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Icon Group in Australia Selects Varian Advanced Radiotherapy Equipment

On June 16, 2016 Varian Medical Systems (NYSE: VAR), reported it has been selected by the Icon Group to provide 10 TrueBeam medical linear accelerators for cancer centers Icon operates across Australia (Press release, InfiMed, JUN 16, 2016, View Source [SID:1234513413]). Varian will install the TrueBeam systems in the Icon centers over the next two years and continue to service them under a multi-year agreement.

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Varian’s TrueBeam family of medical linear accelerators incorporate numerous technical innovations that dynamically synchronize imaging, patient positioning, motion management, and treatment delivery during a radiotherapy or radiosurgery procedure. In addition to the TrueBeam systems, Icon is also ordering Varian’s software suite including the Eclipse treatment planning system and ARIA oncology information management system.

"This agreement is reflective of the strong relationship between our two companies and the high quality cancer treatment equipment and service Varian delivers," said Mark Middleton, CEO of Icon Group. "These ten new TrueBeam systems mean we can provide advanced cancer treatment to more patients across Australia, in addition to the five systems ordered last year and the nine currently in place. Varian technology and services make it possible to deliver quality care rapidly and efficiently so that we can serve more patients."

"We are honored Icon selected Varian systems and software to increase its ability to deliver precise treatments to a greater number of cancer patients across Australia," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "We will continue to work closely with Icon on the deployment of these systems and increasing patient access to high quality cancer care."

OncoSec Presents Preliminary Findings from Head and Neck Phase II Clinical Trial at EUROGIN 2016 Conference

On June 16, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported preliminary findings from OMS-I130, a Phase II clinical trial of ImmunoPulse IL-12 in patients with treatment-refractory, metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC) (Press release, OncoSec Medical, JUN 16, 2016, View Source [SID:1234513411]). These preliminary findings, indicating that ImmunoPulse IL-12 may lead to an increase in CD8+ T-cells and ‘adaptive immune resistance’ in HNSCC patients, are consistent with preclinical and clinical data previously reported in other indications. Together, the data from these multiple studies support a rationale for combining ImmunoPulse IL-12 with anti-PD-1 blockade therapies.

Robert H. Pierce, MD, Chief Scientific Officer at OncoSec, presented the findings in an oral presentation entitled: "Intratumoral IL-12 Therapy in HNSCC: Can In-Situ Vaccination Solve the Problem of Anti-PD-1 Non-Response?" at the EUROGIN 2016 Conference in Salzburg, Austria. The oral presentation is part of the conference session entitled: "Updates on Immunotherapy Trials in HPV-HNSCC," chaired by Sara I. Pai, MD, PhD, a faculty member at Massachusetts General Hospital and Harvard Medical School and co-author of the abstract.

Dr. Pierce described a role for intratumoral immunotherapy in driving anti-tumor CD8+ responses and altering the immune environment to enable tumors to become responsive to anti-PD-1 blockade. Specifically, Dr. Pierce described new cases from the single-agent ImmunoPulse IL-12 Phase II HNSCC trial, in which intratumoral electroporation of DNA-based IL-12 drove a CD8+ T-cell response and associated increase in interferon-gamma-related genes in some patients. Moreover, one patient, who went on to receive anti-PD-1 therapy in combination with ImmunoPulse IL-12, experienced a significant tumor regression and has an ongoing partial response.

"Although we have treated only four patients to date, these data in patients with head and neck cancer are entirely consistent with our previous studies in melanoma and Merkel cell carcinoma as well as our preclinical models—namely, that in-situ vaccination with plasmid IL-12 can convert low-TIL, poorly-inflamed tumors into high-TIL inflamed tumors. That conversion may augment responses to T-cell checkpoint therapy, such as anti-PD-1 antibodies," said Dr. Pierce.

The lead investigators for OMS-I130 are Tanguy Seiwert, MD, from the University of Chicago and Alain Algazi, MD, from the University of California, San Francisco. OMS-I130 is a single-arm, open-label study evaluating the safety and anti-tumor activity of ImmunoPulse IL-12 in patients with treatment-refractory metastatic and unresectable HNSCC. The trial (NCT02345330) is open, but currently not recruiting patients.

"We have paused enrollment in the HNSCC trial for two main reasons. First, we are currently focusing our internal resources on moving toward a registration trial in melanoma. Additionally, our strategy is aimed at demonstrating that ImmunoPulse IL-12 is a rational choice for combination therapy with anti-PD-1/PD-L1 and that ImmunoPulse IL-12 will increase the number of patients who will benefit from these treatments," said Punit Dhillon, President and CEO. "As approval of one or more of the PD-1/PD-L1 antibodies in HNSCC seems likely in the near term, we will explore a combination of our technology with the approved agent at that time."

Kura Oncology Doses First Patient in Phase 2 Study of Tipifarnib in Lower Risk Myelodysplastic Syndromes

On June 16, 2016 Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company, reported the first patient has been dosed in a Phase 2 clinical trial of tipifarnib in patients with lower risk myelodysplastic syndromes (MDS) (Press release, Kura Oncology, JUN 16, 2016, View Source [SID:1234513434]).

"We believe there is a significant unmet need for therapies targeting MDS," said Antonio Gualberto, M.D., Ph.D., Chief Medical Officer of Kura Oncology. "We were encouraged by data from a previous Phase 2 trial of tipifarnib conducted by Johnson & Johnson that showed modest activity of this agent in the overall population of patients with intermediate to high risk MDS. Using translational medicine methodologies, we identified potential predictive biomarkers of this activity, and one key goal of this study is to validate the ability of those biomarkers to identify the patients most likely to benefit from tipifarnib."

"Patients with MDS, a group of diverse bone marrow disorders, suffer from a dearth of treatment options and the development of new drugs is vital to combat the disease," said Joseph G. Jurcic, M.D., Professor of Medicine and principal investigator at Columbia University Medical Center. "The analyses from previous studies provide a strong rationale for evaluating tipifarnib in this indication."

MDS is a group of hematopoietic stem cell malignancies with significant morbidity and mortality. MDS is characterized by ineffective blood cell production, or hematopoiesis, leading to low blood cell counts, or cytopenias, and a high risk of progression to acute myeloid leukemia. MDS is estimated to have an annual incidence of approximately 13,000 patients in the United States. These patients generally have a poor prognosis due to the low response rate to available treatment options.

The trial is designed to enroll approximately 58 patients and will evaluate tipifarnib as a treatment for patients with lower risk myelodysplastic syndromes. Patient samples will be analyzed for the presence or absence of various biomarkers potentially relevant to the activity of tipifarnib. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT02779777.

About Tipifarnib

Kura Oncology’s lead program, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown a well-established safety profile and compelling and durable anti-cancer activity in certain patient subsets. Preclinical and clinical data suggest that, in the appropriate context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, Kura Oncology will seek to identify patients most likely to benefit from tipifarnib. Kura Oncology holds an exclusive license to develop and commercialize tipifarnib in the field of oncology, under an agreement with Janssen Pharmaceutica NV.

Tri-Institutional Therapeutics Discovery Institute, Inc. Expands Partnership with Takeda Pharmaceutical Company, Ltd.

On June 16, 2016 Memorial Sloan Kettering Cancer Center, The Rockefeller University and Weill Cornell Medicine reported that they will expand the focus of the successful Tri-Institutional Therapeutics Discovery Institute, Inc. (Tri-I TDI), a partnership established in 2013 to expedite early-stage drug discovery of innovative new therapies (Press release, Takeda, JUN 16, 2016, View Source [SID:1234513420]). Under this expansion, Tri-I TDI will extend its current relationship with its industry partner, Takeda Pharmaceutical Company, Ltd. (TSE:4502) from the realm of small molecule discovery into the new research area of antibody drug discovery. All three institutions will benefit from Tri-I TDI’s expansion.

"We are thrilled at the prospect of growing our strong Tri-I TDI partnership, where we continue to tackle important health questions and improve drug development efficiency. Through our current work, we’ve established a streamlined process to apply our breakthrough research into clinical application and look forward to adding antibody knowledge into our expanding range of capabilities" said Dr. Augustine Choi, interim dean of Weill Cornell Medicine.

"TDI has already had an important impact by providing an opportunity for our scientists, and those of our collaborating institutions, to develop small molecules that might lead to new drugs," said Dr. Marc Tessier-Lavigne, president of The Rockefeller University. "With the addition of its antibody program, TDI will go even further, jumpstarting the development of an additional type of therapy for poorly treated diseases."

"What began as a novel partnership between academia and industry has now become a powerful voice in medical research," said Memorial Sloan Kettering President and CEO Dr. Craig B. Thompson. "Our collaboration has provided more efficient paths to translate laboratory discoveries into bedside treatments that lead to improved patient care and well being. This partnership is a great example of how collaboration and open partnerships are the future of medical research."

"As we look ahead to what’s next, beyond small molecule drug discovery, this flagship collaboration will continue to push the boundaries of what’s possible in medical research," said Andrew Plump, Takeda’s chief medical and scientific officer. "We at Takeda understand the value of, and connection between, innovation and external collaboration. This is why we are so pleased to continue our relationship with the Tri-I TDI and help expand its mission to move toward novel research frontiers such as antibody drug discovery."

Takeda and M2Gen Collaborate with ORIEN to Speed Clinical Development and Discovery of Cancer Treatments Through Health Informatics

On June 16, 2016 Takeda Pharmaceutical Company Limited (TSE: 4502) and M2Gen, a healthcare informatics solutions company, reported that it has established a new collaboration to generate broad genomic data from consenting cancer patients (Press release, Takeda, JUN 16, 2016, View Source [SID:1234513412]). Under the agreement, Takeda will help build the Oncology Research Information Exchange Network (ORIEN) AvatarTM Research Program based on the Total Cancer Care Protocol, a prospective observational study enrolling patients with various cancers, and access information generated under this program.

Understanding and mapping the genetic profiles of patients with various types of cancer has the potential to speed new treatment discovery and development for millions of cancer patients worldwide. The data provided through M2Gen’s ORIEN Avatar Research Program has the potential to enable ORIEN cancer centers to more rapidly find and enroll patients with specific biomarkers into Takeda clinical studies, among others. In addition, the genomic data will accompany clinical information such as stage of disease, demographics and treatment history, further enhancing translational medicine efforts. This collaborative approach, which brings together leading pharmaceutical companies, cancer research centers and patients, may allow for more effective and efficient development of treatments across many different cancers.

"One of the biggest challenges in oncology research is identifying the right cohort of patients for enrollment into clinical trials," said Phil Rowlands, Interim Head, Oncology Therapeutic Area Unit, Takeda. "Our innovative partnership with M2Gen has the potential to enable us to more quickly and precisely enroll patients at sites with a strong commitment to high quality translational medicine."

Through the agreement, Takeda will have access to patient de-identified information generated through the ORIEN Avatar Program, representing ORIEN’s growing network of participating cancer centers. These 12 institutions, all leaders in cancer care, treat diverse populations of patients, who can elect to join the Total Cancer Care Protocol to potentially gain access to groundbreaking therapies and clinical trials. Patients who consent to participate in the protocol agree to be followed throughout their lifetime. ORIEN Avatar is focused on the use of rich clinical and molecular data to anticipate patient need, especially for novel cancer treatments through clinical trials open at ORIEN institutions.

"Our health informatics solutions allow us to share clinically meaningful data across the entire cancer care and research community – from patients to healthcare providers to the companies developing novel medicines," said William S. Dalton, Ph.D., M.D., Founder and CEO, M2Gen.

"We are excited to welcome Takeda as one of the founding partners for our ORIEN Avatar program and look forward to working together to open new doors in oncology research," said Michael A. Caligiuri, M.D., Director, The Ohio State University Comprehensive Cancer Center and CEO, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

This agreement is partially developed on the experience of Takeda and M2Gen, which previously partnered in 2014 to identify patients for several Phase 2 studies in gastric and pancreatic cancer. This pilot program demonstrated M2Gen’s capability to identify patients who might benefit from enrollment in the clinical trials and to facilitate rapid trial enrollment. Through ongoing collaborative learning, Takeda and M2Gen see the continued potential for success in scientific and clinical trial development and in meeting patient needs.