Immuno-Oncology Xchange
West Coast
September 21, 2021
san francisco
Welcome to hubXchange’s West Coast Immuno-Oncology Xchange 2021, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in developing immuno-oncology therapies, through a series of highly-interactive roundtable discussions.
Discussion topics will cover Immune Biomarkers & Translational Research, Preclinical Research, Clinical Development, Cell Therapies and Next-Generation Therapies.
Take advantage of this unique and productive meeting format designed for maximum engagement, collaboration and networking with your peers.
Immune Biomarkers & Translational Research
Opening Address & Keynote Presentation: Uncovering the Complexities of TiME in a Digital Era
Vice President, Medical Director
Ultivue
Keith is a board-certified human anatomic pathologist leading Ultivue’s Pathology and Biomarker Analytics team, he brings expertise in investigative pathology, multiplex microscopy and imaging, and digital pathology to our customers striving to realize the promise of personalized medicine.
- What is the evidence that early tumor marker data are predictive of positive outcomes in patients?
- How are we leveraging early markers such as tumor size, tumor burden, circulating tumor DNA (ctDNA), NLR, etc.
- What quantitative and modeling approaches can help us leverage available data – eg. RWD, clinical trials database etc.
- Can AI/ML be applied to leverage which patients are likely to respond using Morpho-genomic analyses?
Vice President, Clinical Pharmacology
Gilead Sciences
Novel biomarkers strategies to illuminate insights into the TME
- Exploring the dynamic nature of the TME
The need for new biomarker discovery and development - Harnessing the ability to derive more meaningful information from precious tissue samples
- Novel strategies for advanced image analysis
Vice President, Vice President, Digital Health Strategies
Ultivue
Florian Leiss is VP Digital Health Strategies at Ultivue. He is responsible for digital and data-driven offerings and image analysis. Florian has been working for the 10+ years in software development for healthcare to make AI-powered CDx in oncology a reality, to support radiologists with routine reporting, or to empower pathologists with image analysis at AstraZeneca, Smart Reporting and Definiens. He holds PhDs in neuroscience and philosophy.
Senior Vice President, Marketing & Corporate Strategy
Ionpath
Brad Nelson has twenty five years of experience in leading rapid growth life science organizations, delivering new technology and applications for drug discovery, development and clinical markets. Working closely with leading pharmaceutical and biotech companies at Velocity11 (acquired by Agilent), Labcyte (acquired by Danaher), and Ionpath, Brad’s focus has been to deliver technologies that continually advance biopharmaceutical development.
- Discuss the current challenges and key considerations to be taken when designing assays to identify new
biomarkers in pan tumor applications. - Examine the importance of biomarker quantification when phenotyping multiple targets across cell types.
- Explore how novel tissue staining technologies can be applied to interrogate new drug targets and
immune cell while preserving tissue architecture for spatial analysis.
Vice President of Research & Applications
Invicro
Joseph Krueger serves as the scientific leader for Invicro’s Advanced Pathology Services and is responsible for developing new biomarker applications to meet drug development needs. Furthermore, he provides scientific expertise needed to support sponsor-based projects across therapeutic areas. Prior to joining Invicro, Joseph was Chief Scientific Officer at Flagship Biosciences where he led the R&D and Scientific efforts in applying novel quantitative tissue image analysis approaches to immuno-oncology and rare diseases to support drug and companion diagnostic development. Prior to Flagship Biosciences, he served in senior scientific roles in oncology drug development for OSI Pharmaceuticals and Pfizer.
Chief Medical Officer
Invicro
Kenneth Bloom serves as the Chief Medical Officer for Advanced Pathology and Genomic Services at Invicro and Ambry Genetics, both Konica Minolta precision medicine companies. Kenneth brings more than 30 years of clinical and business experience in pathology, oncology, telemedicine, and bioinformatics. His role at Konica Minolta is to expand, strengthen and commercialize the full-suite of precision medicine capabilities offered within the pathology and genomics markets. Prior to joining Invicro, Kenneth held leadership positions within oncology at Human Longevity and GE Healthcare. He has also held faculty positions in clinical pathology at USC and Rush Medical Center.
3:10 – 3:40pm
No Session
- What are the next promising immune checkpoint pathways?
- What is the best strategy to target multiple immune checkpoint pathways?
- How to identify biomarkers to predict response to immune checkpoint blockade?
Director, Clinical Biomarkers
Compugen
Yu Liang is currently Director of Clinical Biomarkers at Compugen heading implementation of biomarkers in clinical trials to develop drugs targeting immune checkpoints. He brings in 20 years of expertise and leadership in precision medicine, including assay development in research and IVD, and application of genomic and genetic profiling for patient stratification. Before Compugen, he was Director of Translational Sciences in Oncology at Ipsen, leading translation of pre-clinical biomarkers into early phase clinical trials. Prior to Ipsen, he led development of clinical biomarker for drugs targeting amino acid metabolism at Calithera and managed the clinical biomarker portfolios of Ibrutinib for non-Hodgkin’s lymphomas at Pharmacyclics.
Preclinical Research
Opening Address & Keynote Presentation: Uncovering the Complexities of TiME in a Digital Era
Vice President, Medical Director
Ultivue
Keith is a board-certified human anatomic pathologist leading Ultivue’s Pathology and Biomarker Analytics team, he brings expertise in investigative pathology, multiplex microscopy and imaging, and digital pathology to our customers striving to realize the promise of personalized medicine.
Developing humanized mouse models to assess therapeutic potential of IO therapies
- Absence of mouse cross-reactive agents, is surrogate agents the answer?
- Lack of “faithful” mouse models that totally recapitulate the heterogenicity of human cancer, immune milieu, and stromal cell population within the complex tumor microenvironment. Are syngeneic, GEMM and mouse models with humanized immune system the answer?
- Should mouse models be limiting, are ex vivo (and tox) data in place of in vivo models be sufficient for filing?
- Flatlining of tumor growth is not always possible, what then are acceptable successful metrics?
- What are the appropriate benchmarks to be used for bispecific agents?
Senior Director, Immuno-Oncology
Exelixis
Bee-Cheng Sim is Sr. Director ImmunoOncology at Exelixis. Bee has over 20 years of experience in cell biology and preclinical pharmacology. Since joining Exelixis in 2019, she has supported the continued expansion of Exelixis’ Biotherapeutics pipeline in ImmunoOncology/Oncology. Prior to Exelixis, Bee was VP, Preclinical at Amunix and guided the preclinical development of protease-sensitive T-cell recruiters and ADCs; was Head of Biological Sciences at Ambrx and contributed to the advancement of two PEGylated biologics from discovery into clinical evaluation. She was on the faculty at The Scripps Research Institute, Department of Immunology before joining the biotechnology industry.
1-2-1 Meetings/Networking Break
No Session
Spotlight Presentation: Next-Generation Spatial Proteomic Advancements for Quantitative Analysis of the Tissue Microenvironment
Senior Vice President, Marketing & Corporate Strategy
Ionpath
Brad Nelson has twenty five years of experience in leading rapid growth life science organizations, delivering new technology and applications for drug discovery, development and clinical markets. Working closely with leading pharmaceutical and biotech companies at Velocity11 (acquired by Agilent), Labcyte (acquired by Danaher), and Ionpath, Brad’s focus has been to deliver technologies that continually advance biopharmaceutical development.
Modelling combination strategies and potential toxicities in pre-clinical models
- Exploring rat tumor models for small molecule studies
- NHP tolerability studies to support combinations
- What can be learned from models of inflammation?
Director, Immuno-Oncology
Gilead Sciences
Michelle Kuhne is an immunologist with over 18 years of industry experience ranging from small biotech to large pharma. She started her career in immuno-oncology at Medarex when nivolumab/Opdivo was still in preclinical development. During her time at Medarex and then at Bristol-Myers Squibb, she successfully led the pre-clinical development of several human monoclonal antibodies from concept to drug candidate selection and first in human clinical trials. Currently she is director of Immuno-Oncology research at Gilead Sciences where she is building a portfolio of small and large molecule therapeutics for oncology.
3:10 – 3:40pm
Vice President, Research & Applications
Invicro
Joseph Krueger serves as the scientific leader for Invicro’s Advanced Pathology Services and is responsible for developing new biomarker applications to meet drug development needs. Furthermore, he provides scientific expertise needed to support sponsor-based projects across therapeutic areas. Prior to joining Invicro, Joseph was Chief Scientific Officer at Flagship Biosciences where he led the R&D and Scientific efforts in applying novel quantitative tissue image analysis approaches to immuno-oncology and rare diseases to support drug and companion diagnostic development. Prior to Flagship Biosciences, he served in senior scientific roles in oncology drug development for OSI Pharmaceuticals and Pfizer.
Designing rational preclinical studies to inform efficacious, combination ICP therapies
- Recent failures of TGF beta-PDL1 bispecific and ICOS+PD1 combination
- Need for better human in vitro models for non-responders and PDL1 negative tumor models
- Lag in biological understanding of TIGIT axis
Vice President, Biology Translational Development
Coherus Biosciences
Taruna Arora is a R&D leader and immunologist with 20 years of experience in biotherapeutics drug development. Taruna is currently Vice President at Coherus Biosciences leading translational and preclinical strategies and operations for both biosimilars and novel I-O pipeline. Prior to Coherus, Taruna worked for several years at Amgen, and NGM Biophama. She has contributed to several approved and successfully marketed biologics serving patients with unmet need. Under her leadership at Amgen a number of initiatives were taken for next generation antibody therapeutics including bi- and multi-specifics, fusions, and drug conjugates. Taruna is inventor on several issued patents and patent applications. She is also member of NIH Immunology SBIR study section. Taruna received her PhD in Immunology at Mayo Clinic.
Clinical Development
Opening Address & Keynote Presentation: Uncovering the Complexities of TiME in a Digital Era
Vice President, Medical Director
Ultivue
Keith is a board-certified human anatomic pathologist leading Ultivue’s Pathology and Biomarker Analytics team, he brings expertise in investigative pathology, multiplex microscopy and imaging, and digital pathology to our customers striving to realize the promise of personalized medicine.
- What are the dominant drivers of immune resistance to therapy?
- What are the current challenges to effectively target regulatory T cells in the TME?
- How to identify the right patient population early during clinical development?
Senior Vice President, Biology
RAPT Therapeutics
Senior Vice President, Marketing & Corporate Strategy
Ionpath
Brad Nelson has twenty five years of experience in leading rapid growth life science organizations, delivering new technology and applications for drug discovery, development and clinical markets. Working closely with leading pharmaceutical and biotech companies at Velocity11 (acquired by Agilent), Labcyte (acquired by Danaher), and Ionpath, Brad’s focus has been to deliver technologies that continually advance biopharmaceutical development.
Vice President & Global Therapeutic Area Lead, Hematology-Oncology
Jazz Pharmaceuticals
Anne Borgman is a seasoned oncology drug development physician with 21 years of industry experience. She has held several senior roles in this time with Abbot, Hana Biosciences, Klabios, Exelixis before joining Jazz Pharmaceutials as Therapeutic Area Head in Hematology-Oncology. Anne’s training was in Pediatric Hematology Oncology & Bone Marrow Transplantation at University of California, Los Angeles, David Geffen School of Medicine following a Residency at Baylor College of Medicine, Texas Children’s Hospital. Anne retains active medical licenses in both Illinois and California.
3:10 – 3:40pm
- Protocol considerations
- Site Selection and startup strategies
- Strategies to streamline communication between all stakeholders involved in handling investigational product
- Real-world case studies and lessons learned while conducting cell therapy trial
Associate Director, Clinical Trial Manager
Medpace
Madhavi Malladi, is Associate Director, Clinical Trial Manager with over 9 years of clinical research experience, including work involving advanced therapies for rare disease indications. Prior to joining Medpace, she was an Assistant Research Director at New York Presbyterian/Queens. She received her PhD in Cell and Molecular Biology from The University of Texas at Austin. She completed her Postdoctoral Fellowship in Cancer genetics at Herbert Irving Cancer Center at Columbia University, focusing on molecular classification of diffuse large B-cell lymphomas using transcriptome profiling, next generation sequencing and RNAi technologies. Her therapeutic experience includes ophthalmology, hematology and oncology, cardiovascular, endocrine disorders, obstetrics/gynecology and neonatology.
Cell Therapies
Opening Address & Keynote Presentation: Uncovering the Complexities of TiME in a Digital Era
Vice President, Medical Director
Ultivue
Keith is a board-certified human anatomic pathologist leading Ultivue’s Pathology and Biomarker Analytics team, he brings expertise in investigative pathology, multiplex microscopy and imaging, and digital pathology to our customers striving to realize the promise of personalized medicine.
- How do we define the product: what are best practices towards process and product characterization to ensure consistency of the drug product?
- What are the best strategies for overcoming elimination of allogeneic cells by the patients’ immune system: can we safely extend the pharmacokinetics of allogeneic cell therapies?
- How best to avoid cell exhaustion, both during manufacture and following administration?
- What are the current practical and regulatory constraints on genome engineering of allogeneic cells?
Chief Scientific Officer
Nkarta Therapeutics
James Trager joined Nkarta in 2016 and leads all new product discovery efforts. James is deeply versed in the development and application of cellular therapies for cancer. He previously served as Vice President of Research and Development at Dendreon, where he was responsible for product development, clinical immunology, analytical development, and process automation, supporting the late stage development of sipuleucel-T through clinical study, approval, and commercialization. Prior to Dendreon, James was a Senior Scientist at Geron, where he was part of the team that cloned human telomerase, and later established a Quality Control function to enable the manufacture and clinical development of a telomerase inhibitor.
James is a graduate of St. John’s College in Santa Fe New Mexico; and served as a Peace Corps volunteer in the Central African Republic. He received his doctorate in Molecular Biology and Biochemistry from the University of California at Berkeley, where he performed mechanistic studies on the src oncogene.
- IMMUNE BIOMARKERS & TRANSLATIONAL RESEARCH topic Strategies to streamline integration and interpretation of TME multi-omic data sets for clinical application
- When taking on a multi-omic approach (e.i. a combo of NGS, mIHC, RNAish, WES, etc.) to understanding the TME within a study, what are the key considerations and risks associated with such initiatives?
- What are the current challenges faced when integrating and interpretating multi-omic data sets in translational/clinical IO research studies?
- What strategies, processes, and/or tools are currently being utilized to help facilitate the success and efficiency of such research studies?
Senior Vice President, Marketing & Corporate Strategy
Ionpath
Brad Nelson has twenty five years of experience in leading rapid growth life science organizations, delivering new technology and applications for drug discovery, development and clinical markets. Working closely with leading pharmaceutical and biotech companies at Velocity11 (acquired by Agilent), Labcyte (acquired by Danaher), and Ionpath, Brad’s focus has been to deliver technologies that continually advance biopharmaceutical development.
3:10 – 3:40pm
- Following the success in heme malignancies, how does cell therapy address solid tumors, which present multiple challenges including target antigen expression in normal tissues and tumor heterogeneity? What can cell therapy learn from the experience with ADCs or BiTEs?
- How can cell therapy overcome the various barriers to efficacy in the solid tumors, including a suppressive microenvironment?
- In addition to T cell mediated therapies, what other engineered cell types may prove to be efficacious in treating solid tumor malignancies?
- How can combinations with other agents be leveraged with cell therapy?
- How can cell therapy best address potential toxicity in treating solid tumors?
Executive Director, Cell Biology
Kite Pharma
John Langowski is the Site Head for the Kite Research site in Emeryville, California which is focused on the development of multiple programs and platform enhancements related to cell therapy. Following a PhD in Immunology from the MD Anderson UT Health Graduate School, John completed his postdoctoral training at the DNAX Research Institute in Palo Alto, California (currently Merck Labs), studying the role of inflammatory cytokines in tumor promotion and progression. Following this, he was involved in multiple cancer drug research programs at the Novartis Institutes of Biomedical Research in Emeryville, which was focused on small molecule therapeutics, and Nektar Therapeutics, which utilized pegylated cytokines for therapy in oncology and inflammation. John has expertise in project leadership, in vivo pharmacology, and mouse models of oncology, with more than 18 years of industry drug development and multiple patents and successful INDs related to his work.
Next-Generation Therapies
Opening Address & Keynote Presentation: Uncovering the Complexities of TiME in a Digital Era
Vice President, Medical Director
Ultivue
Keith is a board-certified human anatomic pathologist leading Ultivue’s Pathology and Biomarker Analytics team, he brings expertise in investigative pathology, multiplex microscopy and imaging, and digital pathology to our customers striving to realize the promise of personalized medicine.
- Is targeting these immune suppressive myeloid cells the next wave of drug discovery and development in I-O?
- What would be the best strategy to target tumor associated myeloid cells: Depletion? Specific pathway regulation? Re-programming?
- What are the key myeloid checkpoints being worked on in academia and industry? Their biology and rationale of targeting?
Director, Research
Immune-Onc Therapeutics
Maria Costa is a creative and accomplished biologist, leading research teams on multiple projects in oncology/immuno-oncology therapeutics R&D. Her research focuses on discovery of cancer cell-targeted therapies, as well as drugs targeting immune suppressive cells in the tumor microenvironment. Maria has extensive experience collaborating within crossfunctional teams and academic investigators in both small biotech and large pharma. Her work has resulted in multiple peer-reviewed original research publications, patent applications and presentations at scientific conferences. She has received several awards for her outstanding productivity, leadership and collaboration skills.
Maria has also led basic research projects in various top-tier academic organizations across 3 different countries and her discoveries are documented in many peer reviewed research papers, including several published in top-tier journals.
IMMUNE BIOMARKERS & TRANSLATIONAL RESEARCH topic: Early-stage characterization of immuno-oncology leads through in-vitro cell-based assays and beyond
- From checkpoint inhibitors towards neoepitope vaccines, does one size fits it all?
- Which functional assays; Types and Stages
- From early characterization towards clinical biomarkers
Strengths & Limitations?
Challenges?
Founder & Chief Technology Officer
ImmunXperts
Sofie Pattijn has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development with a focus on functional assays for immunogenicity, immune oncology and Cell and Gene Therapy products. She has extensive hands-on lab experience and has managed and coached several In Vitro teams over the last decade. From 2008 till 2013 she was Head of the In Vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics, Belgium for over 15 years.
Spotlight Presentation: Next-Generation Spatial Proteomic Advancements for Quantitative Analysis of the Tissue Microenvironment
Senior Vice President, Marketing & Corporate Strategy
Ionpath
Brad Nelson has twenty five years of experience in leading rapid growth life science organizations, delivering new technology and applications for drug discovery, development and clinical markets. Working closely with leading pharmaceutical and biotech companies at Velocity11 (acquired by Agilent), Labcyte (acquired by Danaher), and Ionpath, Brad’s focus has been to deliver technologies that continually advance biopharmaceutical development.
Identification of novel pHLA targets for solid tumor targeting with high potency modalities
- Advantages of intracellular targets (pHLAs) versus conventional cell surface antigens
- Strategies to find the most prevalent and immunogenic targets in tumors of CPI
responders - Selection of pHLA targets with highest tumor vs normal ratios to avoid off-tumor target toxicities
Chief Scientific Officer
3T Biosciences
Hanspeter has over 20 years of research and development experience in oncology, including antibody-drug conjugates (ADCs), redirected T-cell targeting compounds and adoptive T-cell therapies. He has been leading Pfizer’s Bioconjugates division as CSO, overseeing Pfizer’ s efforts in ADC, redirected T-cell targeting and nanoparticle development. He previously held senior leadership positions at Seattle Genetics and Genentech. Hans-Peter is currently CSO and Senior Vice President at 3T Biosciences, where he is overseeing platform- and therapeutic program development of TCR-T, TCR mimetic antibodies and cancer vaccine therapeutics. He is a recognized leader in oncology drug development, spanning from target identification and validation, development of novel therapeutic modalities and companion diagnostics, regulatory filings and translational support for early clinical development. He has a proven track record in making initial contacts and to successfully execute external collaborations and licensing deals with academia and corporate partners.
3:10 – 3:40pm
Cytotoxic cells are key players in the anti-tumour immune response. CD8+ T cells, also known as cytotoxic T lymphocytes, recognize and kill cells presenting antigens bound to MHC class I molecules, such as neoantigen present on the tumour cells.
Activation of CD8+ T cells requires at least two signals from antigen presenting cells: binding of their T cell receptor (TCR) to the appropriate peptide presented on MHC I and co-stimulation by B7 binding to CD28. However, tumour environment developed different mechanisms to reduce this immune cell killing such as checkpoint inhibitors expression. In that case, the immune system will be dampened. A second type of cytotoxic cells, named Natural killer cells, are an innate immune cell type that plays an important role in anti-cancer immunity. NK cells target cells lacking MHC I expression, including cancer cells that have lost expression of MHC I. NK cells induce apoptosis in cancer cells via release of perforin and granzymes from granules, like CD8+ T cells. But here too, NK cells can be broken down by the tumour cells, notably by the PD1/PDL1 interaction.
Increasing their efficacy as a therapeutic strategy has made the development of new therapeutics enhancing their anti-tumour response a priority. Those new therapeutics can have several shapes. The Antibody-dependent cell-mediated cytotoxicity (ADCC) activity of the IgG1 isotypes is one of the mechanisms that can be applied by immunoglobulin-based therapeutics. Another way to increase the killing of cancer cells is to target tumour antigens expressed by those cells using for example bispecific molecules that will enhance on the other side the T cell activation.
Using primary immune cells, in vitro bioassays were developed to better screen the potential effect of new therapeutics on immune cell killing activity. Their ability to increase or induce a cytotoxic activity and facilitate the anti-tumour immune response can as a result be assessed early in the drug development process.
Founder & Chief Technology Officer
ImmunXperts
Sofie Pattijn has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development with a focus on functional assays for immunogenicity, immune oncology and Cell and Gene Therapy products. She has extensive hands-on lab experience and has managed and coached several In Vitro teams over the last decade. From 2008 till 2013 she was Head of the In Vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics, Belgium for over 15 years.
- Using multi-specific antibodies to recruit and activate alternative immune cell types and kill tumors (NKs, macrophages, dendritic cells, NKTs, gdTs, etc.):
- Which challenges associated with classic T-cell engagers (TCEs) may be addressed by leveraging other types of immune cells? How should they work?
- When activating alternative cell types, should we think differently about design of the multi-specific antibody candidates? (Fc engagement, tumor-associated vs. TME-based targets, affinities, etc.)
- Might the likelihood of achieving single agent efficacy be lower than with classic TCEs? Does that matter?
- Does the natural role of the cell type in the immune system affect how we think about using it? (adaptive vs. innate response, direct vs. indirect killing activities)
Chief Executive Officer
Rondo Therapeutics
Shelley Force Aldred is Founder and CEO of Rondo Therapeutics. Prior to this, she served as VP for Preclinical Development at TeneoBio where she led the preclinical efforts creating a CD3xBCMA bispecific antibody, from product concept to IND-ready package. Shelley was formerly director of R&D for Active Motif following the acquisition of SwitchGear Genomics in 2013. In 2006, she co-founded SwitchGear Genomics and she served as its COO. Prior to founding SwitchGear Genomics, Shelley was a Scientific Director on Stanford’s ENCODE Project and received her Ph.D. from Stanford University.