AML Biomarker Identification Can Improve Clinical Trials for New Drugs and Accelerate Drug Approvals

ATLANTA--(BUSINESS WIRE)-- Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, today announced results from a clinical study using the Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) to predict therapy response for individual Acute Myeloid Leukemia (AML) patients were featured in a poster presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition held December 11-14, 2021 in Atlanta, Georgia. The complete results from this study are available online in the ASH Meeting Library as Abstract 1299.

In the study, the Cellworks Biosimulation Platform and CBM was used to assess cytarabine (ARA-C) and anthracycline response and novel biomarker response criteria for the addition of etoposide (VP16) in AML. The study found that Cellworks biosimulation identifies novel biomarkers that predict therapy response in AML patients, which offers the opportunity to tailor FDA-approved chemotherapy regimens to each patient to improve disease control and minimize toxicity. In addition, biosimulation is emerging as an essential tool to improve the success rate of clinical trials and speed the development of lifesaving medicines for the patients that need them.

From comprehensive genomic inputs, the Cellworks Biosimulation Platform identifies pathway based polygenic biomarkers that predict the efficacy of novel drug combinations and new drugs for AML patients, said Dr. Michael Castro, MD, Chief Medical Officer at Cellworks. Cellworks AML biomarker identification and therapy response prediction capabilities should accelerate clinical trials for new therapies and improve trial success rates by predicting if a patients genomic profile will respond to specific regimens. Biosimulation has the ability to improve outcomes for patients, avoid drugs that produce only toxicity and extend the reach of precision medicine in the clinic.

The Cellworks Biosimulation Platform simulates how a patient's personalized genomic disease model will respond to therapies prior to treatment and identifies novel drug combinations for treatment-refractory patients. The platform is powered by the groundbreaking Cellworks Computational Omics Biology Model (CBM), a network of 4,000+ human genes, 30,000+ molecular species and 100+ signaling pathways. By reliably predicting an individual patients therapy response prior to receiving the treatment, the Cellworks Platform can guide the selection of the optimal treatment, help patients avoid ineffective therapies and improve patient outcomes.

Clinical Study: ASH Abstract 1299

Biosimulation using Cellworks Computational Omics Biology Model (CBM)-based assessment of cytarabine (ARA-C) and anthracycline response and novel biomarker response criteria for the addition of etoposide (VP16) in AML.

Background

Genomic heterogeneity in leukemic blasts characterizes AML patients and is associated with variable drug responses. In this study, 539 AML patients were selected based largely on genomic data published in TCGA and PubMed. The Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) was used to identify novel genomic biomarkers associated with response among AML patients treated with cytarabine (ARA-C) + idarubicin or daunorubicin (anthracycline) with or without etoposide (VP16).

Results

Cellworks biosimulation of ARA-C + anthracycline with and without VP16 identified biomarkers responsible for therapy responses. Additionally, the biosimulation identified novel drug combinations for non-response to these standard combinations. Altogether, 89 of the 539 patients (16.5%) could have been managed with a potentially superior treatment approach based on the biosimulation by either adding or omitting VP16 or being treated with an alternative therapy.

Conclusion

This study highlights patients for whom triplet therapy promises potential superior benefit, others who would benefit equally from doublet therapy without VP16 and others unlikely to respond to standard or triplet therapy for whom an alternative personalized approach might offer better outcomes. In AML, Cellworks biosimulation offers the possibility to tailor the chemotherapy regimen to each patient to improve disease control and minimize toxicity.

About Cellworks Group

Cellworks Group, Inc. is a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology. Using innovative multiomics modeling, computational biosimulation and Artificial Intelligence heuristics, Cellworks predicts personalized therapy responses for patients. The Cellworks Therapy Biosimulation Platform optimizes the uniqueness of each patients cancer by utilizing their multiomic data to create a personalized disease model using Cellworks proprietary Computational Omics Biology Model (CBM). The Cellworks Platform uses the personalized disease model to identify disease-biomarkers unique to each patient and biosimulate the patients responses to drugs and therapy regimens. Backed by UnitedHealth Group, Sequoia Capital, Agilent and Artiman, Cellworks has the worlds strongest trans-disciplinary team of molecular biologists, cellular pathway modelers and software technologists working toward a common goal attacking serious diseases to improve the lives of patients. The company is based in South San Francisco, California and has a research and development facility in Bangalore, India. For more information, visit http://www.cellworks.life and follow us on Twitter @cellworkslife.

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Cellworks Personalized Therapy Biosimulation Study Identifies Novel Biomarkers Predictive of Response in AML Patients - BioSpace