Breakout Discussions

These interactive, problem-solving breakout discussions are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.

Room: Harborview
Monday, 3:00-4:15 pm

TABLE 1: Delivery and Administration of Oncolytic Virotherapies

Matthew Mulvey, PhD, CEO, BeneVir Biopharm, Inc.

• Delivery mechanisms
• Tumor targeting strategies
• Intravenous vs Intratumoral delivery

TABLE 2: Bringing OVs to Market: Manufacturing and Commercialization Considerations

David Kirn, MD, Co-Founder & Executive Chairman, IGNITE Immunotherapy

• Commercialization considerations – OVs as combinations? Which combinations?
• Moving from clinical to commercial development – filings, what to tell the regulators, and when
• CMC and manufacturing considerations for OVs – outsourcing landscape, in-house development, procurement strategies

TABLE 3: Machine Learning and Systems Approaches to Help Guide Combination Immunotherapy

Janusz Dutkowski, PhD, CEO, Data4Cure, Inc.

• Recent combination trials and success stories; rational approaches to combination immunotherapy
• Deep omics-based disease subtyping and predictive modeling to guide combination strategies
• Reverse translation: iterative learning from successes and failures in clinical trials

TABLE 4: Optimizing Dose and Schedule for Biological and Immunological Therapies in Combination with Traditional Therapies

Jaime F. Modiano, VMD, PhD, Perlman Professor of Oncology and Comparative Medicine, Veterinary Clinical Sciences, College of Veterinary Medicine and Masonic Cancer Center, University of Minnesota

• How are clinical trials assessing systematically combinations of immunotherapy agents and other conventional therapy modalities (surgery, chemotherapy, radiation)?
• What should be goals for therapies that activate the innate vs. the adaptive arms of the immune system when used as adjuvants to other conventional therapy modalities?
• What are the benefits of upfront vs. backend immunotherapy added to other conventional therapy modalities?
• Are therapies that activate innate immunity redundant with other conventional therapy modalities?
• How do we predict if immune-related adverse events and potential negative impact on quality of life are additive to adverse events from other conventional therapy modalities?

TABLE 5: Clinical and Economic Considerations in Patient Selection for Cancer Immunotherapy

George Poste, DVM, PhD, Chief Scientist, Complex Adaptive Systems, Arizona State University

• Technical challenges in the development of multiparameter assays to predict responsiveness and/or toxicity in immunotherapy
• Are high cost immunotherapeutic regimens economically sustainable without the ability to predict responder and non-responder patients?
• Hype versus hope: managing patient expectations in immunotherapy, the ethics of commercial and cancer center advertising and the implications of recent “right-to-try” legislation

TABLE 6: Use of Checkpoint Inhibitors: Benefits and Limitations

Michael Olin, PhD, Assistant Professor, Pediatrics, University of Minnesota; CSO, OX2 Therapeutics

• What are the limitations of current checkpoint inhibitors?
• Will combination immunotherapy enhance treatment?
• Will immunotherapy replace radiation?

TABLE 7: Potential Diagnostic/Prognostic Role of Plasma-Derived Exosomes in Cancer

Theresa Whiteside, PhD, Professor, Pathology, Immunology & Otolaryngology, Hillman Cancer Center, University of Pittsburgh School of Medicine

• Is exosome isolation a major factor in exosome profiling?
• Protein profiling, miR detection or both?
• DNA analysis in exosomes

TABLE 8: Emerging Themes in Cancer Immunotherapy Resistance

Brent Hanks, MD, PhD, Assistant Professor, Cancer Immunology/Immunotherapy, Duke Cancer Institute, Duke University School of Medicine

• How prevalent are the development of tumor cell autonomous mutations in mechanisms of immunotherapy resistance and how heterogeneous are these mutations in the same patient?
• What are the mechanisms linking tumor mesenchymal transformation and the development of primary and acquired immunotherapy resistance?
• How might the mutational burden of the tumor influence the development of immunotherapy resistance?
• Is there any relationship between the development of adaptive resistance and observed cases of disease hyper-progression?
• What can we say about combination Immunotherapy regimens and sequencing in light of the currently described immunotherapy resistance mechanisms?

TABLE 9: 3D Tumor Organoids

Christoph Sachse, PhD, Site Head Berlin, NMI TT Pharmaservices

• What are their current and future applications in translational oncology?
• Where are the advantages over PDX and what are the limitations in drug development?
• How close are we to predicting personalized treatment responses in the clinic?

TABLE 10: Selection of the Right Target Pairs for Bispecific Biologics

Rakesh Dixit, PhD, DABT, Vice President, R&D; Global Head, Biologics Safety Assessment, MedImmune

• What targets to select and not select?
• Agonist pairs, antagonist pairs or mixed pairs
• Soluble ligand pairs vs. membrane ligand pairs
• ADA, PK and safety risks with the target pairs, cross-linking
• Potency, valency and other considerations

Room: Beacon Hill
Friday, 8:00-9:00 am

TABLE 11: CAR T Cell Therapy for Solid Tumors

Prasad S. Adusumilli, MD, FACS, FCCP, Associate Attending and Deputy Chief, Thoracic Surgery; Head, Solid Tumors Cell Therapy, Cellular Therapeutics Center; Director, Mesothelioma Program, Memorial Sloan Kettering Cancer Center

• Results to date of CAR T cell trials for solid tumors
• Role of combination therapies along with CAR T cells
• Next-gen CARs
• New strategies in overcoming hurdles in solid tumor cell therapy

TABLE 12: Standardization for Apheresis Centers and Transplant Centers by the Cell Therapy Industry

Amy Hines, Director, Collection Network Management, Be The Match BioTherapies

• Apheresis and transplant center certification/approval process: Audit, risk assessment, training
• Collection protocols: Apheresis equipment, minimum cell dose and viability, processing/cryopreservation, labeling/packaging/shipping
• Infusion protocols: Cryopreserved product thaw, concurrent medications, supportive medications
• Required data collection: Apheresis collection data, infusion data, patient follow-up data
• Reimbursement: Apheresis collection, supportive medications, supportive care
• Software platforms

TABLE 13: Antigen Heterogeneity and Cell Therapy

Paul Rennert, PhD, President & CSO, Aleta Biotherapeutics, Inc.

• Antigen loss and patient relapse
• Multi-antigen targeting solutions
• Antigen heterogeneity and solid tumors
• Are there safer ways to target antigens (or safer antigens)?

TABLE 14: Future Directions: Outsmarting Tumors with Biology-Targeted Epitope Vaccines

William C. Watt, PhD, President & CEO, EpiThany

• Epitopes work in cancer vaccines – epitopes from mutated antigens can work if selected properly; epitopes from overexpressed antigens can work if selected properly. Which tumors might be vulnerable via both biological processes? In which settings?
• Is there a rationale for greater vaccine efficacy by combining mutation-targetable antigens and overexpression-targetable antigens in a vaccine, analogous to combination of direct-acting antivirals; i.e., protease + polymerase inhibitors?
• What differences in immunogenicity among mutated epitopes and over-expressed epitopes are there that might create challenges to hybrid vaccine formulation? Amplitude/potency? Durability? Preexisting immunity? Vector compatibility?

TABLE 15: Personalized Cancer Vaccines: What’s Important for Efficacy?

David Anderson, PhD, CSO, Research & Development, VBI Vaccines, Inc.

• What’s the relative importance of CD4 vs. CD8 T cell epitopes?
• How important is the overall magnitude of T cell response vs. the breadth of that response?
• Do we have any idea what is an optimal therapeutic vaccination schedule?

TABLE 16: Targeting Cells of the Tumor Microenvironment

Raymond Tesi, MD, President and CEO, Acting CMO, INmune Bio

• What cells of the TME should we target?
• Should we target cells of the TME as part of first-line therapy or after failure to first-line therapy?
• Are the biomarkers in the peripheral blood that correlate with the cells in the TME?

TABLE 17: How to Develop Personalized Cancer Vaccines for the Market

Agnete Fredriksen, PhD, President and CSO, Vaccibody AS

• What are the major regulatory hurdles for reaching the market with a personalized cancer vaccine?
• How will the regulators classify the neoepitope selection process in individualized neoepitope vaccine development, and which requirements will be imposed at different levels of development?
• What will be the biggest manufacturing challenges when developing personalized cancer vaccines, and how can we work to overcome these challenges?