Show Preview: Immuno-Oncology Summit--Exploring the next generation of IO

Immuno-Oncology Summit looks at how to apply new science and technology in developing effective and safe immunotherapies

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Cambridge Healthtech Institute’s 5th Annual
Immuno-Oncology Summit
August 28–September 1, 2017
Exploring the next generation of IO
Immuno-Oncology Summit looks at how to apply new science and technology in developing effective and safe immunotherapies
Cambridge Healthtech Institute’s 5th Annual Immuno-Oncology Summit makes a return trip to Boston this year after gracing the city last year, bringing to the Boston Sheraton Hotel an extensive and diverse array of programming to help support researchers in developing the next generation of immunotherapies.
As Cambridge Healthtech Institute (CHI) notes, immuno-oncology (IO) researchers are changing the way cancer is treated “by unleashing the immune system and achieving functional cures in some cancers.”
CHI says that this year's IO Summit has been designed to give attendees a complete picture of the field and its advances with 12 conference tracks, one in-depth training seminar and four instructional short courses, with topics including immunotherapy discovery, development, biomarkers and translational oncology as well as emerging topic areas such as cancer vaccines, oncolytic viruses and advances in synthetic biology techniques.
“Overall, this event provides a focused look at how researchers are applying new science and technology in the development of effective and safe immunotherapies,” according to CHI. The conference program’s educational sessions are broken down broadly in the five areas of development, translational IO, therapy, biomarkers and vaccines. Let’s take a peek at a few of the offerings in each arena.
One of the areas under the development umbrella that the IO Summit will explore is immunomodulatory therapeutic antibodies for cancer, which have been driven, CHI notes, in large part by recent regulatory approvals and a succession of favorable clinical data.
That said, this space is said to be rapidly filling with agents directed against similar targets. Also, issues with non-responders and a limited amount of capacity for clinical studies have created barriers for emerging companies wishing to enter this space, according to CHI, and thus it wanted to explore the science and strategies behind developing unique approaches to the unmet medical needs in this market. Also in the mix are updates on mechanistic understandings of efficacy, side effects and patient populations.
This program will kick off with a keynote presentation by Dr. Gregory Adams of Eleven Biotherapeutics titled “Enabling Effective Immuno-Oncology,” looking at the promise of
checkpoint inhibitors and other immune-oncology agents that have shown significant promise and discussing strategies that may be used to effectively set the stage for immune-oncology treatments.
Combination cancer immunotherapy will also be a focus under the development theme, examining in part how the clinical and regulatory successes of checkpoint proteins are driving a resurgence of interest in immunotherapy as a primary form of cancer treatment. This topic area will also explore the scientific and strategic considerations for different immunotherapy combination strategies and consider the business and clinical challenges facing research organizations wanting to successfully link their therapeutic programs to approved checkpoint inhibitors.
The keynote kicking off this part of the development programming is “Combination Cancer Immunotherapy: Current State and Future Opportunities” by Dr. Jon Wigginton of MacroGenics, who will address guiding principles in the clinical development of immune-oncology combinations, including patient selection, dose and schedule selection and optimizing risk/benefit, along with an analysis of the unique role and key considerations for bispecific approaches for combination immunotherapy.
The third area under development covers techniques in synthetic biology. This inaugural event was inspired by the fact that while cell-based immunotherapies provide an opportunity to incorporate synthetic biology approaches to create safer, more effective cancer therapies, the field has not reached the point where genetic parts can be predictably combined to achieve a desired outcome. Presenters will review the development of synthetic receptors, switches and circuits to control the location, duration and strength of T cell activity against tumors; address cellular engineering and genome editing of host cells to improve the efficacy of cell-based cancer therapeutics; and help attendees “build a solid foundation for a robust and impactful synthetic biology toolbox.”
Translational Immuno-Oncology
Preclinical and translational IO is one of the broad areas under this educational track, and returns this year after a successful run at the IO Summit 2016 to help attendees learn about new clinically relevant models for screening IO therapies and translational strategies to support clinical IO programs. As CHI notes, “The recent advancements in immunotherapies, such as immune checkpoint modulators, bispecific antibodies and adoptive T cell transfer, are shifting the way cancer patients are treated. Rapid development of novel immuno-oncology programs is creating the need for predictive preclinical models and translational strategies to understand combination cancer therapy, study responses to cancer immunotherapy and identify novel biomarkers and targets.”
While that may be a returning area of interest, CHI also has an inaugural program this year under the translational track, looking at emerging immuno-oncology targets, with CHI noting, “While cancer immunotherapy has made a giant leap in the past five years, the majority of therapies at advanced stages of development are clustered in a similar target space. The increased investment in immuno-oncology has created an urgent opportunity to discover and populate new target spaces that either present new classes of immunotherapies or can be used in combination with existing products.”
As such, presenters will cover such topics as immunomodulatory inhibitor and agonist targets, stromal and immune cell targets, as well as share case studies of preclinical and translational approaches to the discovery and validation of new immuno-oncology targets and combinations.
Also under the translational IO banner is a day-and-a-half-long training seminar titled “Immunology for Drug Discovery Scientists” that will cover the fundamentals of human immunology for biologists working in cancer therapeutic areas at pharmaceutical and biotech organizations. The class will offer perspectives on how immune responses can be monitored by assessment of biomarkers and modulated through biopharmaceutical intervention, as well as cover a historical perspective, basic mechanisms and approaches to developing therapeutics and their combinations in immuno-oncology.
This, the third of CHI’s broader tracks, is broken down into the areas of oncolytic virus immunotherapy, adoptive T cell therapy and personalized cancer vaccines.
As CHI described the first of those three, “Oncolytic virotherapy represents an exciting new area of cancer treatment which exploits a virus’ ability to selectively replicate and kill tumor tissue while stimulating a patient-specific immune response against cancer. Interest in the field is at an all-time high following significant deals by Pfizer, Celgene, Amgen, BMS and Boehringer Ingelheim; however, questions still remain around delivery, product and clinical development, preclinical modeling, scale-up, manufacturing and suitable commercial models.”
The adoptive T cell track is a returning topic area—this being the fourth time it has been offered—inspired by the accelerated pace of immunotherapy development, which, spurred by greater understanding of T cell biology and promising patient outcomes, has led to immunotherapies accelerating at an unprecedented pace. The programming here will focus on the steps needed to deliver CAR, TCR and TIL therapies to the patient by examining emerging science, autologous immune cell products and allogenic immune cell products.
Finally, the second annual Personalized Cancer Vaccines and Neoantigen Targeted Therapies meeting under the therapy umbrella will gather thought leaders to share research and case studies for using patient-centric approaches that employ the immune system to beat cancer, including utilizing next-generation sequencing to identify tumor-specific neoantigens, using in-silico tools to predict immunogenic neoepitopes and targeting them with personalized vaccines or vaccine combination therapies.
This track is split between quantitative immune profiling and biomarkers for immuno-oncology. The first area, broadly titled “Quantitative Immune Profiling and Immune Monitoring,” is an inaugural event that will bring together presenters to cover quantitative approaches to assess the state of the immune system, profile the tumor microenvironment and peripheral blood, determine tumor mutational burden and profile neoepitopes and develop predictive and response biomarkers. Of the “Biomarkers for Immuno-Oncology” programming, now in its second year, CHI says, “As pharmaceutical and biotechnology companies increase their investment in immuno-oncology programs to facilitate rapid development of novel immunotherapies, there is increasing pressure to discover and validate relevant biomarkers.” As such, this meeting will bring together biomarkers experts from industry and academia to address rapid development of predictive and prognostic IO biomarkers, utility of these biomarkers in clinical trials and their potential as companion diagnostics.
Among the areas covered in this track are advances in oncolytic virus immunotherapy, vaccine technologies, vaccine adjuvants and personalized cancer vaccines. The first and fourth of those are the same programming as described earlier in the therapy track.
“Advances in Vaccine Technologies” will present the latest advancements and applications of vaccine technology and a look forward to overcoming current challenges. Synthetic vaccine candidates, genomic analysis of disease progression and vaccine response, structure-based antigen design and nanoparticle delivery systems will be among the areas covered.
Of “Vaccine Adjuvants” CHI says, “Many recently developed vaccines are comprised of recombinant molecules or subunits of pathogenic organisms, requiring formulation with adjuvants to increase and direct the immune response. The benefit of adjuvants is clear: they may reduce the amount of antigen and number of vaccinations needed, accelerate the immune response, increase cross-protection and improve efficacy in populations that are poor responders. As we continue to confront emerging and re-emerging disease threats and progress toward developing new vaccines to improve global health, there is also an urgent need for the development of effective adjuvants.”

Plenary Keynotes
One of the major components of the Immuno-Oncology Summit is the plenary keynote session, because, as CHI notes, it brings together hundreds of attendees from across all of the conference programs, adding: “This session aims to cover pain points the entire field faces, with this year’s focus on FDA approval, market access and reimbursement. Particular attention will be given to approval of adoptive cell therapies, which are on the cusp of breaking into the market, and cancer vaccines. Then, an overview of the current healthcare system will be provided in the context of getting reimbursed for this new class of therapeutics.”
The keynote addresses will take place on Tuesday, Aug. 29.
The first is “Regulatory and Scientific Considerations for Cancer Vaccines and Adoptive Cellular Immunotherapy” by Dr. Raj Puri, division director of the Center for Biologics Evaluation and Research (CBER) at FDA. As he says of his presentation, “Cell and gene therapy, including therapeutic vaccines and cellular immunotherapy products, are evaluated at FDA’s Center for Biologics Evaluation and Research in the Office of Tissues and Advanced Therapies (OTAT), previously known as Office of Cellular, Tissue and Gene Therapies. I will discuss current general regulatory and scientific considerations in the regulation of therapeutic cancer vaccines and cellular immunotherapy. In addition, research activities in OTAT will be summarized.”
Puri is also chief of FDA’s Tumor Vaccines and Biotechnology Branch. Prior to joining FDA/CBER, he was trained at National Cancer Institute’s Surgery Branch in cancer vaccines and immunotherapy approaches for cancer. At FDA, Puri oversees evaluation, manufacturing and regulation of therapeutic vaccines, cellular immunotherapy, cellular and gene therapy, tissue engineering and xenotransplantation products under various regulatory pathways. In addition, he oversees and manages FDA mission-relevant regulatory science-related research programs to support cutting-edge medical product development, and he directs translational research program in his own lab in the field of cancer vaccines, cancer targeting and cellular immunotherapy of cancer.
The second plenary keynote address is “Market Access and Reimbursement for Immuno-Oncology Drugs in Today’s Healthcare System” by Dr. Gergana Zlateva, vice president, Payer Insights and Access, Oncology at Pfizer. As described by CHI, “Now that immunotherapies have hit the market, with the promise of more to come, the healthcare system will need to establish standards for cost and reimbursement of immuno-oncology agents. This talk will address how the healthcare marketplace can prepare for the adoption of novel pricing and reimbursement models to increase patient access to immunotherapies. Establishing the value of IO therapies to payers and HTAs will also be addressed in the context of pricing and evidence generation.”
At Pfizer, Zlateva’s team provides both region-specific and global support in the development and implementation of market access, pricing, reimbursement and health technology assessment strategies for Pfizer’s oncology portfolio. During her 13 year tenure with Pfizer, she has held various positions of increasing responsibility covering health economics, outcomes research and pricing and reimbursement activities across several therapy areas and different geographies, and she has led multiple cross-functional teams in preparation of pricing and reimbursement negotiations in developed markets. Prior to joining Pfizer in 2003, Zlateva worked for five years on public health, civil society and business development programs with several United Nations agencies.

The 2017 IO Summit Emerging Investigator Initiative
The IO Summit 2017 will feature a new initiative wherein a select number of presentations will be given by rising stars from the field of immune-oncology. The goal of this initiative is to not only showcase the future of the field, but also to provide our delegates with cutting-edge research that they won’t see elsewhere.
Presentations include:
Immunomodulatory Therapeutic Antibodies for Cancer
Immunomodulatory Antibodies—Potentiation by Fc Receptor Engagement
Dr. Rony Dahan of the Weizmann Institute of Science
The Role of Metabolism in Immune Response in Tumors: Merging the Past and the Present of Tumor Microenvironment
Dr. Allison S. Betof of Memorial Sloan Kettering Cancer Center
PI3Kgamma Is a Molecular Switch that Controls Immune Suppression
Dr. Megan M. Kaneda of the University of California, San Diego
Emerging Techniques in Synthetic Biology
Hacking Immune Cells with Synthetic Notch Receptors to Expand Their Therapeutic Potential
Dr. Kole T. Roybal of the University of California, San Francisco
Synthetic Biology Approaches for Engineering Platelets as Delivery Systems for Treating Disease
Dr. Tara L. Deans of the University of Utah
Preclinical and Translational Immuno-Oncology
Using Radiation to Elicit In Situ Tumor Vaccination
Dr. Zachary S. Morris of the University of Wisconsin School of Medicine and Public Health
The Role of Batf-3 DC in the T Cell-Inflamed Tumor Microenvironment
Dr. Stefani Spranger of the Massachusetts Institute of Technology
Vaccine Therapy for Primary and Secondary Breast Cancer Prevention
Dr. Sasha Stanton of the  University of Washington
Emerging Immuno-Oncology Targets
Targeting IDO1 to Enhance Cancer Immunotherapy: Not So Simple After All
Dr. Derek A. Wainwright of the Northwestern University Feinberg School of Medicine
Development of TGFβ Inhibitors for Immune-Oncology
Dr. Rikke Holmgaard of Eli Lilly
Dual Targeting Bispecific Antibodies Selectively Block Innate Immune Checkpoint Receptor CD47 on Tumor Cells
Dr. Stefano Majocchi of Novimmune SA
Predicting the Efficacy and Safety Profile of ImmTAC Molecules: The Preclinical Challenge
Dr. Martina Canestraro of Immunocore Ltd.
Oncolytic Virus Immunotherapy
Development of OV Immunotherapy Using a Novel Preclinical GBM Model
Dr. Hiroshi Nakashima of Brigham and Women’s Hospital
Oncolytic Virus-Induced Rad51 Degradation: Synergy with Poly(Adp-Ribose) Polymerase Inhibitors in Treating Glioblastoma
Dr. Jianfang Ning of Massachusetts General Hospital and Harvard Medical School
Adoptive T Cell Therapy
PET-Imaging of Chimeric Antigen Receptor T Cells
Dr. David Huss of Juno Therapeutics
Quantitative Immune Profiling and Immune Monitoring
Antigen-Presenting Tumor B Cells Impact the Phenotype of CD4 Tumor Infiltrating T Cells in Lung Cancer Patients
Dr. Tullia Bruno of the University of Pittsburgh
Quantifying Non-Self in Cancer
Dr. Benjamin Greenbaum of the Icahn School of Medicine at Mount Sinai
Biomarkers for Immuno-Oncology
Understanding the Heterogeneity and Dynamics of Responses to Checkpoint Blockade in Melanoma
Dr. Alexandre Reuben of The University of Texas MD Anderson Cancer Center
Biomarkers of Response/Progression in RCC Patients Receiving PD-1/PD-L1 Inhibitors
Dr. Aly-Khan Lalani of Dana-Farber Cancer Center
Advances in Vaccine Technologies
A Systems Approach to Develop HIV Vaccines
Dr. Jishnu Das of the Ragon Institute of MGH, MIT & Harvard
Vaccine Adjuvants
Driving Humoral Responses against HIV Envelope via Multivalent Display of Env Trimers on Synthetic Liposomes
Dr. Talar Tokatlian of the Massachusetts Institute of Technology

Dinner Short Courses
(separate registration required)
Tuesday, August 29
6:30 p.m. to  9 p.m.
Short Course 1: Bioinformatics for Immuno-Oncology and Translational Research
Dr. Yuriy Gusev of Georgetown University Medical Center
Short Course 2: Microbiome in Immuno-Oncology - Detailed Agenda
Dr. Aly-Khan A. Lalani of Dana-Farber Cancer Institute
Dr. Dario Gutierrez of Merck Research Labs Cambridge Exploratory Science Center
Dr. Lata Jayaraman of Seres Therapeutics
Thursday, August 31
6:30 p.m. to  9 p.m.
Short Course 3: Study Design and Statistical Data Analysis of Flow Cytometry Assays for Cancer Immunotherapy - Detailed Agenda
Dr. Shuguang Huang of Stat4ward LLC
Short Course 4: CRISPR/Cas9 Applications in Immunotherapy
Dr. Kathrin Schumann of the University of Californa San Francisco
Dr. Hao Yin of the David H. Koch Institute for Integrative Cancer Research

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