Draft agenda DAY 1 Monday, January 25 th , 2016 7.15 Registration & buffet breakfast in the Exhibition & 121 Partnering Area Morning plenary Opening plenary: Immuno-Oncology ‘State of the Nation’ 8.45 Chair’s opening remarks Dr Rachel Humphrey, CMO, CytomX 8.50 ‘State of the Nation Address’ Examine recent clinical advances and major on-going studies in the field of cancer immunotherapy. Reassessing the scope, promise and limitations of the field Assess how future studies combining different types of immunotherapies and other therapeutic modalities, such as drugs against specific signalling pathways driving cancer cell growth, are needed to pave the way for the development of effective anticancer treatments causing durable responses The realities of immunotherapy for metastatic, pre-metastatic and resectable tumours Dr Michael Giordano, SVP, Head of Oncology and Immuno-Oncology, BMS 9.05 Executive panel of leading clinical developers in Immuno-Oncology Dr Robert Iannone, Head, Immuno-oncology, AstraZeneca Dr Helen Sabzevari, Former SVP Immuno-Oncology, EMD Serono Dr Roger Dansey, SVP, Clinical Research, Oncology, Merck Dr Jon Wigginton, SVP Clinical Development, MacroGenics
Transcript
Draft agenda
DAY 1
Monday, January 25th
, 2016
7.15 Registration & buffet breakfast in the Exhibition & 121 Partnering Area
Morning plenary
Opening plenary: Immuno-Oncology ‘State of the Nation’
8.45 Chair’s opening remarks
Dr Rachel Humphrey, CMO, CytomX
8.50 ‘State of the Nation Address’
Examine recent clinical advances and major on-going studies in the field of cancer immunotherapy.
Reassessing the scope, promise and limitations of the field
Assess how future studies combining different types of immunotherapies and other therapeutic modalities, such as drugs against specific signalling
pathways driving cancer cell growth, are needed to pave the way for the development of effective anticancer treatments causing durable responses
The realities of immunotherapy for metastatic, pre-metastatic and resectable tumours
Dr Michael Giordano, SVP, Head of Oncology and Immuno-Oncology, BMS
9.05 Executive panel of leading clinical developers in Immuno-Oncology
Dr Robert Iannone, Head, Immuno-oncology, AstraZeneca
Dr Helen Sabzevari, Former SVP Immuno-Oncology, EMD Serono
Dr Roger Dansey, SVP, Clinical Research, Oncology, Merck
Dr Jon Wigginton, SVP Clinical Development, MacroGenics
9.35 Next generation of Immunotherapy – Toward a unified field approach?
After decades of disappointing results, immunotherapy has finally been recognized as a treatment that can provide significant clinical benefit
Checkpoint inhibitors (CTLA-4, PD-1) require a suppressed resident effective immune response to tumors to have an effect
Few patients present with effective immune responses that are suppressed, therefore methods to create effective responses de-novo are required to
increase response rates and indications for checkpoint drugs
Currently moving in direction of multiple checkpoint blockade drugs, CAR-T and other customized approaches to adoptively transfer effective
immune responses—economically sustainable?
What is needed is an immunological 'unified field' approach whereby through an understanding of the immune cascade of events leading to anti-
tumor destructive immunity and memory, one treatment can orchestrate the complex cascade of spatial and temporal positive and negative immune
signaling events that result in destructive immunity and memory.
A unified field approach to immunotherapy is possible through the reverse engineering of the proven curative effects of allogeneic, non-
myeloablative stem cell transplant models
Dr Michael Har-Noy, Founder, Immunovative and Hadassah-Hebrew University Medical Center Dept of Bone Marrow Transplant and Cancer
Immunotherapy
9.55 The diagnostic landscape for checkpoint inhibitors
Dr Miro Venturi, Global Head Diagnostics Biomarkers, Roche
10:10 Clinical meets economic value: managing the quality and cost of care
The evolving role of Health Technology Assessment in the US
Value vs. affordability: the budget issue
Can pharma and payors solve these issues?
Dr Ed Pezalla, VP, National Medical Director for Pharmacy Policy and Strategy, Aetna
10.25-11.25
INTERACTIVE SESSION
Roundtable discussion based on licensing, partnering and innovation incubation
- Reaching a global research and licensing agreement to develop and commercialize novel cellular immunotherapies
- Capitalizing on the advent of non-exclusivity and combination product deal structures
- Subject areas are covered by opening panels followed by roundtable discussions
- How do we structure combination therapy partnerships?
- How are companies differentiated and how can investors work these differences out?
- Combining high-profile technologies to develop targeted therapies
Dr Jennifer Buell, VP Clinical Research, Agenus
Dr Scott Ogg, VP Corporate Development, ARMO Biosciences
INTERACTIVE HOUR This feature of the event offers attendees their choice of a variety of interactive sessions and formats, including:
Biotech Showcase presentations in the Showcase Theater
Panel of judges:
Dr Stephen Rubino, Global Head, Business Development & New Products Marketing, Cell &
Gene Therapies Unit, Novartis Pharmaceuticals
Dr Vincent Ossipow, Venture Partner, Omega Funds
Reni Benjamin, Senior Vice President/Senior Biotechnology Analyst, Raymond James
Financial, Inc
Rafael Amado, MD, Chief Medical Officer, Adaptimmune
Dr Mark Metzke, Associate, Knobbe Martens
OR
Tutorial: Intellectual Property
Moderator: David Brindley, Cooksey-Saïd Fellow in Healthcare Translation & Nuffield
Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford
11.25 Morning coffee in the Exhibition & 121 Partnering Area
Featuring, in the Showcase Theater: Keynote Address & Investor Panel
Speaker:
Dr Stephen Knight, President & Managing Partner, Fidelity Biosciences
Panellist:
William Podd, Founder, President & Chief Executive Officer, Landmark
Capital/Landmark Angels
Followed by your choice of 3 parallel sessions Focus session 1 (shared with Cell & Gene Therapy World)
CARs, TCRs, NK cells: Are the new wave of cellular cancer immunotherapies really justifying the hype? How close is the first approved product? 12.05 Chair’s introduction
Dr Michel Sadelain, Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center
Case studies: Summarizing clinical data and progress to date with leading CAR T-cell and TCR product candidates in both leukaemia and solid
tumour indications - how are these companies differentiating themselves in terms of their R&D strategies? (Eg. in vector selection) Mapping progress in the T-cell cancer immunotherapy over recent years. How have ‘next-generation’ approaches differed from previous generations,
specifically?
How are they tackling the barriers imposed by solid tumours? (Specificity, trafficking to tumour sites, inhibitory tumour microenvironment)
Where does gene editing fit into successful development of these products? To what extent does it increase regulatory risk? To what extent are they
adding new safety mechanisms and broadening the scope of the next generation?
12.20 Evolution and Globalization of Chimeric Antigen Receptor T Cell Therapies: From Model T to Model X
Professor Bruce Levine, Director, Clinical Cell & Vaccine Production Facility, University of Pennsylvania, Perelman School of Medicine
12.35 Recovery of normal B cell compartment in lymphoma and leukemia patients with durable clinical remission induced by anti-CD19 CAR T
cell therapy
Dr Adrian Bot, Vice President of Translational Medicine, Kite Pharma, Inc
12.50 Case study 3 – presentation reserved
1.05 Panel discussion
How to address key remaining R&D issues and pave the way for future commercial success?
Exactly how significant is the toxicity challenge? And what are we doing to address it? (Eg. Controlling off-target toxicity; employing suicide
genes to eliminate transferred T-cells in the event of toxicity)
Has any progress been made in pre-identifying responders and non-responders?
What will help T-cell therapies to work durably?
Are there any CAR T-cell targets other than CD19/20/22/mesothelin?
o How will we harness Big Data analytics tools to enable novel target discovery?
What will follow CAR T-cell therapy?
o Analyzing progress with – and the relative pros and cons of - allogeneic NK cells and other emerging and re-emerging (eg. cancer
vaccines) modalities
Panellists:
Rafael Amado, MD, Chief Medical Officer, Adaptimmune
Dr Sicco Popma, Scientific Director, Gene Modified Cell Therapies, Janssen Research & Development, LLC
Dr Hans Klingemann, Vice President of R&D, NantKwest, Inc
Dr Graeme Price, Staff Scientist, Gene Transfer & Immunogenicity Branch, Division of Cellular & Gene Therapies, OCTGT, CBER, US Food &
Drug Administration
1.30 Close of session – buffet lunch in the Exhibition & 121 Partnering Area
Or
Focus session 2
Immune-checkpoint inhibitors: Where are we now?
12.05 Chair’s introduction
Case studies: Current development status of and future challenges in utilizing immune checkpoint inhibitors
The current state of the market with respect to the key players, developmental stage of pipeline products (both clinical/pre-clinical) and indications
targeted. Speakers include researchers investigating the prospects for targeting PD-L1, PD-1 and CTLA4 in various tumour types
Exploring and validating novel checkpoint pathways eg. Killer immunoglobulin receptor (KIR) inhibition, PARP inhibitors, other immune checkpoints –
TIM3, LAG3 and VISTA
Validation of clinical combinations
12.10 Anti-PD-1 therapies in melanoma
Dr Scot Ebbinghaus, Executive Director, Merck
12.25 Case study reserved for sponsor
12.40 Case study reserved for sponsor
12.55 Extending the benefits of immunotherapies through novel combinations
Dr Robert Iannone, Head, Immuno-oncology, AstraZeneca
1.10 Closing panel discussion involving all speakers
1.30 Close of session – buffet lunch in the Exhibition & 121 Partnering Area
Focus session 3
Next generation approaches to Immuno-Oncology: Investigative Therapies, Tools and Tech
12.05 Chair’s introduction
12.10 Presentation reserved for sponsor
12.25 Bispecific T-cell Engager Technology: What has CD19 taught us and where can we go next?
Dr Gregory Friberg, Global Product General Manager, Blincyto (blinatumomab), AMG 330, AMG 596, Amgen
12.40 Presentation reserved for sponsor
13.00 Argos Therapeutics & Roswell Park Cancer Institute: Development of AGS-003 and area of neoadjuvant immunotherapy (Title TBC)
Dr Thomas Schwaab, Associate professor in the departments of urology and immunology and urology clinic director, Roswell Park Cancer
Institute
1.15 Modulation of Tumor microenvironment with use of intratumoral IMO-2125, a TLR9 agonist, for effective therapy in combination with
checkpoint inhibitors
Creating a beneficial tumor microenvironment for effective checkpoint-targeted therapy by the use of intratumoral Toll-like receptor 9 agonist
Dr Sudhir Agrawal, President of Research, Idera Pharmaceuticals
1.30 Close of session – buffet lunch in the Exhibition & 121 Partnering Area
Featuring:
Start-up Boot Camp in the Showcase Theater
Followed by your choice of 3 parallel sessions
(Lunch to afternoon tea)
Focus session 1 (shared with Phacilitate Cell Gene Therapy World)
Cellular cancer immunotherapy: Optimizing combination therapy development strategy
14.40 Chair’s introduction and opening remarks
Dr David Lebwohl, SVP and Executive Global Program Head, CAR-T Global Team, Cell & Gene Therapies Unit, Novartis
14.55 Presentation reserved
15.10 Challenges and opportunities for translational science to guide angiogenesis and combinations with immunotherapy
Dr Laura Benjamin, VP Cancer Biology and Angiogenesis, Eli Lilly
15.25 Case study
Combination between gp96-Ig vaccination and stimulation of OX40, as well as developing therapies targeting other T cell co-stimulatory receptors
such as ICOS and 4-1BB.
Dr Taylor Schreiber, Vice President, Research, Heat Biologics
15.40 Combination Immunotherapies – Opening the Gate: Increasing Tumor Infiltrating Activated T-cells to Optimize and Expand the Benefits of
Immune Checkpoint Therapies Dr Jeff Hutchins, Vice President, Pre-Clinical Research, Peregrine Pharmaceuticals
15.55 Closing panel - What does commercialization look like?
Analyzing complimentary mechanisms in therapeutics and building solid partnerships
Utilizing scientifically-driven data to build a product value story
Demonstrating how a product fits within a treatment in combination(s) and against competitive therapies
16.20 Close of session – afternoon tea in the Exhibition & 121 Partnering Area
Featuring:
Techs of Tomorrow in the Showcase Theater with GE Healthcare
Or
Focus session 2
Translational science and cancer cell targets 14.40 Chair’s introduction – Dr Richard Buller, VP & Head, Oncology Clinical Development, Pfizer
14.45 The role of target biology in optimal therapeutic modality in immunotherapy - Bispecific antibodies targeting novel checkpoint inhibitors
- Bioinformatics programmes for target discovery
- Tumour antigens for targeting: Insights from genomics
- Screening compounds to identify ones with the greatest potential impact on an oncology pathway
Dr Peter Smith, VP, Drug Discovery, H3 BioMedicine
15.00 Presentation reserved for sponsor
15:15 ICOS Target
Dr Jennifer Michaelson, Head, Tumour Biology, Jounce Therapeutics
15.30 Discovering and developing immune modulating therapies to treat cancer
Dr Robert Sikorski, VP, Head of Clinical Development, Five Prime Therapeutics
15:45 Preclinical characterization of LV305, a lentiviral vector targeting tumours expressing NY-ESO-1
Dr Peter Berglund, Senior Director, Research, Immune Design
16.00 Presentation title TBC
Dr Roopa Srinivasan, Director, Head of Translational Research, ImmunoOncology R&D, GSK
16:15 Q&A from the audience on previous presentations
16.25 Close of session – afternoon tea in the Exhibition & 121 Partnering Area
Featuring:
Techs of Tomorrow in the Showcase Theater with GE Healthcare
Focus session 3
Next generation approaches to Immuno-Oncology: Investigative Therapies, Tools and Tech
As list above, sessions run with case studies from 12.05 to 16.20
14.40 Chair’s introduction 14.45 CRS-207 and GVAX; STING receptor technology (Title TBC) Dr Tom Dubensky, Chief Scientific Officer, Aduro Biotech
15.00 – FAK inhibitors induce T cell-mediated tumor regression: Prospects for combination with checkpoint inhibitors
Dr Jonathan Pachter, VP, Head of Research, Verastem
15.15 Presentation reserved for sponsor
15.30 Presentation reserved for sponsor
15.45 Closing panel: Moving beyond the first generation of immunotherapies
Emerging and well-established scientific tools and techniques for the analysis of cancer cells, immune cells and their microenvironment can be
combined to yield new insights into the nature of tumorigenesis, immune system recruitment and treatment optimization
Few cancer therapies in recent history have demonstrated such extraordinary and durable responses for patients as immunotherapies. How can we
best intensify this area of research and clinical focus for the years ahead?
Additional Panellists:
Dr Robert Hershberg, SVP, Immuno-Oncology, Celgene
16.20 Close of session – afternoon tea in the Exhibition & 121 Partnering Area
Followed by plenary sessions
(Afternoon tea to close of conference)
Determining clinical benefit and value for Immuno-oncology therapies Chair: Asthika Goonewardene, Senior Biotech Analyst, Bloomberg Intelligence
16.55 Towards a platform for cost-effective cancer immunotherapy, tailored to the patient and tumour
17.15 Concluding Panel
What is a reasonable cost? Starting a national discussion about which drugs are reasonable to prescribe and pay for
What patients will benefit most? A discussion about appropriate use
Demonstrating clinical benefit to stakeholders and engaging this evidence into market access strategies
Routes to commercialization; Increasing the acceptance and value of immunotherapy to payers and PBM
Mapping out an approval and reimbursement pathway
When will the price be too high: balancing the cost/benefit equation?
Panellists: Thomas Sondergeld, Director of Health, Benefits and Well-Being, Walgreens
Gardner Gendron, Head of Market Access/Commercial Operations, NewLink Genetics
18.15 Close of day 1 – drinks reception in the Exhibition & 121 Partnering Area
DAY 2
Tuesday, January 26th
, 2016
7.30 Registration & buffet breakfast in the Exhibition & 121 Partnering Area
Morning plenary
Accelerating Immuno-Oncology Clinical Trials and maximising success in your development
9.00 Opening Chair’s remarks
9.05 Opening address
Dr Roger Dansey, SVP and Therapeutic Area Head, Oncology Late Stage Development, Merck
9.20 Presentation title TBC
Nanobodies as a versatile approach for developing next generation immunotherapies
Dr Antonin de Fougerolles, CSO, Ablynx
9.35 Advancing into clinical development and approaches for combination therapies Dr Jon Wigginton, SVP Clinical Development, MarcoGenics
9.50 Presentation Title TBC
Dr Linda Powers, CEO, Northwest Biotherapeutics
10.10 Collaboration on clinical trials
Dr Jeff Humphrey, President, Chief Medical Officer, Kyowa Hakko Kirin Pharma
10.25 Close of session
Then
10.20-11.20
INTERACTIVE HOUR – details to follow This feature of the event offers attendees their choice of a variety of interactive formats, including:
Biotech Showcase presentations in the Innovation Accelerator Theatre
Roundtables for limited numbers of attendees on specific topics
‘Tech room’ demonstrations
White paper/clinical review data sessions
Regulatory ‘drop-in clinic’/workshop
Speed Networking session
Biotech Showcase presentations in the Showcase Theater
Panel of judges:
John McDonald, JD, MBA, Vice President, Business Development and Mergers &
Acquisitions, Biogen
Christian Homsy, CEO, Celyad
Dr Josh Schimmer, Managing Director & Senior Research Analyst, Piper Jaffray & Co
Don Healey, PhD, Chief Scientific Officer, Opexa Therapeutics
Dr Mark Metzke, Associate, Knobbe Martens
11.20 Morning coffee in the Exhibition & 121 Partnering Area
Featuring, in the Innovation Accelerator Theatre:
Keynote Address & Panel
How is Big Pharma meeting the challenge of fostering innovation in emerging
biotechnology areas?
Speaker:
R&D innovation in large pharma – the Internal Venture model
r ark immerman, Venture Leader/Vice President, Janssen Research & Development, LLC
Panellist:
Dr Stephen Rubino, Global Head, Business Development & New Products Marketing, Cell
& Gene Therapies Unit, Novartis Pharmaceuticals
Jan Thirkettle, Vice President, Cell & Gene Therapy Product Development & Supply,
Platform Technology & Sciences, GlaxoSmithKline
Followed by your choice of 2 parallel sessions (Morning coffee to lunch)
Focus session 1
Tolerance and cancer: Mechanisms of tumour evasion and strategies for breaking tolerance
Dr Amy Rosenberg, Director, Division of Therapeutic Proteins, FDA
12.15 T-cell traffic and biomarkers in immunotherapy
Dr Laszlo Radvanyi, CSO, Lion Biotechnologies
12.30 Presentation reserved for sponsor
12.50 New developments in solid tumour therapy
Impact of MoA on solid tumours, checkpoint regulation and understanding roles of Tregs among others
Dr Stefan Gluck, VP, Global Medical Affairs, IO Solid Tumours, Celgene
13.05 Tumour-directed immunotherapy: pre-clinical and clinical development of the CD40 agonistic antibody ADC-1013 Dr Per Norlen, CMO VP Development, Alligator Biosciences
13.20 Close of session - buffet lunch in the Exhibition & 121 Partnering Area
Featuring:
Start-up Boot Camp in the Showcase Theater
Immune suppression and tumor microenvironment
How understanding the tumour micro-environment is aiding our selection of candidate agents in clinical oncology
Critical strategies to overcome acquired resistance
Prevent metastasis and improve therapeutic efficacy
Understanding its impact in multiple stages of disease progression
Or
Focus session 2
Diagnostics to guide cancer immunotherapy
12.00 Chair’s introduction
12.05 The real opportunity for Personalized Medicine: where are we now?
Dr Claudio Carini, Global Head, Clinical Immunology/Biomarkers, Pfizer
12.25 Biomarkers for predicting clinical benefit and adverse reactions in immunotherapy Dr Jakob Dupont, Chief Medical Officer, OncoMed
12.40 Presentation reserved for sponsor
12:55 Regulatory considerations for diagnostics to guide cancer immunotherapy
Shyam Kalavar, Scientific Reviewer for Immunotherapy Diagnostics, FDA
Followed by panel: Standardization and harmonization in therapies/CDx adoption Challenges of standardizing companion diagnostics development when there are multiple drugs in the same class. Tackling the reality of a
convergence of multiple drugs, multiple tests, multiple indications for the same analyte.
Focusing on real-life uncertainties the healthcare community will face when a number of new PD-L1 and PD-1 inhibitors come to market, each with
their own companion tests. What are the differences in analytical validation on the patient?
Critical appraisal of the research environment related to issues of immunotherapy pricing and companion diagnostics
13.25 Close of session - buffet lunch in the Exhibition & 121 Partnering Area
The diagnostic landscape for checkpoint inhibitors
Exploring novel immune-related toxicities and endpoints with these therapies
Monitoring the autoimmune or inflammatory immune-mediated adverse effects. Determining the optimal immune-mediated toxicity
management program.
Establishing an immunomonitoring system to be applied during therapy
Enabling informed clinical use of companion diagnostics by physicians and patients
The ability to identify, collect and understand biomarkers and immunobiology of patient response and lack of response
Featuring:
Start-up Boot Camp in the Showcase Theater
Followed by your choice of 3 parallel sessions
(Lunch to afternoon tea)
Focus session 1 (shared with Phacilitate Immunotherapy World)
Cell-based immunotherapy/ex vivo gene therapy: Manufacturing business models for commercial success
Part 1: Bioprocess development strategy 14.30 Chair’s introduction
Isabelle Riviere, PhD, Director, Cell Therapy & Cell Engineering Facility, Memorial Sloan Kettering Cancer Center
Case studies: Comparing & contrasting the bioprocess business models of key developers of autologous and allogeneic cellular cancer
immunotherapies - how are they seeking to differentiate themselves through their varying approaches to scale-up?
What approaches are being taken to harness automation in order to transition to hi-thruput bioprocessing? What steps of the process can/should be
automated?
What steps are being taken to control Cost of Goods? (Integrating disposables for use in large scale production)
How are novel production technologies and producer cell lines helping to address the viral vector capacity challenge as more and more product
candidates reach the latter stages of development?
How realistic is the enablement of allogeneic T-cell therapies? What are the key challenges remaining in that space?
14.35 Industry perspective
Dr Mark Dudley, Director, Cell Process Development, Cell & Gene Therapies, Novartis
14.55 Title to be announced
Dr Boro Dropulic, CSO & General Manager, Lentigen Technology, Inc., a wholly owned subsidiary of Miltenyi Biotec
15.15 Cellectis’ anufacturing Process Platform to produce allogeneic “off-the-shelf” gene-edited CAR-T products from healthy qualified donor
T-cells
Dr David Sourdive, Executive Vice President, Corporate Development, Cellectis
15.35 Presentation reserved
15.55 Further questions for the speakers & panel discussion
What would it take to move autologous to a more distributed manufacturing model, and away from the centralized model?
Just how significant is the pivotal trial and commercial capacity shortfall worldwide for these technologies today? And what is being done to
address it?
Panellist:
Dr Larry Couture, Vice President, Centre for Applied Technology, Beckman Research Institute of the City of Hope
16.10 Close of session – afternoon tea in the Exhibition & 121 Partnering Area
Featuring:
Techs of Tomorrow in the Showcase Theater
Or
Focus session 2
The next generation of combination therapies
14.30 Chair’s introduction
14.35 Development insight from Medi4736
Dr Tony Ho, Global Medicine Leader Duvalumab (Medi4736), VP, ImmunOncology GMD, AstraZeneca
14.50 Progress with IDO inhibitor and plans for evaluating JAK and Pi3k-delta inhibition in combinations
Approaching combination immunotherapy to improve therapeutic benefit of CPI through targeting key mechanisms of resistance to
immunosurveillance in the TME: Tregs, MDSC, TAM
Dr Lance Leopold, Vice President, Clinical Development, Immuno-Oncology, Incyte Corporation
15.05 Presentation reserved for sponsor
15.20 Presentation title TBC
Dr Matthew Fury, Regeneron Pharmaceuticals
15.35 Presentation title tbc
Dr Aron Thall, Senior Director, Global Clinical Lead, Immuno-Oncology, Pfizer
15.50 Closing panel session
Additional panellist - Dr Roel Funke, Senior Clinical Scientist, Genentech
16.10 Close of session – afternoon tea in the Exhibition & 121 Partnering Area
Featuring:
Techs of Tomorrow in the Showcase Theater
Or
Focus session 2
Immunotherapy for every patient
14.30 Opening address
Dr Lee Schwartzberg, Chair (Director, West Clinic), ICLIO
14.45 Tailoring immunotherapies of cancer for stage and type of disease
On-treatment and predictive immunotherapy biomarkers
Relationship between clinical and immunological responses
Dr Dolores Schendel, CSO, Medigene AG
15.00 The challenges of tumor-specific neo-antigen Identification
Correlations to genetic/mutational burden
Assessing abnormalities in tumour DNA
Results from clinical studies, including evidence that melanoma-associated somatic mutations broaden the antigenic breadth and clonal diversity
of the antitumor response
Dr Andrew Allen, CEO, Gritstone Oncology
15.15 Presentation reserved for sponsor
15.30 [Short presentations followed by Q&A] Considerations in bringing Immunotherapies into the clinic
- How do you identify patients which need to undergo more rigorous treatment (eg. combinational therapy)
- Establishing an Immune-Related Response Criteria (Stable disease, mixed response and delayed response).
- Examination of acquired immune resistance and post-immunotherapy relapse strategies.
Dr Zhen Su, VP Oncology Medical, EMD Serono
16.10 Close of session – afternoon tea in the Exhibition & 121 Partnering Area
Featuring:
Techs of Tomorrow in the Showcase Theater
Followed by plenary sessions
(Afternoon tea to close of conference)
Managing the expectations of stakeholders (regulators, physicians, patients) regarding immunotherapy
16.45 Regulatory Discussion: How products with novel mechanisms of action are assessed Considerations when designing and presenting results of clinical studies
Working towards formalizing observations in immune-related response criteria and clinical endpoints that are specific to immunotherapies
Dr Paul Kluetz, Clinical Reviewer, US FDA
17.00 Interactive Panel
How will healthcare professionals select, prescribe and administer combinations? Looking at ethical issues – establishing a hierarchy of criteria for
treatment, remission and compassionate use
How are we going to model and accomplish reasonable reimbursement for: immunotherapy combinations, companion diagnostics, total care costs
Comparing the pathway for specific and non-specific immunotherapy
Dr Tim Turnham, Executive Director, Melanoma Research Foundation
Dr Keting Chu, Vice President, TAP, The Leukemia and Lymphoma Society
Gwen Darien, EVP, Programs & Services, Cancer Support Community
17.30 End of day two
DAY 3
Wednesday, January 27th
, 2016
7.30 Registration & buffet breakfast in the Exhibition & 121 Partnering Area
Plenary agenda
Next generation approaches to Immuno-Oncology 9.00 Chairperson introduction
9.05 Improving the response rates to checkpoint inhibition with TLR9 agonists
Patients who respond to anti-PD-1 therapy generally show evidence of an anti-tumor CD8+ T cell response infiltrating the tumor; patients who lack
such TIL rarely respond
Therefore, agents that increase TIL may be expected to improve anti-PD-1 response rates
TLR9 agonists (CpG oligos) induce TIL and have demonstrated excellent human safety in prior clinical trials
TLR9 agonists induce very strong CTL responses to cancer vaccines but these T cells express PD-1, and fail to promote tumor regression in most
patients
The combination of CpG oligos with anti-PD-1 (and other checkpoint inhibitors) shows synergistic activity in preclinical models and is expected to
be effective in cancer patients as well
Dr Art Krieg, CEO, Checkmate Pharmaceuticals
9.25 Building an immuno-oncology portfolio across all modalities of antibodies, small molecules, bispecific molecules and cell & gene therapies
9.45 AST-VAC1: A Novel Immunotherapy approach to critical unmet needs in older AML
Dr Katharine Spink, VP COO, Asterias Biotherapeutics
10.05 Presentation reserved for sponsor
10.25 Closing panel
11.00 Morning coffee in the Exhibition & 121 Partnering Area
Featuring:
Biotech Showcase presentations in the Showcase Theater
Panellists:
Christian Homsy, CEO, Celyad
Dr Josh Schimmer, Managing Director & Senior Research Analyst, Piper Jaffray & Co
r ladimir anko ic, Director, Preclinical & Translational Development, Celgene
Cellular Therapeutics
Using viruses to kill cancer: The potential of virotherapy approach
Using oncolytic virotherapy overcomes systemic tumour resistance to immune checkpoint blockade immunotherapy
Oncolytic virotherapy and checkpoint inhibitors
11.45 Dr Steve Russell, Professor of Molecular Medicine, Mayo Clinic
12.05 Dr John Bell, Founder Jennerex Therapeutics, Ottawa Hospital
12.25 Dr Kerry Fisher, CSO, PsiOxus
12.45 Presentation reserved for sponsor
1.05 Closing panel
1.40 Close of Immunotherapy World 2016 – buffet lunch in the Exhibition & 121 Partnering Area
