IMMUNO-ONCOLOGY XCHANGE
WEST COAST
San Francisco
September 26, 2023
Welcome to hubXchange’s Immuno-Oncology Xchange West Coast 2023, 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 roundtable discussions.
Discussion topics will cover Immune Biomarkers, Translational Research, Clinical Development, Cell Therapies and Next-Generation Therapies.
Take advantage of this unique highly interactive meeting format designed for maximum engagement and collaboration with your peers.
Please note this is an In-Person meeting.
Venue Details: DoubleTree by Hilton San Francisco Airport, 835 Airport Blvd, Burlingame CA 94010-9949
SNAPSHOTS OF DISCUSSION TOPICS
- The rise of spatial omics technologies and their potential for new biomarker discovery
- Predictive biomarkers for IO treatment used in clinical practice now and in the future
- How to select the right translational screening model to monitor IO agents
- Pre-clinical in vivo models for improved toxicity prediction
- Early signals of efficacy, biomarkers and confidence in early clinical I/O trials
- How to maximize clinical success: Patient / indication selection strategies beyond target expression and PD-L1 status during early clinical development
- Exploring different cellular modalities
- TME-targeting combinations – improving efficacy
- Antibody discovery for ADCs and other therapeutic modalities
- Using next-gen multi-specific antibodies for the treatment of solid tumors
Full Xchange Agenda
Click on each track for detailed agenda
Immune Biomarkers
Opening Address & Keynote Presentation by Synexa
The Search for Immunological Beauty
The immune system elegantly strives to control and balance the interplay of flexibility and robustness in the interaction of an organism with its environment. Scientific understanding and appreciation of the coordinated biological complexity of the immune system is expanding on a daily basis. This growth has been paralleled by our ability to harness the power of the immune system for the development of therapeutic interventions. Subjectively we may describe the immune system as “a thing of beauty” in our attempts to abstract, acknowledge and to some degree comprehend the enormity of its intricacies. There is however merit in exploring alternative views to define and quantify immunological beauty as a means of generating fresh insights into the fundamental organization of the immune system which in turn will likely impact our ability to develop and better monitor immunotherapies.
Justin Devine is a medical doctor, immunologist, pharmacologist (Stellenbosch University) and a co-founder of Synexa. Currently operating as Chief Innovation Officer, his primary focus is to understand clients’ objectives in new drug development by designing biomarker strategies to bring real insight to the challenges of clinical development. Justin has a very deep understanding of the role that biomarkers and pharmacogenetics play in understanding the performance of a candidate drug. He is particularly passionate about improving the drug development process by bringing innovative approaches to early phase research, including new ideas in translational medicine, bioinformatics and artificial intelligence.
Pharmacodynamic and predictive biomarkers for IO from preclinical to clinical stages
- What’s the value of peripheral PD biomarkers during dose-escalation if IO agents are targeting tumor microenvironment?
- To select or not to select? The Pros and Cons of selecting patients for tumor-targeted IO agents.
- Will the spatial analysis of tumor microenvironment help for future patient stratification?
Jack Chen is currently Scientific Director within Precision Medicine Organization at AbbVie. He leads a group of PhD and non-PhD scientists at Bay Area and North Chicago sites to develop translational research strategy for 10+ IO programs including preclinical and clinical stages. Prior to this, he was Senior Principal Scientist in Cancer Immunology Discovery group at Pfizer and previously worked at OncoMed and Eli Lilly. He obtained his PhD from Johns Hopkins University.
- How does measuring the biology of the tumor and surrounding TIME provide a clearer picture of which patients may respond to ICI therapy?
- What biomarker considerations currently go into designing ICI clinical trials?
- What challenges do you currently face with patient selection and biomarker use in ICI trials?
- A wide net or a targeted approach?
- What constitutes a reliable predictive biomarker for better patient selection and clinical trial design?
Rob Seitz currently works as a consultant in the biomarker space providing expertise with discovery, development (both scientifically and commercially), clinical validation (retrospective studies) and study design (prospective studies). His 20 years of experience has included CEO, chief biotechnology officer, head of data science and over five years of consulting in the biotechnology space. Commercial biomarker products that he has developed include: DetermaIO, Mammostrat, and TLE3. He has authored dozens of peer reviewed publications in the biomarker space, and holds 13 patents, with several more pending.
Networking Lunch
Spotlight Presentation by Inotiv
Quantitative Profiling of Immune Checkpoint Protein Target Systems with Target Sufficiency
New therapeutics targeting the immune checkpoint (IC) TIGIT are in clinical development with PD-1/PD-L1 inhibitors for solid tumors indications, but without protein biomarkers. We used targeted mass spectrometry to precisely quantify TIGIT, DNAM1, PVR, PD-1, PD-L1, and PD-L2 in 97 primary non-small cell lung cancers (NSCLC) and matched tumor draining lymph nodes (TDLN). Only 56% of NSCLC cases expressed TIGIT, which was quantifiable almost exclusively in TDLN. TIGIT, DNAM1 and PVR abundance varied over approximately 25-fold and were co-expressed only in some tumors. Quantitation of target system proteins may explain differences in response to combined anti-TIGIT anti-PD-1/PD-L1 therapeutics.
Daniel C. Liebler is Vice President for Proteomic Technologies at Inotiv, Inc. He received a Ph.D. in Pharmacology at Vanderbilt and did postdoctoral training in Biochemistry and Biophysics at Oregon State University. He held faculty appointments for 30 years at the University of Arizona and at the Vanderbilt University School of Medicine. Dr. Liebler has been a leader in the application of mass spectrometry and proteomic technology to chemical biology and cancer proteogenomics. In 2017, Dr. Liebler founded Protypia (acquired by Inotiv in 2022) to provide a mass spectrometry platform for drug target analysis for diverse therapeutic areas, including immuno-oncology.
Spotlight Presentation by EnableMedicine
From Images to Insights: Deep Spatial Profiling Reveals Disease and Treatment Biomarkers
Selecting the right biomarkers is important for success in phase transition of clinical trials. Multiplex immunofluorescence (mIF) has increasingly allowed us to select high-quality protein biomarkers that correlate more strongly with patient outcomes. There is a growing need to identify high-quality protein biomarkers to support clinical research, and spatial biology is showing promise in providing these answers.
We are using a 51-plex protein panel that covers a range of functional and tumor microenvironment-related biomarkers, including lymphoid and myeloid cell markers, tissue biomarkers, antigen presenting cells, and immune checkpoint and activation markers. By analyzing this comprehensive panel of biomarkers, we have identified cell types that are up or downregulated in different disease states. Further, we have explored the spatial relationships between cells, uncovering important differences in cell-to-cell interactions and neighborhoods between disease states. These spatial analyses provide a powerful toolkit for discovering key biomarkers in various diseases and treatments.
Gulpreet covers Business development at Enable Medicine for West coast and Central US. She completed her Ph.D. in Cell and Molecular Biology at University of Wisconsin-Madison, where she studied organelle biology using live cell imaging and instructed at the Vision Research Microscopy Core Facility. Gulpreet served as National Representative at Olympus Scientific Solutions, supporting researchers in various microscopy and image analysis applications. She is an experienced biotech professional with a strong research background and expertise in helping researchers apply cutting edge technologies to their studies.
Spotlight Presentation by Burning Rock Dx
Unraveling the Implications of ctDNA As a Biomarker Using Tumor-Informed MRD for Solid Tumors
Circulating tumor DNA (ctDNA) has been an emerging biomarker of minimal residual disease (MRD) incorporated into clinical trials and practices for prognosis prediction, treatment efficacy evaluation, and patient stratification. The sensitivity of the MRD test plays a crucial role in detecting ctDNA in patients due to the extremely low abundance of ctDNA in blood. A variety of technical approaches to MRD assessment have been published and validated. The presentation will cover the potential utilizations of MRD, different technical methods to optimize the test results, and real-world applications in clinical studies.
Michael Chen is a translational medicine scientist at Burning Rock Dx with prior medical affairs experiences leading projects in inflammatory disease, obesity, and hematologic malignancy therapeutic portfolios. He obtained a doctorate of pharmacy from the University of Southern California in 2022 with a passion for advancing precision oncology.
The rise of spatial omics technologies and their potential for new biomarker discovery
- What is the current state of leveraging spatial immune relationships as biomarkers?
- Which spatial relationships show promise for future use as biomarkers?
- How much plexing is actually enough for 1) the discovery of new spatial biomarkers, and 2) the detection of these biomarkers in clinical practice?
- What are spatial tools will we see in the future clinical setting for diagnostics, prognostics, and CDX?
Tyler Risom is a Principal Scientist in the Research Pathology Department at Genentech, with a lab focused on developing new hyperplex spatial proteomics strategies to elucidate mechanisms of action in our early development targets, and to identify new biomarkers for improved patient selection in our late stage and reverse translation efforts.
Drinks-Canape Reception
Translational Research
Opening Address & Keynote Presentation by Synexa
The Search for Immunological Beauty
The immune system elegantly strives to control and balance the interplay of flexibility and robustness in the interaction of an organism with its environment. Scientific understanding and appreciation of the coordinated biological complexity of the immune system is expanding on a daily basis. This growth has been paralleled by our ability to harness the power of the immune system for the development of therapeutic interventions. Subjectively we may describe the immune system as “a thing of beauty” in our attempts to abstract, acknowledge and to some degree comprehend the enormity of its intricacies. There is however merit in exploring alternative views to define and quantify immunological beauty as a means of generating fresh insights into the fundamental organization of the immune system which in turn will likely impact our ability to develop and better monitor immunotherapies.
Justin Devine is a medical doctor, immunologist, pharmacologist (Stellenbosch University) and a co-founder of Synexa. Currently operating as Chief Innovation Officer, his primary focus is to understand clients’ objectives in new drug development by designing biomarker strategies to bring real insight to the challenges of clinical development. Justin has a very deep understanding of the role that biomarkers and pharmacogenetics play in understanding the performance of a candidate drug. He is particularly passionate about improving the drug development process by bringing innovative approaches to early phase research, including new ideas in translational medicine, bioinformatics and artificial intelligence.
Translational strategies to develop clinically safe and effective immune cell engagers
- Which of the following mouse models provide the most relevant efficacy readouts for immune engagers – humanized immune system versus syngeneic models expressing human transgenes of interest?
- Are newer animal-free technologies (organs-on a chip, organoids, spheroids, etc) considered complementary or a possible replacement to in vivo murine models?
- What are novel ways to preclinically address on target off tumor toxicities for solid tumor targets? Do cynomolgus toxicology studies truly recapitulate these toxicities?
- What are the key lessons learned from using the above preclinical models in regulatory submissions in your experience?
Udaya Rangaswamy is Director of preclinical development at Rondo therapeutics, a start-up focused on advancing the immuno-oncology field by developing novel multi-specific engagers for solid tumors. Prior to Rondo, Udaya was a Principal Scientist at Amgen following Amgen’s acquisition of Teneobio in 2021. Between both Amgen and Teneobio, Udaya has led oncology programs taking T cell engager molecules from lead optimization through first-in-human studies, including three programs currently active in the clinic. Prior to Teneobio, Udaya was a post-doc at MedImmune/Astrazeneca working on mechanisms of oncolytic virotherapy. Udaya received her PhD in microbiology and molecular genetics from Emory University and her thesis work identified novel signaling pathways driving the pathogenesis of a oncogenic viral protein.
Early-stage characterization and selection of immuno-oncology leads through in-vitro cell-based assays and beyond
- From checkpoint inhibitors towards neoepitope vaccines, does one size fits it all?
- Fit for purpose in vitro assay development
- Early characterization and immunogenicity testing of lead candidates
- Exhausted and regulatory T cells, NK cells, macrophages, neutrophils, who’s next?
Sofie Pattyn has over 25 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 by Inotiv
Quantitative Profiling of Immune Checkpoint Protein Target Systems with Target Sufficiency
New therapeutics targeting the immune checkpoint (IC) TIGIT are in clinical development with PD-1/PD-L1 inhibitors for solid tumors indications, but without protein biomarkers. We used targeted mass spectrometry to precisely quantify TIGIT, DNAM1, PVR, PD-1, PD-L1, and PD-L2 in 97 primary non-small cell lung cancers (NSCLC) and matched tumor draining lymph nodes (TDLN). Only 56% of NSCLC cases expressed TIGIT, which was quantifiable almost exclusively in TDLN. TIGIT, DNAM1 and PVR abundance varied over approximately 25-fold and were co-expressed only in some tumors. Quantitation of target system proteins may explain differences in response to combined anti-TIGIT anti-PD-1/PD-L1 therapeutics.
Daniel C. Liebler is Vice President for Proteomic Technologies at Inotiv, Inc. He received a Ph.D. in Pharmacology at Vanderbilt and did postdoctoral training in Biochemistry and Biophysics at Oregon State University. He held faculty appointments for 30 years at the University of Arizona and at the Vanderbilt University School of Medicine. Dr. Liebler has been a leader in the application of mass spectrometry and proteomic technology to chemical biology and cancer proteogenomics. In 2017, Dr. Liebler founded Protypia (acquired by Inotiv in 2022) to provide a mass spectrometry platform for drug target analysis for diverse therapeutic areas, including immuno-oncology.
Spotlight Presentation by EnableMedicine
From Images to Insights: Deep Spatial Profiling Reveals Disease and Treatment Biomarkers
Selecting the right biomarkers is important for success in phase transition of clinical trials. Multiplex immunofluorescence (mIF) has increasingly allowed us to select high-quality protein biomarkers that correlate more strongly with patient outcomes. There is a growing need to identify high-quality protein biomarkers to support clinical research, and spatial biology is showing promise in providing these answers.
We are using a 51-plex protein panel that covers a range of functional and tumor microenvironment-related biomarkers, including lymphoid and myeloid cell markers, tissue biomarkers, antigen presenting cells, and immune checkpoint and activation markers. By analyzing this comprehensive panel of biomarkers, we have identified cell types that are up or downregulated in different disease states. Further, we have explored the spatial relationships between cells, uncovering important differences in cell-to-cell interactions and neighborhoods between disease states. These spatial analyses provide a powerful toolkit for discovering key biomarkers in various diseases and treatments.
Gulpreet covers Business development at Enable Medicine for West coast and Central US. She completed her Ph.D. in Cell and Molecular Biology at University of Wisconsin-Madison, where she studied organelle biology using live cell imaging and instructed at the Vision Research Microscopy Core Facility. Gulpreet served as National Representative at Olympus Scientific Solutions, supporting researchers in various microscopy and image analysis applications. She is an experienced biotech professional with a strong research background and expertise in helping researchers apply cutting edge technologies to their studies.
Spotlight Presentation by Burning Rock Dx
Unraveling the Implications of ctDNA As a Biomarker Using Tumor-Informed MRD for Solid Tumors
Circulating tumor DNA (ctDNA) has been an emerging biomarker of minimal residual disease (MRD) incorporated into clinical trials and practices for prognosis prediction, treatment efficacy evaluation, and patient stratification. The sensitivity of the MRD test plays a crucial role in detecting ctDNA in patients due to the extremely low abundance of ctDNA in blood. A variety of technical approaches to MRD assessment have been published and validated. The presentation will cover the potential utilizations of MRD, different technical methods to optimize the test results, and real-world applications in clinical studies.
Michael Chen is a translational medicine scientist at Burning Rock Dx with prior medical affairs experiences leading projects in inflammatory disease, obesity, and hematologic malignancy therapeutic portfolios. He obtained a doctorate of pharmacy from the University of Southern California in 2022 with a passion for advancing precision oncology.
How to select the right translational screening model to monitor IO agents
- Although immuno-oncology agents are demonstrating durable responses in select patients in the clinic, many challenges remain.
- A variety of translational screening models may be used by researchers to evaluate novel IO agents in the preclinical setting.
- In this roundtable, we will discuss advantages and limitations of syngeneic models, humanized immune system models, humanized knock in and GEMM models, and surrogate molecules.
Stephanie C. Casey Parks obtained her B.S. in Microbiology, Immunology, and Molecular Genetics from UCLA and her PhD in cancer biology from UC Irvine. She performed her postdoctoral work at Stanford, where she studied the role of oncogenes in the regulation of the anti-tumor immune response using genetically engineered mouse models. At Amgen, her group works to understand in vivo biology of emerging targets, characterize the pharmacodynamic and efficacy responses to new molecules, and create new syngeneic and humanized models. Stephanie’s research interests include both discovery and translational oncology research, spanning from tumor-intrinsic biology to immuno-oncology and the tumor microenvironment.
Drinks-Canape Reception
Clinical Development
Opening Address & Keynote Presentation by Synexa
The Search for Immunological Beauty
The immune system elegantly strives to control and balance the interplay of flexibility and robustness in the interaction of an organism with its environment. Scientific understanding and appreciation of the coordinated biological complexity of the immune system is expanding on a daily basis. This growth has been paralleled by our ability to harness the power of the immune system for the development of therapeutic interventions. Subjectively we may describe the immune system as “a thing of beauty” in our attempts to abstract, acknowledge and to some degree comprehend the enormity of its intricacies. There is however merit in exploring alternative views to define and quantify immunological beauty as a means of generating fresh insights into the fundamental organization of the immune system which in turn will likely impact our ability to develop and better monitor immunotherapies.
Justin Devine is a medical doctor, immunologist, pharmacologist (Stellenbosch University) and a co-founder of Synexa. Currently operating as Chief Innovation Officer, his primary focus is to understand clients’ objectives in new drug development by designing biomarker strategies to bring real insight to the challenges of clinical development. Justin has a very deep understanding of the role that biomarkers and pharmacogenetics play in understanding the performance of a candidate drug. He is particularly passionate about improving the drug development process by bringing innovative approaches to early phase research, including new ideas in translational medicine, bioinformatics and artificial intelligence.
Early signals of efficacy, biomarkers and confidence in early clinical I/O trials
- Understanding the current landscape in clinical trial design for early decision making
- How can we optimize dose selection as required by FDA’s Project Optimus
- What biomarker strategies can inform early decision making and contribution of components in combination therapies
Sree Kasichayanula is currently a Sr Director at Gilead Sciences. He is leading the IO Clinical Pharmacology group with responsibilities across all phases of development in IO therapies. Prior to joining Gilead, Sree worked at AbbVie and Amgen in the Oncology development. He has extensively published in the field of Clinical Pharmacology and Clinical Development across several therapeutic areas.
The evolving role of dynamic early efficacy markers in clinical trials
- Discuss methodologies for evaluating treatment response and the role of early efficacy markers
- Delve into data supporting the use of ctDNA dynamics as a tool for early prediction of therapy efficacy and the potential impact on clinical development
- Share key considerations and prioritize clinical settings for implementing efficacy markers
Vikki Cerniglia is a Senior Director of Biopharma at Natera, where she has worked on their pharma partnerships for the past 6 years. She leads the efforts collaborating on retrospective testing of completed clinical trials, testing in prospective trials, and companion diagnostic (CDx) co-development. Vikki oversees Natera’s collaborations and CDx co-development efforts with their pharma partners, including one with Roche/Genentech for IMvigor011, a Phase III randomized study of adjuvant atezolizumab in muscle-invasive bladder cancer, which uses the Signatera assay to select for high-risk patients who are ctDNA positive following cystectomy.
Spotlight Presentation by Inotiv
Quantitative Profiling of Immune Checkpoint Protein Target Systems with Target Sufficiency
New therapeutics targeting the immune checkpoint (IC) TIGIT are in clinical development with PD-1/PD-L1 inhibitors for solid tumors indications, but without protein biomarkers. We used targeted mass spectrometry to precisely quantify TIGIT, DNAM1, PVR, PD-1, PD-L1, and PD-L2 in 97 primary non-small cell lung cancers (NSCLC) and matched tumor draining lymph nodes (TDLN). Only 56% of NSCLC cases expressed TIGIT, which was quantifiable almost exclusively in TDLN. TIGIT, DNAM1 and PVR abundance varied over approximately 25-fold and were co-expressed only in some tumors. Quantitation of target system proteins may explain differences in response to combined anti-TIGIT anti-PD-1/PD-L1 therapeutics.
Daniel C. Liebler is Vice President for Proteomic Technologies at Inotiv, Inc. He received a Ph.D. in Pharmacology at Vanderbilt and did postdoctoral training in Biochemistry and Biophysics at Oregon State University. He held faculty appointments for 30 years at the University of Arizona and at the Vanderbilt University School of Medicine. Dr. Liebler has been a leader in the application of mass spectrometry and proteomic technology to chemical biology and cancer proteogenomics. In 2017, Dr. Liebler founded Protypia (acquired by Inotiv in 2022) to provide a mass spectrometry platform for drug target analysis for diverse therapeutic areas, including immuno-oncology.
Spotlight Presentation by EnableMedicine
From Images to Insights: Deep Spatial Profiling Reveals Disease and Treatment Biomarkers
Selecting the right biomarkers is important for success in phase transition of clinical trials. Multiplex immunofluorescence (mIF) has increasingly allowed us to select high-quality protein biomarkers that correlate more strongly with patient outcomes. There is a growing need to identify high-quality protein biomarkers to support clinical research, and spatial biology is showing promise in providing these answers.
We are using a 51-plex protein panel that covers a range of functional and tumor microenvironment-related biomarkers, including lymphoid and myeloid cell markers, tissue biomarkers, antigen presenting cells, and immune checkpoint and activation markers. By analyzing this comprehensive panel of biomarkers, we have identified cell types that are up or downregulated in different disease states. Further, we have explored the spatial relationships between cells, uncovering important differences in cell-to-cell interactions and neighborhoods between disease states. These spatial analyses provide a powerful toolkit for discovering key biomarkers in various diseases and treatments.
Gulpreet covers Business development at Enable Medicine for West coast and Central US. She completed her Ph.D. in Cell and Molecular Biology at University of Wisconsin-Madison, where she studied organelle biology using live cell imaging and instructed at the Vision Research Microscopy Core Facility. Gulpreet served as National Representative at Olympus Scientific Solutions, supporting researchers in various microscopy and image analysis applications. She is an experienced biotech professional with a strong research background and expertise in helping researchers apply cutting edge technologies to their studies.
Spotlight Presentation by Burning Rock Dx
Unraveling the Implications of ctDNA As a Biomarker Using Tumor-Informed MRD for Solid Tumors
Circulating tumor DNA (ctDNA) has been an emerging biomarker of minimal residual disease (MRD) incorporated into clinical trials and practices for prognosis prediction, treatment efficacy evaluation, and patient stratification. The sensitivity of the MRD test plays a crucial role in detecting ctDNA in patients due to the extremely low abundance of ctDNA in blood. A variety of technical approaches to MRD assessment have been published and validated. The presentation will cover the potential utilizations of MRD, different technical methods to optimize the test results, and real-world applications in clinical studies.
Michael Chen is a translational medicine scientist at Burning Rock Dx with prior medical affairs experiences leading projects in inflammatory disease, obesity, and hematologic malignancy therapeutic portfolios. He obtained a doctorate of pharmacy from the University of Southern California in 2022 with a passion for advancing precision oncology.
How to maximize clinical success: Patient / indication selection strategies beyond target expression and PD-L1 status during early clinical development
- Importance of understanding the MOA of your drug
- How can we leverage preclinical in vivo and in vitro models for indication and patient selection?
- Access to relevant patient data sets to match your drug with the right patient population
Dirk G. Brockstedt is the Chief Scientific Officer at RAPT Therapeutics and has more than 20 years of experience in the fields of immunology and oncology originating with his PhD from the University of Kiel and Stanford University. Dirk joined RAPT Therapeutics in 2018, bringing a wealth of experience in immunology at all stages of discovery, translational and clinical development. He joined RAPT from Aduro Biotech, where he served as Executive Vice President of Research and Development. Prior to Aduro, Dirk held positions of increasing responsibility within the immunology department of Cerus Corporation and at Aventis in the immunotherapy and anti-angiogenesis groups. Dr. Brockstedt co-authored over 50 scientific papers and is a named inventor on several issued patents and pending applications.
Drinks-Canape Reception
Cell Therapies
Opening Address & Keynote Presentation by Synexa
The Search for Immunological Beauty
The immune system elegantly strives to control and balance the interplay of flexibility and robustness in the interaction of an organism with its environment. Scientific understanding and appreciation of the coordinated biological complexity of the immune system is expanding on a daily basis. This growth has been paralleled by our ability to harness the power of the immune system for the development of therapeutic interventions. Subjectively we may describe the immune system as “a thing of beauty” in our attempts to abstract, acknowledge and to some degree comprehend the enormity of its intricacies. There is however merit in exploring alternative views to define and quantify immunological beauty as a means of generating fresh insights into the fundamental organization of the immune system which in turn will likely impact our ability to develop and better monitor immunotherapies.
Justin Devine is a medical doctor, immunologist, pharmacologist (Stellenbosch University) and a co-founder of Synexa. Currently operating as Chief Innovation Officer, his primary focus is to understand clients’ objectives in new drug development by designing biomarker strategies to bring real insight to the challenges of clinical development. Justin has a very deep understanding of the role that biomarkers and pharmacogenetics play in understanding the performance of a candidate drug. He is particularly passionate about improving the drug development process by bringing innovative approaches to early phase research, including new ideas in translational medicine, bioinformatics and artificial intelligence.
Exploring different cellular modalities, pros and cons
- What cellular modalities have your used and/or are contemplating and why?
- What is a main hurdle you have faced in cellular therapy development and ways you have addressed it?
- What are promising new approaches in cellular therapy you are contemplating and why?
Ana completed PhD at University of Rochester. As a post-doc and scientist at LBNL and UCSF she explored the influence of microenvironment on carcinogenesis and stem cell phenotype. Ana co-founded and was CEO of StemLifeLine, a startup focusing on cell therapy and development of the cancer drug discovery platform. Ana led preclinical, new indication and translational efforts in oncology, neurology, inflammation, rare diseases and critical care at multiple biotechs including Omniox, where she developed and advanced programs from early discovery to clinic. She currently manages preclinical, translational and new indication efforts in oncology and immune disorders at Oryn. Ana received >$5M in grants and serves on NIH Review Boards. She authored multiple patent applications and published >30 research papers.
Networking Lunch
Spotlight Presentation by Inotiv
Quantitative Profiling of Immune Checkpoint Protein Target Systems with Target Sufficiency
New therapeutics targeting the immune checkpoint (IC) TIGIT are in clinical development with PD-1/PD-L1 inhibitors for solid tumors indications, but without protein biomarkers. We used targeted mass spectrometry to precisely quantify TIGIT, DNAM1, PVR, PD-1, PD-L1, and PD-L2 in 97 primary non-small cell lung cancers (NSCLC) and matched tumor draining lymph nodes (TDLN). Only 56% of NSCLC cases expressed TIGIT, which was quantifiable almost exclusively in TDLN. TIGIT, DNAM1 and PVR abundance varied over approximately 25-fold and were co-expressed only in some tumors. Quantitation of target system proteins may explain differences in response to combined anti-TIGIT anti-PD-1/PD-L1 therapeutics.
Daniel C. Liebler is Vice President for Proteomic Technologies at Inotiv, Inc. He received a Ph.D. in Pharmacology at Vanderbilt and did postdoctoral training in Biochemistry and Biophysics at Oregon State University. He held faculty appointments for 30 years at the University of Arizona and at the Vanderbilt University School of Medicine. Dr. Liebler has been a leader in the application of mass spectrometry and proteomic technology to chemical biology and cancer proteogenomics. In 2017, Dr. Liebler founded Protypia (acquired by Inotiv in 2022) to provide a mass spectrometry platform for drug target analysis for diverse therapeutic areas, including immuno-oncology.
Spotlight Presentation by EnableMedicine
From Images to Insights: Deep Spatial Profiling Reveals Disease and Treatment Biomarkers
Selecting the right biomarkers is important for success in phase transition of clinical trials. Multiplex immunofluorescence (mIF) has increasingly allowed us to select high-quality protein biomarkers that correlate more strongly with patient outcomes. There is a growing need to identify high-quality protein biomarkers to support clinical research, and spatial biology is showing promise in providing these answers.
We are using a 51-plex protein panel that covers a range of functional and tumor microenvironment-related biomarkers, including lymphoid and myeloid cell markers, tissue biomarkers, antigen presenting cells, and immune checkpoint and activation markers. By analyzing this comprehensive panel of biomarkers, we have identified cell types that are up or downregulated in different disease states. Further, we have explored the spatial relationships between cells, uncovering important differences in cell-to-cell interactions and neighborhoods between disease states. These spatial analyses provide a powerful toolkit for discovering key biomarkers in various diseases and treatments.
Gulpreet covers Business development at Enable Medicine for West coast and Central US. She completed her Ph.D. in Cell and Molecular Biology at University of Wisconsin-Madison, where she studied organelle biology using live cell imaging and instructed at the Vision Research Microscopy Core Facility. Gulpreet served as National Representative at Olympus Scientific Solutions, supporting researchers in various microscopy and image analysis applications. She is an experienced biotech professional with a strong research background and expertise in helping researchers apply cutting edge technologies to their studies.
Spotlight Presentation by Burning Rock Dx
Unraveling the Implications of ctDNA As a Biomarker Using Tumor-Informed MRD for Solid Tumors
Circulating tumor DNA (ctDNA) has been an emerging biomarker of minimal residual disease (MRD) incorporated into clinical trials and practices for prognosis prediction, treatment efficacy evaluation, and patient stratification. The sensitivity of the MRD test plays a crucial role in detecting ctDNA in patients due to the extremely low abundance of ctDNA in blood. A variety of technical approaches to MRD assessment have been published and validated. The presentation will cover the potential utilizations of MRD, different technical methods to optimize the test results, and real-world applications in clinical studies.
Michael Chen is a translational medicine scientist at Burning Rock Dx with prior medical affairs experiences leading projects in inflammatory disease, obesity, and hematologic malignancy therapeutic portfolios. He obtained a doctorate of pharmacy from the University of Southern California in 2022 with a passion for advancing precision oncology.
Drinks-Canape Reception
Next-Generation Therapies
Opening Address & Keynote Presentation by Synexa
The Search for Immunological Beauty
The immune system elegantly strives to control and balance the interplay of flexibility and robustness in the interaction of an organism with its environment. Scientific understanding and appreciation of the coordinated biological complexity of the immune system is expanding on a daily basis. This growth has been paralleled by our ability to harness the power of the immune system for the development of therapeutic interventions. Subjectively we may describe the immune system as “a thing of beauty” in our attempts to abstract, acknowledge and to some degree comprehend the enormity of its intricacies. There is however merit in exploring alternative views to define and quantify immunological beauty as a means of generating fresh insights into the fundamental organization of the immune system which in turn will likely impact our ability to develop and better monitor immunotherapies.
Justin Devine is a medical doctor, immunologist, pharmacologist (Stellenbosch University) and a co-founder of Synexa. Currently operating as Chief Innovation Officer, his primary focus is to understand clients’ objectives in new drug development by designing biomarker strategies to bring real insight to the challenges of clinical development. Justin has a very deep understanding of the role that biomarkers and pharmacogenetics play in understanding the performance of a candidate drug. He is particularly passionate about improving the drug development process by bringing innovative approaches to early phase research, including new ideas in translational medicine, bioinformatics and artificial intelligence.
- Which formats of next-gen multi-specific antibodies are being tested in clinics to modulate tumor microenvironment?
- Which type of cell engagers would be efficacious in treating solid tumors?
- Among next-gen multi-specific antibodies targeting costimulatory receptors, checkpoint receptors, and cytokines, which mechanism of action would be efficacious for solid tumor treatment?
- What are the current challenges in next-gen multi-specific antibodies for treating solid tumors?
• Short half-life
• Bio-distribution and tumor localization
• Cytokine release syndrome
Hyewon started her academic career as a T cell immunologist, then transitioned into the Pharmaceutical Industry. She was an Assistant Professor in the Department of Microbiology and Immunology at Northwestern University. After leading a lab to study T cell signal transduction pathways that govern T cell activation and function, she joined Amgen Discovery Research to pursue target discovery research in Inflammation and Oncology. She worked on numerous novel target discovery projects in Oncology and Inflammation at Amgen, including cancer vaccines, cytokines, and large antibody biologics aiming to inflame tumor microenvironments. After her tenure at Amgen, she joined IGM Biosciences as a director in Immuno-Oncology. Currently, she is focusing on developing novel IgM-based therapeutics to generate immune agonists.
Networking Lunch
Spotlight Presentation by Inotiv
Quantitative Profiling of Immune Checkpoint Protein Target Systems with Target Sufficiency
New therapeutics targeting the immune checkpoint (IC) TIGIT are in clinical development with PD-1/PD-L1 inhibitors for solid tumors indications, but without protein biomarkers. We used targeted mass spectrometry to precisely quantify TIGIT, DNAM1, PVR, PD-1, PD-L1, and PD-L2 in 97 primary non-small cell lung cancers (NSCLC) and matched tumor draining lymph nodes (TDLN). Only 56% of NSCLC cases expressed TIGIT, which was quantifiable almost exclusively in TDLN. TIGIT, DNAM1 and PVR abundance varied over approximately 25-fold and were co-expressed only in some tumors. Quantitation of target system proteins may explain differences in response to combined anti-TIGIT anti-PD-1/PD-L1 therapeutics.
Daniel C. Liebler is Vice President for Proteomic Technologies at Inotiv, Inc. He received a Ph.D. in Pharmacology at Vanderbilt and did postdoctoral training in Biochemistry and Biophysics at Oregon State University. He held faculty appointments for 30 years at the University of Arizona and at the Vanderbilt University School of Medicine. Dr. Liebler has been a leader in the application of mass spectrometry and proteomic technology to chemical biology and cancer proteogenomics. In 2017, Dr. Liebler founded Protypia (acquired by Inotiv in 2022) to provide a mass spectrometry platform for drug target analysis for diverse therapeutic areas, including immuno-oncology.
Spotlight Presentation by EnableMedicine
From Images to Insights: Deep Spatial Profiling Reveals Disease and Treatment Biomarkers
Selecting the right biomarkers is important for success in phase transition of clinical trials. Multiplex immunofluorescence (mIF) has increasingly allowed us to select high-quality protein biomarkers that correlate more strongly with patient outcomes. There is a growing need to identify high-quality protein biomarkers to support clinical research, and spatial biology is showing promise in providing these answers.
We are using a 51-plex protein panel that covers a range of functional and tumor microenvironment-related biomarkers, including lymphoid and myeloid cell markers, tissue biomarkers, antigen presenting cells, and immune checkpoint and activation markers. By analyzing this comprehensive panel of biomarkers, we have identified cell types that are up or downregulated in different disease states. Further, we have explored the spatial relationships between cells, uncovering important differences in cell-to-cell interactions and neighborhoods between disease states. These spatial analyses provide a powerful toolkit for discovering key biomarkers in various diseases and treatments.
Gulpreet covers Business development at Enable Medicine for West coast and Central US. She completed her Ph.D. in Cell and Molecular Biology at University of Wisconsin-Madison, where she studied organelle biology using live cell imaging and instructed at the Vision Research Microscopy Core Facility. Gulpreet served as National Representative at Olympus Scientific Solutions, supporting researchers in various microscopy and image analysis applications. She is an experienced biotech professional with a strong research background and expertise in helping researchers apply cutting edge technologies to their studies.
Spotlight Presentation by Burning Rock Dx
Unraveling the Implications of ctDNA As a Biomarker Using Tumor-Informed MRD for Solid Tumors
Circulating tumor DNA (ctDNA) has been an emerging biomarker of minimal residual disease (MRD) incorporated into clinical trials and practices for prognosis prediction, treatment efficacy evaluation, and patient stratification. The sensitivity of the MRD test plays a crucial role in detecting ctDNA in patients due to the extremely low abundance of ctDNA in blood. A variety of technical approaches to MRD assessment have been published and validated. The presentation will cover the potential utilizations of MRD, different technical methods to optimize the test results, and real-world applications in clinical studies
Michael Chen is a translational medicine scientist at Burning Rock Dx with prior medical affairs experiences leading projects in inflammatory disease, obesity, and hematologic malignancy therapeutic portfolios. He obtained a doctorate of pharmacy from the University of Southern California in 2022 with a passion for advancing precision oncology.
Antibody drug conjugate as tumor immunotherapy agents
- Recapitulating Human Tumor Microenvironment.
- Accounting for the lack of Immune System Similarities between species and Predictive Biomarkers and Clinical Correlations.
Dayson F. Moreira, PhD, is a Senior Scientist at Sutro Biopharma, a clinical-stage pioneer in next-generation cancer therapeutics, with a focus on antibody-drug conjugates (ADCs) and immunostimulant ADCs (iADCs). He earned his PhD in pharmacology from Sao Paulo University and holds a Bachelor of Science degree in Biological Science from State Sao Paulo University, Brazil. As a post-doctoral researcher at Beckman Research Institute at City of Hope National Medical Center, he played a vital role in the development of new ASO molecules for cancer immunotherapy.
Drinks-Canape Reception