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APPLICATION NOTE: Immunotherapy Treatment Response & Toxicity Risk

Immunotherapy agents show great promise and are currently used to treat a growing range of cancers. However, emerging evidence from randomized trials and clinical practice demonstrate highly variable patterns of toxicity and treatment response that can lead to severe immune-related adverse events. The complex interplay between tumor response, immune-induced organ toxicity and immune system activation make a comprehensive assessment of treatment response extremely difficult.

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APPLICATION NOTE: Theranostic Treatment Response & Toxicity Risk

Theranostic therapies combine molecular targeted diagnostics with radionuclides for imaging and therapy in many advanced malignancies. Frequently however, due to heterogeneity of treatment response, complete remission in theranostic treatment is rare; residual lesions often progress and the treatment can induce severe symptoms. Contributing to the problem, are the number of lesions that often metastasize to other areas of the body such as bone and liver. Identifying, measuring and tracking the treatment response of numerous metastatic lesions, using standard medical images, is difficult and challenges the ability to understand the efficacy and safety of a new theranostic treatment expeditiously. This lapse of understanding can cost researchers valuable time and resources.

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BLOG: Going Beyond Biomarkers to Predict Immunotherapy Effectiveness

The ASCO Educational Book recently published a paper by Dr. William McKean and colleagues that speaks to both the promise and challenges of treating cancer patients with immunotherapies. This well-researched article, titled “Biomarkers in Precision Cancer Immunotherapy: Promise and Challenges,” systematically reviews the effectiveness of different classes of biomarkers in predicting both beneficial treatment response and harmful side effects. Ultimately, the authors conclude that “none of these are comprehensive in predicting potential benefit.” The paper makes only a brief mention, however, of another technology that could offer a real solution: advanced imaging. At AIQ Solutions (AIQ) we are working on technology that combines PET/CT scan data with advanced algorithms to better determine which patients will have a desirable response to immunotherapy.

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BLOG: The Value of a Treatment Response Software

It’s generally accepted that not all patients respond the same way to a given therapy. This makes a lot of sense because we’re all different. However, what’s less understood, is how each individual lesion within our body responds differently to a specific therapy. With access to better tools, we’re able to capture more information with less invasive techniques in order to visualize what’s truly happening inside a patient as they undergo treatment.

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BLOG: Enhancing Precision Medicine Through Technology

A substantial amount of excitement and hope has been placed on the promise of “Precision Medicine.” And for good reason! The idea that medicine is finally reaching a point where we can personalize treatment for individuals in order to improve overall outcomes is very exciting. For the first time, there is a real possibility that we will be able to treat individuals based on prediction and personalization rather than treating a patient based on how a population responded to a given drug. However, we must collectively set our overall expectations accordingly…for now. Precision medicine in practice is still complex and presents limitations on how it can be effectively applied individually, as well as scaled to the general public.

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BLOG: The Heterogeneity Challenges in Understanding Patient Treatment Response

Heterogeneity is defined as the state of diverseness. Although greatly appreciated as a unique part of human nature, it leads to immense unpredictability when treating human disease. Inter-patient heterogeneity is well studied where each patient responds differently to a particular therapy. However, intra-patient heterogeneity is under-recognized where individual disease sites within a patient respond differently to the same therapy at different times.

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Information on this page is intended for research use only. Not all applications and/or claims listed are currently cleared for use in treatment of patients. TRAQinform IQ software has been cleared by the FDA for clinical use under 510(k) K173444.

Alessandra Cesano, MD, PhD
Chief Medical Officer, ESSA Pharma

Alessandra Cesano, MD, PhD is the Chief Medical Officer at ESSA Pharma since July 2019. Previously she has been the Chief Medical Officer of NanoString Inc from July 2015 until June 2019 where she focused in the development of translational and diagnostic multi-plexed assays for the characterization and measurement of mechanisms of immune response/resistance. Prior to joining NanoString, Dr. Cesano was Chief Medical Officer at Cleave Biosciences, Inc. and before then she served as Chief Medical Officer and Chief Operations Officer at Nodality, Inc., where she built and led the R and D group, while providing the overall clinical vision for the organization. Between 1998 and 2008, Dr. Cesano held various management positions at Amgen, Biogen Idec and SmithKline Beecham Pharmaceuticals, where she helped to advance various oncology drugs through late stage development and FDA approvals. Early in her professional career Dr. Cesano spent 12 years conducting research in tumor immunology, including nine years at the Wistar Institute, an NCI Basic Cancer Center connected with the University of Pennsylvania. She also holds membership in several professional and scientific societies including ASCO, ESMO, ASH, EHA, AACR and SITC. In the latter she serves as co-chair in the SITC Industry Committee, Associate Editor for the Biomarker section of JITC and is an active member of the SITC Biomarker Working Group. Over her careers she has been an author on over 140 publications. Dr. Cesano received an MD summa cum laude, a Board Certification in Oncology and a PhD in Tumor Immunology from the University of Turin.

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Giovanni Selvaggi, PhD
Chief Medical Officer, Xcovery

Dr. Selvaggi held global positions of increasing responsibility in clinical development at various global pharmaceutical companies prior to joining Xcovery in March 2019. Dr. Selvaggi joined the pharmaceutical industry in 2010 as Medical Director in the MAGE-A3 lung cancer vaccine program at GSK. He then played an instrumental role in the successful development and approval of ceritinib (Zykadia) in ALK-translocated NSCLC at Novartis in 2013. Most recently, Dr. Selvaggi was part of the immunotherapy team at Bristol-Myers Squibb, serving as a program lead in thoracic malignancies, with a focus on SCLC and mesothelioma, leading to the approval of nivolumab (Opdivo) in third line SCLC indication with NDA in 2018. Dr. Selvaggi received his medical degree at the University of Torino School of Medicine, in Torino, Italy, in 1992 and served as staff physician of thoracic oncology at the University Hospital in Torino, participating in several clinical trials in lung cancer and mesothelioma over a span of 16 years.

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Eric Horler
President and Chief Executive Officer, AIQ Solutions

Eric Horler joined AIQ Solutions as its first President and CEO in September 2018. He has led AIQ through two rounds of equity financing, team construction, product commercialization, and international expansion. Before joining the AIQ team, Eric was President and CEO of Swallow Solutions LLC, a medical device start-up with both therapeutic devices and functional beverages for dysphagia patients. Before that, Eric was General Manager, Premium Anesthesia and Respiratory Care at GE Healthcare. While at GEHC, Eric was responsible for a $220 million global business and a large team spread over three continents. He has also held a series of marketing and business development roles at Baxter Healthcare, including Director of Renal Products and Services for the Latin America region. Eric has a B.S. in Chemical Engineering from Rice University and both an MBA and Master of Engineering Management degrees from the Kellogg School of Business. He lives in Madison with his wife and two children.

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Information on this page is intended for research use only. Applications and/or claims listed are not currently cleared for use in treatment of patients.