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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.

Dr. McKean et al. defined the problem, “[A] significant limitation behind these current treatment modalities is an irregularity in clinical response, which is especially pronounced among checkpoint inhibition. This unpredictability leads to significant side effects, financial costs, and health care burden, with unsatisfactory clinical benefit in the majority of treated patients.” Several studies have shown that immunotherapies are effective for less than 50% of patients who qualify. At the same time, immune-related adverse events (irAE) can occur in up to 60% of patients with certain cancers, according to the ASCO clinical practice guidelines for the treatment of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy. To improve the effectiveness of immunotherapies, oncologists need a better way to balance the potential for therapeutic benefit with the risk of irAE.

There is a complex interplay between tumor response, irAE, and immune system activation. Establishing the patient-specific relationship among these three factors is necessary for an accurate prediction of a therapy’s benefit and risk. This may be a tall order for traditional biomarkers like those reviewed by McKean et al. Time-series PET/CT images, however, contain a wealth of information about the patient’s physiologic state. It would be a similarly tall order to manually extract and distill the critical data from this image set. Instead, AIQ has developed a software platform that uses deep learning to automatically analyze tumor response, toxicity risk in healthy organs, and overall immune system activation. AIQ’s technology can help better understand the relationship among these interdependent factors and use that to improve predictions of treatment effectiveness and risk.

Dr. McKean and his colleagues conclude their paper with recommendations for how biomarkers should be developed and validated. They identify five characteristics of the “ideal” biomarker: noninvasive, time-sensitive, multifactorial and comprehensive, therapy-specific, and (able to predict) resistance and toxicity. AIQ’s platform is designed to deliver all of these. Finally, the authors assert, “all future clinical trials must be designed to incorporate biomarkers to some degree. At a minimum, pretreatment and on-treatment information…must be collected…This is especially important for early-phase trials of novel immunotherapies.”

For pharmaceutical companies developing novel immunotherapies, AIQ can provide unique insights into treatment response and toxicity risk while collaborating on the development and validation of a technology that may ultimately improve patient outcomes. AIQ has ongoing partnerships with several research institutions and biotech companies and is actively seeking other partners. If you are interested in working with AIQ Solutions, please reach out to our team to discuss potential collaborations.

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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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