Draft agenda
DAY 1
Monday, January 26th 2015
7.30
Registration & buffet breakfast in the Exhibition/1-2-1 Meeting Area
Morning plenary
Reframing expectations for immunotherapy – what are the highlights and
cautionary messages from 2014?
9.00
Chair’s introduction and opening keynote
Michael Giordano, MD, Senior Vice President, Head of Oncology Development, BristolMyers Squibb
Reassessing the scope, promise and limitations of the field: Industry, investor and key opinion
leaders reflect on 2014 results and look forward to 2015 R&D commitment:
Trial successes and product approval progress in 2014
What’s next after the poster children of PD-1, PD-L1 and CAR-T?
Have we buried the idea of immunotherapy only working in ‘immunogenic’ tumors?
Progress with effectively targeting solid tumors
9.20
Industry keynote
Roy D. Baynes, MD, PhD, Senior Vice President Global Clinical Development, Merck
Research Laboratories
9.40
Question & discussion
9.45
Investor view
Howard Liang, PhD, Managing Director Biotechnology Equity Research, Leerink Partners
LLC
10.05
Key opinion leader view
Dr Laurence J. N. Cooper, Director, Immunology Laboratory of Physician Scientists,
Department of Immunology, The University of Texas MD Anderson Cancer Center
10.25
Questions & discussion
10.30
Personalized approaches to immune therapy
Linda F. Powers, CEO, Chairman of the Board, Northwest Biotherapeutics, Inc
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
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For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
1
10.50
Panel discussion
How might immunotherapy complement or displace current treatment regimens?
What can a monotherapy achieve?
What role for small molecules as immunotherapeutic agents?
When will immunotherapy be front line? The realities of immunotherapy for metastatic,
pre-metastatic and resectable tumors
Panellists include:
Dr Klaus Bosslet, Site Head Discovery Oncology, Pharmaceutical Research & Early
Development (pRED), Roche Innovation Center Penzberg, Roche Diagnostics GmbH
Dr Peter Emtage, Vice President Immune Mediated Therapy, Oncology Innovative
Medicines Unit (iMed), MedImmune, Inc
James Noble, CEO, Adaptimmune
Dr Helen Sabzevari, Senior Vice President TIP Immuno-Oncology & Head of Anti PDL1
R&D Unit, EMD Serono
Jeb Keiper, Vice President, Oncology Business Development, GlaxoSmithKline Worldwide
Business Development
Dr Gregory Friberg, Executive Medical Director, Global Program Area Lead & US
Medical Organisation TA Head, Amgen
Alex Franzusoff, PhD, Senior Vice President R&D, Bavarian Nordic, Inc
11.30
Morning coffee in the Exhibition/1-2-1 Meeting Area
Followed by your choice of 3 parallel
breakout sessions:
Focus session 1
Cell therapy manufacture 1: Are we ready to deliver commercially feasible
cellular immunotherapy products at scale?
Shared with the Cell & Gene Therapy Forum
12.05
Chair’s introduction
US FDA and industry perspectives on the key regulatory challenges facing commercial scale
autologous cell therapy manufacture (eg. quality, comparability)
12.10
US FDA perspective
Dr Keith Wonnacott, Chief of Cellular Therapies Unit, Office of Cellular Tissue and Gene
Therapies (OCTGT), US Food and Drug Administration (FDA)
12.25
Presentation reserved
Examining the evolution and future role of automated cell therapy bioprocessing technologies
•
Addressing issues of cost and timing (how/when to automate?)
12.40
Industry perspective
Dr James Trager, Vice President, Research & Product Development, Dendreon
1.00
Automate sooner than later: The need for flexible, fully automated processing platforms
Dr Kai Pinkernell, Global head of Clinical Business, Miltenyi Biotec GmbH
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
2
1.20
Buffet lunch in the Exhibition/1-2-1 Meeting Area
OR
Lunch Briefing sponsored by
(Optimal session for a maximum of 50 attendees)
Neural stem cell-mediated therapy for brain tumors
Margarita Gutova, MD, Associate Research Professor, Department of Neurosciences,
City of Hope National Medical Center & Beckman Research Institute
2.30
Case studies & multiple stakeholder panel discussion
How are the leading industrial and academic players progressing in developing
economically feasible, commercial scale manufacturing models for CAR T-cell
immunotherapy and other ex vivo genetically modified cell technologies?
o Ensuring sufficiently robust supply of starting materials (eg. lentiviral vectors)
 Clarification of evolving classification of raw versus starting materials
and the associated regulatory repercussions
o Cell procurement
o Cell characterization
o Cost of Goods
o Testing of cells – how much can you actually test after they have been modified?
o Traceability
Point of Care bioprocessing or regional manufacturing centers – which model is
optimal/commercially realistic? Examining the challenges and benefits in either approach
Panellists:
Dr Larry Couture, Senior Vice President and Founding Director, Centre for Applied
Technology Development, Beckman Research Institute of the City of Hope
Dr Kenneth LeClair, Executive Director, Novartis Cell & Gene Therapy Unit
Dr Isabelle Riviére, Director Cell Therapy & Cell Engineering Facility, Memorial Sloan
Kettering Cancer Centre
Mitchell H. Finer, Chief Scientific Officer, bluebird bio
J. Joseph Melenhorst, PhD, Director, Product Development & Correlative Sciences
Laboratories, Translational Research Program, Department of Pathology and Laboratory
Medicine, University of Pennsylvania
3.40
Close of session, followed by afternoon tea in the Exhibition/1-2-1 Meeting Area
Or
Focus session 2
Clinical updates in specific therapeutic areas – mechanistic approaches and
innovative trial design
Lung cancer
12.05
Chair’s introduction
Drawing on case studies of different modalities in the clinic, speakers will present latest data
and illustrate innovative approaches to clinical development strategy. Presentations will
focus around:
Establishing which patient population/tumor type is being targeted:
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
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For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
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o Metastatic
o Resectable cancers
o Pre-metastatic
Rationale for selection of immunotherapy modality, as monotherapies or in combination:
o Check point inhibitors
o Adoptive T cell therapy
o Cancer vaccines
o Oncolytic viruses
o Co-stimulatory molecules
Specifics of trial design:
o Mono or combination therapy
o Use of biomarkers and patient stratification
o End point selection and relevance – short and long-term
o Efficacy markers - response rate and overall survival expectations
o Use of adaptive and in silico trials to improve data
12.25
Studies of pembrolizumab in lung cancer and other malignancies beyond melanoma
Eric Rubin, MD, Vice President Oncology Clinical Research, Merck Research
Laboratories
12.45
Questions & discussion
12.55
Presentation reserved
1.15
Questions & discussion
1.20
Buffet lunch in the Exhibition/1-2-1 Meeting Area
OR
Lunch Briefing sponsored by
(Optimal session for a maximum of 50 attendees)
Neural stem cell-mediated therapy for brain tumors
Margarita Gutova, MD, Associate Research Professor, Department of Neurosciences,
City of Hope National Medical Center & Beckman Research Institute
2.30
Phase II progress in late stage NSCLC with combination Viagenpumatucel-L and lowdose Metronomic Cyclophosphamide
Taylor H. Schreiber MD, PhD, Vice President Research & Development, Heat Biologics
Inc.
2.50
Immunotherapy of lung cancer 2015: new developments and future prospects
The treatment of advanced lung cancer has historically been anchored in cytotoxic
chemotherapy and molecularly-targeted small molecules
Emerging data suggests that immunotherapy may also become an important component of
the treatment of lung cancer either alone or in combination with conventional agents
Current data suggests that in some settings, immunotherapy could even replace
chemotherapy as a new standard-of-care in the future
Jon M. Wigginton, MD, Senior Vice President Clinical Development, MacroGenics, Inc
3.10
Panel discussion
Promising new targets and functionality in the lung cancer field - what is being
investigated in early and pre-clinical development?
Panellists:
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
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For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
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Roel Funke, PhD, Senior Clinical Scientist, Genentech, Inc
Lance Leopold MD, Vice President, Head of Oncology Development, Incyte Corporation
Alex Franzusoff, PhD, Senior Vice President R&D, Bavarian Nordic, Inc
3.40
Close of session, followed by afternoon tea in the Exhibition/1-2-1 Meeting Area
Or
Workshop
(Highly interactive session for a maximum of 25 participants)
Licensing & partnering strategies – capitalizing on the advent of nonexclusivity and combination product deal structures
12.05 Moderator’s introduction
12.15
Session 1
Incorporating first-hand experience from pharma and biotech speakers, the first part of
this session will be an interactive discussion which highlights the key learning points
from recent licensing and collaboration deals.
Special challenges of:
o Exclusive and non-exclusive deals
o Deals involving unapproved products
o Combination product licensing
What are investors looking for in a deal? What information is typically used to base their
commercial models on?
Speakers/panellists:
Dr Helen Tayton-Martin, COO, Adaptimmune
Jeb Keiper, Vice President, Oncology Business Development, GlaxoSmithKline Worldwide
Business Development
Stephen T. Isaacs, Chairman & CEO, Aduro BioTech, Inc
Dr Ronald A. Pepin, Senior Vice President & Chief Business Officer, Celldex Therapeutics
1.20
Buffet lunch in the Exhibition/1-2-1 Meeting Area
OR
Lunch Briefing sponsored by
(Optimal session for a maximum of 50 attendees)
Neural stem cell-mediated therapy for brain tumors
Margarita Gutova, MD, Associate Research Professor, Department of Neurosciences,
City of Hope National Medical Center & Beckman Research Institute
2.30
Session 2
The second part of the session will look at the specifics of deal structure in different
scenarios. Interactive discussion between smaller biotech and pharma/large biotech will
help provide a checklist of issues to consider prior to deal making
Who owns the data?
How is value derived from the data?
Who pays for it?
IP issues – what about new IP created even if drug may not be developed further?
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
5
How can companies ensure that their technology is going to get used in the right
combinations?
Biotech challenges - know your product; know its mechanism; know its limitations; know
its value
Speakers/panellists - speakers from session 1, plus:
Daniel Kenny, Chief Commercial Officer, Vice President Business Development, Abivax
Dr Simon Tsang, Partnering & Strategy Head, Oncology, MedImmune, Inc
Dr Manish Singh, Chairman & CEO, Lion Biotechnologies, Inc
3.35
Moderator’s closing summary
3.40
Close of session, followed by afternoon tea in the Exhibition/1-2-1 Meeting Area
Then
Afternoon plenary session
Where next for the melanoma field - learning from complex tumor
response and survival data
4.20
Chair’s introduction – KOL in the field
4.30
Short presentations and panel discussion
What has 2014 told us about the relative strengths and weaknesses of the more
advanced clinical stage modalities in the immunotherapy armoury?
Immune checkpoint inhibitors (iCPIs)
o Mechanism of action
o Where to interfere? On the ligand or on the receptor of T cell
o Side effect profiles; Efficacy signals; Dose and sequencing
o Class effects
Antigen based cancer vaccines
o Potency
o Alternative delivery mechanisms / adjuvant
o Combination strategies
Oncolytic viruses
o Efficacy and mechanism of action
What’s next in the melanoma field?
o Novel combinations
o Earlier stage treatment and identification of responders
o Promising new compounds entering the clinic
o Small molecules as immunotherapeutic agents
o Elegant trial design - end point selection, efficacy markers
o Applying lessons learned to new disease areas
Panellists include:
Dr Helen Sabzevari, Senior Vice President TIP Immuno-Oncology & Head of Anti PDL1
R&D Unit, EMD Serono
Dr Gregory Friberg, Executive Medical Director, Global Program Area Lead & US
Medical Organisation TA Head, Amgen
David Berman MD, Exploratory Development Lead, Immuno-oncology Portfolio, BristolMyers Squibb
Scot W. Ebbinghaus, MD, Executive Director, Oncology Clinical Research, Merck
Research Laboratories
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
6
6.00
Close of day 1, followed by a cocktail reception in the Exhibition/1-2-1 Meeting Area
DAY 2
Tuesday, January 27th 2015
7.30
Buffet breakfast in the exhibition area
OR
7.45
Breakfast Briefing sponsored by
(Optional session for a maximum of 50 attendees)
Creating a Cell Therapy Manufacturing System for Commercial Production
Workshop leader:
Richard Grant, Director of Cell Therapy, Invetech Pty Ltd
Panellists:
Dr Fred Miesowicz, Chief Operating Officer, Argos Therapeutics
Donald Powers, Principal Scientist, Janssen Cell Therapy
Nick Timmons, Director, Product and Process Development, Centre for
Commercialisation of Regenerative Medicine
Morning plenary
Routes to commercialization: increasing the acceptance and value of
immunotherapy to payers, physicians and patients
9.00
Chair’s introduction
Dr Laurence J. N. Cooper, Director, Immunology Laboratory of Physician Scientists,
Department of Immunology, The University of Texas MD Anderson Cancer Center
9.05
Insight into reimbursement decisions and health economics calculations for novel
immunotherapies
Price and value – how do they relate to cure or protracted good quality remission?
What are the multiple parameters that are modelled?
How are we going to model and accomplish reasonable reimbursement for
o immunotherapy combinations?
o companion diagnostics tests
o total care costs – especially for CAR-T immunotherapy
Comparing the commercialization path for specific and non-specific immunotherapy
Matthew Farber, MA, Director, Provider Economics & Public Policy, Association of
Community Cancer Centers
9.25
Questions & discussion
9.30
Physician’s perspective
Managing the expectations of physicians regarding immunotherapy – so that they can
better communicate to, and manage expectations of, their patients
o Understanding mechanism of action and response
o Measuring whether a novel immunotherapeutic agent is effective or not
o Knowing which patients would not benefit from it
How will they select, prescribe and administer combinations?
Which boxes will immunotherapeutic products have to tick to be embraced within
existing clinical practice?
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
7
James L. Gulley, MD, PhD, FACP, Chief, Genitourinary Malignancies Branch
Director, Medical Oncology Service, Center for Cancer Research, National Cancer Institute
9.50
Questions & discussion
9.55
Presentation reserved
10.15
Panel discussion
Communication and ethical issues – establishing a hierarchy of criteria for treatment,
remission and compassionate use
What are the major bioethics issues which should be considered by the industry as we
move forward into commercialization of IO therapies?
What are the ethical issues of treating patients through the progression of the disease?
Panellists – speakers of the session, plus:
Dr Anirban Maitra ,MBBS, Professor of Pathology and Translational Molecular
Pathology; Scientific Director, Sheikh Ahmed Bin Zayed Al Nahyan Center for Pancreatic
Cancer Research, University of Texas MD Anderson Cancer Center
Dr James W. Hodge, Investigator, Head, Recombinant Vaccine Group, Laboratory of
Tumor Immunology and Biology, National Cancer Institute
10.50
New technology showcase – novel adjuvants, novel delivery mechanisms, novel scaffolds
11.20
Morning coffee in the Exhibition/1-2-1 Meeting Area
De-risking combination strategies - adopting a more mechanistic and
rational approach to targeted + systemic immunotherapy combinations
12.00
Chair’s introduction
Dr James W. Hodge, Investigator, Head, Recombinant Vaccine Group, Laboratory of
Tumor Immunology and Biology, National Cancer Institute
Thought leadership on the rational selection and sequencing of immunotherapy combinations
Faced with an infinite number of possibilities, what constitutes a rational approach?
Beyond anti PD-1: what are the next generation combination components?
How best to combine and sequence – vaccine first and then iCPI? Is that the right way to go?
Are we looking at right tumor types? Are we looking at right antigens? How to combine the
antigens themselves?
Conducting more nimble clinical trials to better inform the selection and sequencing of
combinations
What collaborations and partnerships are needed to facilitate a more rational approach to
combination selection?
12.10
Molecules in development for immuno-oncology combinations
Where we can intervene (antigen presentation, inhibition and immune system agonist)
Dr Peter Emtage, Vice President Immune Mediated Therapy, Oncology Innovative
Medicines Unit (iMed), MedImmune, Inc
12.30
Combinations of targeted therapies and chemotherapy with the PD-L1 inhibitor
MPDL3280A
MPDL3280A is well tolerated and has shown single-agent activity in a number of
indications
Broad potential exists for combining checkpoint inhibitors with targeted agents,
chemotherapy, and other immunotherapeutic approaches
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
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Early data suggest that MPDL3280A combines safely with a range of targeted agents and
chemotherapies
The rationale and challenges for several combinations will be discussed
Roel Funke, PhD, Senior Clinical Scientist, Genentech, Inc
12.50
Panel discussion
Opportunities to resurrect mono-immunotherapies as combination products
1.15
Buffet lunch in the Exhibition/1-2-1 Meeting Area
Followed by your choice of 2 parallel
breakout sessions:
Focus session 1- shared with the Cell & Gene Therapy Forum
Adoptive T cell immunotherapy clinical updates:
promise and limitations of CAR-T
TCRs and TILs waiting in the wings
2.25
Chair’s introduction
Simon F. Lacey PhD, Director, Translational and Correlative Studies Laboratory,
Translational Research Program, Perelman School of Medicine, University of Pennsylvania
2.35
Short presentations and panel discussion
Drawing on clinical case studies speakers will address issues including:
Safety prediction and monitoring
o Correlates of on- and off-target effects
Efficacy prediction and monitoring
Specificity – is one protein enough?
How broadly do the technologies scale?
Application beyond malignant patients
How do TCRs and TILs compare with CAR-T in terms of commercial promise and
limitations, particularly for solid tumors?
Combination strategies – with checkpoint inhibitors, vaccines…
When/how to move combinations up to earlier-stage cancer patients
What has driven the interest of big pharma to these technologies?
Speakers include:
Dr Helen Tayton-Martin, COO, Adaptimmune
David D. Chang, MD, PhD, Executive Vice President R&D & Chief Medical Officer,
Kite Pharma, Inc
Mitchell H. Finer, Chief Scientific Officer, bluebird bio
Dr Manish Singh, Chairman & CEO, Lion Biotechnologies, Inc
4.00
Close of session, followed by afternoon tea in the Exhibition/1-2-1 Meeting Area
Or
Focus session 2
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
9
Clinical updates in specific therapeutic areas – mechanistic approaches and
innovative trial design
Pancreatic cancer
2.25
Chair’s introduction – KOL in the pancreatic cancer field
Dr Anirban Maitra ,MBBS, Professor of Pathology and Translational Molecular
Pathology; Scientific Director, Sheikh Ahmed Bin Zayed Al Nahyan Center for Pancreatic
Cancer Research, University of Texas MD Anderson Cancer Center
Drawing on case studies of different modalities in the clinic, speakers will illustrate
innovative approaches to clinical development strategy. Presentations will focus around:
Establishing which patient population/tumor type is being targeted:
o Metastatic
o Resectable cancers
o Pre-metastatic
Rationale for selection of immunotherapy modality:
o Check point inhibitor approaches
o Adoptive T cell approaches
o Cancer vaccines
o Oncolytic viruses
o Co-stimulatory molecules
Specifics of trial design:
o Use of biomarkers and patient stratification
o End point selection and relevance – short and long-term
o Use of adaptive and in silico trials to improve data
Experiences with accelerated development pathways - primary review versus fast track versus
breakthrough status
2.45
Update on GVAX Pancreas and CRS-207 in the Phase 2b ECLIPSE trial (Efficacy of
Combination Listeria/GVAX Immunotherapy in the Pancreatic Cancer Setting)
Randomized, controlled 3-arm trial to evaluate the safety, immune response and efficacy of
the combination immunotherapy of GVAX Pancreas (with low-dose cyclophosphamide) and
CRS-207 compared to chemotherapy or to CRS-207 alone
Stephen T. Isaacs, Chairman, President & CEO, Aduro BioTech, Inc
3.05
Questions & discussion
3.10
Personalized immunotherapies for glioma and pancreatic cancer
Current targeted T-cell immunotherapeutic approaches are restricted to a few previously
described antigens with limited tumor specificity
Personalized immunotherapy with multivalent biologicals may overcome these
limitations
Introducing the concept of "active personalization" referring to biomarker-guided active
drug tailoring for a given patient
o start of a first multicentric clinical trial, the GAPVAC consortium
o two additional development tracks: ACT with autologous endogenous T cells
(ACTolog) and ACT with engineered T cells (ACTengine)
For each patient, tumor and blood biomarkers will be used to select targeted T-cell
therapies from pre-manufactured target warehouses
These concepts will be initially pursued in glioblastoma and pancreatic cancer
Dr Steffen Walter, Vice President Immunology, immatics biotechnologies GmbH
3.20
Panel discussion
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
10
Promising new targets and functionality in the pancreatic cancer field - what is being
investigated in early and pre-clinical development?
4.00
Close of session, followed by afternoon tea in the Exhibition/1-2-1 Meeting Area
Then
Afternoon plenary
Prostate cancer focus – integrating immunotherapy into standard of care
4.40
Chair's introduction
How is the profile of immunotherapy being raised amongst oncologists in the prostate
field?
James L. Gulley, MD, PhD, FACP, Chief, Genitourinary Malignancies Branch
Director, Medical Oncology Service, Center for Cancer Research, National Cancer Institute
Presentations will focus around:
What has 2014 told us about the relative strengths and weaknesses of the more advanced
clinical stage modalities in the immunotherapy armoury?
o Is there are role for immune checkpoint inhibitors (iCPIs)?
Establishing which patient population/tumor type is being targeted
Rationale for selection of immunotherapy modality, as monotherapies or in combination
with standard of care, or with each other
Immunotherapy for active surveillance
5.00
Tailoring immunotherapies for patients with different stages of prostate cancer
Complex patient immune monitoring to guide antigen selection for immune targeting
Unique preclinical models underpin target antigen selection
Adapting the form of immunotherapy to stage and disease risk
Professor Dr Dolores J. Schendel, CSO, Medigene AG; Managing Director, Trianta
Immunotherapies GmbH
5.20
Prostvac poxvirus-based active immunotherapy: single agent and clinical development
of rational combination therapies in prostate cancer
PROSTVAC mechanism of action studies
PROSTVAC PROSPECT phase 3 trial update
Evolving landscape for urologists and medical oncologists treating metastatic castration
resistant prostate cancer
Scientific rationale, preclinical and clinical development of PROSTVAC combination
therapies
o Androgen deprivation therapies
o Immune checkpoint modulation
o Radiotherapeutics
Concurrent vs. sequential combination therapies: clinician plus patient vs. payors, or
shared vision?
Alex Franzusoff, PhD, Senior Vice President R&D, Bavarian Nordic, Inc
5.40
Panel discussion
Use of biomarkers and patient stratification
End point selection and relevance – short and long-term
Efficacy markers - response rate and overall survival expectations
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
11
6.00
Close of day 2
DAY 3
Wednesday, January 28th 2015
7.30
Buffet breakfast in the exhibition area
OR
7.45
Breakfast Briefing sponsored by
(Optional session for a maximum of 50 attendees)
Strategy and innovation for cell therapy manufacturing – creating a roadmap to a
commercial future
Speakers include:
Dr Knut Niss, Senior Technical Project Leader, Novartis
Dr Jurjen Velthuis, Vice President CMC, Kiadis Pharma
Morning plenary
Early detection - increasing the specificity and selectivity of the next
generation of immunotherapeutic agents
9.00
Chair’s introduction
Dr James Trager, Vice President, Research & Product Development, Dendreon
9.05
Mechanistic approaches to early detection – how can we identify and select the right
patients and the right tumors early? What are the early predictors of response?
How do we better understand the mechanism of action of PD-1-targeted
immunotherapies, and use that information to develop biomarkers that are prognostic or
predictive of response?
David R. Kaufman, Senior Principal Scientist, Clinical Research, Merck Research
Laboratories
9.30
Questions & discussion
9.35
Novel approaches to manipulate the tumor microenvironment
CSF1R selective MAb to eliminate immunosuppressive M2 macrophages
The role of cancer associated fibroblasts in resistance, escape and immunosuppression
Dr Klaus Bosslet, Site Head Discovery Oncology, Pharmaceutical Research & Early
Development (pRED), Roche Innovation Center Penzberg, Roche Diagnostics GmbH
9.55
Questions & discussion
10.00
Parallel development of biomarkers and companion diagnostics to enrich patient
selection and predictive testing
Biomarker-supported development of cancer-antigen targeting mAB drugs mobilizing
immune effector mechanisms
Life-cycle managed and personalized medicine compliant exploitation of novel immune
therapy targets
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
12
Discovery and development of predictive biomarkers concurrent to the development of
immune effector activating mABs
Dr Özlem Türeci, CEO, Ganymed Pharmaceuticals
10.20
Questions & discussion
10.25
Immunomonitoring / immune profiling – building better predictors of immune response
Strategies for targeting cancers associated with oncogenic viruses
Methods to characterize an effective immune response against cancer
Gregg Sando, CEO, Cell Medica
10.45 Panel discussion
What advancements can we expect in the short and longer term to optimize the
specificity and selectivity of the next generation immunotherapeutic agents to deal with
the diversity that is the tumor?
What additional functions should the T cells/molecules be equipped with going forward?
Are they going to require antigen specificity or not?
Early insight into advancements in the bladder, colon and head & neck cancer fields
Panellists – speakers of the session, plus:
Professor Dr Dolores J. Schendel, CSO, Medigene AG; Managing Director, Trianta
Immunotherapies GmbH
11.20
Morning coffee in the Exhibition/1-2-1 Meeting Area
New targets and new functionality to both break and build tolerance –
cross learning between the disciplines
12.00
Chair’s introduction
Dr Amy Rosenberg, Director Division of Therapeutic Proteins, US Food & Drug
Administration (FDA)
Is your product applicable to diseases in the autoimmune / allergy field? Cross learning between
oncology and immune tolerance fields
What targets might you go for in autoimmune disease given that they aren’t well characterised?
Eg. overlap in location of tissue..
Functionality - in cancer we know effector function broadly – but when inducing tolerance what
functionality are we looking for?
Antigen specific immune tolerance therapy – a first step towards commercialization?
12.10
Role of IDO and JAK inhibition in reversing tumor-induced immunosuppression
Reviewing data supporting a role for cytokines and IDO expression in the tumor
microenvironment contributing to local immunosuppression
Potential role of JAK/STAT inhibition and IDO inhibition as a strategy to improve
immune surveillance
Lance Leopold, MD, Vice President, Head of Oncology Development, Incyte Corporation
12.30 Immune tolerance induction: revisited and rebooted
Despite being the ‘holy grail’ of immunotherapeutic treatment of autoimmunity,
conventional efforts to induce immune tolerance have generally failed in the clinic
A combination of new knowledge and technologies is allowing fulminant
commercialization of this space
We present an overview of field at-large and how Pfizer Immunoscience is revisiting and
rebooting this space, with lessons learned from immune oncology
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
13
Micah J. Benson, PhD, Principal Scientist, Immunoscience Research Unit, Pfizer Inc
12.50
Antigen specific immunotherapy – immune tolerance induced by peptide apitopes
Effective therapeutic peptides mimic naturally processed epitopes and are designed as
antigen processing independent epitopes (apitopes)
Apitope therapy correlates with induction of anergy and a cytokine switch from proinflammatory to the anti-inflammatory cytokine IL-10
Apitope therapy has been used to treat autoimmune and allergic diseases in experimental
models and has proven safe with evidence of efficacy in man
Apitope therapy is equally effective in preventing the generation of neutralising
antibodies to therapeutic proteins such as factor VIII in haemophilia
Lotta Jansson, PhD, Research Director, Apitope International N.V.
1.10
Panel discussion
Promising new targets to break / reinstate immune tolerance – what is entering the
clinic?
o Promising new immunomodulatory targets and novel immune checkpoints
o Beyond immune check points – other suppressor cells eg MDSC
o Co-stimulatory molecules - TNFRSF axes - OX40, CD27, CD40, 4-1BB, GITR,
TNFSFR25
o Innate immune system targets (anti-KIR, CSF1R)
o Metabolic targets
Panellists – speakers of the session, plus:
Gregg Sando, CEO, Cell Medica Limited
David Berman, MD, Exploratory Development Lead, Immuno-oncology Portfolio, BristolMyers Squibb
1.30
Close of the Phacilitate Immunotherapy Forum 2015 – buffet lunch in the Exhibition/
1-2-1 Meeting Area
Phacilitate Immunotherapy Forum 2015, 26th – 28th January, Grand Hyatt Washington, DC.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected]
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