On March 10, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), reported a publication in Nuclear Medicine and Biology, the official journal of the Society of Radiopharmaceutical Sciences, which describes the clinical linkage between immunodiagnostic and immunotherapeutic agents (Press release, Navidea Biopharmaceuticals, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147463 [SID:1234509457]). This process is exemplified by the self-transforming nature of Navidea’s Manocept immunotargeting platform which provides high specificity against receptor-bearing targets and is a promising approach to immunotherapy.

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The first product of the Manocept platform, Lymphoseek (technetium Tc 99m tilmanocept) injection was launched as a novel immunodiagnostic agent approved by the FDA and used in breast, melanoma and oral cavity cancer sentinel lymph node biopsy (SLNB) procedures. Lymphoseek has demonstrated its effectiveness through many evidence-based studies in SLNB, due to its unique structure and targeting of CD206 found on macrophages in tumor-draining lymph nodes. Its Manocept backbone, enabled by the ability to interchange radionuclides for biological modifier molecules, has the potential to target macrophage-mediated diseases and deliver an effective, specifically targeted drug for purposes of disease treatment and reducing or eliminating side effects.

"Past therapeutic strategies attempting to harness the power of the immune system to manage, treat or kill macrophages in disease states like cancer and inflammatory conditions have had limited to no success," said Michael S. McGrath, M.D., Ph.D., Professor, Departments of Laboratory Medicine, Pathology, and Medicine at the University of California, San Francisco (UCSF). "The Manocept platform possesses a unique potential to not only target aberrant macrophages for detection or treatment but also shields non-affected cells, which could profoundly address broad unmet needs for patients both diagnostically and therapeutically."

"These newly published results highlight the remarkable specificity and sensitivity of the Manocept platform, and its plasticity which allow it to exploit the natural history of macrophage-mediated diseases," said Frederick O. Cope, Ph.D., M.S., FACN, Navidea’s Chief Scientific Officer. "It is rare to find a platform that selectively targets activated macrophages, which are central to the immune system. These results provide further validation of the Manocept platform, as we continue to build a pipeline of additional immunodiagnostic and immunotherapeutic products across oncology, inflammatory and infectious diseases."

Summary of Results

A series of studies supported by patient exposure to immunodiagnostic imaging drug, targeting studies, patient explant studies, and in vivo and ex vivo animal data examined Manocept agents including 99mTc-tilmanocept, Cy3-tilmanocept, and Manocept-doxorubicin. These studies validated the self-transforming nature of the Manocept platform from immunodiagnostic imaging to effective Manocept therapeutic targeting. Data from studies in several macrophage-mediated diseases including Kaposi’s sarcoma, rheumatoid arthritis, and cardiovascular disease show that Manocept platform compounds bind almost exclusively to human macrophages and that the mannose receptor (CD206) is the major receptor for its recognition. For complete details of the studies, findings and results, "The Inextricable Axis of Targeted Diagnostic Imaging And Therapy: An Immunological Natural History Approach" appears in the March 2016 print journal Nuclear Medicine and Biology. 2016 Nuclear Medicine and Biology. Volume 43, Issue 3, Pages 215–225. [doi: 10.1016/j.nucmedbio.2015.11.007].

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 March 10, 2016 Committed to technologies that assist in the goal of reducing lung cancer morbidity worldwide, Medtronic (NYSE: MDT) reported European enrollment in the NAVIGATE clinical trial (Press release, Medtronic, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147494 [SID:1234509456]). This 2,500-patient international study will assess the long-term impact of its superDimension(TM) navigation system as an aid in early detection of lung cancer and subsequent treatment.

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The superDimensionsystem uses LungGPS(TM) technology, the first of its kind to enable Electromagnetic Navigation Bronchoscopy (ENB) procedures. ENB procedures provide a minimally invasive approach to access difficult-to-reach areas of the lung, which can aid in the diagnosis of lung disease, can help patients avoid surgery for benign disease and other invasive procedures like transthoracic needle aspiration, and lead to earlier, personalized treatment – potentially saving lives. The superDimension system has received CE Mark in Europe, 510(k) clearance in the US and has also been approved for use in numerous international markets.

"Early detection, diagnosis and intervention are crucial to the survival of people living with lung cancer," said Mag. Petra Lichtenberger, Assistant to Prof. Dr. Lamprecht at the Department of Pulmonology of Kepler University Clinic Linz, Austria, which enrolled the first ENB patient in Europe. "Technology that allows medical professionals to view areas of the lung that could not be accessed before is a major advance that is changing the landscape of lung cancer diagnosis and helping save patient lives."

Up to 75 centers around the world will enroll patients in the single-arm, multi-center post-market observational study designed to evaluate the impact of ENB procedures on early diagnosis and treatment. The NAVIGATE study will also determine the success rate of physicians using the technology to obtain biopsy samples from the surrounding lymph nodes. In addition, the study will assess the effectiveness of physicians’ placement of fiducial markers or dyes to guide subsequent procedures to treat or remove lung tumors.

More than 22 sites have been activated to enroll patients since the study first launched in the U.S. in April 2015. Healthcare professionals will follow patients for 24 months.

"The NAVIGATE study represents our commitment to delivering meaningful solutions that support the early detection and treatment of lung cancer to save patient lives," said Vafa Jamali, president, Early Technologies business in the Medtronic Minimally Invasive Therapies Group. "The enrollment of patients in Europe for the NAVIGATE study is a significant milestone and an important step to help establish ENB procedures as the gold standard for detecting lung cancer in the earlier, more curable stages."

According to the World Health Organization, lung cancer is the number one cancer killer in the world, accounting for 1.59 million deaths in 2012.1 In its early stages, lung cancer presents few, if any, symptoms. As a result, diagnosis for the vast majority of lung cancer patients happens in the late stages, and long-term survival rates drastically decline. When diagnosed early, an estimated 85 percent of lung cancer cases appear at a more curable stage.2 Early detection and immediate treatment dramatically increases the typical long-term survival rate from 15 percent at five years3 to 88 percent at 10 years.

To date nearly 100,000 ENB procedures have been performed globally at more than 600 hospitals commercially and as part of prior clinical trials.

Additional information about the NAVIGATE study and enrolling sites can be found at clinicaltrials.gov/ct2/show/NCT02410837.

Multimedia Release
A multimedia version of this release, with video and links to graphics can be found at: http://bit.ly/1TIeoLk.

On March 10, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported its financial results for the year ended December 31, 2015 (Press release, BioLineRx, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147470 [SID:1234509454]).

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Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, "2015 was a year of significant progress for BioLineRx on several fronts, as we advanced our lead therapeutic clinical programs both from a development and regulatory perspective, and entered into an exciting new collaboration in the immuno-oncology space."

"During the past year, we enhanced and expanded the development strategy for our BL-8040 cancer therapy platform, which is currently being investigated for multiple cancer and hematological indications. These include a Phase 2 study for treating relapsed and refractory AML patients, top line results of which are expected by the end of this month. Results from the first part of this trial continue to demonstrate substantial mobilization of leukemic cells from the bone marrow to the peripheral blood and robust induction of cancer cell apoptosis, which, combined with the reported 38% composite remission rate, strongly suggest that BL-8040 has potent anti-leukemic activity. In addition, we are also assessing BL-8040 as an AML consolidation treatment in a large Phase 2b study that is currently up and running at full steam. Successful top-line safety and efficacy results were also reported from a Phase 1 study in stem cell mobilization, supporting BL-8040 as one-day, single-dose collection regimen, which is a significant improvement upon the current standard of care. We now await receipt of regulatory approval in order to begin, by the end of the month, a Phase 2 trial for BL-8040 as a stem cell mobilizer for allogeneic transplantation. Finally, we are advancing an ongoing Phase 1/2 study for BL-8040 as a novel treatment for hMDS and AA, two bone marrow failure conditions."

"We recently entered the exciting field of immuno-oncology through our collaboration with Merck, a pioneer and world leader in cancer immunotherapy. A Phase 2 study is planned to commence by mid-year investigating BL-8040 in combination with KEYTRUDA, Merck’s anti-PD-1 immunotherapy, in patients with metastatic pancreatic cancer. Although there have been significant advances in the immuno-oncology field, many cancer types, such as pancreatic cancer, remain resistant to immunotherapy, and combination treatments appear to offer a better chance to treat these cancers. We are therefore enthusiastic about this opportunity to evaluate the potential of our lead drug candidate as a combination therapy with immune checkpoint inhibitors. We are also planning to commence a Phase 2a trial for BL-8040 in the second half of 2016, for the treatment of AML patients with the FLT3-ITD mutation. With the guidance and insight of our newly established Oncology Scientific Advisory Board, consisting of world-renowned key opinion leaders, we look forward to realizing the potential of this promising oncology platform and to reaching several meaningful development milestones during 2016."

"BL-7010, for the treatment of celiac disease and gluten sensitivity, which was found to be safe and well tolerated in a Phase 1/2 trial in celiac patients, has recently received confirmation for the medical device designation pathway in Europe. Over the past year, we have invested considerable efforts in examining the potential of BL-7010 as a food supplement, in order to address the multi-billion dollar market for gluten sensitivity, which we believe has a significantly shorter time to market than drug or device pathways, especially in the US market. We are currently conducting a number of activities towards the development of BL-7010 as a food supplement, including the development of a suitable product formulation, preparation of the documents necessary for a GRAS designation submission, and preparations for a relatively small clinical trial to support future marketing efforts. We expect to complete these activities by mid-2017, in order to support future expected partnering discussions for the food supplement market in the US and other relevant territories. We also plan to continue to evaluate the pathway in Europe for celiac disease and intend to make a decision about the timing and scope of the next efficacy study for European registration over the next few months."

"Regarding BL-5010, our partner Omega Pharma, now part of Perrigo, is swiftly progressing with its development as an OTC solution for the non-surgical removal of benign skin lesions. Omega Pharma submitted a CE Mark application for BL-5010 during the third quarter of 2015, and has completed the initial manufacturing process automation to support the product’s commercial launch, expected during 2016. We also look forward to the potential expansion of this product to other markets and to non-OTC indications."

"During 2015, we invested significant efforts in our new strategic collaboration with Novartis and have been jointly evaluating promising therapeutic candidates to be developed under the collaboration. In addition, we continue to explore other collaboration possibilities for maximizing the value of our current pipeline assets, including some of our non-core programs."

Dr. Savitsky concluded, "Yesterday, we announced the appointment of Dr. Merril Gersten as our new Chief Scientific Officer. Merril brings with her many years of leadership in both academia and the pharma industry in the US. I am confident that she will bring great value to BioLineRx and I am very excited to begin working with her. Finally, with almost $48 million on our balance sheet, we remain well capitalized to execute on our development programs and achieve significant milestones across our expanded therapeutic pipeline well into 2018."

Financial Results for Year Ended December 31, 2015

Research and development expenses for the year ended December 31, 2015 were $11.5 million, a decrease of $0.4 million, or 3.4%, compared to $11.9 million for the year ended December 31, 2014. The decrease resulted primarily from a decrease in spending on BL-7010 and various other projects, partially offset by increased spending on BL-8040.

Sales and marketing expenses for the year ended December 31, 2015 were $1.0 million, a decrease of $0.6 million, or 37.5%, compared to $1.6 million for the year ended December 31, 2014. The decrease resulted primarily from professional fees related to business development activities carried out in 2014, including professional services related to the strategic collaboration agreement with Novartis and the out-licensing agreement with Omega Pharma regarding BL-5010.

General and administrative expenses for the year ended December 31, 2015 were $3.7 million, a decrease of $0.1 million, or 2.6%, compared to $3.8 million for the year ended December 31, 2014. The decrease primarily resulted from a decrease in salary-related payments, partially offset by a small increase in professional fees.

The Company’s operating loss for the year ended December 31, 2015 amounted to $16.2 million, compared with an operating loss of $17.3 million for the year ended December 31, 2014.

The Company recognized net non-operating income of $1.4 million for the year ended December, 2015, compared to net non-operating income of $3.1 million for the year ended December 31, 2014. Non-operating income for both periods primarily relates to fair-value adjustments of liabilities on account of warrants issued in the private and direct placements conducted in February 2012 and 2013. These fair-value adjustments were highly influenced by the Company’s share price at each period end (i.e., warrant revaluation date).

Net financial income amounted to $0.4 million for the year ended December 31, 2015, compared to net financial income of $3.1 million for the year ended December 31, 2014. Net financial income for 2015 primarily relates to investment income earned on bank deposits, partially offset by banking fees. The 2014 period also includes significant exchange rate differences primarily relating to changes in the USD/NIS exchange rate prior to adoption of the dollar as the Company’s functional and reporting currency, effective as of January 1, 2015.

The Company’s net loss for the year ended December 31, 2015 amounted to $14.4 million, compared with a net loss of $11.1 million for the year ended December 31, 2014.

The Company held $47.7 million in cash, cash equivalents and short-term bank deposits as of December 31, 2015.

Net cash used in operating activities for the year ended December 31, 2015 was $14.2 million, compared to $15.8 million for the year ended December 31, 2014. The decrease in net cash used in operating activities in 2015 was primarily the result of a decrease in the Company’s operating loss.

Net cash used in investing activities for the year ended December 31, 2015 was $15.6 million, compared to $19.7 million for the year ended December 31, 2014. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the year ended December 31, 2015 was $29.5 million, compared to $32.6 million for the year ended December 31, 2014. The cash flows in 2015 primarily reflect the underwritten public offering of the Company’s ADSs in March 2015. The cash flows in 2014 primarily reflect the underwritten public offering of the Company’s ADSs in March 2014, as well as the investment made by Novartis pursuant to the strategic collaboration agreement with them signed in December 2014.