ASH 2021: Cellworks Personalized Therapy Biosimulation Study Identifies Novel Biomarkers Predictive of Response in Resistance Cases of MCL

Novel Biomarkers Can Help Identify Treatment Alternatives for Relapsed MCL Patients, Improve Clinical Trial Success Rates and Accelerate New Drug Approval

ATLANTA, Georgia, December 14, 2021 – Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, today announced clinical study results using the Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) to predict therapy response for individual Mantle Cell Lymphoma (MCL) 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 3550.

The study used the Cellworks Biosimulation Platform and CBM to predict novel biomarkers for Hyper-CVAD treatment response and combination of Rituximab and Cladribine (RC) in CVAD resistant cases of MCL. The study found that the Cellworks Platform can be useful to identify treatment alternatives for patients with low likelihood of response to standard therapy or who may be ineligible for CVAD because of co-morbidities.

“The use of reliable and predictive biomarkers to guide the optimal treatment strategy for MCL patients with diverse genomic profiles remains a critical unmet need in the clinic and would be valuable for clinical trial patient selection,” said Dr. Michael Castro, MD, Chief Medical Officer at Cellworks. “Genomics-guided therapy for MCL patients is generally restricted to a single-gene approach, which rarely has sufficient predictive power to be clinically useful for relapsed patients. However, the use of comprehensive DNA sequencing and Cellworks personalized biosimulation can predict therapy response for individual patients with diverse genomic profiles in advance of treatment. Utilizing personalized therapy biosimulation prior to enrolling patients in clinical trials can positively affect the success of studies and accelerate the approval of new therapies, which ultimately improves patient outcomes.”

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 patient’s 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 3550

Biosimulation using the Cellworks Computational Omics Biology Model (CBM) predicted novel biomarkers for Hyper-CVAD treatment response and combination of Rituximab and Cladribine (RC) in CVAD resistant cases of MCL.

Background

Hyper-CVAD (CVAD) with or without Rituximab constitutes first line therapy for treatment of MCL, yet the use of this combination is associated with high toxicity and only modest efficacy. But impressive clinical efficacy has been reported in relapsed MCL patients treated with Rituximab and Cladribine (RC). Predicting response based on cancer genomic heterogeneity creates an opportunity to personalize treatment and avoid toxic therapy which has little chance of response.

Results

Ninety-four newly-diagnosed MCL patients were selected for the study based largely on genomic data published in PubMed and TCGA. Among the 94 MCL patients treated with CVAD, the Cellworks Biosimulation Platform identified novel biomarkers to predict treatment response or failure. The biosimulation also identified unique drug combinations for patients that were non-responders to both treatments. In considering both regimens, 27 patients were predicted as responders to both CVAD and RC, 14 to RC but not to CVAD, 30 to CVAD but not RC and 23 as not responders to both regimes. For the latter group, biosimulation predicted that a venetoclax-based combination would be effective in many cases due to the high incidence of TP53 GOF mutation within this subgroup.

Conclusion

By using novel biomarkers derived from comprehensive mutational and copy number analysis, the Cellworks Biosimulation Platform identified pathway-based, polygenic biomarkers that can determine optimal therapy combinations for MCL patients. The Cellworks Platform can be useful to identify treatment alternatives for patients with low likelihood of response to standard therapy or who may be ineligible for CVAD because of co-morbidities.

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 patient’s 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 patient’s responses to drugs and therapy regimens. Backed by UnitedHealth Group, Sequoia Capital, Agilent and Artiman, Cellworks has the world’s 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 www.cellworks.life and follow us on Twitter @cellworkslife.

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Michele Macpherson, Chief Business Officer
Cellworks Group, Inc.
Michele.macpherson@cellworksgroup.com
650-346-9980