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Navidea Announces Presentation of Results Demonstrating Performance of Lymphoseek® in Breast Cancer at SNMMI

On June 16, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), reported results from three investigator-initiated studies that demonstrate beneficial performance characteristics of Lymphoseek (technetium Tc 99m tilmanocept) injection and positive comparative results versus commonly-used, non-receptor-targeted imaging agents (Press release, Navidea Biopharmaceuticals, JUN 16, 2016, View Source;p=irol-newsArticle&ID=2178174 [SID:1234513414]). The data were presented by the investigators this week at the 2016 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in San Diego, CA.

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"These data further reinforce the beneficial clinical performance attributes of Lymphoseek (technetium Tc 99m tilmanocept) Injection. And, in addition, they support Lymphoseek’s rapid adoption in sentinel lymph node biopsy procedures and its pre-surgical imaging utility for other solid tumors," commented Michael Blue, M.D., Senior Medical Director of Navidea. "We believe results from these and other performance-based studies will encourage surgeon’s to use Lymphoseek as they look to optimize outcome for their patients and improve patient experience."

Experimental Results

In the presentation entitled, "Performance of Tc-99m tilmanocept when used alone is as or more effective in localizing sentinel nodes than sulfur colloid plus blue dye," Jonathan Unkart and Anne Wallace, M.D., Department of Surgery at the University of California San Diego (UCSD), described a retrospective evaluation of the rate of localization of Lymphoseek when used alone compared to sulfur colloid (SC), blue dye (BD) and SC plus BD. The study included results from 148 breast cancer patients evaluated in two, prospective Phase 3 Lymphoseek clinical trials (data published in Annuls of Surgical Oncology 2013). SC and BD data was derived from a literature search presented at SNMMI 2013 Annual Meeting including treatment groups of 17,814 SC alone, 12,821 BD alone and 19,627 SC+BD patients. Results show the following localization rates: Lymphoseek alone: 0.9865, SC alone: 0.9249, BD alone: 0.8294 and SC+BD: 0.9636. The author’s analysis suggests that Lymphoseek provided superior sentinel lymph node localization in breast cancer patients compared to the other non-targeting agents alone or in combination providing surgeons the option to use just a single agent.

The presentation, "Use of lymphoscintigraphy with Tc-99m tilmanocept does not affect the number of nodes removed during sentinel node biopsy (SLNB) in breast cancer," also presented by Dr. Unkart shows data from a retrospective review evaluating whether there is a difference in the number of nodes removed using Lymphoseek during SLNB in patients who had a pre-operative imaging procedure called lymphoscintigraphy prior to SLNB versus those who only had intra-operative Sentinel Node (SN) identification. The results indicate that in Breast Cancer, identification and removal of SNs using lymphoscintigraphy (3.0 SNs) did not significantly alter the number of SLNs removed during a SLNB procedure with no imaging (2.7 SNs). Lymphoseek’s selective-targeting performance characteristic enables the utilization of only a single dose of Lymphoseek per patient irrespective of whether both lymphoscintigraphy and SLNB are performed. The authors concluded that by using Lymphoseek, lymphoscintigraphy imaging procedures may be eliminated in this patient population and may reduce health care cost without impacting patient outcomes.

The presentation entitled, "Rate of sentinel lymph node visualization in fatty breasts: Tc-99m Tilmanocept versus Tc-99m filtered sulfur colloid," describes results from a study at Emory University School of Medicine using Lymphoseek in patients with fatty breast tissue a population that is known to be more difficult to localize nodes when doing SLNB. The results suggest that Lymphoseek more effectively visualized sentinel lymph nodes (SLN) both on lymphoscintigraphy and during surgery compared to filtered sulfur colloids (Tc-SC) with 100% localization using Lymphoseek intraoperatively. Dr. Maryam Shahrzad, M.D. presented retrospective data compiled from 29 consecutive patients with early stage breast cancer where lymphoscintigraphy was performed using Tc-SC and 28 patients where lymphoscintigraphy was performed using Lymphoseek. Multiple patient variables were recorded. The Tc-SC cohort included 96% of patients with fatty breasts versus 89% in the Lymphoseek group. Statistically significant findings included:

In lymphoscintigraphy, SLN visualization occurred in 86% of the Lymphoseek group compared to 59% of the TC-SC group. (p-value: 0.02)
At surgery, 100% of patients in the Lymphoseek group showed a "hot" SLN compared to only 79% of patients in the Tc-SC group. (p-value: 0.01)
About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT: WWW.LYMPHOSEEK.COM

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.

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."