On May 26, 2016 Amgen (NASDAQ:AMGN) reported that the Kyprolis Global Economic Model (K-GEM)1 has been published in the Journal of Medical Economics showing that in the United States (U.S.), Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone (KRd) is cost-effective compared to lenalidomide and dexamethasone (Rd) alone in patients with relapsed or refractory multiple myeloma (Press release, Amgen, MAY 26, 2016, View Source;p=RssLanding&cat=news&id=2172860 [SID:1234512822]). The K-GEM demonstrated an incremental cost-effectiveness ratio of $107,250 per Quality-Adjusted Life Year (QALY). Kyprolis provides substantial value when its cost per QALY is contrasted against willingness-to-pay estimates of $150,000-$300,000 per QALY, which are cited as reasonable benchmarks for cancer in the U.S.2-4

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"We recognize that there are different methods, assumptions and perspectives needed to assess the value of innovation," said Joshua Ofman, M.D., M.S.H.S., senior vice president of Global Value and Access at Amgen. "The K-GEM was developed with input from experts worldwide as one of the multiple perspectives needed to assess value. Robust analysis, relying on clinical trial data to assess cost-effectiveness analysis is one approach that can help inform payer and provider decision-making related to value and costs. Ultimately, individual patient treatment decisions for diseases like multiple myeloma should be made by doctors and their patients, based on sound clinical data and evidence-based practice guidelines."

"Each time a patient with multiple myeloma experiences a relapse, the ability to achieve and sustain a meaningful response to treatment declines, so we continue to seek better ways of treating patients with this complex disease.5 For the healthcare system, each relapse means the disease burden and cost of care increases," said Andrzej Jakubowiak, M.D., Ph.D., lead author of the manuscript. "The rigorous approach taken in the K-GEM demonstrates the economic value of the KRd regimen over standard of care, with clear evidence of compelling value for patients, payers and society."

The K-GEM incorporated data directly from a head-to-head Phase 3 trial (ASPIRE) in patients with relapsed or refractory multiple myeloma who had received one to three prior therapies. The ASPIRE trial showed that treatment with KRd resulted in a significant improvement (additional 8.6 months) in median progression-free survival (PFS) compared to Rd (26.3 months vs. 17.6 months, hazard ratio for progression or death = 0.69; 95 percent confidence interval [CI]: 0.57 to 0.83; p<0.0001).6 The most common adverse reactions leading to discontinuation in the KRd arm included pneumonia (1 percent), myocardial infarction (0.8 percent) and upper respiratory tract infection (0.8 percent). A critical assumption in economic models of cancer and also the K-GEM, where trial results have not matured sufficiently to fully characterize the extent of survival, is the extrapolation of overall survival. While a common evidence-based practice in health economics, it should not be considered a claim of extended survival.

About the Kyprolis Global Economic Model
The Kyprolis Global Economic Model (K-GEM) provides a robust framework for considering the value of Kyprolis in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. It was co-developed with experts worldwide over a number of years, and has been used as the basis for a number of statutory Health Technology Assessment analyses around the world. The K-GEM incorporated data directly from a comparative Phase 3 trial (ASPIRE) in patients with relapsed multiple myeloma who had received one to three prior therapies.

About ASPIRE
The international, randomized Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial evaluated Kyprolis in combination with lenalidomide and dexamethasone (KRd), versus lenalidomide and dexamethasone (Rd) alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens.6 The primary endpoint of the trial was PFS, defined as the time from treatment initiation to disease progression or death.6 Secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DOR), disease control rate, health-related quality of life (HR-QoL) and safety.6 Patients were randomized to receive Kyprolis (20 mg/m2 on days 1 and 2 of cycle one only, escalating to 27 mg/m2 on days 8, 9, 15 and 16 of cycle one and continuing on days 1, 2, 8, 9, 15 and 16 of subsequent cycles), in addition to a standard dosing schedule of lenalidomide (25 mg per day for 21 days on, 7 days off) and low-dose dexamethasone (40 mg per week in four-week cycles), versus lenalidomide and low-dose dexamethasone alone.6 The study randomized 792 patients at sites in North America, Europe and Israel.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.7 It is a disease that, in 2012, accounted for approximately one percent of all cancers globally.8,9 In the U.S., there were more than 95,000 people living with, or in remission from, multiple myeloma in 2013.10

About Amgen’s Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen’s supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.

About Kyprolis (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.11 Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.11 In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.11,12 The irreversibility of Kyprolis’ binding has also been shown to offer a more sustained inhibition of the targeted enzymes.12

Kyprolis is approved in the U.S. for the following:

In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
Kyprolis is also approved in Argentina, Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada, Switzerland and Russia and the European Union. Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.

For more information, please visit www.kyprolis.com.

Important Safety Information Regarding Kyprolis (carfilzomib) for Injection

INDICATION(S)

KYPROLIS (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
KYPROLIS (carfilzomib) is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
IMPORTANT SAFETY INFORMATION

Cardiac Toxicities

New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of KYPROLIS administration.
Monitor patients for clinical signs or symptoms of cardiac failure or cardiac ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart KYPROLIS at 1 dose level reduction based on a benefit/risk assessment.
While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate in patients with baseline cardiac failure or who are at risk for cardiac failure.
Patients > 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment (including blood pressure and fluid management) prior to starting treatment with KYPROLIS and remain under close follow-up.
Acute Renal Failure

Cases of acute renal failure and renal insufficiency adverse events (including renal failure) have occurred in patients receiving KYPROLIS. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.
Tumor Lysis Syndrome

Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred in patients receiving KYPROLIS. Patients with multiple myeloma and a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly. Withhold KYPROLIS until TLS is resolved.
Pulmonary Toxicity

Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in patients receiving KYPROLIS. Some events have been fatal. In the event of drug-induced pulmonary toxicity, discontinue KYPROLIS.
Pulmonary Hypertension

Pulmonary arterial hypertension (PAH) was reported in patients treated with KYPROLIS. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart KYPROLIS based on a benefit/risk assessment.
Dyspnea

Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart KYPROLIS based on a benefit/risk assessment.
Hypertension

Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with KYPROLIS. Some of these events have been fatal. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart KYPROLIS based on a benefit/risk assessment.
Venous Thrombosis

Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed with KYPROLIS. Thromboprophylaxis is recommended for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient’s underlying risks.
Patients using oral contraceptives or a hormonal method of contraception associated with a risk of thrombosis should consider an alternative method of effective contraception during treatment with KYPROLIS in combination with dexamethasone or lenalidomide plus dexamethasone.
Infusion Reactions

Infusion reactions, including life-threatening reactions, have occurred in patients receiving KYPROLIS. Symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration of KYPROLIS. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms of an infusion reaction and to contact a physician immediately if they occur.
Thrombocytopenia

KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Thrombocytopenia was reported in patients receiving KYPROLIS. Monitor platelet counts frequently during treatment with KYPROLIS. Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure

Cases of hepatic failure, including fatal cases, have been reported during treatment with KYPROLIS. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate.
Thrombotic Microangiopathy

Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome have occurred in patients receiving KYPROLIS. Monitor for signs and symptoms of TTP/HUS. Discontinue KYPROLIS if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS therapy in patients previously experiencing TTP/HUS is not known.
Posterior Reversible Encephalopathy Syndrome (PRES)

Cases of PRES have occurred in patients receiving KYPROLIS. PRES was formerly known as Reversible Posterior Leukoencephalopathy Syndrome. Consider a neuroradiological imaging (MRI) for onset of visual or neurological symptoms. Discontinue KYPROLIS if PRES is suspected and evaluate. The safety of reinitiating KYPROLIS therapy in patients previously experiencing PRES is not known.
Embryo-fetal Toxicity

KYPROLIS can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals.
Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS. Males of reproductive potential should be advised to avoid fathering a child while being treated with KYPROLIS. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.
ADVERSE REACTIONS

The most common adverse events occurring in at least 20 percent of patients treated with KYPROLIS in the combination therapy trials: anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper respiratory tract infection, hypokalemia.
The most common adverse events occurring in at least 20 percent of patients treated with KYPROLIS in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.
Please see full Prescribing Information at www.kyprolis.com.

On May 26, 2016 OncoResponse, an immuno-oncology antibody discovery company, reported an investment from Baxalta Incorporated (NYSE: BXLT) (Press release, OncoResponse, MAY 26, 2016, View Source [SID1234522899]). In October 2015, OncoResponse closed a Series A financing co-led by ARCH Venture Partners, Canaan Partners and MD Anderson, with William Marsh Rice University and Alexandria Real Estate Equities also participating . The investment by Baxalta brings the total Series A to $12.5 million and will be used to support OncoResponse’s ongoing efforts to interrogate the humoral response of elite responders to cancer immunotherapy to identify antibodies and potential targets for novel therapeutic development.

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OncoResponse utilizes a validated platform technology to rapidly screen antibodies made by the human immune system and identify those with exceptional reactivity to cancer immunotherapy. The company has an ongoing strategic alliance with the MD Anderson Cancer Center, which provides access to patient samples and oncology and translational medicine expertise including clinical and regulatory input.

"We are pleased to welcome Baxalta to our solid team of investors," said Clifford J. Stocks, CEO of OncoResponse. "Our current partnership with MD Anderson has seen significant progress, and this additional investment reinforces our continued commitment to the identification of rare cancer-fighting antibodies and novel targets that may lead to the development of improved cancer treatments."

"This investment will assist OncoResponse in the advancement of its research programs which seek to develop a deeper understanding of the immune response in patients who have responded exceptionally well to cancer immunotherapy," said Geeta Vemuri, PhD, Managing Venture Partner at Baxalta. "Their innovative approach is in line with Baxalta’s investment strategy to accelerate the development of cuttingedge biotechnologies that address unmet patient needs in hematology, immunology and oncology."

On May 26, 2016 Cancer Research Technology and Pangaea Biotech reported to sign license agreement for new cancer drugs (Press release, Cancer Research Technology, 26 26, 2016, View Source [SID1234523185]).

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These promising new drugs have been developed by scientists at CRT’s Discovery Laboratories with support from Cancer Research UK-funded scientists at King’s College London.

PAK is involved in cell growth and survival and is overexpressed in many cancers including ovarian, breast, pancreatic, melanoma and lung. Scientists hope that the PAK inhibitors will block the activity of overexpressed PAK protein – killing cancer cells. Although researchers have linked PAK with tumour development, there are no approved compounds available on the market.

Under the terms of the agreement, Pangaea Biotech will be responsible for research and development of the PAK inhibitors, taking CRT’s compounds through clinical development. CRT will receive undisclosed upfront and downstream payments.

CRT and Pangea Biotech will work collaboratively to complete lead optimisation, then Pangaea will assume responsibility for pre-clinical and clinical development.

Javier Rivela, CEO of Pangaea Biotech, said: "This strategic agreement maximises the capabilities of both parties, with CRT focusing on the earlier stages of development involving specialised medicinal chemistry work, and Pangaea on regulatory preclinical development, early stage clinical trials and development of biomarkers, where our main abilities and experience lie.

"We are excited about this partnership as it marks the beginning of what we expect to be a fruitful long-term collaboration with one of the most important global players in cancer drug development."

Dr Phil L’Huillier, CRT’s director of business management, said: "It’s fantastic to see this new investment in Cancer Research UK-funded science that has progressed through our Discovery Laboratories. We look forward to working with Pangaea to develop the PAK inhibitor for clinical trials."

CRT’s Discovery Laboratories build on Cancer Research UK’s investment in world-class research and focus on forming drug discovery alliances with industry, to develop potential novel therapies based on the cancer targets identified in academic research.

On May 26, 2016 Caladrius Biosciences, Inc. (NASDAQ:CLBS) ("Caladrius" or the "Company"), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, reported that it has licensed to AiVita Biomedical, Inc. ("AiVita") the exclusive global rights to its tumor cell/dendritic cell technology for the treatment of ovarian cancer (Press release, Caladrius Biosciences, MAY 26, 2016, View Source [SID1234528899]). In return, Caladrius will receive certain development milestone payments as well as royalties on sales of any commercial product. This transaction supports the Company’s strategy to monetize non-core assets. Under the license agreement AiVita will assume responsibility for all costs to develop a product using the licensed intellectual property, including the maintenance costs of the associated intellectual property.

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The license contributes to AiVita’s intellectual property protection for its next generation immunotherapy targeting cancer stem cells. AiVita intends to begin a Phase II clinical trial to evaluate the efficacy of its novel appoach for ovarian cancer in 2016. To facilitate these clinical objectives, AiVita has also assumed a sublease of the Company’s former Irvine, California facility. This sublease obligation will cover for the remainder of the lease term all cash obligations of Caladrius with respect to the rent and overhead of the Irvine facility.

"Licensing this technology to AiVita is another step forward in streamlining our strategic focus and reducing our operating expenses while monetizing non-core assets through royalty and other milestone-driven transactions," said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. "This agreement adds to the one signed in February 2016 whereby we licensed to AiVita exclusive global rights to our cell-derived dermatological technology for topical skin applications."

On May 26, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) reported the receipt of an initial notice of award for a Fast- track Small Business Innovation Research (SBIR) grant providing for up to $1.8 million from the National Institutes of Health’s (NIH) National Cancer Institute (NCI) to fund evaluation of an investigational Manocept-based immunotargeted treatment for Kaposi’s Sarcoma (KS) (Press release, Navidea Biopharmaceuticals, MAY 26, 2016, View Source;p=RssLanding&cat=news&id=2172821 [SID:1234512817]).

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The novel Manocept construct is designed to specifically deliver doxorubicin, a chemotoxin, which can kill KS tumor cells and their tumor-associated macrophages (TAMs) potentially altering the course of cancer. KS is a serious and potentially life threatening illness in persons infected with the human immunodeficiency virus (HIV) and the third leading cause of death in this population worldwide. The prognosis for patients with KS is poor with high probabilities for mortality and greatly diminished quality of life. The development activities of the Manocept immunotherapeutic platform will be conducted by Navidea and its subsidiary, Macrophage Therapeutics.

The funds for this Fast-track grant (National Cancer Institute of the National Institutes of Health under Award Number R44CA206788) will be released in three parts, which together have the potential to provide up to $1.8 million in resources over 2.5 years with the goal of completing an investigational new drug (IND) submission for a Manocept construct (MT1000 class of compounds) consisting of tilmanocept linked to doxorubicin for the treatment of KS. The first part of the grant will provide $232,000 to support analyses including in vitro and cell culture studies and will be followed by Part 2 and 3 animal testing studies. If successful, the information from these studies will be combined with other information in an IND application that will be submitted to the U.S. Food and Drug Administration (FDA) requesting permission to begin testing the compound selected in human KS patients.

"We believe that given the data to date from the Manocept platform, these studies along with a host of other human tumor model studies ongoing and planned for animal testing will provide a powerful gateway to a new class of anti-TAM immunotherapies directed at solid tumors. A drug that selectively kills cells that are highly expressing CD206 is expected to have an overwhelming, immediate, conspicuous and easily measured effect on KS tumors," said Frederick Cope, Ph.D., M.S., F.A.C.N., C.N.S., Senior Vice President and Chief Scientific Officer of Navidea. "This grant will bring us to submission of an IND and the first time human evaluation for a Manocept immunotherapeutic. We anticipate if trials are successful, we can bring an effective and life-sparing new therapy to KS patients who are in desperate need for such a new treatment."

"The Manocept platform may offer a unique approach to the treatment of Kaposi’s sarcoma (KS) and is, we believe, a translational portal to the therapy of a number of other solid tumors in which macrophages and tumor-associated macrophages play a key role in tumorigenesis and metastasis," said Michael Goldberg, M.D. Chairman of the Board of Navidea, "We believe that KS serves as model for a development strategy that can be expanded to other macrophage-dependent solid tumors as well as a model for therapeutics targeting viruses that incubate in macrophages. We are encouraged that our therapeutic program has been recognized by the NIH so soon after we began our therapeutic development effort. We plan on submitting additional grant requests as soon as we obtain results from the multiple ongoing studies in various cancer models, which should read out shortly."

About the MT1001 Study Efforts in KS

These IND-enabling studies will be conducted in three parts. Part 1 studies require in vitro and cell culture experiments related to safety and efficacy of an intravenous injection of MT100. In Part 2 and 3, nine preclinical animal studies will build on the Part 1 results and will further refine safety and efficacy variables including dosing and drug administration regimens and evaluating the feasibility of the MT 1000-class of molecules, as a novel treatment for KS. Following these studies, Navidea expects to submit an IND application to the FDA seeking permission to begin Phase 1/2 clinical evaluation of MT1001 in KS patients.

About KS

Kaposi sarcoma (KS) is a serious and potentially life threatening illness in persons infected with the HIV, the causative agent of acquired immunodeficiency syndrome (AIDS). Tumor associated macrophages (TAMs) constitute an important tumor component for most types of cancer (including KS) that contributes to tumor growth and protection from immune responses. Navidea, through its subsidiary Macrophage Therapeutics, is developing a receptor targeted drug construct that may be able to effectively treat KS and could contribute to effective immunotherapy for a wide variety of cancers.

About the Manocept CD206-targeting platform

Navidea Biopharmaceuticals is developing Manocept, a new pharmaceutical platform technology, targeting cells that express the macrophage mannose receptor (CD206). A wide variety of immune-targeting applications for this platform technology are envisioned. Macrophages play important roles in many disease states and are an emerging target in many disorders. This flexible and versatile platform acts as an engine for purpose-built molecules that may enhance diagnostic accuracy, clinical decision-making, targeted treatments and ultimately patient care. As an immunodiagnostic tool, the Manocept technology can utilize a breadth of imaging modalities, including SPECT, PET, intra-operative and/or optical-fluorescence detection. By linking a therapeutic agent on the Manocept molecular backbone, there is the potential to develop novel, targeted immunotherapies specifically designed to selectively deliver an agent that can kill or alter disease-associated macrophages. MT1000 class of compounds , consisting of a Manocept construct linked to doxorubicin, is the first in a series of drug delivery constructs that will utilize Navidea’s Manocept CD206 targeted drug delivery platform. Navidea’s FDA-approved immunodiagnostic agent, Lymphoseek (technetium 99m tilmanocept) injection, is representative of the platform’s ability to successfully exploit this mechanism and offer the potential for development of new CD206-targeted immunodiagnostic agents and immunotherapeutics. The development activities of the Manocept immunotherapeutic platform will be conducted by Navidea‘s subsidiary, Macrophage Therapeutics.

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