NantOmics Releases Result from ITOMIC Study Demonstrating Benefit of Comprehensive, Panomic Next Generation Sequencing in Routine Cancer Care

The power of precision medicine is clearly becoming a reality with the integration of next-generation sequencing technology (NGS) into routine clinical cancer care.

For breast cancer patients, NGS has enabled the precise, patient-specific identification of clinically relevant genomic alterations, allowing a physician to select the most appropriate therapy for their patients.

NGS also highlights the significant challenges associated with the identification of profound heterogeneity that often exists between patients and also within an individual patient's own cancer.

Addressing these challenges, on Saturday, December 12th, NantOmics will release results at the San Antonio Breast Cancer Symposium in San Antonio, Texas on the ITOMIC study, Intensive Trial of OMics in Cancer Study, which is an adaptive learning clinical study utilizing a distributed network of physicians and a molecular tumor board to provide individualized deep analysis and treatment guidance to the patient's physician on an n-of-one basis.

Enrolling patients with metastatic triple negative breast cancer (mTNBC) who were platinum-naive and scheduled to receive cisplatin therapy, the objective of the study was to establish the safety and feasibility of collecting, storing, analyzing, and utilizing comprehensive, panomic, whole genome sequencing analysis from TNBC patients intensively monitored longitudinally over time to generate high resolution molecular maps of the patient's cancer over the course of time.

The ITOMIC study investigated intra and inter patient tumor heterogeneity among 12 patients enrolled in the study to determine the benefit of NGS-based, comprehensive panomic analysis to inform and optimize treatment decisions.

The results of this analysis, using multiple biopsies to track patients longitudinally over time, found high heterogeneity within and between primary and metastatic tumor sites, demonstrating the molecular evolution of a cancer patient's mutations over time.

Providing additional granularity to these results, the study found one patient who responded to ponatinib, a tyrosine kinase inhibitor, as predicted by the presence of FGFR activating genomic mutations, but still subsequently progressed, potentially due to the loss of FGFR protein expression over time, suggesting the need to transition to alternative investigational therapies.

A second patient, initially responding to enzalutamide, an anti-androgen drug, subsequently progressed, potentially due to a reduction in androgen receptor expression over time. Although the patient was diagnosed with TNBC, ERBB2 amplification and borderline HER2 overexpression were detected at the time of death, suggesting an anti-HER2 therapeutic approach could have benefitted this patient.

The study's conclusion was that intensive longitudinal monitoring of patients with metastatic cancer with multiple biopsies and the use of NantOmics' molecular diagnostic platform using a panomic, whole genome and quantitative proteomic analysis, can identify extensive heterogeneity in a patient's cancer that evolves over time leading to molecular signatures that may result in a lack of response or the development of resistance to single agent, targeted therapies.

To effectively utilize this complex molecular diagnostic information, the study authors identified the importance of an adaptive, real-time learning system and a distributed network of physicians working with molecular tumor boards in order to analyze the enormous amount of information generated and translate this highly complex information into optimal treatment choices that may include investigational therapies and combination therapies on an individualized, patient-specific basis.

Combined with the increasing availability of novel cancer immunotherapies, combination therapies and other investigational therapies that can harness the power of the patient's own immune system, the results of this study clearly demonstrate the power of NantOmics molecular diagnostic platform. When combined with a distributed network of physicians and a molecular tumor board, fully integrated into an adaptive learning system, we have the potential to dramatically change the current paradigm of cancer care and bring the promise of 21st century precision medicine to cancer patients today.

For additional information, NantOmics is presenting detailed results from this study, Poster Session, P6-05-08, at the San Antonio Breast Cancer Symposium in Austin, Texas on Saturday, December 12, 2015 from 7:30 a.m. – 9 a.m.

About NantOmics

NantOmics, a member of the NantWorks ecosystem of companies, delivers molecular diagnostic capabilities with the intent of providing actionable intelligence and molecularly driven decision support for cancer patients and their providers at the point of care. NantOmics is the first molecular diagnostics company to pioneer an integrated approach to unearthing the genomic and proteomic variances that initiate and drive cancer, by analyzing both normal and tumor cells from the same patient and following identified variances through from DNA to RNA to protein to drug. NantOmics has a highly scalable cloud-based infrastructure capable of storing and processing thousands of genomes a day, computing genomic variances in near real-time, and correlating proteomic pathway analysis with quantitative multi-plexed protein expression analysis from the same micro-dissected tumor sample used for genomic analysis. For more information, please visit www.nantomics.com and follow Dr. Soon-Shiong on Twitter @solvehealthcare.

About NantWorks

NantWorks, LLC, founded by renowned physician scientist and inventor of the first human nanoparticle chemotherapeutic agent Abraxane®, Dr. Patrick Soon-Shiong, is the umbrella organization for the following entities: NantHealth, NantMobileHealth, NantOmics, NantBio, NantCell, NantPharma, NantCapital and NantCloud. Fact-based and solution-driven, each of NantWorks' division entities operate at the nexus of innovation and infrastructure.

The core mission of NantWorks is convergence and a systems approach to human biology: to develop and deliver a diverse range of technologies that accelerates innovation, broaden the scope of scientific discovery, enhance ground-breaking research, and improve healthcare treatment for those in need. NantWorks is building an integrated fact-based, genomically and proteomically -informed, personalized approach to the delivery of care and the development of next generation diagnostics and therapeutics for life threatening diseases such as Cancer, Infectious Diseases and Alzheimer's. For more information, please visit www.nantworks.com and follow Dr. Soon-Shiong on Twitter @solvehealthcare.