Director Scientific Affairs, Ultivue

Angela Vasaturo Ph.D is the Associate Director Scientific Affairs at Ultivue. Prior to Ultivue, Angela was a Senior Researcher in Dr. Jerome Galon’s Laboratory of Integrative Cancer Immunology at the Cordeliers Research Center. From 2010-2015 Angela was a postdoctoral researcher in the field of Tumor Immunology at the NCMLS in Nijmegen, NL, and was the recipient of an EMBO short-term fellowship, amongst others. In 2012, Angela was among the first postdocs in Europe to be involved in the development of multiplex IHC and multispectral imaging and analysis of up to six immunofluorescence markers, and today is considered a leading European expert in multiplex IHC techniques, multispectral digital pathology, and tissue imaging.

12:20 – 13:20

Networking Lunch

13:25 – 13:55

Sponsor-led Poster Session

Utility of multiplexed Immunofluorescence and AI-based deep learning image analysis to resolve immune tumour heterogeneity

Immunotherapy has transformed the treatment of metastatic and recurrent solid tumors but is challenged in that only a minority of patients respond, especially those therapies that rely on immune activation due to the complex and heterogeneous immune escape mechanisms which can develop in each patient. Therefore, the development of robust biomarkers, enabling rational patient selection and the design of precise combination therapies, is key for the continued success and improvement afforded by this valuable treatment.

Advances in the use of multipleximmunofluorescence (mIF) provides the much-needed insight affording a comprehensive study of cellular composition, cellular functions, and cell-cell interactions. Importantly recent studies have used mIF to explore specific immune cells as part of the tumor immune microenvironment (TiME) and found that it is helpful for clinical prognosis and efficacy prediction in patients with cancer. High-level multiplexing, whole slide imaging, and spatial analysis are all must-have requirements for effective mIF solutions.

The purpose of this presentation is to guide research scientist sand clinicians through the deployment and utility of an automated high throughput, high-plex staining protocol coupled to advanced quantitative image analysis enabling a detailed assessment of the immune cell types and interactions of the tumor microenvironment associated with specific cancer types allowing researchers to reveal the true biology of their tissue samples.

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

Angela Vasaturo

Associate Director Scientific Affairs, Ultivue

14:00 – 14:30

1-2-1 Meetings/Networking Break

14:30 – 15:00

1-2-1 Meetings/Networking Break

15:00 – 15:10

Afternoon Refreshments

15:10 – 16:10

Immune landscape and gene signatures in immuno-therapy

What biomarkers can we measure in early oncology studies to design subsequent clinical development?
How do current immune landscapes and gene signatures inform clinical trials in immuno-oncology?
How can we apply lessons learned from PD1 and PDL1 development to other immuno-oncology agents?
How can we unify efforts across research and industry?

Diana Stoycheva

Principal Expert Scientist, Scailyte

Diana Stoycheva is a principal expert scientist at Scailyte with a focus on immuno-oncology. She obtained her PhD in Berlin in anti-tumor immunotherapy. She pursued postdoctoral studies in immunology at the ETH Zurich before joining Scailyte in 2020 to evaluate opportunities for the application of cutting-edge single-cell technologies for biomarker discoveries in immunology and immuno-oncology.

17:15 – 18:15

Canape/Drinks Reception

Translational Research

Time

Titles and Bullets

Facilitator

8:00 – 8:30

Registration

8:30 – 9:00

Opening Address & Keynote Presentation:

Immune Perspectives – Standing Back and Looking Forward

Justin Devine

Chief Medical Officer, Synexa

9:05 – 10:05

Preclinical immuno-oncology models for antibody drug development – from industry “standards” to new trends

What are the main advantages and limitations in the different systems?
What can we do to improve predictivity of clinical outcome?
How can we study Fc functions in mice?

Laura von Schantz

Vice President Discovery, Alligator Bioscience

Laura von Schantz is VP Discovery at Alligator Bioscience. With the firm believe that biotech companies in the field of immuno-oncology must invest in establishing strong technologies and advantageous translational processes to be able to generate compounds at a competitive pace, Laura has established a platform at Alligator that allows for fast generation of bispecific drug candidates with excellent properties in respect to function, manufacturability and stability. Laura is trained in antibody engineering as well as project management and corporate strategy. Laura holds a PhD in immunotechnology from the University of Lund.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings/Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Sponsor-led Roundtable discussion

Immune Biomarkers topic: A contrarian of view of cancer immunobiology – Thinking outside of the box to find the right drug at the right dose for the right person

How to unravel the complexity of the immune system through strategic biomarker development
Harnessing clinically relevant biomarkers for targeted PK/PD studies and patient stratification for cell therapies

Justin Devine

Chief Medical Officer, Synexa

12:20 – 13:20

Networking Lunch

13:25 – 13:55

Sponsor-led Poster Session

Functional Evaluation of Unique Anti-PDL1 Antibodies Generated through Single Plasma B Cell Cloning on the Beacon® Platform Versus a Standard Hybridoma Approach

We investigated whether superior anti-PD-L1 antibodies with greater diversity, affinity, and/or
functional activity could be generated using the Beacon® platform (Berkeley Lights, Inc., (BLI))
as a single B cell cloning (BCC) process which could circumvent a labor-intensive and time-
consuming Hybridoma process.
We screened 33,377 antibody secreting plasma B cells (PCs) onto OptoSelect TM chips and
identified over 200 antibodies with binding to PD-L1, and of those, 35 antibodies blocked
binding of PD-1 to PD-L1 (using Image-based analysis).
For the traditional approach, 13,536 hybridoma cells were screened with standard RBA assay for
identifying potential blockers.
Overall, we purified 44 hybridoma antibodies and 24 BCC antibodies which were characterized
for FACS binding, receptor blocking, epitope binning using the Carterra LSA and affinity by
Biacore 8K and Carterra LSA.
We found that 2 antibodies from Beacon and 3 antibodies from hybridoma had triple-digit pM
affinity. Among these, 2 BCC antibodies retained their potency and diversity while none for
hybridoma (when compared to Benchmark antibodies).

Andreas Loos

Director Biologics Discovery, ChemPartner

Andreas Loos, PhD, has joined ChemPartner in 2021 as Director of Biologics Discovery and he currently leads the Biologics Discovery Team at ChemPartner’s South San Francisco site. The team was one of the
first adopters of BLI’s Beacon technology and successfully uses the platform since 2019 to conduct antibody discovery projects. Prior to joining ChemPartner, Andreas has led an antibody discovery and
assay development group at Aridis Pharmaceuticals. During his PhD and post-doctoral training in Gent (Belgium), Heidelberg (Germany) and Vienna (Austria), he studied production and post-translational modifications of biologics in plants.

14:00 – 14:30

1-2-1 Meetings/Networking Break

14:30 – 15:00

1-2-1 Meetings/Networking Break

16:15 – 17:15

Improving the translational relevance of experimental models in Immuno-Oncology, which reverse based information to move to “forward translational models” to assess combination therapies

What are the critical clinical insights to move forward to establish more predictive models for cancer immunotherapy?
What are the challenges to develop Tissue/tumor/site-agnostic therapies in the face of the high tumoral and immunological heterogeneity?
Are we ready to deliver the promise of precision oncology for Cancer Immunotherapy?

Claudio Murgia

Principal Scientist & Group Leader Precision Cancer Modeling & In-Vivo Pharmacology Group, Roche

I graduated in Veterinary Medicine. In 2006, I obtained a PhD in Molecular Pathology as Wellcome trust fellow at University College London, where I applied concepts from evolutionary genetics to study tumor evolution. To continue my interest in translational cancer research, I was awarded a Wellcome Trust Intermediate Clinical Fellowship to investigate the molecular pathogenesis of NSCLC in domestic animals at the School of Veterinary Medicine, Glasgow. In 2011, I joined the Beatson Institute for Cancer Research in Glasgow, to dissect molecular mechanisms involved in the progression and evolution of CRC and PDAC cancer using GEMM models. In 2016, I joined Roche, where I am Principal Scientist and leader of the Precision Cancer Modeling & In-Vivo Pharmacology Group at the Roche Innovation Center Zurich, Center of Excellence for Cancer Immunotherapy.

17:15– 18:15

Canape/Drinks Reception

Clinical Development

Time

Titles and Bullets

Facilitator

8:00 – 8:30

Registration

8:30 – 9:00

Opening Address & Keynote Presentation:

Immune Perspectives – Standing Back and Looking Forward

Justin Devine

Chief Medical Officer, Synexa

9:05 – 10:05

Challenges and Solutions for Enriching Patient Data and Accelerate Clinical Trials

Fragmentation, challenges and solutions affecting the organization and coordination of clinical trial phases
Technologies and methodologies you can use to shortcut the execution and modification of clinical trials
How Infrastructure as Code, Big Data and AI/ML can help you to greatly increase your probability of success

Fausto Artico

Global R&D Tech Head and Director of Innovation and Data Science, GlaxoSmithKline

Fausto has a double PhD (Information Technology and Computer Science), earning his second master’s and PhD at the University of California – Irvine. He has worked in multi-disciplinary teams and has over 20 years of experience in academia and industry. As a Physicist, Mathematician, Engineer, Computer Scientist, and HPC and Data Science expert, Fausto has worked on key projects at European and American government institutions and with key individuals, like Nobel Prize winner Michael J. Prather. After his time at NVIDIA corporation in Silicon Valley, Fausto worked at the IBM T J Watson Center in New York and now at GSK.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings/Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Sponsor-led Roundtable discussion

Boosting the IO within bIomarker analysis and precision medicine: The NeXT generation of comprehensive molecular characterization of tissue and liquid biopsy.

Rapid advances in NGS technologies have revolutionized progress in personalized cancer vaccines, precision medicine and biomarker discovery.
Despite improvements in many aspects, there are still many existing challenges that must be addressed for both tissue profiling and liquid biopsy approaches.
This roundtable discussion will review various prevailing issues and strategies facing the field.

Maik M. Pruess

Senior Field Application Scientist, Personalis

Maik joined Personalis, Inc. as a Sr. Field Application Scientist (FAS) in 2020 with 20 years of research and field experiences in the area of molecular biology & immune-oncology, pharmacogenetics & genotyping, and clinical & molecular diagnostics. He provides technical support for the Personalis immuno- and precision oncology portfolio. He received his doctoral degree for the molecular tumor genetics analysis of a T-cell oncogene from the Free University of Berlin, and his University diploma was completed by a thesis about transcript mapping on the human X-Chromosome within the Human Genome Project in Berlin.

12:20 – 13:20

Networking Lunch

14:00 – 14:30

1-2-1 Meetings/Networking Break

14:30 – 15:00

1-2-1 Meetings/Networking Break

15:00 – 15:10

Afternoon Refreshments

15:10 – 16:10

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

Understand the presence and past: Federated outcome data bases to mine for insights
Understand the Biology: Markers for Tumor, microenvironment and the patient and AI to combine
From complex markers to simple ones
Move from treating tumors to treat challenges

Michael Zaiac

Head of Medical Affairs Oncology Region Europe, Novartis

Michael initially pursued a career in General, Cardiovascular and Surgical Oncology in Germany and the UK, gaining an MD and an FRCS. He joined pharmaceutical industry 25 years ago and has since been in clinical development, project leadership, and commercial and medical affairs roles at country, regional and global level. To date, Michael leads the Medical Affairs Team of Novartis Oncology, Region Europe Throughout his industry career, Michael mainly covered specialty care areas, e.g. Oncology and Immunology. He qualified as a Pharmaceutical Physician and as an MBA. Research interests and publications are in Oncology and Immunology, advanced analytics/AI as well as in general aspects of Medical Affairs and Medicine Development in the Industry.

16:15– 17:15

Defining the clinical trial endpoints

Endpoints in oncology, goals and classification according to the stage of the development
Specific issues faced with endpoints in immuno-oncology trials
Future perspectives

Valérie Doopler

Director of Clinical Development, Invectys

I have been involved in clinical research for over 30 years. I have extensive knowledge of clinical trial design, with a strong scientific background in immunology and oncology. I have a doctorate in medicine, a master’s degree in pharmacology and statistics. I train investigators in their responsibilities on behalf of the GSK laboratory. I set up and coordinated international clinical trials from phase I to III as a promoter as well as an investigator, notably within the Clinical Investigation Center that I founded and supervised for 12 years at the Pitié hospital (Paris). Since 2012, I have been in charge of clinical development in immuno-biotechnology companies. I joined INVECTYS in 2017 for the clinical development of a pipeline dedicated to immuno-oncology.

17:15– 18:15

Canape/Drinks Reception

Combination Strategies

Time

Titles and Bullets

Facilitator

8:00 – 8:30

Registration

8:30 – 9:00

Opening Address & Keynote Presentation:

Immune Perspectives – Standing Back and Looking Forward

Justin Devine

Chief Medical Officer, Synexa

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings/Networking Break

11:10 – 11:20

Morning Refreshments

12:20 – 13:20

Networking Lunch

13:25 – 13:55

Poster Session

Immune Biomarkers Topic: Delta-radiomics to predict response in solid tumours after immune checkpoint inhibitors therapy

The aim of our study was to determine the role of CT-based radiomics and delta-radiomics
signatures for treatment response and survival prediction in patients with advanced NSCLC treated with PD-1/PD-L1 inhibitors. We compared the results obtained to early RECIST v1.1 assessment (first follow up visit).
The study included 188 patients with NSCLC treated with PD-1/PD-L1 inhibitors who underwent a pre-treatment and at least one follow-up CT scans. All the lesions, both target and non-target according to RECIST v1.1 criteria, were manually segmented by radiologist. Radiomics analysis was performed on both single and multiple lesions per patient.
– The delta-radiomics model showed the best performance for treatment response prediction with an AUC of 0.81 (95% CI: 0.66-0.95). The delta-radiomics model was also the most accurate at predicting survival with a concordance index of 0.68 (95 % CI: 0.56-0.80) (p=0.02).
The comparison between the delta radiomics signatures and early RECIST v1.1 assessment showed a clear improvement in both treatment response prediction (AUC of 0.66 for early RECIST against 0.81 for delta radiomics) and survival prediction (C-index of 0.56 for early RECIST against 0.68 for delta radiomics).
Our delta radiomics models were able to early identify patients with advanced NSCLC who were more likely to benefit from immunotherapy.

Wim Vos

CEO, Radiomics

Based on the knowledge gained in over 15 years in different leadership roles in quantitative imaging companies, CEO, Wim Vos is the driver behind Radiomics’ vision. As one of Radiomics’ greatest assets, Wim has shaped the organisation’s pathway to success since 2019. With an MSc in Aerospace Engineering from TU Delft and a PhD in Physics from the University of Antwerp, Wim exploits his strengths not only in identifying unseen opportunities but also in leading the team using strategic innovative thinking. Wim also co-founded FLUIDDA, where he led the technical development team and was responsible for the global commercial activities.

14:00 – 14:30

1-2-1 Meetings/Networking Break

14:30 – 15:00

1-2-1 Meetings/Networking Break

15:00 – 15:10

Afternoon Refreshments

15:10 – 16:10

TME-targeting combinations – improving efficacy

What is the expected gain and differentiation when targeting suppressive myeloid
cells in addition to targeting T cell checkpoints?
What should be the goal of TME targeting agents in the clinic: myeloid depletion
versus myeloid reprogramming?
Are there appropriate preclinical models to reliably evaluate the efficacy of myeloid
therapies, both alone and in combination with classical immune-checkpoint
blockers?
How could we best identify patients and tumor types that are most likely to respond
to combination therapy that targets both innate and adaptive arm of the anti-tumor
immune response?
Are there better alternatives to anti-PD1 when considering combination potential
with TME modulating agents?

Nisit Khandelwal

Founder & Head of Research, iOmx Therapeutics AG

Nisit is the scientific co-founder and Head of Research of iOmx Therapeutics, an immuno-oncology biotech located near Munich. Prior to founding iOmx in 2016, Nisit served as a PI for a joint research project between the German Cancer Research Center (DKFZ) and Bayer Health Care. He is a research-driven entrepreneur with an impressive portfolio of patents and impactful scientific publications focusing on novel drug targets and early-stage drug development in the field of cancer immunotherapy. Nisit completed his undergraduate in Biotechnology from VIT University in India and Masters in Biomedical Sciences from the University of Edinburgh in U.K. In 2011, he received the Helmholtz Scholarship to conduct his doctoral thesis at the DKFZ in Germany.

17:15– 18:15

Canape/Drinks Reception

Next-Generation Therapies

Time

Titles and Bullets

Facilitator

8:00 – 8:30

Registration

8:30 – 9:00

Opening Address & Keynote Presentation:

Immune Perspectives – Standing Back and Looking Forward

Justin Devine

Chief Medical Officer, Synexa

9:05 – 10:05

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

Can NK cell engagers really circumvent the lack of immune cell infiltration (incl NK cells) within tumors?
How powerful is the potential of NK cells in the clinic really and which treatment combinations will recruit the other immune cells to support?
Can NK cell engagers be superior to cell therapy or is combination the ultimate goal?
How substantial are and how to circumvent the effects of ligand shedding by tumor cells for NK cell receptors?
Have we missed out to long on harvesting the innate immune system for cancer therapy?

Katharina Filarsky

Head of Assays 3 in Antibody Research Immuno-Oncology, Bayer

After finishing her PhD in Cancer Biology at the German Cancer Research Center in 2016, Katharina Filarsky, joined the Biologics Department, R&D at Bayer AG. Here she first worked as a Scientist on the implementation of platforms for antibody screening. She than became a lab head and project lead, within Screening & Automation and later in the Portfolio & Assays group of the Biologics Department, responsible for HTS screening of biologics as well as setup and implementation of cell-based and biochemical in vitro assays for validation and characterisation of compounds for new Immuno-Oncology treatments.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings/Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Sponsor-led Roundtable discussion

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

From checkpoint inhibitors towards neoepitope vaccines, does one size fits it all?
Fit for purpose assay development
From early characterization towards clinical biomarkers
Strengths & Limitations?
Challenges?

Sofie Pattyn

CTO and Founder, ImmunXperts

Sofie Pattyn (CTO and founder, ImmunXperts, a Q2 Solutions Company) has over 25 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development with a focus on functional assays for immunogenicity, immune oncology and Cell and Gene Therapy products. She has extensive hands-on lab experience and has managed and coached several In Vitro teams over the last decade. From 2008 till 2013 she was Head of the In Vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics, Belgium for over 15 years.

12:20 – 13:20

Networking Lunch

14:00 – 14:30

1-2-1 Meetings/Networking Break

14:30 – 15:00

1-2-1 Meetings/Networking Break

15:00 – 15:10

Afternoon Refreshments

16:15 – 17:15

Cell Therapies going off-the-shelf: non-modified NK cells, CAR-NK cells, TCR-NK cells, combination therapies

What are the opportunities of “universal” effector cells?
What are challenges with “universal” effector cells?
How can you scale your manufacturing process to thousands of patients per year?
What is the importance of potency tests?
What do chimeric antigen receptors, T cell receptors, therapeutic antibodies add to the potential of Natural Killer cells?

Volker Huppert

Chief Development Officer, Glycostem Therapeutics

Volker is a bioprocess engineer from Aachen Technical University by training. He is Chief Development Officer at Glycostem Therapeutics B.V., a clinical stage biotech company in the Netherlands, leading the activities for process development and assay development for manufacturing of a cord blood stem cell derived NK cell product.

He has previously pioneered clinical grade processing of Hematopoetic Stem Cells and
Natural Killers in closed, automated manufacturing sytems with Miltenyi Biotec, including cell separation, cell culture, transduction and analysis. Volker has been instrumental in bringing the first applications of the CliniMACS Prodigy device to the market.

17:15– 18:15

Canape/Drinks Reception

IMMUNO-ONCOLOGY XCHANGEEUROPE 2022Zurich, November 23

Immune Biomarkers

Partners

IMMUNO-ONCOLOGY XCHANGE
EUROPE 2022
Zurich, November 23