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Myriad Will Highlight New Data on Its myRisk(TM) Hereditary Cancer Test at the National Society of Genetic Counselors Annual Conference

On October 21, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that new data on its myRisk Hereditary Cancer molecular diagnostic test will be featured in five presentations at the National Society of Genetic Counselors (NSGC) Annual Conference being held Oct. 21 to 24, 2015 in Pittsburgh, Pa (Press release, Myriad Genetics, OCT 21, 2015, View Source [SID:1234507751]).

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"Myriad is a pioneer in translating genetic information into products that save and improve lives. More than ever, we’re dedicated to research that advances the science of hereditary cancer testing for patients now and in the future," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "The data we’re presenting at NSGC this year demonstrate that the myRisk Hereditary Cancer Panel identifies more harmful mutations than testing one gene at a time. Furthermore, as we expand our testing to broader gene panels and identify mutations in genes that have not traditionally been linked to certain family histories, we are challenging the fundamentals of our historical thinking on cancer genetics."

A list of Myriad’s presentations at NSGC (#NSGC2015) follows:

Poster Presentations

Title: Pathogenic mutations identified in patients with 6 or more colon polyps.
Date: Thursday, Oct. 22, 2015, 2:00-3:00 p.m. ET.

Location: Poster 55.

Title: Hereditary Cancer Testing in Patients of Ashkenazi Jewish Ancestry in the Era of Panel Testing.
Date: Thursday, Oct. 22, 2015, 2:00-3:00 p.m. ET.

Location: Poster 71

Title: Pedigree modeling demonstrates that family history performs poorly for the identification of women with inherited risks for breast cancer.
Date: Thursday, Oct. 22, 2015, 2:00-3:00 p.m. ET.

Location: Poster 111.

Title: Outcomes of multi-gene testing for inherited cancer risk in patients of varied ancestries.
Date: Friday, Oct. 23, 2015, 1:15-2:15 p.m. ET.

Location: Poster 72.

Title: Identification of a Recurrent Pathogenic Variant in BRIP1.
Date: Friday, Oct. 23, 2015, 1:15-2:15 p.m. ET.

Location: Poster 74.

For more information about these presentations, including a complete list of posters, please visit the NSGC website at View Source

About Myriad myRisk Hereditary Cancer Testing

The Myriad myRisk Hereditary Cancer test uses next-generation sequencing technology to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: View Source

MabVax Therapeutics HuMab 5B1 Antibody Featured in Five Presentations at the World Molecular Imaging Congress

On October 21, 2015 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX) a clinical-stage oncology drug development company reported its antibody, HuMab 5B1 was featured in five separate presentations at the recently held World Molecular Imaging Congress (WMIC) in September (Press release, MabVax, OCT 21, 2015, View Source [SID:1234507749]). The presentations were made by investigators from the Department of Radiology at Memorial Sloan Kettering Cancer Center (MSK) describing the novel use of MabVax’s lead antibody as a PET imaging agent and a radioimmunotherapy agent targeting pancreatic cancer.

Following is a summary of the key points from the presentations;

Jacob Houghton, Ph.D. presented data demonstrating that the HuMab 5B1 antibody based PET imaging agent could be useful even in the context of shed antigen. Most pancreatic cancer patients shed an antigen called CA 19-9, which is a validated biomarker for pancreatic cancer. This same target is overexpressed on the surface of pancreatic cancer cells in more than 80% of patients and is the target for the HuMab 5B1 antibody. In animal models of pancreatic cancer, the experiments examined adding small amounts of HuMab 5B1 antibody not labeled with radiotracer to "soak up" excess circulating antigen. By varying the amount of unlabeled antibody and the time before injection of the HuMab 5B1 PET agent, Dr. Houghton was able to determine the variables required to optimize PET images. However, regardless of time of administration or amount of non-radiotracer antibody administered, images consistently illuminated the cancer.

Ryan Lanning, M.D., Ph.D. presented the results of experiments using the HuMab 5B1 antibody as a radioimmunotherapy agent against pancreatic cancer. Dr. Lanning conjugated the HuMab 5B1 antibody to two different and commonly used radiometals in radioimmunotherapy and tested them in animal models of pancreatic cancer. He varied the dose administered as well as examined the impact of combining the 5B1 radioimmunotherapy agent with chemotherapy. Both the radioimmunotherapy conjugates demonstrated significant tumor toxicity and excellent tumor localization potentially minimizing toxic adverse effects. Subsequent to administration of the radioimmunotherapy agent, follow-on administration of the HuMab 5B1 PET product continued to demonstrate sustained tumor selectivity allowing for administration of additional antibody based therapeutic or diagnostic agents.
Jan-Philip Meyer, Ph.D. and Jacob Houghton, Ph.D. each presented research using pretargeting as an effective way to combine the favorable pharmaocokinetic properties of radiolabeled small molecules with short half-lives with the affinity and specificity of the HuMab 5B1 antibody. Using different linking technologies and different radiotracers each investigator reported very good PET images with very favorable tumor-to-background activity ratios. The objective of both sets of experiments was to demonstrate methods that could be used to reduce the exposure of patients to excess radiation when undergoing PET imaging. Both investigators were able to achieve that objective even in the presence of shed antigen.

Dalya Abdel-Atti presented research showing that using a HuMab 5B1 based PET imaging agent produced high-quality images in a pancreatic cancer murine organoid model even in the presence of shed antigen. A central drawback of many animal models of disease is that they aren’t always predictive of the results obtained in actual patients. The murine organoid model is a newly developed model that more faithfully replicates metastatic pancreatic cancer in patients. The investigators at MSK believe that this is the first time PET imaging has been successfully performed in a murine organoid model of pancreatic cancer.

David Hansen, CEO of MabVax commented "These investigators need to be commended for the pioneering work they presented and the important steps forward they have made in building capabilities to diagnose and treat a very difficult cancer. MabVax is grateful to Jason S. Lewis, Ph.D. and his team for their pioneering work done with our HuMab 5B1 antibody. All of these results are helpful steps forward in advancing the collective knowledge of this devastating cancer and provide valuable insights for MabVax as we continue to develop HuMab 5B1 as both a therapeutic and diagnostic product."

About HuMab 5B1

The fully human antibody HuMab 5B1 was recovered from patients undergoing cancer vaccine treatment at Memorial Sloan Kettering Cancer Center. The HuMab 5B1 has demonstrated high specificity, affinity, and lack of cross-reactivity with similar antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancers. Ongoing toxicology results continue to demonstrate an acceptable profile in acute and repeat dose studies in animals. MabVax plans to initiate two complementary Phase I clinical trials in the first quarter of 2016. One clinical trial is aimed at determining the safety and potential utility of HuMab 5B1 as a therapeutic agent in subjects with metastatic pancreatic cancer. The second clinical trial is aimed at demonstrating the utility of 89Zr-HuMab 5B1, the Company’s radio-labeled HuMab 5B1 antibody, as a next-generation PET imaging agent for the diagnosis, staging, and management of pancreatic cancer.

Cancer Experts Detail How InSightive™ Analytics Can Be Used To Enhance Outcomes Across A Network Of Radiation Oncology Treatment Centers

On October 21, 2015 Varian Medical Systems reported that radiation oncology experts from Sarah Cannon, the global cancer institute of Hospital Corporation of America (HCA), recently reported that InSightiveTM analytics software from Varian Medical Systems (NYSE: VAR) can be used to identify and track key healthcare metrics for better patient care (Press release, InfiMed, OCT 21, 2015, View Source [SID:1234507748]). In a pilot study presentation here last week, they highlighted the value of using InSightive to identify leading indicators that can be used to improve care delivery for cancer patients receiving radiation oncology services.*

Speakers from Sarah Cannon detailed their findings before an audience of some 800 radiation oncology professionals at a Varian User’s Meeting that was held just prior to the 2015 annual meeting of the American Society for Radiation Oncology (ASTRO).

"The use of InSightive analytics has supported our capabilities to more rapidly access comprehensive data captured during radiation oncology operations to inform clinical and operational best practices," said Andrew Kennedy, MD, physician in chief, Radiation Oncology for Sarah Cannon. "Identifying leading indicators for performance improvement is essential to providing the highest quality care to cancer patients, and we look forward to expanding our use of real-time analytics to enhance patient experiences and outcomes long-term."

Sarah Canon is consolidating clinical and administrative metrics using Varian’s ARIA oncology information system in pilot markets, in order to be able to measure quality, outcomes, and operational performance across business lines from one single platform. "A standardized OIS platform is the foundation for removing variation and improving efficiency," said Kennedy.

InSightive analytics enables ARIA users to quickly access, organize and analyze data that was captured during clinical and administrative operations. With a vision of aligning operations across its more than 45 radiation oncology sites, Sarah Cannon aims to use the real-time analytics to inform best practices across its network.

Sarah Cannon has developed enterprise-level dashboards and reports that mine the ARIA database to show quality, outcomes, and operational metrics such as daily treatments across technologies, patient consultations, referral trends, retention statistics, toxicity trends, and treatment patterns, creating a comprehensive report for opportunities to improve care and outcomes.

"From this data, we can use an analytics-driven approach to make forward-looking decisions to enhance quality and safety across our coordinated network," said Kennedy.

With access to more than 100,000 newly-diagnosed cancer patients per year, Sarah Cannon offers integrated cancer services with convenient access to cutting-edge therapies through its network of cancer programs across the United States and United Kingdom. InSightive analytics is helping Sarah Cannon to improve treatment outcomes by identifying patterns in patient data that support the development of personalized treatment plans for patients.

Novartis broadens immuno-oncology pipeline with acquisition of Admune Therapeutics and licensing agreements with XOMA and Palobiofarma

On October 21, 2015 Novartis reported that it is broadening its portfolio of cancer immunotherapies with the acquisition of Admune Therapeutics and licensing agreements with Palobiofarma and XOMA Corporation (Press release, Novartis, OCT 21, 2015, View Source [SID:1234507745]).

With four candidates currently in clinical trials and five more agents expected to enter the clinic by the end of 2016, Novartis has rapidly built a robust portfolio of programs focused on stimulating the body’s immune system to combat cancers that includes novel checkpoint inhibitors, chimeric antigen receptor T-cell (CART) technology, myeloid cell targeting agents, and STING agonists. Currently Novartis’ myeloid cell targeting program (MCS-110) and checkpoint inhibitors targeting PD-1 (PDR001), LAG-3 (LAG525), are in phase 1 clinical trials. The CART program (CTL019) is in phase 2 clinical trials. The anti-TIM-3 program (MGB453) is expected to enter the clinic by the end of 2015 and a STING agonist (MIW815), through collaboration with Aduro Biotech, and GITR agonist are progressing toward first-in-human clinical trials in 2016.

The acquisition of Admune adds an IL-15 agonist program currently in phase I clinical trials for metastatic cancer. The licensing agreement with Palobiofarma gives Novartis development and commercialization rights to PBF-509, an adenosine receptor antagonist currently in phase I clinical trials for non-small cell lung cancer. The agreement with XOMA gives Novartis development and commercialization rights to XOMA’s TGF-beta antibody programs. All three programs will be explored as monotherapies and in combination with therapies in Novartis’ immuno-oncology and targeted therapy portfolios.

"The first wave of immuno-oncology therapies has demonstrated the impact this approach can have in treating certain types of tumors, " said Mark Fishman, President of the Novartis Institutes for BioMedical Research. "To realize its full potential requires exploration of the complex system of biological pathways in the tumor microenvironment with agents that can stimulate the immune system to attack a wider variety of tumors."

In pre-clinical studies, IL-15 therapies have been shown to activate CD8+, CD4+ memory T cells and Natural Killer (NK) cells that play a critical role in stimulating the immune system. Adenosine and TGFß both drive immune suppression in the tumor microenvironment, which allows cancer cells to escape immune surveillance, making inhibition of these two pathways an attractive next-generation immuno-oncology approach.

Synta Announces Termination for Futility of Ganetespib Phase 3 GALAXY-2 Trial in Lung Cancer

On October 20, 2015 Synta Pharmaceuticals Corp. (NASDAQ: SNTA) treported that the Company has decided to terminate the Phase 3 GALAXY-2 trial of ganetespib and docetaxel in the second-line treatment of patients with advanced non-small cell lung adenocarcinoma (Press release, Synta Pharmaceuticals, OCT 20, 2015, View Source;p=RssLanding&cat=news&id=2098806 [SID:1234507747]). Based on the review of a pre-planned interim analysis, the study’s Independent Data Monitoring Committee (IDMC) concluded that the addition of ganetespib to docetaxel is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to docetaxel alone. The IDMC noted that the combination of ganetespib and docetaxel was generally well tolerated in the study, with an adverse event profile consistent with previous studies combining these agents.

GALAXY-2 is a Phase 3 global, randomized, multi-center trial. Synta continues to support enrollment in four additional large, randomized, multi-center investigator-sponsored studies, including: the GANNET53 trial of ganetespib and paclitaxel in ovarian cancer; the AML LI-1 trial of ganetespib with low dose cytarabine (Ara-C) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS); the AML18 trial of ganetespib with standard DA (daunorubicin and Ara-C) in AML and high-risk MDS; and the I-SPY 2 TRIAL of ganetespib and standard chemotherapy in women with newly diagnosed, locally advanced breast cancer.

"This disappointing outcome underscores the challenges of treating lung cancer in the second-line setting and determining the precise population for whom ganetespib may be most effective," said Chen Schor, President and Chief Executive Officer of Synta. "We thank the patients, caregivers and investigators who participated in GALAXY-2."

Mr. Schor continued: "Despite the outcome of this trial, and pending discussions with the relevant investigators, we will continue to support ongoing investigator-sponsored studies while we determine the appropriate path forward for ganetespib. We also look forward to advancing candidates from our HDC platform into the clinic. With the significant cash reserves we have in hand, our pipeline, our scientific internal leadership and network of advisors, we expect to undertake a comprehensive review of our strategy going forward."

Upon formal acceptance of the IDMC’s recommendation, Synta will communicate with regulatory authorities, and will notify study investigators that treatment with ganetespib should be discontinued in the GALAXY-2 trial.