On June 2, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), reported that results from investigator studies using Lymphoseek (technetium Tc 99m tilmanocept) injection are being presented at the 2016 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) to be held June 11-15, 2016 in San Diego, CA (Press release, Navidea Biopharmaceuticals, JUN 2, 2016, View Source;p=RssLanding&cat=news&id=2174435 [SID:1234512958]). The oral and poster presentations highlight the comparative performance of Lymphoseek against commonly-used non-receptor targeted colloidal materials as well as other performance characteristics in breast cancer and melanoma.

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Results being presented at SNMMI 2016 include:

Presentation Title: Use of lymphoscintigraphy with Tc-99m tilmanocept does not affect the number of nodes removed during sentinel node biopsy in breast cancer
Author: Jonathan Unkart, Anne Wallace, Surgery, University of California San Diego, San Diego, CA
Date: June 15, 2016
Session Breast, Clinical Applications

Presentation Title: Performance of Tc-99m tilmanocept when used alone is as or more effective in localizing sentinel nodes than sulfur colloid plus blue dye
Author: J. Unkart,1 D. W. King,2 L. A. Christman,2 A. M. Wallace1; 1UCSD, San Diego, CA, 2Statking Consulting, Inc, Fairfield, OH
Date: June 15, 2016
Session Breast, Clinical Applications

Presentation Title: Comparative analysis of 99mTc-Tilmanocept (Lymphoseek) vs. 99mTc-Sulfur Colloid Sentinel Node Lymphoscintigraphy and Biopsy
Author: J. H. Pollard, B. Zaidi, M. Graham; University of Iowa Hospital, Iowa City, IA
Date: June 14, 2016
Session: Sarcoma/Melanoma

Poster Title: Rate of sentinel lymph node visualization in fatty breasts: Tc-99m Tilmanocept versus Tc-99m filtered sulfur colloid
Author: Maryam Shahrzad, Valeria Moncayo, John Malko, and Raghuveer Halkar; Emory University School of Medicine, Atlanta, GA
Date: June 13, 2016
Session Oncology, Clinical Science Track – MTA I: Breast Cancer Posters

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

On June 02, 2016TG Therapeutics, Inc. (Nasdaq:TGTX) today recapped the schedule of data presentations at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 3 – 7, 2016, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, JUN 2, 2016, View Source [SID:1234512960]).

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Poster Presentation & Discussion Session:

Title: Long-term follow-up of the PI3Kδ inhibitor TGR-1202 demonstrates a differentiated safety profile and high response rates in CLL and NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: 7512 (Poster Board # 68)
Presentation Date & Time: Monday, June 6, 2016 8:00 AM – 11:30 AM CT
Track: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Howard A. Burris MD, Sarah Cannon Research Institute/Tennessee Oncology
Discussion Session:
1:15 PM – 2:45 PM CT, at Room E354b

A copy of the above referenced abstract can be viewed online through the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org. Following the presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

TG Therapeutics will also host a reception on Monday, June 6, 2016 beginning at 7:00pm CT, with featured presentations beginning promptly at 7:10pm CT. The event will take place at the Peninsula Chicago Hotel in the Avenues Ballroom. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. In order to access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics June 2016 Investor & Analyst Event.

On June 1, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that the General and Digestive Surgery team at HM Sanchinarro University Hospital, led by Emilio Vicente, M.D. and Yolanda Quijano, M.D., has successfully launched the hospital’s Hepatic Chemosaturation Program (Press release, Delcath Systems, JUN 1, 2016, View Source;p=RssLanding&cat=news&id=2173899 [SID:1234512920]). The Sanchinarro team successfully performed three procedures with Delcath’s proprietary Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (CHEMOSAT or Melphalan/HDS). The team at HM Sanchinarro is using the CHEMOSAT procedure in peripheral cholangiocarcinoma, neuroendocrine tumours and colorectal liver metastases. HM Sanchinarro University Hospital is the second center in Spain to offer the treatment.

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"This is an exciting approach for the treatment of liver tumors," said Drs. Vicente and Quijano. "We believe that the administration of high-dose melphalan directly to the liver has great promise in the treatment of a variety of tumor types, and the associated side effects are also minimized and more manageable. In recent years, the successful development of this percutaneous procedure has been a breakthrough, as it significantly reduces the technique’s morbidity rate. We are very excited about adopting this new procedure at HM Sanchinarro University Hospital."

Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems Inc., said, "We are extremely pleased that the HM Sanchinarro Hospital has commenced its Chemosaturation Program with our CHEMOSAT Delivery System. HM Sanchinarro is one of the leading cancer centers in Spain, both in terms of treatment and research. This underscores how CHEMOSAT continues to be increasingly accepted as an effective therapy for patients with liver metastasis who would otherwise have few, if any, treatment options."

On June 1, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported the launch of a mechanism of disease (MOD) awareness initiative designed to educate community and academic hematologists/oncologists about the role of the tumor microenvironment in patients with certain hematologic malignancies, or blood cancers (Press release, Infinity Pharmaceuticals, JUN 1, 2016, View Source;p=RssLanding&cat=news&id=2173919 [SID:1234512925]). With more research emerging about the role of the tumor microenvironment in hematologic malignancies, Infinity developed this campaign to contribute to the emerging knowledge of this scientific concept and its clinical relevance. The initiative will be showcased in the Infinity booth (#22415) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago from June 3 – June 7, 2016. Additional information and resources on the tumor microenvironment are available on a newly launched website: www.manipulatedTME.com.

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In B-cell malignancies, the tumor microenvironment is made up of healthy, non-cancerous cells that are recruited by malignant (cancerous) B-cells to promote tumor survival.[1] The tumor microenvironment is thought to support key characteristics of cancer, including disease progression, resistance to cell death and sustained proliferation.[2]

"Research suggests that the tumor microenvironment may provide protection and support for malignant B-cells that hinder treatment effectiveness, resulting in poor responses to treatment," said Nathan Fowler, M.D., Associate Professor, Department of Lymphoma/Myeloma at the University of Texas MD Anderson Cancer Center. "As hematologists and oncologists continue to conduct research and develop treatment plans for patients living with incurable B-cell malignancies, this online resource may provide insights as to why patients continue to relapse."

The campaign artwork is centered around a sinister character, representing a malignant B-cell, who is supported by cells in the tumor microenvironment, such as macrophages, endothelial cells, and immune cells. The B-cell character is shown to have manipulated these healthy cells to form the tumor microenvironment, a network of support and protection for malignant B-cells that may enable tumor growth and proliferation.

Learn more about the MOD campaign at www.manipulatedTME.com.

On June 1, 2016 Nektar Therapeutics (Nasdaq: NKTR) reported that it has entered into an agreement with Daiichi Sankyo Europe for Nektar’s investigational drug therapy, ONZEALD (etirinotecan pegol, NKTR-102), which has completed a Phase 3 clinical trial (the BEACON study) in patients with advanced breast cancer (Filing, 8-K, Nektar Therapeutics, JUN 1, 2016, View Source [SID:1234512942]). The agreement grants Daiichi Sankyo Europe exclusive rights to market ONZEALD in Europe (EEA), Switzerland and Turkey. Nektar Therapeutics will retain rights to ONZEALD in the United States and the rest of the world.

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Under the terms of the agreement, Nektar Therapeutics is entitled to an upfront payment of $20 million as well as an additional $60 million in milestone payments, based upon the achievement of European regulatory milestones and European sales of ONZEALD. Nektar is also entitled to significant double-digit royalties on net sales in Europe.

"This new collaboration with Daiichi Sankyo Europe allows Nektar to advance ONZEALD to a potential conditional approval and availability in Europe as early as next year, and also enables us to retain ownership of the drug in the U.S. and rest of world," said Howard W. Robin, President and Chief Executive Officer of Nektar Therapeutics. "We are pursuing conditional approval for ONZEALD based on highly promising data from our Phase 3 BEACON clinical trial in the pre-specified subgroup of patients with advanced breast cancer who have a history of brain metastases. A diagnosis of brain metastases in women with advanced breast cancer is devastating and there are no therapies approved to treat this specific patient population."

Nektar plans to submit an MAA filing in June 2016 seeking conditional approval from the European Medicines Agency (EMA) for the use of ONZEALD in the treatment of patients with advanced breast cancer and brain metastases. On May 26, 2016, the Committee for Medicinal Products for Human Use (CHMP) granted an accelerated assessment procedure for the planned ONZEALD filing, which provides for an accelerated MAA review timeline.

Nektar will be responsible for sponsoring and funding the confirmatory trial which will support the Marketing Authorization Application (MAA) filing for ONZEALD in Europe. The data from the confirmatory trial can be used by Nektar for a potential U.S. new drug application (NDA) filing for ONZEALD.

Breast cancer is the most frequently diagnosed cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012.1 There are approximately 250,000 newly-diagnosed cases of breast cancer in the United States and 470,000 in Europe each year. 1 Approximately 10-30 percent of patients with advanced breast cancer are also diagnosed with brain metastases. 2

Nektar’s planned MAA filing is based upon data from a subgroup of patients from the completed BEACON study of single-agent ONZEALD in patients with advanced breast cancer. In this subgroup of 67 patients who also had a history of brain metastases, treatment with single-agent ONZEALD resulted in an improvement in median overall survival (OS) of 5.2 months compared to treatment with a single-agent chemotherapy of physician’s choice (TPC) (10 months vs. 4.8 months, P < 0.01). TPC included a choice of ixabepilone, vinorelbine, gemcitabine, eribulin or a taxane. In the planned primary analysis for the overall patient population in the BEACON study, ONZEALD median OS was 2.2 months longer than TPC (12.4 months vs. 10.3 months, P= 0.08).3 In the overall patient population in the BEACON study, fewer patients in the ONZEALD arm had grade 3 or worse adverse events (AEs) than those in the TPC arm (204 [48%] vs. 256 [63%]; p<0·0001).3 The most common grade 3 and above AEs observed with ONZEALD were diarrhea (9.6%), neutropenia (9.6%), anemia (4.7%) and fatigue (4.5%). The most common grade 3 and above AEs observed with TPC were neutropenia (30.8%), anemia (4.7%), and dyspnea (4.4%).

In order to satisfy the EMA’s requirement for additional controlled data with the MAA for conditional approval, Nektar will sponsor a global, randomized Phase 3 trial of ONZEALD in approximately 350 patients with advanced breast cancer and brain metastases. The trial will compare ONZEALD to TPC and the primary endpoint in the trial will be OS. The trial will include a pre-specified interim analysis for OS which is to be conducted after 130 events have been observed in the trial. The U.S. Food and Drug Administration has also reviewed the Phase 3 study design with the Statistical Analysis Plan, and indicated the trial could serve as a potential registrational study by Nektar for purposes of seeking approval of ONZEALD to treat this patient population in the U.S.
The EMA may grant conditional marketing authorization when the potential treatment addresses a severely debilitating disease with an unmet medical need, has a positive benefit to risk profile, and the benefits to public health of its immediate availability outweigh the risks inherent in the fact that additional data are still required. Ongoing or new studies must be completed with the objective of confirming that the benefit to risk balance is positive. A conditional approval granted by the EMA is renewed on an annual basis until all obligations have been fulfilled, at which point a full approval may be granted by the EMA.

For additional terms and conditions of the licensing agreement between Nektar and Daiichi Sankyo Europe, please refer to the Current Report on Form 8-K filed today with the Securities and Exchange Commission.

About ONZEALD (etirinotecan pegol) (formerly NKTR-102)

ONZEALD is the first long-acting topoisomerase I inhibitor with an extended half-life and a unique structure that is designed to concentrate the drug in tumors. In patients, ONZEALD leads to greatly prolonged plasma SN38 exposure compared with irinotecan (elimination half-life of 37 days compared with 2 days) yet peak SN38 concentrations are at least 5- to 10-times less, which may also result in a favorable tolerability profile. ONZEALD was evaluated in a Phase 3, open-label, randomized, multicenter study (the BEACON study) that enrolled 852 women with locally recurrent or metastatic breast cancer, who have previously been treated with an anthracycline, taxane and capecitabine therapies.