IMMUNO-ONCOLOGY XCHANGE
2024
Boston, June 18th
Welcome to hubXchange’s Immuno-Oncology Xchange Boston 2024, 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.Â
Discussion topics will cover Immune Biomarkers, Translational Research, Clinical Development, and Tumor Microenvironment.
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: Woburn Hilton Hotel, 2 Forbes Road, Woburn, MA, 01801, US
SNAPSHOTS OF DISCUSSION TOPICS
- Identification of specific immune biomarkers in blood for gene-edited cellular therapeutics
- Pharmacodynamic and predictive biomarkers for IO from preclinical to clinical stages
- Translational strategies to develop clinically safe and effective immune cell engagers
- How to select the right translational screening model to monitor IO agents
- Early signals of efficacy, biomarkers and confidence in early clinical I/O trials
- How to maximize clinical success: Patient selection strategies beyond target expression
- Exploring different cellular modalities
- TME-targeting combinations – improving efficacy
Full Xchange Agenda
Click on each track for detailed agenda
Immune Biomarkers
Opening Keynote Presentation by Burning Rock Dx
Exploring the potential: harnessing ctDNA MRD in immune-oncology treatment for solid tumors
The research on circulating tumor DNA (ctDNA)-based minimal residual disease (MRD) has emerged in immune-oncology (IO) clinical studies, aiding in assessing drug efficacy, patient stratification, and treatment decision-making for solid tumors. Despite the absence of approved ctDNA-based companion diagnostic (CDx) assays for IO therapies, studies highlight the value of ctDNA monitoring for patient management in IO settings. With various ctDNA MRD tests launched, understanding tests have become immensely significant to clinical uses. The presentation will delve into the potential of ctDNA MRD in IO, technical approaches for detection, and real-world applications in clinical studies.
Michael Chen is a translational medicine scientist at Burning Rock Dx, focusing on providing scientific communication on utilizing in-house developed next-generation sequencing-based products in supporting clinical studies. Before joining Burning Rock, he had multiple medical affairs experiences, serving as a project lead in various therapeutic areas to support product launch and medical content generation, including multiple myeloma (Kyprolis), obesity (Wegovy), and rheumatoid arthritis (Jyseleca). He obtained his doctorate of pharmacy from the University of Southern California with a passion for advancing precision medicine.
Identification of specific immune biomarkers in blood for gene-edited cellular therapeutics
- What to look for and do they exist?
- What should be the key attributes of such biomarkers?
- What technology platform are appropriate for their identification?
- How to develop specific assays in the absence of clinical samples?
- What should be the biomarker characterization/validation strategies?
Lalit Kumar, Director of Clinical Bioanalytics and Translational Science at Beam Therapeutics, is currently heading implementation of biomarkers strategy in clinical trials to develop cellular therapeutics targeting T cell leukemia and Lymphoma. He brings in 10 years of clinical bioanalytical expertise and leadership in precision medicine which includes clinical assay design and development.
Before joining Beam Therapeutics, he was Associate Director of Clinical Pharmacology at CRISPR Therapeutics, leading clinical biomarkers strategies for phase I/II clinical trials for hematology and immuno-oncology pipelines, including CASGEVYTM.
As an independent investigator at Harvard medical school, he also worked on human T/B/NK cell primary immunodeficiencies.
Multi-omic immune biomarker selection for novel IO response and toxicity assessment: tissue, blood, plasma, or all of the above?
There are a plethora of immune-based biomarkers that can be harvested from patient specimens using different sample formats and analytical techniques. How to apply these biomarkers to patient populations in the context of drug discovery and clinical trials is an ongoing area of debate. To that end, how can we use immune biomarker strategies to optimize drug development and improve patient outcomes?
- Background – How are immune biomarkers currently used to shape clinical decisions and drug development?
- Landscape – What technologies are widely implemented in biomarker
- Novel approaches – How can we leverage new and emerging technologies and bespoke multi-omic signatures to maximize utility for a particular indication?
- Implementation – What are the minimum standards for analytical and clinical validation and regulatory hurdles for implementation?
Michael Goldberg, PhD joined the R&D department at BostonGene in 2020 as the director of Immunology. He has led the development of a comprehensive immunoprofiling platform from the peripheral blood of cancer patients in a CLIA setting. His group is focused on discovering novel blood-based immune biomarkers for immunotherapy response prediction. Before joining BostonGene, Dr. Goldberg worked on pre-clinical mechanism of action research at Evelo Biosciences. He completed his post-doc at the University of Minnesota Center for Immunology in 2018 and received his PhD in Microbiology & Immunology from the Albert Einstein College of Medicine in 2013. He received his MS in Microbiology from Georgetown University and a BA in Physical Anthropology from the University of Pittsburgh.
Developing autoantibody signatures to predict disease recurrence and immune-related
adverse events in patients receiving adjuvant immunotherapy
- Do autoantibody signatures / biomarkers offer advantages over DNA, RNA and protein
biomarkers? - Can autoantibody profiles be used as a tool for treatment monitoring?
- What are the best approaches for identifying autoantibody signatures?
- What are the preferred platforms for discovering and validating autoantibody signatures?
Scott Paschke is focused on driving a business strategy that helps clients accelerate their research and discoveries using innovative tools and services offered by CDI Labs. Scott has over 20 years of experience in the biotechnology sector working with renowned R&D reagent companies. Prior to joining CDI Labs, Scott was Director of Business Development at Active Motif, and was President and Chief Technology Officer at Lake Placid Biologics. He also held leadership positions at Serologicals Corporation, Lake Placid Biologicals and Upstate Inc. Scott received a BA in biology and a MA in biochemistry from State University College at Buffalo.
Spotlight Presentation by Biorasi
Navigating Precision Oncology Clinical Trials: Paradigm Shifts Critical for Current Trial Needs
Advancements in precision oncology have transformed the landscape of clinical trials. Whether it has been isolating genetic subpopulations, advanced targeted drug delivery, altering epigenetics, CAR-T therapies and beyond, we have seen an explosion of innovative technologies to address the consistently growing oncology treatment needs. Yet, alongside these breakthroughs come numerous risks and challenges. This keynote presentation delves into the complexities of today’s oncology trials, exploring strategies to overcome obstacles and maximize success, including the vital role of partnering with small/mid-sized CROs where we highlight how collaboration can mitigate risks and ensure focus on the efficacy of novel innovative treatments.
As Head of Biorasi’s Neurology, Oncology, and Cell & Gene Therapy Centers of Excellence, Dr. El Hokayem oversees all clinical projects within this space. His unique expertise in the basic, translational, and clinical research spectrum provides critical insights at the strategic, operational, and managerial levels. He is an expert clinical trial decentralizer and strategist as well as an early adopter of digital technologies. With over twenty years’ experience in both academia and clinical research, Dr. El Hokayem has focused his research on several Oncology and Neurology disease causes and mechanisms.
1-2-1 Meetings/Networking Break
Poster Session by Mission Bio
Quantification of Single Cell Vector Copy Number in CAR T Cell Products Utilizing a Novel Microfluidic Technology
CAR-T immuno-therapies have been transformative solutions to treat cancer patients. As most CAR-T therapies rely on the introduction of CAR into host cells using lentiviral vectors followed by re-introducing modified T-cell back into patients, the quality of CAR-T is extensively regulated. Safety and efficacy attributes such as transduction efficiency and transgene copy number needs to be accurately measured. Mission Bio has developed a solution from panel design to data analysis for single-cell targeted DNA sequencing to interrogate transgenes. Using the Tapestri platform we demonstrate that single-cell DNA sequencing identifies transduced versus non-transduced cells with exceptional accuracy and precision, and measures the single-cell level vector copy number for populations of thousands of cells with single nucleotide resolution while reducing sample processing time from weeks to days. In addition, utilizing our oligo conjugated antibody system, we demonstrate single-cell multi-omics characterization of protein expression and transgene information of products.
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George has 13 years experience in the translational oncology and diagnostics spaces, working with industry clients across all -omics modalities. His current role at Mission Bio enables partners to develop GxP assays incorporating numerous CQAs in the cell and gene therapy sectors, and liaising deployment of these assays to clients and their CDMOs. Prior to Mission Bio, George headed up strategic pharmaceutical alliances at Metabolon, and technical applications in clinical Dx development and deployment at Mitra Biotech. George’s research at Rutgers University and the Cleveland Clinic focused on biomaterial engineering for iPS and iN grafting and preferred lineage differentiation applications
Pharmacodynamic and predictive biomarkers for IO from preclinical to clinical stages
- How can we best incorporate pharmacodynamic biomarkers to guide clinical strategy?
- What approaches represent the future of predictive biomarkers in the IO space?
- How can we best design clinical biomarker studies to drive better reverse translation?
Dr. Dan Felitsky is currently President and CSO at Sfida Ventures, where he heads R&D efforts to develop novel oncology medicines. Prior to Sfida Ventures, Dan was VP of Immuno-Oncology at TigaTx, developing a novel class of IgA-based neutrophil-driven therapeutics, and head of Discovery Research at Pyxis Oncology, establishing the company’s scientific team and building through a successful IPO. He also led the Translational Science Platform at Jounce Therapeutics, originating a program partnered with Gilead for $805 million. As a scientific leader, Dan has contributed to over 40 preclinical programs, 8 INDs, and multiple clinical programs. Dan began his industry career at GlaxoSmithKline after a postdoctoral fellowship at Scripps Research. Dan holds a Ph.D. in Biochemistry from the University of Wisconsin-Madison and a B.S. in Cell and Molecular Biology from the Pennsylvania State University.
