Immuno-Oncology Xchange Europe

Clinical Development

Time

Titles and Bullets

Facilitator

8:30am – 9:00am

Opening Address & Keynote

9:05am – 10:05am

“Looking back from the future” – Rational based sequencing of “last” line therapies

Should Immunological anti-cancer therapies precede non immunological interventions?
Are there absolute no go areas for certain sequences due to feasibility?
We are able to test therapies reasonably well. Are we really able to identify the right patients for each sequence ?
If only sequences in select order lead to true OS advantages, how do we handle development, approval and reimbursement of each phase?

Michael Zaiac

Head of Medical Affairs, Oncology,
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 concerning Medical Affairs and Medicine Development in the Industry.

10:10am – 10:40am

1-2-1 Meetings

10:45am – 11:45am

Strategies for biomarker screening, identification, and validation in early stage translational research projects into clinical application

Current approaches/platforms for biomarker screening, identification and validation moving from translational research into clinical validation
What are the major barriers to moving biomarker research initiatives into a clinical application (eg. technology limit, biological relevance, validation)?
Among available platforms, what are the strengths and weaknesses of current technologies in deploying strategies to develop biomarkers to ultimately aid in more intelligently advancing clinical trials?

Angela Vasaturo

Senior Field Application Scientist
Ultivue

Angela Vasaturo is a Senior Field Application Scientist 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.

11:50am – 12:20pm

1-2-1 Meetings

12:20pm – 1:00pm

Lunch Break

1:00pm – 2:00pm

Biomarker strategies to select and stratify patients for appropriate IO based therapy

Who will benefit from checkpoint inhibition monotherapy? Who needs immune stimulation in order to benefit from checkpoint inhibition?
Why can early stage cancer patients elicit an anti-tumour response much easier than more advanced patients? What are the necessary clues from basic immuno-biology needed for drug and CDx development?
How to deal with immune biomarker dynamics? What are disease-specific differences in immune biomarker testing?

Regula Deurloo

Medical Affairs Biomarker Leader, gRED Oncology Biomarker Development Group
Roche

Regula has 12 years of experience in Pharma Development at Roche 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.

2:05pm – 2:35pm

1-2-1 Meetings

2:35pm – 3:05pm

1-2-1 Meetings

4:15pm – 5:15pm

Closing Keynote & Address

Cell Therapies

Time

Titles and Bullets

Facilitator

8:30am – 9:00am

Opening Address & Keynote

9:05am – 10:05am

Adoptive cell therapy – the search for the optimal cell

Which critical parameters for either TCR, CAR T cell/NK cells are needed to be successful in the field?
How could we increase the cellular yield of an allogeneic product?
How could we harmonize product characteristics, and which would be crucial?

Eytan Breman

Head of CAR- Engineering Group
Celyad

Eytan Breman is the R&D manager and current head of the chimeric antigen receptor (CAR) engineering group at Celyad Oncology. He started his work in the field of immunology focused specifically on transplant immunology back in 2009, and from 2015 onwards has left academia to focus on developing CAR T cells for the treatment of cancer at Celyad. He has developed both the allogeneic and autologous CAR T cell platforms for the treatment of both haematological and solid cancers and has worked extensively on developing new tools for the future of the CAR T cell field.

10:10am – 10:40am

1-2-1 Meetings

11:50am – 12:20pm

1-2-1 Meetings

12:20pm – 1:00pm

Lunch Break

2:05pm – 2:35pm

1-2-1 Meetings

2:35pm – 3:05pm

1-2-1 Meetings

3:10pm – 4:10pm

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

Engineering/format, complexity, timelines of discovery phases to reach clinical candidate?
Antigen selection
Targeting solid tumors
Manufacturing aspects
Safety: CRS management
Current and future challenges

Thierry Wurch

Senior Director, Global External Innovation & Partnering in Oncology
Ipsen

Thierry leads the Global External Innovation activities for Europe at Ipsen. Prior to that, he was at Servier where he successively led the immunotherapy discovery research programs until end 2016 then joining the newly created External Research and Innovation group overseeing global Search and Evaluation activities in Oncology.

Thierry Wurch holds a Ph.D in Molecular and Cellular Biology from the University Louis Pasteur (Strasbourg, FR, 1992), followed by a post-doctoral training at the University of Ghent (BE). He is member of the Editorial board of MABS (Taylor & Francis), Distinguished Advisor of The Antibody Society and Chair of the IUPHAR-NC Antibody Committee. He is co-author of more than 90 publications.

4:15pm – 4:45pm

Closing Keynote & Address

Next-Generation Therapies

Time

Titles and Bullets

Facilitator

8:30am – 9:00am

Opening Address & Keynote

9:05am – 10:05am

Bispecific biologics in IO – promises and challenges

Bi-specific biologics (antibodies, immuno-cytokines, and others)
Interesting concepts, high hopes, huge disappointments
What is needed to make them work safely in humans?

Krzysztof Wicher

Vice President, Head of Drug Discovery
Macomics

Krzysztof Wicher graduated in medical biochemistry at the Uppsala University in Sweden. He did his post docs at the London Research Institute of Cancer Research UK and at the Gurdon Institute, University of Cambridge, UK. In 2013, he moved to industry to Medimmune to work on novel format of biological drugs and then to a small biotech Ossianix where he led the blood-brain barrier program. Therafter at Kymab, Krzysztof led the in vivo pharmacology and translational sciences group supporting development of immune-oncology assets, including immuno-cytokine program. Currently, he is the VP/Head of Drug Discovery at Macomics, a macrophage targeting company

10:10am – 10:40am

1-2-1 Meetings

10:45am – 11:45am

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

Why are early in vitro assays becoming important?
Which types of assays have been the most reliable?
What are some common challenges and how can they be overcome?

Sofie Pattijn

Co-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.

11:50am – 12:20pm

1-2-1 Meetings

12:20pm – 1:00pm

Lunch Break

1:00pm – 2:00pm

Immune checkpoint strategies to activate both innate and adoptive responses

Current cancer treatments aiming at immune checkpoints are not tumour specific = side effects
Passive immunotherapy activates/mimics either humoral (1st generation IT) or cellular (2nd generation IT) immune responses = waste of killing potential
Evolution preferred polyclonal antigen specific B and T cell immune responses, why don’t we make use of that now that we know how?

Geert Mudde

Chief Scientific Officer
TYG Oncology

Geert 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.

2:05pm – 2:35pm

1-2-1 Meetings

2:35pm – 3:05pm

1-2-1 Meetings

3:10pm – 4:10pm

Taking bispecific antibodies as next-generation immune cell engagers to the next level in tumour targeting therapies

Recombinant proteins used in single-use therapies versus monoclonal antibodies, which is better?
Bispecific antibodies can incorporate the best of both worlds, when does it make sense?
What is the advantage, if any, over combination therapies?
What is left to improve?

Jamie Frankish

Head of Immunology
Apogenix

4:15pm – 4:45pm

Closing Keynote & Address

Combination Therapies

Time

Titles and Bullets

Facilitator

8:30am – 9:00am

Opening Address & Keynote

9:05am – 10:05am

How to determine the contribution of single agents in Phase II immuno-oncology combinations

Is it necessary to conduct a monotherapy arm in a Phase II setting to determine its contribution to a novel combination?
If the mechanism of action of the combination is overlapping, which clinical designs are useful to determine the individual contribution of the combination partners?

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

10:45am – 11:45am

Evaluating clinical outcomes of combination therapies using modern biomarker strategies

What are your strategies for leveraging new biomarker technologies to demonstrate the efficacy of a combination therapy?
How are you evaluating combination therapies for cross-reactivity and immunogenicity in vivo?
What types of biomarkers or correlative endpoints have served programs best?

Anthony Stajduhar

Director, International Business Development
Rapid Novor

Anthony has been heading the business development at Rapid Novor for nearly 4 years, merging his previous 8 years of experience in the business roles with a strong passion for biomedical research, stemming from his training in biomedical engineering. His current efforts are focused on the growth of the REpAb™and NovorIg™ platforms with pharmaceutical and biotech companies globally. His partnerships are focused on using REpAb in patients or animal models to sequence monoclonal antibodies from polyclonal sera, as well as immune system profiling using NovorIg, the team’s NGS based analysis to monitor the relative quantity of specific antibodies over time. Anthony’s a maker and in his spare time takes advantage of the Toronto HackLab to do biological research and other engineering projects.

11:50am – 12:20pm

1-2-1 Meetings

12:20pm – 1:00pm

Networking Lunch

1:00pm – 2:00pm

Managing bispecific and checkpoint inhibitor combinations

State of the art remains PD1 + [something]
T cell retargeting to solid tumour is tricky – impossible when amplified by PD1?
Would alternative cell retargeting MOAs pair more safely, with higher TI?
Increased myeloid focus in the field – high power but lower risk?

Jonny Finlay

Chief Executive Officer & Co-Founder
Ultra Human

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.

2:05pm – 2:35pm

1-2-1 Meetings

2:35pm – 3:05pm

1-2-1 Meetings

3:10pm – 4:10pm

Emerging and approved IO combinations

MOA of these combinations and discussion on mechanism for synergies
Main challenges for IO combination trials and ways to address those

Markus Zettl

Director Immuno-Oncology
Pieris Pharmaceuticals

Prior to joining Pieris Pharmaceuticals as Director Immuno-Oncology overseeing pre-clinical development of Pieris´s innovative pipeline projects, Markus Zettl was Project Leader at Boehringer-Ingelheim from 2011, leading antibody programs in the field of Immuno-Oncology from early preclinical into clinical phases.

During his PhD and postdoctoral studies, Markus worked in a variety of areas of cancer biology at the EMBL in Heidelberg Germany and at the MRC-LMB in Cambridge UK. Research topics covered molecular mechanisms of how oncolytic viruses exploit the host cytoskeleton and the impact of metallo-protease (TACE) activation on cytokine and growth factor signalling with implications for cancer and inflammatory disorders. Markus has authored numerous high impact publications and patents in the field of Immuno-Oncology.

4:15pm – 4:45pm

Closing Keynote & Address

Immuno-Oncology Xchange Europe

Clinical Development

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