April 16-17, 2023

Orlando • FREE

Advancing Cancer Therapeutic R&D Through a Multi-Omic Approach to Diagnostics

Your Science Can’t Wait Article Courtesy of Element Biosciences High-quality, low-cost DNA sequencing with the Element AVITITM system.

The CHTN: A Leading Prospective Procurement Biospecimen Resource

Biodesix aims to unite biopharma, physicians, and patients to transform the standard of care and improve outcomes with personalized diagnostics. Our clinical diagnostic tests personalize patient care and help improve cancer detection, evaluation, and treatment. We offer five Medicarecovered tests, including the Nodify Lung® testing strategy for nodule malignancy risk

The genomics era has transformed cancer research and treatment, but we have more to do; this is just the beginning. While the early years of the genomics era brought cost reductions that famously outpaced Moore’s Law, more recently, lower costs have only been available through ever

For more than 35 years, and with the support of the National Cancer Institute (NCI), the Cooperative Human Tissue Network (CHTN) continues to provide human biospecimens for researchers throughout North America. Samples are also available to international researchers on a case-by-case basis. Unlike a typical biobank,

continued on page 21

continued on page 10

continued on page 13

Article Courtesy of Biodesix, Inc.

Paraza Pharma: Catering to Startup and Established Biotechs as Well as Pharma Companies Since 2011

An Integrated Multi-Omics Approach to Identify Molecular Regulatory Mechanisms in Breast Cancer Development and ProgressionExh

Multiplex Imaging in ImmunoOncology Research Article Courtesy of Fortis Life Sciences

MONTREAL — Since its inception 12 years ago, Paraza Pharma has supported many pharma and biotech companies and institutions in Canada and around the world. With locations in Montreal, Laval, and Cambridge (USA), Paraza Pharma supports client-partners in efficiently

Dr. Gus Frangou is an assistant professor of oncology and a member of the Department of Molecular and Cellular Biology at Roswell Park Comprehensive Cancer Center in Buffalo, New York. The

From visualizing the localization of the therapeutic to the cellular and tissue changes it exerts, imaging is a powerful tool in oncology research. Multiplex immunofluorescence (mIF) is a powerful technique that allows researchers to visualize and analyze the tumor, immune, and stromal cells within the tumor microenvironment simultaneously, and

continued on page 6

continued on page 18

continued on page 6

Expert Team in Drug Discovery

Fast-Tracking Drug Development With Biomarkers and Companion Diagnostics The realization of precision medicine relies on our ability to select the patients most likely to respond to treatment. This can be accomplished by selecting patients using biomarkers. Those biomarkers need to be discovered and developed as the drugs go through clinical development. Clinical trials in which biomarker-targeted therapies were utilized were found to have the highest rate of success. In the past, most companion diagnostics detected protein expression by immunohistochemistry (IHC) or an continued on page 13

CytoSections™: A Validated Control for IHC, ICC, and InSitu

BioChain Institute Embraces Cutting-Edge Technology

Rachel Gonzalez, Ph.D. — senior scientist at OriGene Technologies® (Booth #529) — sat down with Cancer Research Industry News and answered some questions for us.

A: CytoSections are ready-to-use FFPE sections of cell pellets expressing targeted protein derived from genespecific cDNA clones. These have been tested for IHC and ISH

Traditional technologies, such as immunohistochemistry IHC or in situ hybridization, originally enabled researchers in the lab to characterize cells or molecules at the cellular plane. Recently, these technologies have evolved to a stage where scientists can utilize the local presence of multiple markers in the tissue to further characterize the cells or molecules. Still, it is extremely critical that scientists not only characterize the cells, but also understand the interaction of cells within

continued on page 10

continued on page 13

Q: What are CytoSections?

1st/2nd Edition • April 16-17, 2023

6

What is the Most Comprehensive Assay for Adaptive Immune Receptor Repertoire Profiling Commercially Available Today? Dr. Alex Chenchik — CEO and chief scientific officer at Cellecta — has developed a new platform for adaptive immune receptor (AIR) repertoire profiling of TCR and BCR clonotypes. The multiplex RTPCR approach targets the CDR3 variable region of both TCR and BCR receptors

to identify the more prevalent and active clonotypes in blood or tissue samples. The approach is adapted from, and can be combined with, Cellecta’s DriverMap™ Targeted RNA-Seq Expression Profiling technology. Results demonstrating its utility will be presented at the Cellecta Spot-

An independent publication not affiliated with any other organization Gary Cox Steve Cox Publishers

Matt Crown John McQuaig Deb McQueen Andrew Oseman Senior Associate Publishers

light Theater Presentation on Monday, April 17, 3:00-4:00 p.m. Dr. Chenchik recently sat down with Cancer Research continued on page 21

Genomic Profiling of CMMCs Reveals Key Disease Information Cameron L. Lilly, Ph.D., is a medical science liaison with Menarini Silicon Biosystems, an international biotechnology company. They recently sat down with Cancer Research Industry News and answered some questions for us. Q: What are the key insights emerging from genetic profiling of circulating multiple myeloma cells (CMMCs)? A: Understanding multiple myeloma

PARAZA PHARMA (continued from page 1)

advancing their drug discovery projects, achieving their milestones with success, and growing their businesses. Collaborative and Highly Integrated Drug Discovery Engine Paraza Pharma is an integrated drug discovery organization with chemistry; in vitro and in vivo biology; and DMPK functions which provides flexible business models to suit clients’ needs. Paraza Pharma has been providing drug discovery support to small and large pharma, biotech companies, startups, venture companies looking to increase program/company valuation, and academic institutions requiring expert drug development support. Their world-class drug discovery experts help partners achieve their program milestones, from lead identification through lead optimization and development candidate selection. “We consider ourselves an extension of your R&D team,” says Arshad Siddiqui, Ph.D., president and CEO of Paraza Pharma. Collaborative Model for Drug Discovery That Moves Beyond the “Traditional CRO Approach!” Paraza Pharma has served hundreds of client-partners: some for full and integrated multiyear collaborative support, some for supporting specific functions, and others for one-off support. The organization has demonstrated to be a value-added partner con-

(MM) evolution and heterogeneity is a key driver for translational research. By analyzing single CMMCs isolated from enriched peripheral blood, researchers previously found evidence suggesting convergent evolution of genetic lesions for the first time in MM.1 This includes alterations that developed independently across disparate evolutionary branches, including copy number aberrations (CNAs) often found in MM. Researchers at Dana-Farber Cancer tributing to significant fundraising for its client-partners in addition to supporting the delivery of clinical candidates and supporting patents/applications and publications. At the Forefront of the Protection of Confidential Information Assuming its leading position, Paraza Pharma announced in July 2022 that it had obtained its ISO/IEC 27001:2013 certification — the international standard that defines the criteria that information security management systems (ISMS) should meet to represent best practices. Recognizing confidential information as one of the most valuable assets of its client-partners (and despite its already high standards in the secure management of confidential information), Paraza Pharma has undertaken to raise the bar another notch by submitting to an in-depth assessment process leading to the implementation of an ISMS. Successful Business Trajectory Over the past 12 years, Paraza Pharma has grown steadily from two people to over 250 people strong, and the growth projections for the next five years are equally promising. Therefore, Paraza Pharma expects to continue to hire bright and highly talented R&D scientists and support staff in the foreseeable future. Paraza Pharma also plans to add chemical libraries and screening platforms to its services in the near future. Learn more about Paraza Pharma at Booth #367 or visit their website, www.parazapharma.com.

Jessica Attoe Allison Honeycutt Jennifer Kinsman Christian Mungaray Damaris Mungaray John Pechota Kamraan Quddus Camille Reyes Sandra Robles Rebecca Willingham Associate Publishers Carl F. Shifflette III Art Director Clinton Ellis Graphic Artist Brianna Ward Digital Marketing Joshua Espinal Jordi Espinasa Samuel Rickert Editors Ashley Davis Content Coordinator Monique Carter Tiffany Webster Administration Cancer Research Industry News is published by Source Group LLC ©2023. All rights reserved. Business License #45-4600703 Advertising Inquiries: 520-722-2000

Institute compared the mutational landscape from matched patient samples of

635 N. Craycroft Rd. • Tucson, AZ 85711 Phone: (520) 722-2000 • www.sourceg.net

continued on page 21

FORTIS LIFE SCIENCES (continued from page 1)

to understand changes following treatment. Imaging allows researchers to create a detailed map of cells and proteins and their interactions within the tumor microenvironment. This information can be used to predict therapeutic targets based on phenotypic markers. At scale, it can also assist in identifying novel biomarkers and developing new treatment modalities. Fortis offers high-plex and low-plex options for tissue mIF to uncover cell phenotypes, their functional state, and cell-cell interactions. We can perform the following services: • Full-service IHC/mIF. • Tissue processing and embedding. • Tissue sectioning. • Tissue microarray construction. • Immunostaining. • Whole-slide scanning. • IHC validation. Our team has validated a 10-plex panel that identifies key immune cells and tumor cell markers. Additional antibodies can be added to this panel to detect the proteins and markers that are of particular interest in your study, or a bespoke panel can be created to meet your needs. Using the Lunaphore COMET™, we can support up to 40-plex panels at medium-throughput of up to eight slides per week. For projects that require fewer markers but high-throughput screening, we can

alternatively screen up to 6 antibodies plus DAPI at an 80-slide capacity on the PhenoImager™ HT. This instrument can accommodate larger tissue sections and large tissue microarrays. Why Choose Bethyl for Your R&D For over 50 years, Bethyl Laboratories (a Fortis Life Sciences brand) has been dedicated to improving lives by supporting scientific discovery through qualified antibody products and custom services. We are vertically-integrated from immunization through manufacturing and validation. All of our antibodies are highly validated using six pillars of validation, meaning that our antibodies do what we say they’ll do. Our catalog of over 6,500 primary antibodies, 1,200-plus secondary antibodies, and more than 50 ELISA kits includes reagents for multiplex IF, flow cytometry, and more in fields including immunology, oncology, and neuroscience. You can also collaborate with our scientists to develop a custom monoclonal or polyclonal antibody or a custom IHC or multiplex IF assay. For more information about Fortis Life Sciences, please visit www.fortislife.com or stop by Booth #1625. Fortis Life Sciences and Bethyl are registered trademarks of Fortis Life Sciences. COMET is a registered trademark of Lunaphore Technologies S.A. PhenoImager and Akoya Biosciences are registered trademarks of Akoya Biosciences, Inc.

Why You Should Allow Exhibitors To Capture Your Information Trade shows offer you a great opportunity to meet potential suppliers, network, and learn about new products. The trade show industry is worth $14.6bn in 2021. Exhibitors will be keen to get your contact information. This is because they want to follow up with interested people after the trade show. After all, there isn't time at the show to get into the 'nitty gritty'. These follow-up calls give you the space to talk properly. You might wonder if you should let every exhibitor capture your details. Read on to find out.

Plan Your Visit Before You Go

It's a good idea to research vendors ahead of time. That way, you know which companies to make time for. Use the advance trade show guide to find which trade show exhibits you want to visit. You can also plan which talks or seminars you want to attend. Keep this list of 'target' exhibits handy when you're at the trade show and prioritize visiting these exhibits first. You can browse the rest of the trade show once you've visited the displays that will be useful for you. Attending a virtual trade show? Consider making appointments with specific exhibitors before you go. This guarantees you time to speak to them at the virtual trade show booth. It also means you are able to limit who has your information.

Should You Give Out Your Information?

Exhibitors at trade show displays will try to take your contact details. They want to follow up with potential leads after the trade show. Are they one of your priority exhibitors? Do you want to hear from them again after the show? If you know you will never need their services, you can say no. Otherwise, the company will spend time and effort trying to get you on the phone. That's time they could be better spending on potential leads. That said, just because an exhibitor might not be a perfect fit now doesn't mean they won't be in the future. Your business might pivot, and the new direction will need the exhibitor's help. We recommend that you give your details to exhibitors anyway. You can discuss your specific needs after the trade show. The exhibitors may have other solutions for you. Or you can stay on their mailing list and stay up to date with what they're doing.

Dealing with Exhibitors

Decide which information you want them to have. An email address is a great option because you control when you check your inbox. If you do give them a phone number, provide a window of time when you're available for follow-up calls. Giving them your website add address is also a good way to get extra traffic. Most exhibitors will take down your information electronically. They may also ask extra questions around revenue, needs, or time in business. These questions may seem intrusive but they ensure the right sales staff follow-up. So how do you decline if you don't want exhibitors to have your details? You can simply say you're not interested right now, but you have their website.

Make the Most of Trade Shows

Meeting exhibitors is one of the best parts of attending a trade show. You can ask specific questions and get personalized answers in real-time. Giving the exhibitors your details lets them follow up with you outside the trade show. This gives you both more time and space to talk properly since trade shows can be so busy.

Keen to learn how to get the most out of trade shows? Contact us today to find out how we can help.

1st/2nd Edition • April 16-17, 2023

10

Cell Stress and Mitochondrial Dysfunction Found in Early Alzheimer’s Disease Patients NEEDHAM, Massachusetts — Invicro LLC (Invicro), a global, industry-leading imaging CRO, and a subsidiary of REALM IDx, Inc., recently announced the publication of the paper “Widespread cell stress and mitochondrial dysfunction in early Alzheimer’s Disease” in Science Translational Medicine. The study provides novel in vivo evidence for widespread, clinically relevant cellular stress and bioenergetic abnormalities in patients with early-stage Alzheimer’s Disease (AD) and highlights the potential value of mitochondrial imaging in longitudinal studies of AD. “Invicro’s research and novel biomarkers are significant for the progression of clinical trials in AD and neurodegenerative disorders, and we are delighted to see this important work published in Science Translational Medicine,” said Dr. Roger Gunn, CSO, neuroscience, for Invicro. “This work further extends Invicro’s reper-

toire of biomarkers for use in AD clinical trials.” Position emission tomography and magnetic resonance imaging markers were utilized to show that cell stress and impaired oxidative phosphorylation are central to mechanisms of synaptic loss and neurodegeneration in the cellular pathology of AD. Compared to controls, AD patients had widespread increases in sigma 1 receptor, along with regional decreases in mitochondrial complex I, SV2A, brain volume, and cerebral blood flow. Furthermore, significant reductions in mitochondrial density were seen in AD patients over a 12 to 18-month period, indicating this biomarker may be suitable for use in early-stage trials of novel disease-modifying treatment for this devastating disease. This study was led by Professor Paul Matthews of the UK Dementia Research Institute and Imperial College London as part of the multi-arm, pre-competitive con-

ELEMENT BIOSCIENCES

practical for most researchers. When outsourcing, the pressure to maximally fill flow cells leads to unpredictable queues and longer waits for results, bottlenecking the speed of discovery. The AVITI breaks the NGS cost curve and gives labs of all sizes access to affordable DNA sequencing on their timeline, and Element guarantees your reagent price for the lifetime of your instrument.

(continued from page 1)

more expensive and higher throughput equipment, tying affordability to the centralization of resources. What if every scientist had fewer constraints, more choice, and faster access to better tools? Element has reinvented sequencing from the ground-up with this vision in mind. Our mission is to democratize sequencing by improving data quality at 1/3 the run cost of the leading benchtop system. Key Specifications and Features • Industry-leading quality, with greater than 90% of data Q30 or above. • Two independent flow cells, each delivering 1 billion reads per 300 Gb. • Production-scale costs on a benchtop system at approximately $2 to $5 per Gb or $0.60 to $1 per 1 million reads, with our $200 Genome or list pricing, respectively. • 38-hour per 300-cycle kit; 24-hour per 150-cycle kit runtime with our forthcoming Cloudbreak chemistry. • Validated compatibility with leading library prep ecosystem partners for minimal pipeline disruption. • Batch size flexibility, enabled by unprecedentedly low run costs. Sequence just 24 exomes for $45 per sample, or 8,000 single cells at 40,000 reads per cell for approximately $360, on your schedule. High-Quality Data, Low Run Costs Until now, the lowest costs per gigabase were only available with the NovaSeq. However, the very high capital cost and the need to multiplex very large sample numbers make individual ownership im-

AVITI System Data Has Unique Features That Add Value to a Wide Range of Cancer Sequencing Applications • Polony generation by rolling circle amplification reduces error by only copying from the original template, increasing confidence in variant calling. • No on-instrument PCR limits AT/GC bias, providing low fold-80 figures for exomes and targeted panels. • Ultra-low optical duplicates increase the effective coverage of your samples. • Negligible index hopping provides confidence when multiplexing. • Low Phi-X spike-in requirements (approximately 5%) for applications with low-diversity samples like methylation and amplicon sequencing means less wasted capacity. • The ability to sequence library inserts longer than 500 bp improves data mapping to challenging genomic regions. Element was founded with the idea that all scientists should have access to affordable, accessible DNA sequencing without sacrificing data quality. Democratized access to life science technology will empower the entire research community to accelerate the pace of science. Stop by AACR Booth #559 or contact us at www.elementbiosciences.com/contact to see what the AVITI can do for your lab.

sortium, molecular imaging of neurodegenerative disease — mitochondria-associated proteins and synapses (MIND MAPS) AD cohort. The MIND MAPS consortium was developed and is headed by Dr. Eugenii Rabiner, EVP for Translational Imaging at Invicro. “MIND MAPS is an important industry-academic collaboration that is bringing together experts from across the globe. It was developed with the aim of characterizing imaging biomarkers of the neurodegenerative process to address important problems in the development of novel medication for neurodegenerative disease,” said Dr. Rabiner. “Together, we have shown that mitochondrial and cellular stress biomarkers open the promise of better monitoring of the therapeutic potential of these drugs.” Science Translational Medicine is the leading weekly online journal publishing translational research at the intersection of science, engineering, and medicine. The goal of Science Translational Medicine is to promote human health by providing a forum for communicating the latest research advances from biomedical, translational, and clinical researchers from all established and emerging disciplines relevant to medicine. Science Translational Medicine published “Widespread cell stress and mito-

chondrial dysfunction in early Alzheimer’s Disease” on August 17, 2022.

ORIGENE

can easily be integrated into the regular laboratory IHC/ISH workflow, thus acting as process control. A major pharma customer said, ‘The CytoSections approach has been very effective and will become an integral part of our workflow. Thanks to all at OriGene for their support.’

(continued from page 1)

assays, hence they are an ideal tool for laboratories working on new biomarker discovery and antibody development. Q: What are key issues addressed by CytoSections? A: Limited access to verified positive control tissues, difficulties collecting tissues with mutant targets, changes in gene expression levels (as the tissue blocks are sectioned), and lack of a standard uniform tissue across multiple labs are some of the frequently heard complaints from laboratories performing IHC and ISH regularly. CytoSections address these critical issues. With over 20,000 expression plasmids in stock, OriGene can produce overexpression cell pellets for most human and mouse target proteins and its mutants. The overexpression of the target protein is verified. In addition, these are laboratorycultured cells produced under a stringent quality controls process; enabling us to provide a reproducible and unlimited number of control slides. Q: What are the critical features of CytoSections? A: Many features are unique to CytoSections. The ability to customize CytoSections as per research needs is a unique feature that researchers loved during the prelaunch test period. With our collection of extensive sequence-verified cDNA clones, we can create a mutant, express it in human cells, and verify its expression by western blot and IHC. Another feature that customers love is that CytoSections behave like an FFPE section. Hence, these

About Invicro Headquartered in Needham, Invicro, a subsidiary of REALM IDx, was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro’s multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (preclinical through Phase 0-IV), all imaging modalities, and all therapeutic areas, including neurology, oncology, and systemic and rare diseases. Invicro’s quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by Invicro’s industryleading software informatics platforms, VivoQuant® and iPACS®, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ, and DaTIQ. Invicro operates out of nine global laboratories, clinics, and sites within the United States in Massachusetts, Michigan, California, and Connecticut as well as globally in the United Kingdom, India, Japan, and China. For more information, visit www.invicro.com, or Booth #61.

Q: For how many targets are CytoSections available? A: OriGene offers CytoSections for more than 20,000 human and mouse targets for IHC and ISH. If you don’t see your target gene of interest on our website, try the custom option. Just write to our tech support team at [email protected]. Q: How are CytoSections validated? A: Validation of CytoSections is a threestep process. The first step involves sequence verification of TrueORF cDNA clones used for generating CytoSections. The second step is the validation of the expression of the target protein by western blot. The third step is validation by an IHC assay — only target-specific antibody is available. Q: Can CytoSections be used for any downstream application (e.g., commercial, genomic, in situ, etc.)? A: Yes. We have tested it for immunohistochemistry and in-situ hybridization techniques. To find the CytoSection™ for your target gene of interest, scan the QR code (page 1). For more information about OriGene Technologies®, please visit www.origene. com or stop by Booth #529.

1st/2nd Edition • April 16-17, 2023

13

Multicenter Magic: Diversified Patients With Simple, Centralized Testing Article Written by Jennifer Davids, Ph.D., the Director of Patient Advocacy and Community Engagement With Menarini Silicon Biosystems, an International Biotechnology Company As more targeted therapies come to market, the need for a diverse pool of subjects becomes a more prominent topic than before. Representation truly matters in assessing drug safety, efficacy, and dosing regimens, as individuals with different genetic backgrounds and conditions

BIOCHAIN (continued from page 1)

the microenvironment with other cells, with the surrounding connective tissue, as well as with noncellular components to gain a holistic visualization of diseases. Spatial biology adds a new analytical dimension, “space,” where the spatial context is used to institute a biological correlation by deducing information on the specific position of cells and molecules within the tissue; thus, the information that spatial analysis can provide is critical to unveiling the complex fundamental apparatuses of diseases. The tumor microenvironment (TME) is the intricate organized ecosystem of surrounding cells, blood vessels, signaling molecules, and other components of the extracellular matrix that intimately and constantly interact with the tumor. The comprehensive analysis of the cell-to-cell interactions and the spatially resolved geographic distribution of cells within the TME is therefore spatial by nature and a fundamental desirability of spatial biology. Thus, spatial biomarkers are not only important in defining the boundaries of the tumor, but also in thoroughly studying the TME cells in context, ultimately predicting clinical responses and advancing the success of immunotherapies that are contingent on the state of the tumor microenvironment. “It gives us a great sense of pride to adopt the NanoString GeoMx® DSP and the 10x Genomics Visium® platforms into our portfolio,” said Dr. Zhongdong Liu, COO at Biochain. “We will support academic and biopharma researchers seeking to leverage

CHTN (continued from page 1)

the CHTN is a prospective procurement and distribution service. Based on the research needs of each investigator, the CHTN can collect malignant, benign, diseased, and uninvolved/normal biospecimens to distribute to investigators fresh, frozen, and fixed as paraffin embedded and/or slides. Comprised of multiple academic institutions, the CHTN communicates through a shared database of investigator requests to meet the needs of academic, government, and commercial researchers. As part of the emphasis on quality, the CHTN divisions follow a standard quality

(like pregnancy) may respond differently, and the homogeneous approach of yesteryear left pitfalls that patients discovered at their own expense or excluded large subsets. Various strategies have come forward to offer a solution to enrolling diverse patients into clinical trials, such as multicenter studies. Multicenter studies have gained popularity as a way to not only broaden patient populations tested in clinical trials, but to also reach enough enrollment for very rare disease subtypes. However, certain challenges exist

when coordinating sites located all over the world — namely, sample stability for fragile, yet valuable, biomarkers. One solution is to spread a bevy of instruments

across the trial sites, but this strategy risks machine-to-machine variation and the high cost of purchase and maintenance. A complementary approach is to increase sample stability and send it to a centralized laboratory for processing, which reduces variation and increases the trial’s accessibility for patients in rural areas. Further considerations exist around what type of specimens (cerebral spinal fluid, urine, ascites, whole blood, plasma, tissue biopsy, etc.) provide access to the best panel of analytes for safety/efficacy assessment, which must be counterbalanced with how difficult those samples are to get in areas with less hospital infrastructure. One common solution is to analyze especially fragile analytes (like RNA) continued on page 18

robust spatial technologies to power new therapeutic discoveries and accelerate drug development.” BioChain’s selection of ready-to-use, off-the-shelf, characterized tissues have already completed meticulous spatial workflows (sample prep, imaging, library construction, sequencing, and data analysis), allowing researchers to bypass executing a custom experiment, saving valuable time and money. This enables scientists to unreservedly review the data and the tissues before purchasing while having the option to effectively scale to a custom-tailored experience for further experimental control. BioChain specializes in providing fully customizable, end-to-end, spatial services with in-house IRB-approved tissues (including frozen; FFPE; xenograft; and matched-pair tissues from mice, human, and non-human primate donors), histopathology team services, digital scanning services, and an expert NGS data analysis team to fulfill every spatial research need. Trusted by the top 500 global pharmaceutical, biotechnology, and academic leaders for over 25 years, BioChain’s biggest advocates are their customers. Advancing accurate disease diagnosis and drug discovery for biomedical professionals, BioChain is here for you every step of the way with high-quality biospecimens, kits, reagents, instruments, and services. For more information about their services and products, please stop by Booth #1656. You can also visit their website at www.biochain.com or email them at info@ biochain.com.

DISCOVERY LIFE SCIENCES alteration in the DNA via in situ hybridization or PCR. With the advent of more comprehensive genomic detection methods, such as next-generation sequencing (NGS), genebased companion diagnostics have outpaced the approval of protein-based methods. Despite the active field of drug-targeted therapy and the multitude of biomarker discovery research programs, few biomarkers make it to the companion diagnostic stage. As of 2022, there were approximately 150 Food and Drug Administration (FDA) cleared or approved companion diagnostics (CDx), including imaging and device companion diagnostics. However, most CDx target the same few markers, with only 34 unique markers with approval. For example, there are 31 CDx targeting EGFR and 25 targeting Her2. Furthermore, biospecimen bias also contributes to the difficulty faced in translating biomarkers from preclinical research to the clinical setting. This bias can occur when biospecimens from multiple sources are used to increase the sample size of a study, despite being processed and stored according to different methods, which can dramatically affect the levels of biomarkers detected. A standardized, multisystems approach is needed to increase the efficacy of moving biomarkers from the bench into the clinic. Streamlining biospecimen procurement; utilizing multiple techniques that facilitate target recognition and profiling, such as IHC

and NGS; and flow cytometry are all needed to demonstrate the viability of a biomarker. Successful companion diagnostic campaigns begin by understanding biomarker prevalence when choosing indications; developing a robust assay capable of detecting the biomarker at different expression levels; evaluating it alongside drug treatment throughout the clinical trial stages; and correlating expression with patient response. The importance of identifying a robust biomarker and developing tests that can detect it with accuracy and reproducibility is key to fast-tracking the clinical development of a drug. Incorporating the best cut-offs of the biomarkers in clinical trials will facilitate superior responses from the target population and can be the deciding factor between a failed trial and a new revolutionary treatment option. Expanding the approval of indications through continued research into other cancer indications, and/or other drugs from the same family, will ensure that the scope of use of the CDx increases and more patients benefit from this advancement. Flexibility shown by the FDA in treating each CDx case as an individual and quicker approval time should usher the field into never before seen growth for the industry and the patients that benefit from advancement in science. Fortunately, the innovative potential of CDx has united industry, academic, and regulatory bodies in the effort to personalize treatment therapies to reap the greatest benefits for current and future patients. For more information, please visit Discovery Life Sciences at www.dls.com or stop by Booth #243.

control (QC) protocol for each aliquot of tissue provided to an investigator. The QC is evaluated by board-certified pathologists. The QC of cancer specimens include the percent of tumor in the specimen and of the tumor; the proportion of fibrosis, mucin, and necrosis; as well as the percent of malignant nuclei (cells). Thus, investigators have a microscopic description of the specific specimens they receive. The CHTN QC approach is described in further detail at www.chtn.org/quality.html. To date, the CHTN has distributed more than 1.4 million specimens to more than 3,900 investigators. Thousands of peer-reviewed scientific publications cite the use of CHTN specimens; many being

in high-impact journals. In addition, hundreds of patents have been issued to applications citing the use of CHTN specimens. The use of CHTN specimens has been used in numerous seminal studies and discoveries. The CHTN has supported a generation of novel insights resulting in groundbreaking contributions to the understanding of tumorigenesis; the generation and testing of targeted monoclonal antibodies that have received FDA approval or are in advanced clinical trials for use as diagnostics, therapeutics, and in-patient stratification assays; and the discovery of microRNA characterization in human tissues including cancers. Investigators must complete a CHTN

application in which they specify their detailed specimen requirements, including specific diagnosis, number of specimens needed, sample size, collection parameters, and method of processing and storage. For-profit companies may obtain tissues from the CHTN for research and/ or for product characterization but cannot commercially distribute the specimens or any products extracted from the tissues. The CHTN is customer-focused and works with all investigators to optimize their supply of high-quality tissues. For more information about the CHTN, visit www.chtn. org, contact the CHTN central coordinator at [email protected], or stop by Booth #818.

(continued from page 1)

Why Is SEO Important to Your Success?

Did you know that less than one percent of people click to the second page of Google results? A business that isn't on that crucial first page of Google results will likely get lost to time. It's even better if you're at the very top of the result page. SEO is the way to make sure you wind up on that first page and get all of the clicks you deserve. If you've found yourself asking the question — why is SEO important? — you've come to the right place. This article will walk you through why SEO digital marketing is one of the most important digital marketing tools available today.

People Look For Solutions

One important thing that SEO will teach you is that people don't look for businesses; they look for solutions. If someone wants a hamburger, they're not likely to try to brainstorm their favorite hamburger restaurants and search for them online. More likely, they're abandoning all grammar and quickly searching "cheap hamburger near me." SEO relies on keywords. To get yourself to the top of the search results page, you have to study exactly what people are trying to solve when looking for businesses like yours and scatter those words throughout your website. To do this, you have to study the language that they use. This not only brings more people to your page through SEO, but as a side-effect, you get to know your client base better. This makes it easier to appeal to them when they come through your doors.

It'll Inspire You to Redesign Your Website

If you're going to have people over to your house, you will want to make sure your house looks great. The same is true of your website. Optimizing SEO will bring a flood of potential customers onto your page. Hopefully, this will inspire you to update the design of your website. People in today's world care about aesthetics, and if your site looks like it was designed in 2002, they might not trust it. After all, 94 percent of first impressions are related to your site's web design. When you design a great website, you inspire people to come back to your website. Getting visitors to come back is one of the most important steps in turning prospects into clients.

You'll Get Ahead of Your Competitors

The world of business is such that for you to succeed, someone's going to have to start doing a little worse. When you dominate local SEO by hiring an SEO business, competitors in your area are more likely to lose business to you.

Why is SEO Important?

At the end of the day, the answer to the question — why is SEO important? — is that it's the advertising style of the future. You don't even need to directly market to people for them to come to your business. Instead, you can just put yourself in the place that they're looking.

For more information, contact us today.

1st/2nd Edition • April 16-17, 2023

18

City of Hope Comprehensive Cancer Center Earns Highest Ranking From National Cancer Institute

also emphasized City of Hope’s numerous discoveries in chimeric antigen receptor (CAR) T therapy, in which a patient’s immune cells are reprogrammed to fight their tumors, as well as increased publications in high-impact journals and a 76% increase in NCI funding during the last five years. City of Hope’s Los Angeles campus, located in Duarte, is the location of its NCI-designated comprehensive cancer center, which is the research and innovation hub for its national cancer system. Community-based access to its most advanced treatments, including its renowned hematology and bone marrow transplantation programs, clinical trials, and advanced precision medicine and cellular therapies, has increased due to the expansion of its clinical network in Southern California, the addition of City of Hope campuses in Atlanta, Chicago, and Phoenix, as well as the opening of a new cancer center in Orange County. City of Hope’s system of provider and research entities now serves approximately 134,000 patients each year, with over 11,000 team members, 600 physicians, and more than 1,000 scientists and researchers across a network of locations in California, Arizona, Illinois, and Georgia. Learn more at www.cityofhope.org/aacr-2023, or Booth #949.

LOS ANGELES — City of Hope, one of the largest cancer research and treatment organizations in the United States, announced that its comprehensive cancer center has received the highest rating possible for a U.S. cancer center, “Exceptional,” by the National Cancer Institute (NCI), the federal government’s principal agency for cancer research and training. The ranking puts the center in the top echelon of the nation’s 53 NCI-designated comprehensive cancer centers. City of Hope was also awarded more than $23 million in competitive funding through the renewal of its NCI’s Cancer Center Support Grant to support its research, cancer training, education programs, and community outreach over the next five years. City of Hope has held the prestigious NCI designation since it became an NCI-designated cancer center in 1981. It first received comprehensive cancer center status in 1998, which has been renewed every five years and requires an

intense peer-review process. To receive the “comprehensive” designation, City of Hope met NCI’s rigorous criteria for laboratory, clinical, and population-based research that benefits the communities it serves. Comprehensive designation ensures patients get access to leading-edge treatments, including the development of personalized therapies based on the unique molecular characteristics of individual patients’ tumors and access to clinical trials in early phases of drug development. It also means that the physicians who see patients in clinics are collaborating with researchers to develop new approaches to detecting, preventing, and defeating cancer for all populations. “City of Hope is honored to be recognized once again by the NCI for our research that leads to new discoveries and innovative therapies for our patients. It is an extraordinary tribute to our dedicated doctors, scientists, and staff who carry out City

of Hope’s mission every day,” said Robert Stone, City of Hope’s CEO and Helen and Morgan Chu’s chief executive officer distinguished chair. “Our commitment to research allows for more leading-edge clinical trials to be conducted and highlights our multidisciplinary approach to preventing, detecting, and treating cancer.” “For City of Hope patients, the renewed designation means that they will continue to have access to unique and targeted trials that represent the latest in advanced technology, the best patient care experience achievable, and the best possible outcomes,” said Steven T. Rosen, M.D., City of Hope provost, chief scientific officer and the Irell & Manella Cancer Center director’s distinguished chair, who also serves as principal investigator of the grant. “City of Hope patients can expect that, in addition to surgical, medical, and radiation oncology, their multidisciplinary care team will also include experts in related services vital to their outcome, such as our clinical care team, genetic counselors, pharmacists, supportive care staff, and much more.” NCI praised the organization’s “superb leadership” and “innovative and robust research programs demonstrating high levels of scientific productivity and translation to clinical trials.” The reviewers

MULTICENTER MAGIC

CellRescue from Menarini Silicon Biosystems — which provide, at minimum, 120 hours of CTC or circulating multiple myeloma cell (CMMC) stability, versus an ETDA tube which stabilizes these cells for 24 hours or less. With advanced options like these, a traveling nurse can easily visit a remote patient and draw one tube of blood for serial monitoring of CTCs and other analytes, which al-

lows for a broader cohort of patients to be included. These tubes do not interfere with downstream genetic testing — like NGS panels or qPCR-based gene testing — empowering deep understanding of tumor mutational landscapes and genes involved in treatment response. From this information, biomarkers can be identified for patient stratification and development of new targeted agents,

which in the long term can help eliminate disparities in treatment response and outcomes. Menarini Silicon Biosystems coordinates with clinical trial sites globally and empowers a broad range of inclusive patient populations to be included for more representative and simple trial designs. Learn more by visiting Booth #100 or scanning the QR code near the headline.

and associated pathways, we sought to develop a cost-effective and scalable platform for conducting in vivo pooled CRISPR genetic screens. I will describe a large-scale resource for CRISPR-based disruption of specific-target genes in my talk. The main advantage of our approach is that the results are physiologically relevant because they are discovered directly in vivo.

(oncogenes and tumor suppressor genes) selected by integrating clinical-based and network-based genome-wide gene prediction methods and subsequently identifies driver genes and pathways of potential therapeutic relevance based on combinatorial CRISPR-Cas9 screening.

cells and hierarchies.

(continued from page 13)

on-site and send out whole blood or plasma — looking at circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and micro-RNAs (miRNAs) — as these are inherently more stable. Sample stability can be enhanced with specialty blood tubes, like CellSave or

MULTI-OMICS (continued from page 1)

central aim of the Frangou laboratory is to understand how genetic events in cancer cells contribute to tumorigenesis and identify optimal ways of exploiting this information therapeutically. He will be speaking about his work to identify genes of potential clinical and therapeutic relevance at the Cellecta-sponsored, AACR Spotlight Theater presentation on Monday, April 17, 2023 at 3:00 pm in the Exhibit Hall. He recently sat down with Cancer Research Industry News to answer some questions for us. Q: Dr. Frangou, can you explain the purpose of the study you will present at the Cellecta-sponsored Spotlight Theater event on Monday, April 17? A: Next-generation sequencing has allowed the identification of thousands of somatic alterations in breast cancer (BRCA) and other human tumors. A key biomedical challenge in interpreting cancer genomes is distinguishing which (epi)genetic changes are drivers of tumor initiation, progression, and maintenance. Towards a systems-level understanding of BRCA-related biological processes

Q: What do you mean by “integrated multi-omics approach?” A: Tumorigenesis is a complex process that is driven by a combination of networks of genes. Notably, data integration across different omics platforms (multiomics) — including genomics, epigenomics, and transcriptomics — provides unique opportunities to understand causal relationships across multiple levels of cellular organization. However, efficient approaches to identifying functional networks that are perturbed by the process of tumorigenesis are lacking. We developed a comprehensive network-based strategy for systematically discovering functional synergistic modules that are causal determinants of tumor development and progression. Specifically, our approach prioritizes candidate cancer driver genes

Q: What are the challenges with running CRISPR screens in a mouse in vivo model? A: One critical consideration for the feasibility of in vivo genetic screens is the number of transduced tumor cells that grow after transplantation in mice and the complexity of the CRISPR library that can be used in these studies. Furthermore, there is currently little guidance, standardized methods, or workflows on designing, conducting, and analyzing in vivo CRISPR-pooled screens. To this end, we developed and successfully applied a method for performing large-scale genetic screens in mice based on quantitative pooled CRISPR-based screens to probe the molecular mechanisms underlying cellular transformation through gene-specific perturbations. To expediently validate screen hits, we also developed a barcoding approach, which distinguishes genetically different tumor

Q: What sort of clinical data did you integrate into the mouse screen? How was this data used in designing the screen? A: Leveraging multi-omics, BRCA patient data, and a network-based strategy to nominate a set of putative driver genes, we selected sgRNAs that targeted all mouse protein-coding genes with human orthologs with the following characteristics: recurring somatic mutations detected in pan-cancer tumor sequencing; altered activities in BRCA-related pathways based on copy number applications and gene expression data, which were incorporated into the PARADIGM algorithm; and a compendium of gene signatures from in vitro experiments involving the perturbation of known cancer genes. Conversely, to assess the clinical relevance of screen hits, we performed several cross-species comparisons to identify genes that are highly relevant to carcinogenesis and associated with BRCA risk in humans. Q: How can our readers learn more? A: To learn more, stop by Cellecta’s Booth #1221 or visit www.cellecta.com/ aacr2023.

1st/2nd Edition • April 16-17, 2023

BIODESIX (continued from page 1)

assessment and the IQLung™ testing strategy for cancer treatment decisions, delivering results in an average of three business days. Biodesix collaborates with biopharmaceutical companies to solve complex diagnostic challenges in cancer research and drug development. We deliver biomarker discovery, assay design/development, and clinical trial sample testing services to our partners. Multi-Omic Approach Interrogates Both Sides of Cancer Because we believe that no single technology will answer all diagnostic research questions, we employ a multi-omic approach that leverages AI, genomic, and proteomic platforms to uncover novel insights about tumor biology and patient immune response to cancer.

CELLECTA (continued from page 6)

Industry News to answer some questions for us. Q: Dr. Chenchik, can you briefly describe what makes Cellecta’s clonotype profiling technology unique? A: Cellecta’s DriverMap™ Adaptive Immune Receptor (AIR) profiling assay is designed for bulk profiling in a single assay of all functional TRA, TRB, TRD, TRG, IGH, IGK, and IGL mRNA isoforms with exclusion of nonfunctional pseudogenes and ORFs. Starting from RNA or DNA from immune samples, the AIR assay simultaneously profiles all CDR3, TCR, and BCR clonotypes — all 7 chains — in a single multiplex RT-PCR reaction, which is difficult to do with other conventional technologies. Comprehensive analysis of both TCR and BCR repertoire has been successfully used for discovery of putative biomarkers and to assess response to checkpoint immunotherapy.

GENOMIC PROFILING (continued from page 6)

bone marrow plasma cells (BMPCs) and CMMCs from MGUS and SMM patients via a method they call MinimuMM-Seq.2 They detected 100% of mutations found in BMPCs also in CMMCs, and CMMCs also accumulated additional mutations — including those with established clinical indications. Mutations detected included SNVs, CNVs, and intra- and inter-chromosomal translocations. This approach using whole-genome sequencing (WGS) illuminated mutations and depth of genetic information not attainable with current clinical techniques, bolstering the case for WGS-based molecular pathology on CMMCs as a powerful complement to monitoring bone marrow and BMPCs.

21 While many diagnostic tests in oncology focus on tumor-specific genomic alterations, it is also crucial to understand how an individual’s immune system responds to the presence of that tumor, especially when treating with immunotherapy (IO). We are experts at immune profiling through proteomic testing in addition to delivering traditional genomic insights. Genomic Services: Spotlight on ddPCR™* for Mutation Detection and Treatment Monitoring Biodesix has unmatched expertise in leveraging the Droplet Digital PCR (ddPCR) system to detect gene mutations in plasma, tissue, and other specimen types. Advantages of ddPCR technology include that it is both highly sensitive and quantitative — it provides actual numbers of molecules detected, meaning that the amount of tumor DNA can be monitored over time to assess response to treatment. Q: How did you develop the DriverMap™ AIR Assay? A: We developed a dual-index amplicon labeling strategy to produce CDR3 libraries for NGS analysis using the Illumina 300-n paired kit. To achieve high performance, we experimentally validated and selected the 200 best-performing forward and 20 reverse TCR/BCR genespecific primers to the CDR3 region to develop a novel patented protocol which significantly improved sensitivity and re-

Proteomic Services: Patient Classification Through Immune Profiling We provide custom protein signature discovery services, evaluating immunerelated markers in the circulating proteome. This helps therapeutic development through better prediction of patient outcomes independent of PD-L1 status. Our Medicare-reimbursed, VeriStrat® host immune classifier test provides treatment guidance for lung cancer patients. We have also developed custom immune classifiers across multiple cancer etiologies for biopharma partners.

ML models can generate clinically useful predictions, but these algorithms tend to be “black boxes,” offering little transparency into diagnostic decisions. Since we consider it crucial to understand why a test is giving a certain answer, we apply explainability methods to “break” the box open. We recently used these methods to identify the proteoforms driving VeriStrat test results, proteins directly associated with immune activity. Proteoforms discovered through our methods can help identify biomarkers and therapeutic targets, which can be commercialized and distributed as novel diagnostic tools.

Explainable Machine Learning for Translational Insights Biodesix was among the first companies to use AI/Machine Learning (ML) to develop independently validated multivariate classifiers (e.g., the VeriStrat test).

Learn More About Biodesix To learn more about our capabilities and services, visit us at Booth #1507, check out our plans at www.biodesix.com/ AACR-2023, or contact our Biopharma Services team at [email protected].

duced nonspecific and off-target amplification products. As a result, the DriverMap AIR assay generates robust results from total RNA or DNA isolated from whole blood or tissue. Our benchmarking studies demonstrated that the AIR assay significantly outperformed traditional SMART (5’-RACE) and other multiplex RT-PCR technology-based assays.

between replicates than with other approaches. The sensitivity is also much better, which is an important factor for AIR repertoire profiling of a limited number of immune cells isolated from cancer tissue samples. Also, results can be generated from RNA isolated from whole blood or tissue samples without purification of immune cells. It is not necessary to prepare PBMCs.

*ddPCR is a trademark of Bio-Rad Laboratories, Inc.

Q: In what ways does DriverMap AIR Clonotyping outperform other approaches? A: With the ability to run the assay starting with either DNA and RNA, one can identify activated clonotypes, which is valuable information not readily accessible using other technologies. Additionally, DriverMap AIR assay identifies two- to threefold more clonotypes than conventional TCR clonotyping assays when using the same amount of starting RNA (5 to 50ng). Also, our results show much higher consistency in profiling of the most abundant clonotypes (e.g., 500 to 1,000 from whole blood) identified

Q: How were the CMMCs isolated and analyzed? A: CMMCs were enriched via CELLSEARCH® from the peripheral blood of patients using anti-CD138 ferrofluid for positive enrichment. Immunofluorescent characterization of CD138+ cells was performed using multi-epitope anti-CD38-PE to identify CMMCs, and white blood cells were stained via anti-CD19/CD45-APC. Cell enumeration was based on the colocalization of nuclear DAPI and CD38 staining. CMMCs were further isolated via cell sorting either via DEPArray NxT1 or via FACS2, and ultra-low pass sequencing, low pass sequencing, or WGS were performed on the resulting pure cells. Q: Why is this growing body of data sig-

Q: Can clonotyping can be done from RNA directly isolated from whole blood with the AIR assay? A: Yes, we demonstrated that AIR data could be easily generated using RNA isolated from whole blood collected in Tempus or PAXgene test tubes. It is a benefit since using whole blood reduces pre-assay preparation, which significantly reduces variation introduced by the quality of PBMC preparation, storage, and transport conditions. Q: How can our readers learn more? A: To learn more, visit Cellecta at Booth #1221 or www.cellecta.com/aacr2023.

nificant?

dant information at earlier times.

A: These two studies thoroughly demonstrate that CMMC analysis can be performed downstream of enumeration, and mutational information within CMMCs could have dramatic clinical impact when used with the current standard of care in multiple myeloma and precursor condition patients. Combining powerful genetic analysis with cell enumeration potentially provides both prognostic and diagnostic information in a single liquid biopsy test. These studies pave the way for this liquid biopsy assay to provide a critical snapshot of the cancer’s true mutational landscape beyond the BM, which can be serially monitored with this blood-based test. This real-time liquid biopsy surveillance may show changes in disease that are undetectable via other methods, or show concor-

Q: How can our readers learn more? A: To learn more, visit Booth #100 or scan the QR code near the headline. The CMMC test is CLIA-approved LDT from Menarini Silicon Biosystems, Inc available in the USA. The performance characteristics and safety and effectiveness have not been established and are not cleared or approved by the FDA. For Research Use Only, not for use in diagnostic procedures. References: 1. www.doi.org/10.1158/1538-7445. AM2019-2517 2. www.doi.org/10.1158/2159-8290.CD22-0482