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 (PANEL)
    Session Chair: Sascha Rutz, Genentech
    - Susie Jun, ArsenalBio
    - Elliot Norry, Adaptimmune
    - Tina Albertson, Lyell
    - Hy Levitsky, Century Therapeutics
  • Patentability of Immunotherapies—Latest Developments
    - Janet Xiao, Morrison & Foerster LLP
  • Cell-based Therapy Challenges (PANEL)
    Session Chair: Sharon Benzeno, Adaptive Biotechnologies
    - Arati Rao, PACT Pharma
    - Hy Levitsky, Century Therapeutics
    - Susie Jun, ArsenalBio
  • Next-generation Supply Chain For Cell & Gene Therapies (PANEL)
    Session Chair: Sharon Benzeno, Adaptive Biotechnologies
    - Tim Moore, Pact Pharma
    - Heidi Hunter, Cardinal Health
  • Advances in Multi-Omic Spatial Profiling
    Session Chair: Michael Rhodes, Nanostring
    - Chris Corless, OHSU
  • Biomarkers to Guide Immunotherapy
    Session Chair: Danny Wells, ImmunAI
    - Sanjeev Mariathasan, Genentech
    - Klaus Lindpaintner, InterVenn Bioscience
    - Lacey Padron, PICI
  • NaNots: A New Class of Immunotherapy
    - Lou Hawthorne, Nanotics
  • Engineered Therapeutics (PANEL)
    Session Chair: Paul Parren, Lava Therapeutics
    - Sonja Schrepfer, UCSF
    - Greg Lazar, Genentech

 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

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.


 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

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.


 Session Chair Profile

Ph.D., Principal Scientist, Cancer Immunology, Genentech

Biography
Sascha Rutz is a Principal Scientist in the Cancer Immunology Department at Genentech. He is the Research Lead for the T Cell Therapy program in Oncology at Genentech, focused on developing TCR-engineered T cells targeting neoantigens in solid tumors. Sascha is a T cell immunologist by training, and received his Ph.D. from Humboldt University Berlin, Germany, before joining Genentech as a Postdoc in 2009.


 Session Chair Profile

Ph.D., Sr. Director, Advanced Applications, NanoString Technologies

Biography
At NanoString Dr. Rhodes worked on all aspects of NanoString technologies as developed from a mid plex gene expression company, into a spatial biology company, culminating in the release of GeoMx DSP and CosMx SMI. A a post doc in Chicago working on genetics of metal transport in P. aeruginosa was followed returned to UK to work at United Kingdom Human Genome Mapping Project Resource Centre in charge of four teams: - Mouse resequencing, linkage Hotel, Academic Services and Custom services. Joined Applied Biosystems in 1999, worked on Genotyping, qPCR and Next Generation Sequencing. Joined NanoString in 2012 after seeing the potential of the nCounter technology to take the discoveries from NGS and apply them to translational research.


 Speaker Profile

MD, CMO, Adaptimmune

Biography
Dr. Elliot Norry has served as Chief Medical Officer of Adaptimmune since January 2020 and he is a member of the Executive Team. Previously, Dr. Norry was Vice President of Clinical Safety in Pharmacovigilance at Adaptimmune, and leader of their ADP- A2AFP program. Prior to joining Adaptimmune, Dr. Norry served as Safety Development Leader at GSK, where he managed clinical safety for a broad range of early and late-stage products, including improvement 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. He holds a B.A. from Columbia College and an M.D. from New York University. He performed his residency in Internal Medicine at Temple University Hospital in Philadelphia and his fellowships in gastroenterology at Thomas Jefferson University Hospital in Philadelphia.


 Speaker 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.


 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

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., 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

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.


Clinical Dx Showcase:
InterVenn BioScience

InterVenn has developed a unique technology platform that combines high resolution mass spectrometry with high throughput artificial-intelligence powered data processing, allowing interrogation of the human glycoproteome at clinical study scale.

Glycoproteomic Profiling: Powerful Predictor of Immunotherapy Response
Using InterVenn's platform we have been able to demonstrate that serum glycoprotein profiles are powerful predictors of likely response or non-response to checkpoint inhibitors, clearly superior to currently available biomarkers across a range of indications and drug molecules.

 Speaker Profile

President and Chief Operations Officer, PACT Pharma

Biography
Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Mr. Moore is current the President and Chief Operating Officer at PACT Pharma. Prior to joining PACT, 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. Prior to Kite, Mr. Moore served as the Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. . In this role, Mr. Moore oversaw global leadership 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.


 Speaker Profile

M.D., Director & CMO, Knight Diagnostic Laboratories, OHSU

Biography
Dr. Corless is Professor of Pathology at Oregon Health & Science University and serves as the executive director of the Knight Diagnostic Laboratories. His specialty is clinical implementation of new testing technologies for the molecular characterization of solid tumors.


Talk
Measuring Breast Cancer Biomarkers With The Nanostring GeoMx DSP
The Nanostring GeoMx Digital Spatial Profiler can generate tumor-specific quantitative readouts for over 90 protein and phospho-protein biomarkers using a multiplexed antibody approach. We developed a panel for measuring clinically informative biomarkers in samples of FFPE breast cancer and demonstrated its robust performance across multiple laboratories. The panel is ideal for analyzing clinical trial samples.


 Speaker Profile

M.D., Ph.D., Chief Medical Officer & Head of Development, Lyell

Biography
Prior to joining Lyell, Dr. Albertson was Vice President of Global Drug Development at Juno Therapeutics, a Bristol-Myers Squibb company. Before Juno, Dr. Albertson served as Medical Director at Seagen. Dr. Albertson also completed a pediatric oncology fellowship at University of Washington. Dr. Albertson received a Ph.D. in Cancer Biology from University of Washington, an M.D. from Stanford University, and a B.S. in Biology from University of Oregon.


 Speaker Profile

M.D., Ph.D., Professor at UCSF and SVP at Sana Biotechnology

Biography
Work by Dr. Sonja Schrepfer is at the forefront of stem immunobiology and paves the way for treatment of a wide range of diseases – from supporting functional recovery of failing myocardium to the derivation of other cell types to treat diabetes, blindness, cancer, lung, neurodegenerative, and related diseases. Her work demonstrates that protecting transplanted cells from immune rejection is the key to unlocking the potential of regenerative medicine. Dr. Schrepfer is Professor at the University of California San Francisco (UCSF), Gladstone-UCSF Institute of Genomic Immunology, and a Scientific Founder and SVP (Head of the Hypoimmune Platform) of Sana Biotechnology, Inc.


 Speaker Profile

CEO, NaNotics LLC

Biography
Lou Hawthorne is founder / CEO of NaNotics, LLC, and inventor of the company’s core technology: NaNots, which are injectable “nano-extractors” capable of ultra-rapid depletion of soluble disease drivers from blood. NaNots – the subject of 12 granted patents to date – essentially invert the drug paradigm by subtracting molecules from the body, rather than adding them as drugs do. Lou is an inventor-entrepreneur with 25+ years of experience founding and leading companies developing new biotechnologies – including reproductive cloning, human IVF, and nanomedicine. Lou has been covered by most major media, including appearances on The Oprah Winfrey Show and Good Morning America. Lou holds a B.A. in English Literature from Princeton University, where he was a University Scholar and recipient of the Ward Mathis prize. Lou still misses Mira – the world's first cloned pet dog – a part of his family till she died in 2020, at almost 13.


Talk
NaNots: A New Class of Immunotherapy
NaNots are nanoparticles engineered to deplete soluble targets from blood without engaging cell membrane targets of the same type. For many targets, the soluble form is pathogenic while the membrane form drives essential biologic functions, a distinction drugs cannot generally make. NaNots hold the promise of new, ultra-safe methods of immune modulation.


 Speaker Profile

President, Specialty Solutions, Cardinal Health

Biography
Heidi Hunter is President of Cardinal Health Specialty Solutions, a specialty healthcare business that helps healthcare providers and pharmaceutical companies optimize business success and drive improved patient care. Heidi is an accomplished global healthcare leader with deep experience in innovation, development and commercialization of specialty pharmaceuticals. She began her career in sales and marketing at Ciba-Geigy in Switzerland, then moved to Novo Nordisk in Denmark and later Wyeth (today part of Pfizer) in the US where she led their oncology business. She served as Senior Vice President and General Manager at Boehringer Ingelheim where she built and led their global biosimilars business. She also held senior leadership roles in marketing and commercialization for biologics and oncology at Centocor, a J&J company. Most recently, she was Senior Vice President of the Global Immunology business unit at UCB in Brussels. Heidi holds an MBA from The University of Chicago.


 Speaker Profile

M.D., President, R&D, Century Therapeutics

Biography
Hy Levitsky is President of Research and Development. He was previously EVP and CSO at Juno Therapeutics, and before that, Head of Cancer Immunotherapy Experimental Medicine at Roche Pharma Research and Early Development. He received an MD from Johns Hopkins School of Medicine in 1984, followed by training in internal medicine and medical oncology. He joined the Johns Hopkins faculty in 1991, rising to Professor of Oncology, Medicine and Urology in 2001 while working at the Sidney Kimmel Comprehensive Cancer Center where he served as Scientific Director of the George Santos Bone Marrow Transplant Program. Upon joining industry, he has held an adjunct professorship since 2011. His research has focused on tumor immunology, cancer vaccines, and adoptive T cell therapy. He is a Leukemia and Lymphoma Society Stohlman Scholar, a Member of the American Society for Clinical Investigation, and is a founding member of the Cancer Immunotherapy Consortium of the Cancer Research Institute.


 Speaker Profile

M.D., Ph.D., Chief Medical Officer, ArsenalBio

Biography
Susie leads medical sciences at Arsenal Bio, a programmable cell therapy company, #engineeredtocure, that develops integrated circuit T cell (ICT) therapies for the treatment of solid tumors. She is a physician, scientist, and biopharma executive with over 20 years of experience leading clinical and translational research dedicated to improving patients' lives and finding a cure for cancer. Prior to joining Arsenal Bio, Susie was at Allogene developing allogeneic CAR T cell therapies. Throughout her career, she has worked on novel treatments for solid and hematologic malignancies across modalities including biologics, small molecules, antibody-drug conjugates and bispecific T-cell engagers. Susie has held senior leadership roles at Abbvie, Gilead and Amgen, and is a founding member of the Chicago chapter of Chief, an organization dedicated to supporting, empowering, and mentoring women C-suite leaders.


 Speaker Profile

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

Biography
Greg Lazar received his BS in Molecular & Cell Biology and Chemistry from Penn State, his PhD in Molecular & Cell Biology from the University of California at Berkeley, and did postdoctoral research at the University of Cambridge, UK. Previously he led research groups at Eli Lilly and Xencor. Currently he is Senior Director and Principal Scientist in Antibody Engineering at Genentech. Dr. Lazar is an expert in biotherapeutic engineering and drug discovery, and has developed technologies and molecules that have led to 3 approved drugs and over 10 candidates across all stages of clinical trials. He has authored 40 scientific publications and is an inventor of over 30 patents. His current research focus is the development of novel antibody technologies to enable next generation therapeutics to treat unmet medical needs in oncology and neuroscience.


 Speaker Profile

Ph.D., Vice President, Informatics, Parker Institute

Biography
Lacey leads the Informatics team, which focuses on using integrated multi-omic data analysis to uncover biomarkers, mechanisms of action, and novel therapies from cancer immunotherapy patient data. Lacey's team specializes in interrogating datasets with small N, large P (many data points, few patients). At the Parker Institute, Lacey has also led the development of a best-in-class data platform to store, integrate, and analyze data from 20+ molecular data types with detailed clinical outcomes and annotation. Before joining the Parker Institute, Lacey worked in various roles in industry and academia, creating novel methods and platforms to analyze biological and patient data. She has a PhD from Stanford University, where she developed algorithms for analyzing brain imaging data, and did her bachelors work and cognitive science and AI research at MIT.


Talk
Cancer Immunotherapy Biomarkers from Multi-Omic Data
Lessons in finding biomarkers of response and resistance to cancer immunotherapy using multi-omic data, including DNA sequencing, RNA sequencing, high-dimensional flow cytometry, mass cytometry (CyTOF), proteomics. Discussion of data platforms to store, organize, and analyze multi-omic data. Insights and applications in chemoimmunotherapy for patients with Pancreatic Cancer.