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 © Phacilitate Limited, 2014 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 © Phacilitate Limited, 2014 For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected] 3 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 © Phacilitate Limited, 2014 For more information, please contact Amanda Crabbe on +44 (0)1732 886788 ; [email protected] 4 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] 8 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] 14
© Copyright 2024