Clinical investigators from Moffitt and Walter Reed Army Institute present data of first Phase II Neoepitope Antibody Immunotherapy Clinical Trial completed at John’s Hopkins, Duke and Moffitt as a potential new immunotherapy treatment for cancer care, a Cancer Breakthroughs 2020 milestone.
National Cancer Institute (NCI) investigators to expand on these findings in a CRADA to treat women’s cancers using Neoepitope Antibody Therapy and GPS CancerTM to identify neoepitope sequences as a novel approach to cancer care
BOSTON, Mass. – October 26, 2016 – NantHealth, Inc.(Nasdaq: NH), a leading next-generation, evidence-based, personalized healthcare company, together with Patrick Soon-Shiong, MD, Chairman and CEO of NantHealth and leader of Cancer Breakthroughs 2020, and collaborators from the QUILT Trials (Quantum Immuno-Oncology Lifelong Trial), today announced findings from the nation’s first neoepitope antibody immunotherapy Phase II QUILT Trial during a press conference attended by Philip M. Arlen, MD, Attending Physician at the Walter Reed Military Medical Center and Medical Oncology Branch of the National Cancer Institute, Dr. Christina Annunziata, MD, PhD Head, Translational Genomics Section Women’s Malignancy Branch of the National Cancer Institute and Richard D. Kim, MD, Associate Professor, Department of Gastrointestinal Oncology and Medical Director, H. Lee Moffitt Cancer Center. The results showed that all forms of current standards of care (up to six lines of chemotherapy) had failed in patients with metastatic colon cancer.
In these end-stage patients, historical controls of survival is less than five months. The Phase II trial results of this groundbreaking neoepitope antibody treatment in 48 patients were presented, demonstrating survival up to 30 months with 16 patients still living with high-quality of life more than one year after treatment, despite those patients for whom more than five lines of therapy had failed previously. The neoepitope antibody treatments demonstrated very few toxicities and provided high-quality of life and stable disease for these patients with end-stage colorectal cancer.
Richard Kim, MD, Associate Professor, Department of Gastrointestinal Oncology and Medical Director, H. Lee Moffitt Cancer Center, stated at the press conference: “We were the largest recruiter to this seminal trial in neoepitope antibody therapy, and by all estimates, these were very difficult cases with end-stage metastatic colon cancer in whom all lines of therapy failed. We were impressed to discover that patients reported feeling better with very little side effects following the treatment even after having endured up to six lines of prior therapy."
Identifying the neoepitope, a unique mutational sequence specific only to the tumor, is regarded as the Holy Grail of an individual’s unique signature or “code” found on a cancer tumor. NantHealth reported today that this highly personalized neoepitope can now be identified and deciphered by GPS Cancer™, utilizing whole genome and transcriptomic sequencing, leading the path to next generation cancer vaccines, a Cancer Breakthroughs 2020 goal. Decoding this unique sequence and creating an antibody based specifically on the individual’s unique tumor’s genomic signature is key to delivering more effective personalized medicine. Targeting the cancer cell using the neoepitope is one of the safest and most precise ways to target the cancer since no other such sequence exists in the human body.
“Identifying the neoepitope is the extreme form of precision immune-oncology and represents a paradigm shift in care of the cancer patient,” noted Dr. Soon-Shiong, Chairman and CEO of NantHealth and leader of Cancer Breakthroughs 2020. “The ability to identify these difficult to decipher amino acid sequences in order to target the tumor cells has now been made possible by the supercomputing platform underlying GPS Cancer. The data presented today provides the first clinical evidence that a strategy of neoepitope guided immunotherapy holds great promise. This is the goal of Cancer Breakthroughs 2020, to bring novel immunotherapy treatments to patients suffering from cancer and accelerate clinical trials such that these advances can be completed in five years rather than 10. The advances we have made in our supercomputing network will enable us to strive towards this goal and the data presented today is an indication that we are on the right path to a cancer vaccine. We will announce shortly the launch of multiple novel combination immunotherapies.”
"This trial undertaken by John Hopkins, Moffit and Duke demonstrated the validity of neoepitope immunotherapy as a new treatment for cancer. We will now expand on this neoepitope treatment through a CRADA at the National Cancer Institute with Dr. Christina Annunziata, MD, PhD, Head, Translational Genomics Section Women’s Malignancy Branch to explore neoepitope therapy in women’s cancer, including ovarian cancer and patients suffering from pancreatic cancer,” stated Dr. Phil Arlen, Chief Medical Officer, Precision Biologics, Inc. and Attending Physician at the Walter Reed Military Medical Center and Medical Oncology Branch of the National Cancer Institute.
Building on these lessons, ongoing QUILT clinical trials of neoepitope antibodies will now be expanded at NCI sites and multiple centers around the country, including sites with community oncologists. Our next focus will also include women's cancer, including ovarian cancer and breast cancer.
Leveraging technological advances in whole genome sequencing, GPS Cancer combines bioinformatics, machine learning, and highly sophisticated molecular modeling to enable the search for neoepitopes. This trial demonstrates the strategic importance of finding neoepitopes and how the immune system can recognize and use these unique signatures for the fight against cancer.
Cautionary Note Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding the capabilities and anticipated utility of our GPS Cancer, including predicting patient response and resistance to therapeutics, enabling diagnoses by physicians and accelerating efforts to bring novel combinations of therapeutic agents to cancer patients, as well as our contribution to the Cancer 2020 initiative. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results. Factors that may cause future results to differ materially from management’s current expectations include, among other things, that GPS Cancer may not perform as anticipated, that sufficient physicians may not adopt GPS Cancer to assist their diagnoses or that healthcare payers may not provide reimbursement for GPS Cancer as expected. Our business is subject to numerous additional risks and uncertainties, including, among others, risks relating to market acceptance of our products; our ability to successfully launch new products and applications; competition; our sales, marketing and distribution capabilities; our planned sales, marketing, and research and development activities; unanticipated increases in costs or expenses; and risks associated with international operations. Information on these and additional risks, uncertainties, and other information affecting our business and operating results can be found in our existing and future filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements except as may be required by law.
NantHealth, Inc., a member of the NantWorks ecosystem of companies, is a next-generation, evidence-based, personalized healthcare company enabling improved patient outcomes and more effective treatment decisions for critical illnesses. NantHealth‘s unique systems-based approach to personalized healthcare applies novel diagnostics tailored to the specific molecular profiles of patient tissues and integrates this molecular data in a clinical setting with large-scale, real-time biometric signal and phenotypic data to track patient outcomes and deliver precision medicine. For nearly a decade, NantHealth has developed an adaptive learning system, CLINICS, which includes its unique software, middleware and hardware systems infrastructure that collects, indexes, analyzes and interprets billions of molecular, clinical, operational and financial data points derived from novel and traditional sources, continuously improves decision-making and further optimizes our clinical pathways and decision algorithms over time. For more information please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter @DrPatSoonShiong.
About Cancer Breakthroughs 2020
The Cancer Breakthroughs 2020 program is one of the most comprehensive cancer collaborative initiative launched to date, seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients. This initiative aims to explore a new paradigm in cancer care by initiating randomized Phase II trials in patients at all stages of disease in 20 tumor types in 20,000 patients within the next 36 months. These findings will inform Phase III trials and the aspirational Breakthroughs to develop an effective vaccine-based immunotherapy to combat cancer by 2020. For more information, please visit www.cancerBreakthroughs2020.org and follow @cancer2020 on Twitter.
About GPS Cancer™
GPS Cancer™ is a unique, molecular profile analysis available through NantHealth. GPS Cancer integrates whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics through mass spectrometry, providing oncologists with a comprehensive molecular profile of a patient’s cancer and an assessment of protein pathway function to inform personalized treatment strategies. GPS Cancer scanning is conducted in CLIA-certified and CAP-accredited laboratories, and is a key enabler for Cancer Breakthroughs 2020, the world’s most comprehensive cancer collaborative initiative seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients. For more information, visit www.gpscancer.com and www.cancerBreakthroughs2020.org.
The Quantum Integrative Lifelong Trial Program, or QUILT, is the primary clinical trial program for Cancer Breakthroughs 2020 initiative. QUILT trials are designed to harness and orchestrate all the elements of the immune system (including dendritic cell, T cell, and NK cell therapies) by testing novel combinations of vaccines, cell-based immunotherapy, metronomic chemotherapy, low dose radiotherapy and immunomodulators, including check point inhibitors, in patients who have undergone next generation whole genome, transcriptome and quantitative proteomic profiling analysis. The ultimate goal of the QUILT Program is to achieve durable, long-lasting remission for patients with cancer.