Takeaways from ESMO 2022

Oct 14, 2022

By: Anuja Antony and Dorys Lopez

Our chief medical officer, Dr. Anuja Antony, represented SimBioSys at the ESMO 2022 conference last month. Among the many exciting advances and developments in the breast cancer field, two topics took center stage: 1) antibody-drug conjugates (ADCs) and 2) human epidermal growth factor 2 (HER2)-low cancer. Several presentations focused on updates in immunotherapy (IO) for breast cancer, although this topic took a backseat this time.

Antibody drug conjugates (ADCs)

ADCs have increasingly gained interest due to their inherent versatility. Dr. Barbara Pistilli gave a detailed description of how these drugs are constructed and what the general mechanism of action is. ADCs have three components: an antibody backbone, a payload, and a linker. The antibody enables selective distribution into the tumor tissue, the payload accounts for the cytotoxic agent, and the linker connects the payload to the antibody. The target can be seen as a 4th (external) component of ADCs, as it plays an important role in the construct design. ADCs act mainly as a “trojan horse” where they selectively deliver the toxic payload into the cells expressing their cognate target. However, these molecules have additional mechanisms of action, one being the bystander effect, in which a drug’s activity extends to neighboring cells that do not express the ADC target.

Dr. Pistilli also highlighted the importance of the spatial distribution of the target, which was explained in detail by Dr. Maria Fernanda Mosele. Dr. Mosele presented data from the DAISY trial clearly showing that the HER2-spatial distribution impacts trastuzumab deruxtecan (T-DXd) activity. She observed different responses to T-DXd according to HER2-levels in different regions of the tumor.

Dr. Aditya Bardia presented an overview of the clinical applications for ADCs. Two ADCs have already shown success in the clinic and have been approved for HER2-low and triple negative (TNBC) metastatic breast cancer subtypes – these ADCs being T-DXd (DESTINY-Breast 04) and sacituzumab govitecan (SG, ASCENT). There are many more ADCs in the pipeline targeting different molecules and using different payloads. As Dr. Lisa Carey stated, ADCs will likely become the dominant means of cytotoxic drug delivery.

Dr. Bardia also discussed the use of ADCs in combination with DNA damage repair (DDR) agents in a staggered schedule that avoids overlapping toxicity while maintaining efficacy, a concept he evaluated in a study that combined sacituzumab govitecan with PARPi drugs in concurrent versus staggered schedules.

The use of ADCs in combination with immunotherapy (IO) is also being investigated in several different trials. Sacituzumab govitecan in combination with pembrolizumab is being evaluated as a therapy for metastatic TNBC in the ASCENT-03 trial. The combination of neoadjuvant sacituzumab govitecan and pembrolizumab for TNBC is being evaluated in the NeoSTAR trial. The DESTINY-breast 08 trial is set to evaluate T-DXd in combination with IO and other agents in HER2-low metastatic breast cancer.

HER2-low breast cancer

With the advent of anti-HER2 targeted therapies, the outcome of HER2-positive breast cancer has dramatically changed. Whereas this cancer subtype used to be viewed as one of the most aggressive breast cancer types, it is now considered one of the most treatable, showing some of the best outcomes.

As we gain more knowledge into the biology of HER2 breast cancer subtypes, current treatments and classifications must adapt accordingly. HER2-positive breast cancer is a good example of how the traditional binary classification of HER2 does not paint a full picture. HER2 classification has changed in recent years from a binary (either –positive or -negative) classification, to a gradated one, encompassing -positive, -low and -negative HER2 breast cancers. In his talk, Dr. Paolo Tarantino further expanded on the HER2 classification, proposing a dynamic rather than the current static classification, given the HER2 expression changes over the course of the disease.

Earlier this year at ESMO Breast Cancer 2022, Dr. Penault Llorca raised the question of whether the new HER2-low classification was indeed a clinical entity. Similarly, at ASCO earlier this year and now at ESMO, there were recurrent comments about the need for more sensitive tools to help better define HER2 status in breast cancer. Ultimately, the current consensus is that HER2-low breast cancer is not an independent subtype or clinical entity, but rather a targetable entity dependent on hormone receptor (HR) status.

HER2-low breast cancers can be targeted with anti-HER2 therapy, as was successfully shown in the DESTINY-Breast 04 trial, first presented by Dr. Shanu Modi at ASCO. The results showed a remarkable improvement in progression-free survival (PFS) and overall survival (OS) in HER2-low metastatic patients upon treatment with the anti-HER2 therapy T-DXd. The follow-up question from this trial is: “how low can we go?” The Destiny-Breast 06 trial, currently recruiting, will include HER2-ultra-low patients to investigate what is the lowest threshold of HER2 expression needed to activate T-DXd.


Many different aspects of IO are still being evaluated in breast cancer. Dr. Sherene Loi talked about tumor-infiltrating lymphocyte (TILS) in breast tumors. Despite breast cancer not being as immunogenic as other types of solid tumors (e.g., melanoma), TILs play an important prognostic role in early-stage TNBC. In fact, the quantity of TILs is predictive of the PD-L1 inhibition benefit in patients. Dr. Loi proposed a tumor classification scheme based on percentage (%) of TILs, which she showed can either raise or lower the traditional AJCC stage designations in early stage TNBC.

Dr. Marlene Kok presented the first results from the BELLINI trial. This trial is the first to select TNBC patients based on TILS and is evaluating nivolumab (anti-PD-1) in combination with novel immune-checkpoint inhibitor (ICI) ipilimumab (anti-CTLA-4) in early stage TNBC. As Dr. Loi showed in her talk and Dr. Kok reiterated, high levels of TILs correlate with good prognosis in early TNBC. Dr. Kok showed improved partial radiological response after four weeks of combined therapy and doubling of CD8 T-cells and/or IFN-gamma in both cohorts.

The most exciting news in the realm of IO was not in breast cancer, but instead in colon cancer. Dr. Myriam Chabali presented the results of the NICHE-2 study that evaluated neoadjuvant immune checkpoint inhibition in locally advanced mismatch repair deficient (dMMR) colon cancer. The striking results showed a jump from the 5-7% pathologic response achieved with neoadjuvant chemotherapy to a 95% pathologic response with neoadjuvant immunotherapy. Both the NICHE-1 (n=32) and NICHE-2 (n=112) studies showed similar results. With these promising data, neoadjuvant immunotherapy could become the new standard of care for dMMR colon cancer patients.



TumorScope™ Breast

SimBioSys TumorScope™ currently aids the identification of the safest and most efficacious drug regimens for breast cancer patients.

It provides quantitative and qualitative analysis of a patient’s potential response to therapy, generated with a 3D computational model incorporating previously acquired diagnostic data.

The results from TumorScope™ are intended to be used in conjunction with the oncologist’s professional judgment, patient’s clinical history, symptoms, and other diagnostic tests.

With hundreds of retrospective patients validated, our results speak for themselves – a 95% correlation between simulated final volume and actual clinical volume post-therapy.

The Future
TumorScope™ Brain

Please Stay Tuned

The Future
TumorScope™ Mouth/Throat

Please Stay Tuned

TumorScope™ Lung

SimBioSys is developing TumorScope™ Lung, with the goal of having a positive impact on quality of life, clinical decision-making, and healthcare costs associated with lung cancer.

Though lung cancer is the leading cause of cancer-related deaths worldwide, it is amongst the few solid tumors for which immunotherapeutics have shown great promise.

The structure of lung tissue is dissimilar to that of other tissues we have studied, as the lungs are highly vascularized, oxygenated, and composed of numerous branching sets of airways.

These factors facilitate the need for accurate 3D models of the lung tumor microenvironment, and require nuanced optimization of our image analysis and segmentation methods.

The Future
TumorScope™ Bladder

Accounting for approximately 81,000 new cases in the US each year, bladder cancer is the sixth most-frequently diagnosed solid tumor.

The primary goal of neoadjuvant chemo for advanced bladder cancer is not to enable bladder-conserving treatment, but to downstage the tumor before radical cystectomy.

Bladder cancer staging is strongly dependent on the cancer’s invasion into the bladder wall and surrounding perivesical tissue.

Because of this, the SimBioSys TumorScope™ is poised to offer healthcare providers new methods to predict the degree of downstaging under different treatment regimens, and thereby optimize therapy for patients.

The Future
TumorScope™ Prostate

Affecting approximately 165,000 men in the United States each year, prostate cancers tend to occur in older men, and are often slow to progress.

As a result, management of the disease frequently includes watchful waiting and active surveillance.

SimBioSys TumorScope™ is capable of predicting tumor growth and progression, both with and without intervention.

There exists an obvious application in weighing the risks and benefits of less aggressive approaches to prostate cancer management.

The Future
TumorScope™ Ovary

The “silent killer”, early stage ovarian cancer often presents with symptoms similar to those of other common gynecological or gastroenterological issues.

Approximately 70% of epithelial ovarian cancers are not diagnosed until stage III or IV.

Ovarian cancer represents a natural next step for SimBioSys, allowing us to leverage the knowledge and modeling expertise we’ve accumulated.

This will allow us to target a cancer with high morbidity and mortality, for which neoadjuvant therapy is becoming an increasingly important option.

The Future
TumorScope™ Colon

Please Stay Tuned

The Future
TumorScope™ Skin

Please Stay Tuned

The Future
TumorScope™ Kidney

Please Stay Tuned

The Future
TumorScope™ Liver

Please Stay Tuned

The Future
TumorScope™ Uterus

Please Stay Tuned

The Future
TumorScope™ Thyroid

Please Stay Tuned

The Future
TumorScope™ Pancreas

Please Stay Tuned

The Future
TumorScope™ Esophagus

Please Stay Tuned

Tumor Microenvironment

The tumor microenvironment is understood as a complex space where cancer cells adapt their metabolic behavior, competing and cooperating with nearby healthy cells in order to grow.

Understanding the complex ways in which cancer cells interact with other nearby cell types—competing for some resources, sharing others, and eliciting molecular signals that reshape their surroundings—is critical for understanding tumor progression and response to therapy.

SimBioSys TumorScope™ offers a computational window to these interactions, enabling patients and healthcare providers to explore how different treatment regimens can influence tumor response, and ultimately, patient survival.

Virtual Trials

The logistical and financial requirements of clinical drug trials are burdensome in the context of developing novel cancer therapeutics.

Additionally, there is inherent risk for the participants of these trials, both human and animal.

Building on the aforementioned technology, SimBioSys plans to create software to virtually test the efficacy of a drug on our library of patients.

The goal is to use this technology for planning and selecting the most appropriate cohorts, using computational methods, before a trial begins.

Additionally, this technology will be used for testing the effects of various forms of a drug on virtual patients, as opposed to humans or animals.

This technology will provide a deeper understanding of the mechanisms underlying treatment non-response, and will aid in drug development efforts.

Drug Delivery Modeling

After the SimBioSys platform has been extended to nearly the full range of solid mass tumors, pharmaceutical companies will be able to test their numerous therapies against a range of simulated tumors to discover new uses and delivery methods for drugs.

Studies show a salient relationship between sub-optimal drug delivery and acquired drug-resistance, leading to increased risk of mortality.

TumorScope™ provides an opportunity to reduce the likelihood of this occurrence.

Tushar Pandey
Chief Executive Officer MBA University of Chicago, BS Engineering University of Illinois at Urbana-Champaign

With a passion to support the fight against cancer, Tushar’s focus is to ensure the company delivers on its mission to empower precision medicine. In his prior role as VP of Decision Support at Strata Decision Technology, he worked
with over 150 health systems across the country including Kaiser Permanente, Cleveland Clinic, MD Anderson, Intermountain Healthcare, Dana Farber among others. Under his leadership, Strata Decision received the prestigious “Best in
KLAS” recognition for five consecutive years. With over a decade of healthcare experience, Tushar has been one of the key thought leaders in the healthcare analytics and cost of care space.

Joseph R. Peterson
Chief Technical Officer PhD Chemistry University of Illinois at Urbana-Champaign

Driven by an interest in computing, Joseph’s 10 years of scientific research has spanned investigating combustion and explosion, to analyzing the role of the environment on microbes’ behavior, to examining individual differences in
breast tumors. He is passionate about developing software for the health and scientific R&D sectors. His goal as Chief Technical Officer at SimBioSys, Inc. is not merely to develop enterprise technologies that enable new
clinical action, but to foster lasting relationships between key players in cancer treatment.

John A. Cole, Jr.
Chief Scientific Officer PhD Physics University of Illinois at Urbana-Champaign

John is a biophysicist specializing in stochastic models and systems biology. Equally comfortable with pencil-and-paper mathematical modeling and high-performance computational simulation, John’s “whatever works” approach to problem
solving and friendly, collaborative demeanor has allowed him to contribute significantly to a range of projects in basic science and health. As Chief Science Officer of SimBioSys, Inc., he is excited to extend this line of research
to enable transformative cancer treatment.

Tyler Earnest
Director of Computational Medicine PhD Physics University of Illinois at Urbana-Champaign

Tyler has a long history of mathematical modeling as applied to biological systems. He is also well-versed in software development, 3D visualization, and GPU programming as applied to computational biology. His primary focus is on
conceiving, constructing, and validating new cancer and drug models.

Michael Hallock
VP, Software & IT
MS Bioinformatics University of Illinois Urbana-Champaign

Michael has more than 10 years of experience in the software development and information technology fields. He has extensive experience developing software for scientific computing, high performance computing, and cloud computing.
He applies his extensive knowledge to work on advanced analytics software, focusing on back-end (database, server/client communication, database development, IT infrastructure, etc.) technologies, as well as working closely with
full stack developers. Additionally, he will provide software support for scientific development.

Anu Antony,
Chief Medical Officer MBA Kellogg School of Management at Northwestern University, MPH Harvard School of Public Health, MD University of North
Carolina- Chapel Hill School of Medicine, Stanford University Medical Center, Memorial Sloan-Kettering Cancer

Dr. Antony is a Harvard, Stanford, and Memorial-Sloan Kettering Cancer Center-trained surgeon with 20 years of experience in breast cancer, including multiple leadership positions in Chicago as Professor and Vice-Chair of the Department of Surgery at Rush University, Co-Director of the Breast Cancer Service Line, and Chief of Breast Reconstruction at the Rush University Cancer Center, and Vice-Chair of the Breast Cancer Center at the University of Illinois at Chicago Hospital and Health Services. She is passionate about innovation in precision oncology and commercializing cutting-edge technology to bring it directly into the hands of physicians and patients. Her interest in science and medicine began at UNC-Chapel Hill where she graduated with distinction in Chemistry. After graduating with honors at UNC-Chapel Hill School of Medicine, she became intrigued with medical device innovation during her general surgery and plastic surgery training in silicon valley at Stanford University Medical Center. She furthered her education and training during an oncologic reconstructive surgery fellowship at Memorial Sloan-Kettering Cancer Center, a Masters in Biostatistics and Clinical Outcomes at the Harvard School of Public Health, and an additional research fellowship training at Massachusetts General Hospital/Harvard Medical School. Recognizing the benefits of dovetailing science, medicine, and business, she completed an MBA at the Northwestern-Kellogg School of Management. Dr. Antony has worked in government and private sectors where she actively treated cancer patients, co-led a multimillion dollar NIH program grant as co-PI studying stem cells in a primate model, actively publishes, lectures nationally and internationally, and has served as Chair and President of several regional and national professional societies and conferences.

Tricia Carrigan,
PhD SVP, Precision Medicine PhD

Dr. Tricia Carrigan is an accomplished Biopharmaceutical and Diagnostic Executive with over 24 years of experience across the biomarker discovery- companion diagnostic-drug development and commercialization spectrum. She specializes in Companion Diagnostics (CDx) Strategy & Commercialization, drug development programs, early and late stage drug licensing, Oncology, Women’s Health, Cardiovascular, and Hematology. She has an international experience in assay implementation/development for Phase I-III trials, external innovation and business development/partnering in EU and Asia- Pacific markets.

Eduardo Braun, MD
Head of Clinical Affairs
MD, Rio de Janeiro School of Medicine, RUSH University Medical Center
Eduardo Braun, MD earned his medical degree at the Federal University of Rio de Janeiro School of Medicine. He completed his Fellowship in Hematology/Oncology, and his Residency in Internal Medicine at RUSH University Medical Center in Chicago. He is board certified in internal medicine, medical oncology and hematology.
Dr. Braun actively participates in lung cancer, breast cancer and lymphoma research and his work has been published. He is an active member of the American Society of Clinical Oncology, American Society of Hematology and the International Association for the Study of Lung Cancer.
Dr. Braun practices in Valparaiso, Chesterton, Hobart and Westville, Indiana.

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Hilary Ann Baldwin,
VP, Regulatory & Quality

Hilary Ann Baldwin has over 20 years’ experience in regulatory and quality in the pharmaceutical, diagnostic, and medical device industries. She started in the pharmaceutical and toxicology industry while at Eli Lilly on their early development team, while building significant relationships with the FDA and other regulatory bodies. She then moved on to Roche where she began working on assay development and validation for the diagnostics division, while also taking over management of the regulatory submissions. After Roche, Hilary went to Covance, where she partnered with several pharmaceutical, diagnostic, and medical device companies on US and OUS submissions. During this time, she also took oversight of the companion diagnostic management team. Hilary worked at Stryker as a Staff Regulatory Specialist, eventually managing the global sustainability team, and focusing on OUS submissions. As the Vice President of Regulatory at Caris Life Sciences Hilary focused on domestic and global strategy. Currently, Hilary is the Vice President of Regulatory and Quality at SimBioSys. She recently worked with FDA on the VALID ACT in addition to the SaMD pilot program. Hilary has also partnered with several OUS regulatory bodies for first of kind products and assisted in writing the guidance with PMDA for remanufacturing.