Session Abstract – PMWC 2022 Silicon Valley


Track Chair:
Ira Mellman, Genentech

Human cells have been successfully used as treatment for blood cancers for decades but translating the promise to cell-based treatment for solid tumors has been slow. The advent of gene-editing techniques such as CRISPR, coupled with advances in our understanding of immunology and optimization of growing, manufacturing, transporting, storing, and handling specialized biological samples and materials is transforming the cell therapy field. We will hear in this session about some of the most promising work in the field, as well as the challenges in overcoming resistance

    Sessions:
  • Recent Advances in Cell-based Therapy
    Session Chair: Ira Mellman, Genentech
    - Nicholas Haining, ArsenalBio
    - Elliot Norry, Adaptimmune
    - Sarah Cooley, Fate Therapeutics
    - Liz Homans, Lyell
  • Patentability of Immunotherapies - Latest Developments
    - Janet Xiao, Morrison & Foerster LLP
  • Cell-based Therapy Challenges
    Session Chair: Lawrence Corey, Fred Hutchinson Cancer Research Center
    - Sharon Benzeno, Adaptive Biotechnologies
    - Arati Rao, PACT Pharma
    - Mark Kotter, bit.bio
  • Next-generation Supply Chain For Cell & Gene Therapies
    Session Chair: Sharon Benzeno, Adaptive Biotechnologies
    - Amy DuRoss, Vineti
    - Tim Moore, Pact Pharma
    - Teresa Foy, BMS
  • Biomarkers to Guide Immunotherapy
    Session Chair: Danny Wells, ImmunAI
    - Sanjeev Mariathasan, Genentech
    - Christine Spencer, PICI
    - Klaus Lindpaintner, InterVenn Bioscience
  • Advances in Multi-Omic Spatial Profiling
    Session Chair: Sarah Warren, NanoString Technologies
    - Chris Corless, OHSU
  • Engineered Therapeutics
    Session Chair: Daniel Chen, SITC
    - Kole Roybal, UCSF
    - Paul Parren, Lava Therapeutics

 Session Chair Profile

Ph.D., Vice President, Cancer Immunology, Genentech

Biography
Ira Mellman came to Genentech in the Spring of 2007 as Vice President of Research Oncology, after more than 20 years as a faculty member at the Yale University School of Medicine, where he was chair of his department (Cell Biology), a member of the Ludwig Institute for Cancer Research, scientific director of the Yale Cancer Center, and Sterling Professor of Cell Biology and Immunobiology. Dr. Mellman has a BA from Oberlin College & Conservatory and a PhD in Genetics from Yale. He was a Postdoctoral Fellow at the Rockefeller University with Ralph Steinman, who received the Nobel Prize for the discovery of dendritic cells. His laboratory is known not only for advances in fundamental cell biology particularly in the area of membrane traffic (including the discovery of “endosomes”) but also for applying these insights to understanding the cellular basis of the immune response, especially dendritic cell function. He was also the founder of CGI Pharma, which was recently purchased by Gilead. Ira ran all of oncology research at Genentech until the end of 2013 when he decided to concentrate his efforts on the rapidly developing area of cancer immunotherapy and became Vice President of Cancer Immunology. Ira is a member of the National Academy of Sciences, American Academy of Arts & Sciences, the European Molecular Biology Organization, and the former Editor in Chief of the Journal of Cell Biology. He has also served on the editorial boards of Cell, the Journal of Experimental Medicine, EMBO Journal, among others. He also serves on the boards of the Society for the Immunotherapy of Cancer, the American Society for Cell Biology, and the Cancer Research Institute. He remains a frustrated composer and songwriter, and has recorded two CDs in the little-known genre of “bio-rock”.


 Session Chair Profile

M.D., Professor / Principal Investigator, Fred Hutchinson Cancer Research Center

Biography
Dr. Larry Corey is an internationally renowned expert in virology, immunology and vaccine development, and the former president and director of the Fred Hutchinson Cancer Research Center. His research focuses on herpes viruses, HIV, the novel coronavirus and other viral infections, including those associated with cancer. He is principal investigator of the HIV Vaccine Trials Network, or HVTN, which conducts studies of HIV vaccines at over 80 clinical trials sites in 16 countries on five continents. Dr. Corey is also the principal investigator of the Fred Hutch-based operations center of the COVID-19 Prevention Network (CoVPN) and co-leads the Network’s COVID-19 vaccine testing pipeline. The CoVPN is carrying out the large Operation Warp Speed portfolio of COVID-19 vaccines and monoclonal antibodies intended to protect people from COVID-19.


 Session Chair Profile

Ph.D., Senior Vice President of Strategic Research & Scientific Co-Founder, immunai

Biography
Danny Wells is a scientific co-founder at Immunai and currently serves as the Senior Vice President of Strategic Research. Danny joined the founding team of Immunai during his time as an investigator at the Parker Institute for Cancer Immunotherapy, where he was the founding principal data scientist and led research efforts in genomics and reverse translational medicine. Danny has co-authored dozens of research articles around the intersection of (single-cell) genomics and cancer immunotherapy that have collectively been cited thousands of times, including papers published in Nature, Cell, and Nature Medicine. Before joining the Parker Institute, Danny completed a postdoctoral fellowship in evolutionary biology at the University of California, Berkeley, his PhD in Computational Biology and Applied Mathematics at Northwestern University, where he was an NSF Graduate Research Fellow, and a BA in Mathematics from Carleton College where received the Galovich Prize for accomplishment in undergraduate mathematics research.


 Session Chair Profile

M.D., Ph.D, Director (BoD), SITC

Biography
Daniel S. Chen, MD, PhD, is a Director on the Society for ImmunoTherapy of Cancer (SITC) Board of Directors, the former Chief Medical Officer for IGM Biosciences, and former Vice President, Global Head of Cancer Immunotherapy Development at Genentech/Roche. He is a reviewer for Nature, Immunity and Clinical Cancer Research, serves on the Board of Directors for SITC, gave the keynote presentation at the AACR NCI EORTC Annual Meeting 2014 and presented at the US Congressional Briefing on Immuno Oncology in 2017. He has continued to publish with academic and industry collaborators in the field of cancer immunotherapy, including the often-referenced Chen and Mellman manuscripts, “Oncology meets Immunology: the Cancer-Immunity Cycle,” “Elements of cancer immunity and the cancer-immune set point” and the Hegde and Chen manuscript “Top 10 Challenges in Cancer Immunotherapy.”


 Session Chair Profile

Ph.D., Sr. Director, Translational Science, NanoString Technologies

Biography
Dr. Warren and leads a team to leverages multiplexed, molecular profiling technologies to address key research areas in oncology, immunology, and beyond. She partners with academics, biopharmas, and clinicians to identify unmet needs in translational research, create novel products for transcriptional and proteomic profiling, and deploy those tools to advance scientific discovery. She is also active in the research community to promote the science and application of cancer immunotherapy to improve patient outcomes. She has authors more than 50 articles and book chapters in leading journals.


 Speaker Profile

BM, BCh, Chief Scientific Officer, ArsenalBio

Biography
Nicholas Haining is a physician-scientist, immunologist and drug developer. He received his undergraduate and medical degree from Oxford University and completed his medical training in Pediatrics at Children's Hospital, Boston, and subsequently in Pediatric Hematology/Oncology at Dana-Farber Cancer Institute. As an Associate Professor of Pediatrics at Harvard Medical School and an Associate Member of the Broad Institute of Harvard and MIT his lab defined some of the key transcriptional and epigenetic regulators of T cell exhaustion and used in vivo genetic screens to identify immune vulnerabilities of cancer cells in mouse models. His clinical expertise is in hematopoietic stem cell transplantation, and he attended on the bone marrow transplant service at Children’s Hospital, Boston for almost twenty years. Most recently, he served as Vice-President, Discovery Oncology and Immunology at Merck Research Laboratories, where he led a multi-site, multidisciplinary team developing innovative approaches to identify therapies for cancer and immune diseases. Dr. Haining was elected into the American Society for Clinical Investigation, and received the Presidential Early Career Award for Science and Engineering.


 Speaker Profile

M.D., Chief Medical Officer, Adaptimmune

Biography
Elliot Norry has served as the Chief Medical Officer (CMO) of Adaptimmune since January 2020 after having served as their acting CMO since August 2019. Previously, Dr. Norry was Vice President and Head of Clinical Safety and Pharmacovigilance at Adaptimmune, and leader of our ADP-A2AFP program, having joined the company in July 2015.Prior to joining Adaptimmune, Dr. Norry served as Safety Development Leader at GSK from 2009, where he managed clinical safety for a broad range of early and late stage products, including approval activities for pazopanib for the treatment of soft tissue sarcoma. He was also Chair of GSK’s Hepatic Safety Panel. Prior to his roles in the biotech and pharmaceutical industry, Dr. Norry practiced adult internal medicine at Abington Memorial Hospital in Abington, Pennsylvania for 13 years. He holds a B.A. from Columbia College and an M.D. from New York University. He completed his residency in Internal Medicine at Temple University Hospital in Philadelphia and his fellowship in gastroenterology at Thomas Jefferson University Hospital in Philadelphia.


 Speaker Profile

M.D., Senior Vice President Clinical Translation, Fate Therapeutics

Biography
Sarah Cooley, M.D., M.S. is Senior Vice President, Clinical Translation at Fate Therapeutics and oversees translational medicine across the cell-based cancer immunotherapy programs and for early clinical development of cell product candidates. Dr. Cooley, an expert in the field of natural killer (NK) cell receptor immunogenetics and in the clinical development of NK cell cancer immunotherapies, brings to Fate Therapeutics more than 12 years of leadership in the field of NK cell clinical research and development. Prior to joining Fate, she was an Associate Professor of Medicine in the Division of Hematology, Oncology and Transplantation at the University of Minnesota where her clinical practice included adult Hematologic Malignancy and Blood and Marrow Transplant service and her research included leading 15 clinical trials of NK cell or immunotherapy-based cancer treatments. At the University of Minnesota’s Masonic Cancer Center, Dr. Cooley played a critical role in the development of translational research infrastructure, serving as the Medical Director for the Clinical Trials Office, for the Oncology Informatics Shared Resource and as Director of the Cancer Research Translational Initiative. Dr. Cooley received an undergraduate degree in Biology and Chemistry from Cornell University and graduated from the University of Minnesota Medical School. She completed a residency in Internal Medicine at the University of California, San Francisco and fellowship training in Hematology and Oncology at the University of Minnesota, where she also received her M.S. in Clinical Research from the School of Public Health.


 Speaker Profile

Chief Executive Officer, Lyell Immunopharma

Biography
Liz has served as Lyell’s Chief Executive Officer and member of its board of directors since August 2020 and was President from 2018 until becoming CEO. Between 2009 and 2018, Liz held multiple senior leadership positions at Genentech, including Vice President, U.S. Sales and Marketing Leader for Breast Cancer, Vice President, U.S. Sales and Marketing Leader for Xolair, Vice President, Global Regulatory Operations Leader and Vice President, Global Product Strategy, HER2 Franchise. Ms. Homans was Executive Director, Project Leadership and Portfolio Management at Jazz Pharmaceuticals, between 2004 and 2007. She received an MBA from Columbia University in the City of New York and a B.A. in German and Economics from Bates University.


 Speaker Profile

Ph.D., Chief Business Development Officer, Adaptive Biotechnologies

Biography
Dr. Sharon Benzeno is the Chief Business Development Officer and leads the Drug Discovery group at Adaptive. Sharon oversees the use of the company’s immune medicine platform for novel drug discovery, including TCR discovery to inform next-generation cellular therapy, antibody discovery, and vaccines. Before joining Adaptive in 2014, Sharon was Senior Director at Elsevier Inc., a healthcare informatics company. Prior to Elsevier, Sharon co-led the oncology business unit at Capgemini SE, a consulting and technology services company. Sharon came to Elsevier from Capgemini, where she held a variety of management roles at AstraZeneca plc. Sharon holds a PhD in Biomedical Sciences from New York University School of Medicine, an MBA in Finance and Leadership from New York University Stern School of Business and a BA in Biochemistry from New York University. Sharon completed a postdoctoral fellowship in cancer biology at the University of Pennsylvania Abramson Cancer Center.


 Speaker Profile

M.D., Senior VP, Head of Clinical Development, PACT Pharma

Biography
Dr. Arati Rao is dual fellowship trained Geriatric-Oncologist and a former Associate Professor of Medicine at the Duke University School of Medicine who is passionate about cell therapy development. She has worked both in the heme malignancies CAR T space at Kite-Gilead and now in the solid tumor neoantigen TCR space at PACT. She has in depth knowledge on cell therapy/immunology programs and has worked closely with regulatory agencies including the FDA and EMA. As the global lead and Medical Monitor for ZUMA-2, she was responsible for successfully filing a BLA and received accelerated approval for Tecartus™ (brexucabtagene autoleucel) in relapsed/refractory mantle cell lymphoma with the FDA. During her academic career, she led the myeloid leukemia efforts at Duke and served as a PI/Co-PI on several trials. She was also an NIH funded clinical researcher. She has served as a faculty on the NCCN-Acute Lymphoblastic Lymphoma guidelines (v1.0) and on several ASCO and ASH committees including the ASH- scientific committee for myeloid biology.

Talk
Challenges in Cell Therapy Development
Cell therapy development globally has continued to increase. CAR T therapies have led the way but TCR, TIL, neoantigen and other therapies are also being evaluated. The development of cell therapies brings several challenges: type of study and biometrics, regulatory, operations, manufacturing, cost and reimbursement and most importantly patient related and toxicity issues.


 Speaker Profile

M.B.A, CEO and Co-Founder, Vineti

Biography
From the campaign trail to digital technology, Amy is a long-time leader in expanding patient access to regenerative medicine. Prior to co-founding Vineti, the first cloud-based digital platform for orchestrating cell and gene therapies, Amy was Managing Director of GE Ventures, as well as Chief Business Officer of Navigenics, a genomics company sold to Life Technologies. Amy was also Co-founder and Executive Director of Proposition 71, California's $3 billion stem cell research initiative passed in 2004, as well as Chief of Staff for the resulting state grant oversight agency, the California Institute for Regenerative Medicine. Amy is a Coro Fellow and an Aspen Institute Health Innovators Fellow, and serves on the Board of Directors for BioLife Solutions and the ARM Foundation for Cell and Gene Medicine. Under Amy’s leadership, Vineti received the prestigious Technology Pioneer award from the World Economic Forum in 2019 as “a company with the potential to “improve society for years to come."


 Speaker Profile

Ph.D., J.D., Partner, Morrison & Foerster LLP

Biography
Janet focuses on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Her clients range from large multinational biopharmaceutical companies, such as Celgene and Genentech, to emerging startup companies around the world. She advises her clients on patent matters relating to various technologies, including antibody therapeutics, cell therapeutics, nanomedicine, gene therapy, drug delivery systems, diagnostics, and nutraceuticals. Janet works extensively in performing IP due diligence reviews in the contexts of VC investments, technology transactions, mergers and acquisitions, and marketing and manufacturing clearance for biopharmaceutical products. She is noted for her in-depth knowledge of patent landscapes in the fields of cancer immunotherapy, gene editing, next-generation sequencing, liquid biopsy, antibody manufacturing, and medical devices. She has Ph.D. in Biological Chemistry from University of California, Los Angeles, and an M.S. in Molecular Biology and Protein Chemistry from the Institute of Biophysics, Chinese Academy of Science.


 Speaker Profile

Ph.D., Associate Professor Microbiology and Immunology, Investigator PICI, UCSF; Co-Founder, Arsenal Bio

Biography
Dr. Roybal is an Associate Professor in the Department of Microbiology and Immunology at the UCSF. He is a member of the Parker Institute for Cancer Immunotherapy and an inaugural Chan Zuckerberg Biohub Investigator. He was recently awarded the Sartorius and Science Magazine Prize for Regenerative Medicine and Cell Therapy and the NIH New Innovator Award. The Roybal lab harnesses the tools of synthetic biology to engineer to control and enhance engineered immune cell therapies. His body of work was foundational to the next-generation immune cell therapy company, Cell Design Labs, where he was a founding scientist (now part of Gilead). He was also instrumental in developing universal CAR T cell technology in collaboration with Xyphos Biosciences (now part of Astellas). He has recently co-founded Arsenal Biosciences, which focuses on building cellular therapies for solid tumors with a combination of cutting-edge synthetic biology and gene editing technologies.

Talk
Development of NextGen Cellular Therapeutics with Synthetic Biology
Engineered immune cell therapies for cancer suffer from life-threatening toxicities or inefficacy depending on the clinical indication. I will provide an overview of our synthetic biology toolkit that allows for the control and customization of immune cell responses to improve the safety and efficacy of cell-based therapies.


 Speaker Profile

J.D., CEO, ZealCare

Biography
Maureen O’Connor is a senior healthcare executive passionate about driving change in our health care system to improve lives. Currently, she served as CEO of ZealCare, an early stage health care services and technology company, spun out of Duke, with a mission to empower people with complex chronic conditions to live the life they want. The company provides intensive, individualized support to participants and their care team through personalized planning, education and virtual group visits. Initially, Zeal is targeting individuals with chronic kidney disease and type 2 diabetes. Formerly, Maureen served as president of Whiterabbit.ai, a Silicon Valley company with a mission to eradicate late-stage breast cancer through the use of artificial intelligence. Maureen spent 17 years as an executive with Blue Cross Blue Shield of North Carolina, serving as EVP of diversified businesses, president of Mosaic Health Solutions, and chief strategy and innovation officer.


 Speaker Profile

Ph.D., Associate Director, Informatics, Parker Institute for Cancer Immunotherapy

Biography
Christine Spencer, PhD, is the Associate Director, Informatics in PICI’s Informatics team. At PICI, Spencer works with academic and industry partners around translational research projects and also leads informatics analysis for select PICI-sponsored clinical trials, overseeing the PD1-resistance and Pancreatic efforts. Spencer came to PICI from the laboratory of Dr. Jennifer Wargo at the University of Texas MD Anderson Cancer Center, where she focused on host lifestyle factors and characteristics of the gut microbiome in response to checkpoint blockade immunotherapy. Spencer did her bachelor’s degree in biology at the University of California, Santa Barbara where she also researched immune response to age-related macular degeneration at the Center for the Study of Macular Degeneration. She conducted graduate research at MD Anderson while studying epidemiology, biostatistics & data science at the University of Texas School of Public Health, where she earned both master’s and doctorate degrees.


 Speaker Profile

Ph.D., Principal Scientist/ Senior Director, Genentech

Biography
Sanjeev Mariathasan leads the biomarker strategy for the Atezolizumab/Tecentriq franchise. He also co-leads the Oncology Reverse Translation group. The aim of this group is to derive mechanistic and therapeutically actionable insights from Roche’s extensive clinical database as well as to identify novel targets for the cancer immunotherapy pipeline. Examples of his research include (1) the revelation of TGFβ-mediated signaling in aiding exclusion of T cells in stromal tissues surrounding the tumors and the demonstration of reversing these effects leading to enhanced anti-tumor efficacy with anti-TGFβ and anti-PD-L1 mAb combination therapy in preclinical models (Mariathasan et al, Nature 2018); and (2) the use of ctDNA as an exploratory endpoint in a phase 3 adjuvant bladder cancer trial, the results of which have the potential to change treatment decision paradigms in early-stage bladder cancer and potentially other solid tumor types (Powles et al, Nature 2021).

Talk
Peripheral Biomarkers Guiding Cancer Immunotherapy


 Speaker Profile

Ph.D., Executive Vice President and Head of R&D, Lava Therapeutics

Biography
Prof. Paul W.H.I. Parren is dedicated to translating antibody biology and immunotherapy knowledge into innovative therapeutics and technologies. He holds a PhD in molecular immunology from the University of Amsterdam (1992). Prof. Parren was an Associate Professor at The Scripps Research Institute in La Jolla, California. From 2002-2017, he led research and preclinical development at Genmab, leading to seven product approvals to date. He is an inventor of ofatumumab (Arzerra, 2009; KESIMPTA, 2020), daratumumab (DARZALEX, 2015, DARZALEX-Faspro, 2021), teprotumumab (Tepezza, 2020), amivantamab (RYBREVANT, 2021), tisotumab vedotin (Tivdak, 2021) and two clinically translated technologies to generate bispecific (DuoBody) and effector-function enhanced (HexaBody) antibodies. In 2015, he became a Professor of Molecular Immunology at the Leiden University Medical Center in Leiden. In 2018, he joined LAVA Therapeutics, a biotechnology company focused on developing bispecific gamma-delta T cell engagers to transform cancer therapy, as its Executive Vice President and Head of R&D.

Talk
Bispecific Gamma-delta T Cell Engagers
LAVA is developing a bispecific antibody γδ T cell engager (bsTCEs) platform that leverages the unique qualities of γ9δ2 effector T cells. LAVA’s bsTCEs were selected to create a wide therapeutic window with high activity against tumor cells whilst leaving healthy cells unharmed. LAVA progressed two bsTCEs to the clinic, one in haematological cancer and one in oncology.


 Speaker Profile

M.D., M.P.H., FACP, Chief Medical and Scientific Officer, InterVenn BioScience

Biography
Klaus Lindpaintner, MD, MPH, FACP, Chief Scientific and Medical Officer at InterVenn Biosciences, previously held senior positions at Pfizer as Sr. VP and Global Head, Human Genetics and Computational Biomedicine, at Hoffman-La Roche, as Distinguished Scientist and Global Head, Roche Center for Medical Genomics, spearheading the company’s efforts in personalized health care; as CSO at Thermo-Fisher-Scientific; and on the faculty of Harvard Medical School. Klaus has co-authored some 250 scientific papers, and holds honorary and adjunct professorships at several academic institutions. He serves on numerous boards, working groups, and advisory panels for trade organizations, regulatory authorities, and non-governmental organizations on issues related to the successful implementation and leverage of novel technologies in health care. Klaus graduated from Innsbruck University Medical School with a degree in medicine, and from Harvard University with a degree in public health. He pursued post-graduate training and specialization in internal medicine, cardiology, and clinical and molecular genetics in the US and Germany and is a Diplomate of the Boards in these specialties.


 Speaker Profile

Ph.D., SVP, TRC Immuno-Oncology and Cell Therapy, Research and Early Development, Bristol Myers Squibb

Biography
Teresa Foy is an immunologist with more than 25 years of biotechnology and pharmaceutical industry experience developing novel therapeutics in the areas of oncology and inflammation. At Bristol Myers Squibb, Teri leads the Immuno-Oncology and Cell Therapy Thematic Research Center. With a mission to drive leadership in the use of immune effector cell-based therapies in hematological and solid cancers, Teri and her team focus on the development and translation of BMS’ early I-O and cell therapy pipeline from discovery through human proof of concept. As part of her research, Teri also oversees close collaborations with other key research areas across the company, as well as external scientific partnerships.


 Speaker Profile

President and Chief Operating Officer, PACT Pharma

Biography
Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Most recently, he served as Executive Vice President, Technical Operations at Kite, a Gilead Company, since March of 2016. During this time Mr. Moore was responsible for overseeing the process development, manufacturing, quality and supply chain for the launch of Yescarta®, one of the first CAR T therapies to be developed, manufactured and commercialized, as well as advancement of the Kite pipeline. In addition, Mr. Moore globally expanded the biopharmaceutical operations to serve and support the US, EU, as well as key partners in Asia. Prior to Kite, Mr. Moore served as the Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee since 2010. In this role, Mr. Moore oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Prior to that, Mr. Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He is currently a member of ISPE, PDA and has been a part of the Executive Committee of BioPhorum and serves as a Board member for Cerus. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.