US IMMUNO-ONCOLOGY STRATEGY MEETING 2018

Transcription

1 CONFIRMED FACILITATORS William Hearl Ramon Mohanlal Robert Iannone President & Chief Executive Officer Immunomic Therapeutics Executive Vice President & Chief Medical Officer BeyondSpring Pharmaceuticals Senior Vice President, Head of Immuno-Oncology, Global Medicines Development AstraZeneca Andres Guiterrez Chief Medical Officer Oncolytics Biotech Teng Jin Ong Vice President, Medical Affairs Celgene Cristian Massachesi Vice President Asset Team Leader, Immuno-Oncology Pfizer PANEL DISCUSSION Stefan Scherer Jeffrey Skolnik Harry Raftopoulos Vice President, Head Early Development, Strategy & Innovation Vice President, Clinical Development Inovio Pharmaceuticals Vice President, Translational Medicine - Immuno-Oncology Bayer Novartis Cori Gorman Abdel Halim Charles Sentman Vice President Precision Medicine & Manufacturing Vice President, Translational Medicine, Biomarkers & Diagnostics Professor, Microbiology & Immunology Agenus Bio Celldex Therapeutics Dartmouth Medical School

2 TRACKS 08:00-8:30 REGISTRATION 08:30-09:00 WELCOME ADDRESS AND OPENING KEYNOTE PRESENTATION: 09:00-10:00 Developing predictive biomarkers for immunotherapies to identify mechanisms of resistance How to select right translational models to quantitatively monitor and characterize IO therapeutic agents Developing new clinical endpoints for immune-oncology studies Where do cancer vaccines fit in the current landscape of immunotherapies? How to move them from promising to effective? Next generation I-O combinations for cancer 10:05-10:30 MORNING REFRESHMENTS/NETWORKING/1-2-1 MEETINGS 10:30-11:30 Can proteomics enable immuno-oncology biomarker discovery? Technology for effective translational research Using predictive analytics to accelerate the success of your clinical operations Implementing strategies to tackle resistance to anti-pd-1/ PD-L1 therapies 11:35-12:00 NETWORKING/1-2-1 MEETINGS 12:00-13:00 Bridging the knowledge gap between real-world adaptation of I-O treatments and reliable biomarkers to ensure safe and effective use of this therapy class Evaluating the efficacy of human PD-1 targeting antibodies in humanised mouse models Highly complex early-phase studies with adaptive designs and multi-arm trials requires flexibility 13:00-14:00 NETWORKING LUNCH Developing CAR-T technologies to overcome immune evading mechanisms of tumours How to prioritise which combinations to use during development 14:00-14:20 INDUSTRY TALK: Protein Fingerprints and Novel Biomarker Discovery - Michael Dabrowski, Chief Executive Officer, Pelago Bioscience 14:25-14:50 AFTERNOON REFRESHMENTS/NETWORKING/1-2-1 MEETINGS 14:50:15:15 NETWORKING/1-2-1 MEETINGS 15:15-16:15 Identifying and validating predictive biomarkers for combined immunotherapy and targeted therapy Determining patient selection and eligibility Will bispecific antibodies dethrone monotherapy for treating cancer? Rational design of combination approaches 16:20-17:20 Challenges and opportunities for biomarkers in IO to help inform clinical decisions How to better predict anti-tumor efficacy and toxicity associated with immune cells genetically engineered with CARs and TCRs Can OS still be measured given crossovers in trials? What measures best represent OS? 17:20-17:50 PANEL DISCUSSION Addressing optimal timing and sequencing of immune checkpoint inhibition Strategies to optimize combination therapy 17:50 19:00 CANAPÉ & DRINKS RECEPTION

3 09:00-10:00 Developing predictive biomarkers for immunotherapies to identify mechanisms of resistance 15:15-16:15 Identifying and validating predictive biomarkers for combined immunotherapy and targeted therapy Facilitator : Roopa Srinivasan, Senior Director, Head of Translational Research, Immuno-Oncology R&D, GlaxoSmithKline - Clinically relevant model systems assays to predict biomarkers of resistance and activity - Patient selection biomarkers and stratification to enhance clinical benefit - Understanding failure of response to PD1 treatment to enable viable combinations Facilitator : Christoph Borchers, Chief Scientific Officer, MRM Proteomics - How do targeted proteomic biomarkers of treatment efficacy tell us what genetics alone cannot? - How can we develop fast high-specificity diagnostic assays for protein drug targets? - How can we use multiplexed pathway-driven proteomics and metabolomics panels to identify treatment targets and mechanisms of resistance? - How does reproducible protein quantitation, with isoform and phosphorylation information, help avoid validation pitfalls? - How do we gain insight by going beyond cytokine levels? 10:30-11:30 Can proteomics enable immuno-oncology biomarker discovery? 16:20-17:20 Challenges and opportunities for biomarkers in IO to help inform clinical decisions Facilitator : Michael Dabrowski, Chief Executive Officer, Pelago Bioscience - The use of Thermal Proteome Profiling to map cellular pathways - Direct and indirect target engagement quantification - Predictive biomarker identification and validation 12:00-13:00 Bridging the knowledge gap between real-world adaptation of I-O treatments and reliable biomarkers to ensure safe and effective use of this therapy class Facilitator : Abdel Halim, Vice President, Translational Medicine, Biomarkers & Diagnostics, Celldex Therapeutics - Potential value of biomarkers for different purposes in I-O - Proper identification and qualification of biomarkers in I-O - Where is the gap, using PD-L1 as an example, and how can it be filled? Facilitator : Stefan Scherer, Vice President, Head Early Development, Strategy & Innovation, Novartis - How to tackle a 10x problem identifying biomarkers for response - Microbiome Yes / No, when and how - Tumor-based markers: TILs, mutational load, T-cell repertoire - Biomarkers for toxicity? - Interaction tumor and microenvironment

4 9:00-10:00 How to select right translational models to quantitatively monitor and characterize IO therapeutic agents Facilitator : Maria Karasarides, Executive Director, Immuno- Oncology, Regeneron Pharmaceuticals - Is there a biased focus toward the improvement of patient selection schemes and is this helping or impeding our progress? - No model is perfect: How do we apply fit-for-purpose validation of current models to immunotherapy drug development? - Emerging immune biomarker technologies and the vision for quantification (from high throughput genomics to immune monitoring cytometry) 12:00-13:00 Evaluating the efficacy of human PD-1 targeting antibodies in humanised mouse models Facilitator : William Hearl, President & Chief Executive Officer, Immunomic Therapeutics - Which subsets of immune cells provide the best indicator of the mechanism of action in these model systems? - How closely do the cell populations actually reflect and correlate to human immune cells? - What do the next generation of mouse models look like? - Which new IO targets are the leading candidates for development and validation by these models? - How does the FDA and other regulatory agencies view the mouse model as part of a pre-clinical data package? 10:30-11:30 Technology for effective translational research 16:20-17:20 How to better predict anti-tumor efficacy and toxicity associated with immune cells genetically engineered with CARs and TCRs Facilitator : Mark Paris, Associate Director, Translational Applications, Mitra Biotech Facilitator : Ildiko Csiki, Vice President, Clinical Development, Immuno-Oncology, Inovio Pharmaceuticals - Mechanism of action/proof of biology - Modeling clinical response (efficacy) - Deficiencies/strengths in existing models - Are in vitro assays predictive of CAR/TCR efficacy and toxicity in patients? - Are animal models useful in understanding CAR/TCR efficacy and toxicity? - If in vitro and animal models are not predictive of T cell efficacy and safety, how does the field choose clinical candidates for their trials?

5 9:00-10:00 Developing new clinical endpoints for immuno-oncology studies 15:15-16:15 Determining patient selection and eligibility Facilitator : Jeffrey Skolnik, Vice President Clinical Development, Inovio Pharmaceuticals - How has our thinking of the mechanism of action of immune agents changed our thinking of clinical endpoints in general? - What does the tail of the survival curves (PFS and OS) how we should define clinical benefit? - What is the optimal study design with which to define a maximally tolerated or biologically effective dose? - How can we leverage predictive biomarkers into our studies now? Facilitator : Harish Dave, Chief Medical Officer, Accelovance Inc. - How can patient ineligibility rate be reduced by modification of entry criteria (prior IO therapy exposure, need for pathology samples, biomarker criteria) - What can be done to make it easier for patients to participate (financial burden, lifestyle impact)? - How to overcome physician nihilism (perceived barriers to study site referral, lack of trial knowledge) 10:30-11:30 Using predictive analytics to accelerate the success of your clinical operations 16:20-17:20 Can OS still be measured given crossovers in trials? What measures best represent OS? Facilitator : Peter Malamis, Chief Executive Officer, CRO Analytics - Why have true leading indicators of clinical trial performance not been routinely captured? - How can you use predictive analytics to better select and manage clinical service vendors? - What can you do to Increase investor, investigator, and internal confidence in your ability to meet deadlines and budgets? - Where can you make changes that advance your ability to recruit and retain patients. - Why is creating a data-driven clinical operations culture important, why you don t have one, and how can you get one? 12:00-13:00 Highly complex early-phase studies with adaptive designs and multi-arm trials requires flexibility Facilitator : Teng Jin Ong, Vice President, Medical Affairs, Celgene - What are the appropriate statistical designs for early phase IO phase 1 studies? - What are appropriate expansion rules and when should biopsies be mandated? - What should change when combinations are to be tested rather than monotherapy? - How do we advance IO agents in checkpoint-naive patients? Facilitator : Cristian Massachesi, Vice President Asset Team Leader, Immuno-Oncology, Pfizer - What role will PFS continue to play? - Some CPIs have been conditionally approved based on ORR: can a similar strategy also be pursued in an earlier setting? - Is there a need to validate some surrogate endpoints for OS to continue the development of immuno-oncology agents? What would be the most effective approach to do so? Would it still require to be indication specific?

6 09:00-10:00 Where do cancer vaccines fit in the current landscape of immunotherapies? How to move them from promising to effective? Facilitator : Cori Gorman, Vice President Precision Medicine & Manufacturing, Agenus Bio - Overcoming the challenges posed by immune evasion - How to ensure continuous improvement in the algorithms for neoantigen vaccines? - Can posttranslational modifications be used as a vaccine target - Best approaches to identifying pharmacodynamics (PD) biomarkers to assess response - How to best determine when and what combination therapy is best to administer along with the vaccine 15:15-16:15 Will bispecific antibodies dethrone monotherapy for treating cancer? Facilitator : Yasmina Abdiche, Chief Scientific Officer, Carterra - Is redirecting T-cells with bispecific antibodies safer than CAR-T cell therapy? - Is the complexity of bispecific antibodies hindering their development over conventional antibodies? - Beyond CD3 bispecifics, what is the future for discovering new targets as we understand more about tumor biology? 12:00-13:00 Developing CAR-T technologies to overcome immune evading mechanisms of tumours Facilitator : Charles Sentman, Professor, Microbiology & Immunology, Dartmouth Medical School - What are the key tumor suppressive mechanisms that prevent CAR-T cell activity (e.g. immune checkpoints, cytokines, metabolism)? - How to design CAR T cells to resist the TME? - How to enhance CAR T cell activity and engage the host anti-tumor immune response? - How can CAR T cells be used to solve the problem of tumor heterogeneity? - What are the potential challenges with these approaches? 16:20-17:20 Addressing optimal timing and sequencing of immune checkpoint inhibition Facilitator : Robert Iannone, Senior Vice President, Head of Immuno- Oncology, Global Medicines Development, AstraZeneca - Does tumor burden impact response to immune checkpoint inhibitors (ICI)? - Does the timing of radiation therapy relative to ICI matter? Chemotherapy? - Will NeoAdj ICI improve outcomes in resectables tumors compared to adjuvant only? - What is the optimal duration of ICI for stage 4, stage 3 unresectable and in the adjuvant setting?

7 09:00-10:00 Next generation I-O combinations for cancer 15:15-16:15 Rational design of combination approaches Facilitator : Andres Guiterrez, Chief Medical Officer, Oncolytics Biotech - Is there a preferred agent capable of converting non-inflamed tumors into inflamed ones to synergize the activity of PD-1/ PD-L1 inhibtion? - How much preclinical evaluation is needed for new IO-combos? - How do we optimize trial design to evaluate optimal dose and schedule for combination agents, which may differ across distinct indications? - Are we ready to test triple I-O combinations? - What is the next I-O backbone agent to be tested beyond PD-1/PD-L1 blockade? Facilitator : Mark Paris, Associate Director, Translational Applications, Mitra Biotech - Differential response versus amplification - Patient stratification and or biomarker ID (molecular, preclinical modelling) - Selecting/identifying complementary biology - Methods for predicting response ahead of clinical testing 10:30-11:30 Implementing strategies to tackle resistance to anti-pd-1/pd-l1 therapies 16:20-17:20 Strategies to optimize combination therapy Facilitator : Patrick Mayes, Executive Director, Head of Immuno-Oncology Antibody Research, Incyte Corporation - Combination approaches to overcome primary resistance to PD-1/PD-L1 - Combination approaches to address acquired resistance to PD-1/PD-L1 - How should we define acquired resistance to PD-1/PD-L1? - Should PD-1/PD-L1 therapies be part of the combination regimen in the acquired resistance setting? Facilitator : Ramon Mohanlal, Executive Vice President, Chief Medical Officer, BeyondSpring Pharmaceuticals - Triple combination approaches - Prevention of IR-AEs in PD1 /CTLA4 inhibitor combination - Prevention of IR-AEs and CIN in PD1/chemotherapy combination - Oral IO agents with shorter half lives to better manage IR-AEs 12:00-13:00 How to prioritise which combinations to use during development Facilitator : Harry Raftopoulos, Vice President, Translational Medicine - Immuno-Oncology, Bayer - As pre-clinical models in immune-oncology are poorly predictive of efficacy, what other measures should be used to determine appropriate combinations to develop? - How important is the regulatory requirement to demonstrate the contribution of each component in a combination? - Are data with combinations translatable across agents of the same class? - How will one combination be measured against another if not directly compared?

8 Abbvie, Director, Translational Medicine Abpro, SVP Strategic Alliances PARTICIPANTS EMD Serono, Head, Search & Evaluation, Immuno-Oncology GlaxoSmithKline, Medical Director Adaptimmune, Director, Translational Sciences Agenus Bio, Senior Director Research Biochemistry Agenus Bio, Vice President, Precision Medicine and Manufacturing AstraZeneca, Senior Vice President, Head of Immuno-Oncology, Global Medicines Development Astrazeneca, Director, Immuno-Oncology Life Cycle Management Bayer, Head, Regulatory Strategy - Oncology Early Projects Bayer, Vice President, Translational Medicine - Immuno-Oncology BeyondSpring Pharma, Executive Vice President, Chief Medical Officer Bristol-Myers Squibb, Director, Oncology Clinical Development, Lung Program Bristol-Myers Squibb, Director, IDO1i Clinical Development Program Lead Bristol-Myers Squibb, Head Immuno-Oncology Translational Bioinformatics Celgene, Corporate Vice President, Global Clinincal R&D, Hematology & Oncology Celldex, Vice President, Translation Medicine, Biomarkers & Diagnostics Celyad, Head Clinical Development & Medical Affairs CrisprTx, Executive Vice President, Head of R&D CrisprTx, Head of Immuno-Oncology Dartmouth Medical School, Professor Microbiology & Immunology Eisai, Director External Research GlaxoSmithKline, Senior Director, Head of Translational Research, Immuno-Oncology R&D Glenmark Pharmaceuticals, Executive Director, Clinical Sciences, Oncology Henlix, Senior Director Immatics, Director, Product Sciences Immunome, Vice President R&D Immunomic Therapeutics, President & Chief Executive Officer Incyte, Senior Director Incyte, Executive Director, Head of I-O Antibody Research Inovio, Vice President, Clinical Development Janssen, Director, Immuno-Oncology Discovery Macrogenics, Vice President Immunology & Cell Biology Maverick Therapeutics, President & Chief Scientific Oncology Merck, Executive Director, Clinical Oncology Novartis, Vice President Head Early Development, Strategy and Innovation Oncolytics, Chief Medical Officer Pfizer, Vice President IO Medicine Team Leader Progenra, Senior Director and Head of Drug Discovery Regeneron, Executive Director, Immuno-Oncology Eleven hubxchange, Biotherapeutics 27 Old Gloucester, Chief Street, Scientific London Officer WC1N 3AX, United Kingdom Telephone:

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