Immuno-Oncology Xchange Europe 2019

Immune Biomarkers

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote: Immuno-Oncology: Back to Nature – A Historical Perspective (Geert Mudde, Chief Scientific Officer, Tyg Oncology)

9:05am – 10:05am

Developing predictive biomarkers for immune checkpoints

What are the recognized and perhaps less recognized predictive biomarkers for immune checkpoint inhibitors or other immuno therapies?
Are you using biomarker responses in your clinical trials with immuno therapies?
How are you undertaking to develop novel prognostic or predictive biomarkers?

Michael Lahn

Chief Medical Officer
iOnctura

After obtaining his Medical Doctor degree in Medical Microbiology at the University of Mainz (Germany) in 1992, Michael Lahn was a fellow at the Department of Hematology and Oncology at the University of Freiburg (Germany). In 1996, he joined the Department of Immunology at National Jewish Research and Medical Center in Denver, Colorado, where he was Instructor. During this time he investigated the role of  T cells in early immune responses. In 2000, Michael joined Eli Lilly and Company, where he led drug development teams in early phase drug development for anti-inflammatory and oncology medicines. He was responsible for the development of several novel oncology drugs, including the second generation ASO LY2181308 and the TGF-beta small molecule inhibitor galunisertib. In 2014 Michael joined AstraZeneca’s osimertinib team and contributed to the registration of osimertinib in NSCLC. In Fall of 2015, Michael was named Head of Clinical Development, Europe, at Incyte. He built the global cross-functional drug development team at Incyte’s European hub in Switzerland. In 2019, he joined iOnctura as Chief Medical Officer in Geneva. Michael has authored or co-authored over 100 publications.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Screening T cells by function: biomarker discovery with direct linkage between phenotype and gene expression

What are your requirements for studying T cell interactions vs. primary tumour targets in order to investigate individual cell function and measure cytotoxicity in a single experiment?
How important is precise data on thousands of discrete single T-cell:target interactions for you?
How do you judge the need for a more reliable method for assessment of potency and viability?
What is your opinion on the importance of recovering individual T-cells of interest, post-assay, alive and why?

Mio Muelthaler

Director, Business Development – Europe
Berkeley Lights

Mio Muelthaler has earned his PhD in Molecular Biology at the University of Wuerzburg. He also earned a certificate „Business Science & Management“ in Munich. His career started in R&D at nanotype GmbH, a biotech start-up near Martinsried, where he contributed to the measurement of the smallest binding force ever measured between biomolecules. He also worked at Sigma-Aldrich as Sales Development Manager Life-Science and eCom manager Switzerland, Tecan as a lab-automation and robotics specialist and at Molecular Devices advising drug discovery and bioproduction development customers for e.g. HTP imaging. Today he is responsible for BD in EU at Berkeley Lights.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Evaluating biomarkers for treatment selection and monitoring

Biomarker – What are we talking about? Predictive, diagnostic, prognostic, ….?
Is there a general or preferred path how to implement biomarker development in the
overall drug development process?
What are the key lessons to be learned from approved immuno-oncology therapeutics?

Randolf Kerschbaumer

Chief Eecutive Officer
OncoOne

Randolf Kerschbaumer holds a degree in biotechnology and a PhD from the University of

Natural Resources and Life Sciences, Vienna, Austria. He has more than twenty years of

experience in research and development of biotherapeutics in big pharma organizations and small biotech companies. During his career he held various senior positions, including Head

of Oncology Research at Shire and Head of Antibody Technology at Baxter. He acquired

detailed knowledge of the entire drug development process, from early drug screening to clinical development, in areas of oncology, inflammation and hematologic disorders. Randolf is founder and CEO of OncoOne, an early stage biotech start-up company based in Klosterneuburg near Vienna, Austria.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session: T Cell functional analytics on the Lightning™ platform – Berkeley Lights

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

5:15pm – 5:45pm

Closing Keynote & Address: Unlocking Potent Pharmacology (Jonny Finlay, CEO, UltraHuman)

5:45pm

Canape/Drinks Reception

Translational Research

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote: Immuno-Oncology: Back to Nature – A Historical Perspective (Geert Mudde, Chief Scientific Officer, Tyg Oncology)

9:05am – 10:05am

Pursuing in vitro strategies over animal-centric models to achieve better clinical outcomes

Patient-derived microtumour cultures – is standardisation possible?
Spheroids as high-throughput screening platform – is tumour microenvironment modellable?
Readouts and analysis tools
Summary: What is out there?

Livija Deban

Vice President, Immunology & Oncology
Prokarium

Livija Deban has over 10 years’ experience in mucosal immunology, T cell immunology and tumor immunology from academic and industry positions. Prior to her current position as Vice President Immunology & Oncology at Prokarium, she was Director of Immuno-Oncology at Oxford BioTherapeutics. Livija has also held research positions at Cancer Research UK, King’s College London and The Francis Crick Institute in London. Livija holds a degree in Medical Biotechnology from University of Bologna and a PhD in Molecular Medicine – Basic and Applied Immunology from University Vita-Salute San Raffaele in Milan, Italy.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Characterizing immunotherapeutic function with primary immune cells

What types of questions can be answered using primary immune cells?
What are the challenges of working with primary immune cells?
What types of immunotherapeutic products have been assessed using these methods?

Sofie Pattijn

C0-Founder & Chief Technology Officer

ImmunXperts

Sofie has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics). 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.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

No perfect in vivo models in IO. How can we best use what is available?

Syngeneic models – does mouse immunology translate to human?
How can we best utilise knock-in mouse models and humanised immune system mice to make decisions?
How to inform gaps in the data that can’t be addressed in vivo?

James Legg

Senior Vice President, Research
Crescendo Biologics

James Legg Ph.D is SVP Research at Crescendo Biologics where he is responsible for managing Crescendo’s Immuno Oncology Portfolio from research through to preclinical development as well as the biology/pharmacology functions. James has 15 years’ experience in biologics drug discovery, mostly in the oncology area and has been responsible for the successful progression of multiple oncology biologics programmes through the research phases of drug discovery. Prior to joining Crescendo, James was a member of the oncology leadership team at MedImmune, the Biologics arm of AstraZeneca and held key scientific positions at Cambridge Antibody Technology.

James has a BSc in Applied Biology from Bath University, a Ph.D in Molecular Cell Biology from Imperial College, London and undertook Post-Doctoral research at Imperial Cancer Research Fund (Now CRUK) in London.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session: Translational efficacy of oncolytic HSV-1 in glioblastoma multiforme (GBM) using a human autologous ex vivo platform, Farcast™ – Farcast Biosciences

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

5:15pm – 5:45pm

Closing Keynote & Address: Unlocking Potent Pharmacology (Jonny Finlay, CEO, UltraHuman)

5:45pm

Canape/Drinks Reception

Clinical Trials

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote: Immuno-Oncology: Back to Nature – A Historical Perspective (Geert Mudde, Chief Scientific Officer, Tyg Oncology)

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

11:55am – 12:25pm

1-2-1 Meetings / Networking Break

1:30pm – 2:30pm

Networking Lunch

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

Evaluating efficacy using clinical trial endpoints

Luis Feliz Viñas

Medical Director, Oncology
Incyte

5:15pm – 5:45pm

Closing Keynote & Address: Unlocking Potent Pharmacology (Jonny Finlay, CEO, UltraHuman)

5:45pm

Canape/Drinks Reception

Targeted Immunotherapies

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote: Immuno-Oncology: Back to Nature – A Historical Perspective (Geert Mudde, Chief Scientific Officer, Tyg Oncology)

9:05am – 10:05am

Targeted immunotherapy are not necessarily tumor-specific immunotherapies: we must do much better!

1st generation IT (accompanied by biomarkers) is tumor specific, but not maximally efficacious
2nd generation IT has no reliable biomarker is not tumor specific and causes autoimmune disease
Cell therapy like 1st generation IT is tumor specific, comes with biomarkers but control of the response is still an issue and so is pricing.
3rd generation IT, with active control over positive and negative checkpoints, combines the benefits of the 1st and 2nd IT without the drawbacks. Why is this not in the clinic?

Geert Mudde

Chief Scientific Officer
Tyg Oncology

Geert C. Mudde received a Ph.D. in immunology from the University of Utrecht in 1985 and started his international professional career at the Swiss Institute for Asthma and Allergy Research in Davos in 1989. In 1992, he joined the pharmaceutical/biotech industry, where he held several senior management positions at the Novartis Research Institute in Vienna, Austria, at the Parke Davis Research Institute in Fresnes, France, at Ingenium Pharmaceuticals, Martinsried, Germany and at igeneon in Austria. In 2006, while joining Baxter BioScience in Vienna, he also co-founded the biotech company f-star, where he served as CSO. In 2010, together with Christof Langer, he founded the 1st S-TIR™ technology-based company S-TARget therapeutics GmbH, an allergy company. And in 2013 they founded the spin-off companies OncoQR ML GmbH and TYG oncology Ltd, both focussing on active immunotherapy for oncology.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Translational Research topic: Role of organoids in immuno-oncology

How do organoids fit in as an in-vitro screening tool ?
Utility of using organoids in the IO space: advantages/limitations?
What is the impact of the organoid platform on the relevance of PDX studies?

Ludovic Bourré

Senior Director, Scientific Engagement
Crown Bioscience

Since 2017, Ludovic serve as Senior Director of Scientific Engagement (DSE) for Oncology

in Europe and managing the DSE group in US and Europe.

Prior to joining Crown BioScience, Ludovic worked at Invectys (Paris, France) as head of the

pharmacology, leading the preclinical and clinical evaluation of immuno-oncology programs.

Prior to this Ludovic held positions in preclinical CROs and academia where he focused on

patient-derived xenograft (PDX) model development and utilization, as part of supervising an

integrated preclinical imaging platform, and humanized PDX studies for immunotherapy

evaluation.

Ludovic holds a PhD in Pharmacology from Nantes University (France), and served as a

postdoctoral researcher in University College London, UK and University College Cork,

Ireland.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

CD3 ligation in tumour targeting by T cells: how do we tame this wild child?

T cell ligation via Tumour target x CD3 bispecific biologics is a phenomenally powerful mechanism for killing cancer cells, but this potency comes with high toxicity risk
Few (if any) solid tumour targets are clean enough to allow fully selective targeting to the tumour
Standard human tumour xenograft experiments exaggerate the potency of such molecules (aka the ‘Furry Test Tube’ problem)
How can we overcome this risk profile for CD3 bispecifics and best exploit the rich target repertoire unearthed over the last 40 years?

Jonny Finlay

CEO
UltraHuman

Jonny Finlay is the CEO of UltraHuman, an antibody drug discovery biotech in the UK that is developing a series of therapeutics for inflammation and oncology. Prior to co-founding UltraHuman, Jonny led research teams in Biologics Discovery at Pfizer and Wyeth, and carried out postdoctoral research in recombinant protein engineering at several institutes, including the Centre for Biologics Evaluation and Research, FDA.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session: Effect of immune cell depletion on the responses to PD-1 treatment in syngeneic models – Crown Biosciences

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

5:15pm – 5:45pm

T cell engagers versus CAR T cells: what is the best modality for T cell redirection?

Fast killer versus long persistence, what is the most important feature?
What is the target spectrum for TCEs and CARTs?
Main toxicities and how to manage them
Tumor relapse: similarities & differences
Auto vs. alloCARTs in comparison to TCEs: are there differences?

Thierry Wurch

Senior Director, Head of External Innovation, Oncology
Servier

Thierry Wurch completed a Ph.D in Molecular and Cellular Biology at the University Louis Pasteur (Strasbourg, FR, 1992), followed by a post-doctoral training at the University of Ghent (BE). Back to France in 1994, he raised a molecular biology laboratory at the Pierre FABRE Research Center in Castres (FR). In 2003, he moved to the Centre d’Immunologie Pierre FABRE where he established a Molecular and Cellular Biology Department dedicated to molecular pharmacology and protein and antibody engineering. Since September 2011, he leads the immunotherapy discovery research programs at the Institut de Recherches SERVIER, the largest independent French Parma group. Since December 2016, Thierry is leading the External Research and Innovation for the Center of Therapeutic Innovation in Oncology at SERVIER.

He is currently member of the Editorial board of mAbs (Landes Bioscience) and Distinguished Advisor of The Antibody Society. He is co-author of more than 90 publications.

5:15pm – 5:45pm

Closing Keynote & Address: Unlocking Potent Pharmacology (Jonny Finlay, CEO, UltraHuman)

5:45pm

Canape/Drinks Reception

Combination Therapies

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote: Immuno-Oncology: Back to Nature – A Historical Perspective (Geert Mudde, Chief Scientific Officer, Tyg Oncology)

9:05am – 10:05am

How to stand out in an increasingly crowded market developing agents against the same IO targets

How much differentiation can be achieved by utilizing biochemical properties, affinities, avidities, epitope specificities and FcR interactions of various biologics directed against the same immune receptor?
How much can be “achieved” by varying the “mode” of engagement of a particular receptor?
Tumor targeting, various delivery modes or intra-tumoral activation: who is going to win?

Victor Levitsky

Vice President, Oncology
Molecular Partners

Victor Levitsky is currently Vice President, Head of Oncology Research at Molecular Partners, AG, Switzerland, a clinical stage biopharmaceutical company developing novel biologics in ophthalmology and oncology using the DARPin technology platform. Victor was trained as MD and PhD in Riga, Latvia. He made several seminal contributions to our understanding of tumor and virus-specific immune responses during his academic carrier as a faculty member at the Karolinska Institute, Stockholm and the Oncology Department , Johns Hopkins University, Baltimore. Prior to his current position he was responsible, as a senior principal scientist, Tumor Immunology Leader, for the development of onco-immunology portfolio at F. Hoffmann-La Roche Ltd.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Translational Research topic: Preclinical approaches to maximize clinical success

How to discover and select meaningful biomarkers to inform combination strategies?
Learning from previous clinical studies to direct future combination trials (“from the bench to the bedside and back to the bench”)
How do we gain confidence in clinical success of a particular combination from translational models

Farcast Biosciences

Technical Liaison
Farcast Biosciences

Stefan Jellbauer is the Technical Liaison for Translational Applications and works with clients to craft custom solutions for their drug development needs. He supports the Biopharma Business Development side of Mitra Biotech. After 10 years in academic research he joined Affymetrix/eBioscience, where he worked in the roles of Field Application Scientist and Technical Sales Specialist with Affymetrix and Thermo Fisher Scientific. He joined Farcast Biosciences in May 2018.

Stefan received his Ph.D in Biology from Ludwig-Maximilians University in Munich (Germany), focusing on tumor vaccination. He completed his post-doctoral work at University of California, Irvine studying mucosal immunology and host-pathogen interactions.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Selecting the best indication(s) and line of therapy to evaluate combinations

Is single-agent efficacy in the target indication of at least one combination component required?
How to balance dose intensity between components of a combination regimen to optimise benefit – risk?
Are at least partly non-overlapping toxicity or partly non-overlapping activity/response required for optimising benefit -risk?
Is combination therapy without drug synergy useful?

Richard Sachse

Chief Scientific Officer
Neovii Pharmaceuticals

Richard Sachse holds a degree in medicine and a board certification in Clinical Pharmacology. With more than 25 years experience as a physician and scientist, he has extensive expertise in a variety of different therapeutic areas. In addition to registration studies, he is especially experienced in the design and implementation of translational programs to bridge research programs to the clinic, as well as in the design and implementation of clinical pharmacology programs, enabling successful registration of products at the international level. He has broad general management experience with a focus on leading high performing organizations and change management.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session (Translational Research topic): Case Study – Assessing the therapeutic potential of immuno-oncology candidates in vitro –ImmunXperts

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

Targeted Immunotherapies topic: Centralised vs point-of-care CAR-T manufacturing and supply

Advantages of centralised CAR-T manufacturing
Opportunities and threats of point-of-care CAR-T manufacturing
The promise of off-the-shelf CAR-T therapies
Patients and centers perspective

Simona Paratore

Medical Head, Cell & Gene Therapy
Novartis

Simona Paratore is Medical Head for Cell and Gene Therapy in Novartis Oncology Region Europe. Simona has 13 years oncology experience in the Pharma industry contributing to the development and management of hematological products. Simona holds a degree in Medicine with a specialization in Clinical Pharmacology from the University of Milan and an MBA degree from SDA Bocconi University in Milan.

5:15pm – 5:45pm

Closing Keynote & Address: Unlocking Potent Pharmacology (Jonny Finlay, CEO, UltraHuman)

5:45pm

Canape/Drinks Reception