On March 30, 2017 Samus Therapeutics, Inc. ("Samus" or the "Company"), a privately held Boston-based biopharmaceutical company developing novel therapeutics and diagnostics targeting the epichaperome reported the launch of an expanded development program for the Company’s lead anti-epichaperome candidates, including PU-H71 in various cancers and PU-AD in neurodegenerative diseases (Press release, Samus Therapeutics, MAR 30, 2017, View Source [SID1234519320]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Samus was established in concert with the Memorial Sloan Kettering Cancer Center (MSKCC) in 2011 by Larry Norton, MD, and Gabriela Chiosis, PhD, based on research from the Chiosis Laboratory at the Sloan Kettering Institute ("SKI"), together with collaborators at Rockefeller University and Weill Cornell Medicine. Jonathan Lewis, MD, PhD, was recruited to Samus in 2016 to serve as Executive Chairman and Chief Executive Officer to lead and accelerate the development of the Company’s epichaperome platform.

Epichaperomes are foundational protein complexes that emerge from multiple diseases, including cancer and neurological disorders, the Company’s initial areas of focus. Following various forms of cellular stress, chaperome units are rewired into the epichaperome network. Targeting the epichaperome in cancer results in cell death, and, in neurodegenerative diseases, neuronal survival, with no effect in normal cells. Recent, seminal research on the molecular characteristics and composition of the epichaperome and PU-H71 in cancer were published by the Chiosis lab in the journal Nature (Rodina, A. et al., 538, 397–401, 20 October 2016). This research revealed a direct correlation between the abundance of epichaperomes in cancer cells, and their responsiveness to the cell killing effects of PU-H71, in a manner that is independent of the mutational diversity of the tumor cells, suggesting that PU-H71 may have activity in a wide range of human tumors.

"Samus Therapeutics was founded on novel insights into the structure and function of the epichaperome complex, the modulation of which has been shown to have profound and highly specific effects in preclinical models of cancer, neurodegenerative and other diseases," said Dr. Lewis. "These insights have translated into meaningful and durable results in early clinical Page 2 of 4 study, including responses lasting greater than 24 months in patients with myelofibrosis who stopped responding to ruxolitinib.

" Dr. Lewis added: "We are extremely excited to further elucidate these seminal insights and early results in studies conducted under the support and leadership of Drs. Larry Norton, James Armitage, and Daniel Von Hoff, who will focus on breast, hematologic, and pancreatic cancers, respectively. We also look forward to leveraging the deep experience and expertise of Dr. Geoffrey Ling in neurological disease by exploring the tremendous potential of antiepichaperome small molecules in this challenging and vastly underserved area of medical need."

The Company’s advisors are each a preeminent thought leader in their area of study,
• Larry Norton, MD, is Deputy Physician-in-Chief for Breast Cancer Programs, Medical Director of the Evelyn H. Lauder Breast Center and Norma S. Sarofim Chair in Clinical Oncology.
• Gabriela Chiosis, PhD, is a Member in the Chemical Biology Program of SKI and a TriInstitutional Professor at Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine and Rockefeller University.
• James Armitage, MD, is the Joe Shapiro Professor of Medicine, Division of Oncology & Hematology, at the University of Nebraska Medical Center; and former Dean, University of Nebraska Medical School.
• Daniel D. Von Hoff, MD, is the Physician in Chief, Distinguished Professor, Translational Research at the Translational Genomics Research Institute ("TGen") Senior Consultant, Clinical Investigations for the City of Hope, and Professor of Medicine at the Mayo Clinic.
• Geoffrey Ling, MD, PhD, is Professor of Neurology at the Johns Hopkins School of Medicine, and the former Director of the DARPA Biological Technologies Office, and professor and Acting Chair of the Department of Neurology at the Uniformed Services University of the Health Sciences.

Clinical Development Programs in Cancer and Neurodegenerative Disease

PU-H71, the Company’s lead program targeting the epichaperome network, has demonstrated potent anticancer activity in preclinical in vitro and in vivo studies, including both therapeutic synergy, and reversal of resistance, in combination with multiple standard of care therapies. A Phase 1 study, conducted under an MSKCC-initiated investigational new drug application (IND), has been completed, identifying a maximum tolerated dose, establishing a well-tolerated toxicity profile, and demonstrating activity supporting further combination clinical study.
The Company announces today the launch of several studies in cancer including:
• A Phase 1b/2 combination study in myelofibrosis under a second Company IND, expected to be filed in early Q2. In Phase 1, treatment with PU-H71 demonstrated durable results (>24 months) in this indication in patients who had previously failed ruxolitinib;
• A Phase 1b combination study in advanced breast cancer at MSKCC, with the first patient expected to be treated in early Q2; •
A Phase 1b combination study in chemo-naïve front-line metastatic pancreatic cancer under the Company’s first IND, recently accepted by the U.S. Food and Drug Administration (FDA), with the first patient expected to be treated early Q2.

A companion diagnostic for determining patient selection, response to treatment and dose and schedule, PU-H71-PET, is also being explored in an ongoing Phase 1 study, and the Company Page 3 of 4 is developing a companion diagnostic for in vitro measurement of circulating epichaperome positive cells in blood by flow cytometry ("PU-CYT"). Further, the Company is evaluating trials in other hematologic cancers, and the Chiosis lab was recently awarded a SKI "Big Bet" grant for the study of epichaperome inhibitors in combination with immunotherapy in oncology.

Samus’ second anti-epichaperome small molecule, PU-AD, along with the diagnostic PU-ADPET, are expected to move into neurodegenerative disease-directed clinical studies, including Alzheimer’s disease and chronic traumatic encephalopathy ("CTE"). A Phase 1 positron emission tomography ("PET") diagnostic study is currently active and recruiting Alzheimer’s patients at MSKCC, which the Company expects to expand to include patients with CTE. The Company expects to file an IND for the PU-AD therapeutic and diagnostic in neurodegenerative disease, and an exploratory Phase 1 clinical study for CTE with outside collaborators is currently in the planning stage.

The development of Samus’ candidates will be led by a deeply experienced management and advisory team, including Dr. Lewis, who brings more than 20 years of experience in leadership roles in biotechnology and medicine, Dick Bagley, President and Chief Financial Officer, who has over 40 years of senior leadership in both pharma and biotechnology, and senior level professionals with experience in translational research, clinical trial design and execution, manufacturing, quality control, intellectual property, and global regulatory approvals.

On March 31 2017 Johnson & Johnson (NYSE: JNJ) reported that its Swiss subsidiary, Janssen Holding GmbH ("Janssen"), published the provisional notice of the interim result of its all-cash public tender offer in Switzerland to acquire all publicly held shares of Actelion Ltd (("Actelion") SIX:ATLN) for $280 per share, payable in U.S. dollars, per the offer prospectus of February 16, 2017 (Press release, Actelion, MAR 30, 2017, View Source [SID1234518407]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At the expiration of the main offer period on March 30, 2017, 10:00 a.m. EDT, 4:00 p.m. CEST, a total of 78,629,955 Actelion shares were tendered, corresponding to 73.25% of the 107,339,642 Actelion shares covered by the tender offer. Including the Actelion shares tendered, Janssen and Actelion, a person acting in concert with Janssen, held as of the end of the main offer period 83,195,346 Actelion shares, corresponding to 77.20% of the voting rights and the share capital of Actelion.

Subject to the satisfaction of certain conditions, Janssen has declared the tender offer successful. The additional acceptance period of ten trading days (at the SIX Swiss Exchange) for the subsequent acceptance of the tender offer will commence on April 6, 2017 and expire on April 21, 2017, 10:00 a.m. EDT, 4:00 p.m. CEST.

Johnson & Johnson also announced that the applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to Janssen’s proposed acquisition of Actelion have either expired or been terminated early. The Japan Fair Trade Commission and the Israeli Antitrust Authority have cleared the proposed acquisition of Actelion.

Based on the current understanding of the regulatory approval proceedings in different jurisdictions, the settlement of the tender offer is expected to occur, subject to the satisfaction of all relevant conditions to the tender offer, including regulatory approvals, in the second quarter of 2017.

As previously announced, as part of the transaction, Actelion will spin out its drug discovery operations and early-stage clinical development assets into a newly created Swiss biopharmaceutical company ("Idorsia Ltd"). The shares of Idorsia Ltd are expected to be distributed to Actelion’s shareholders as a dividend in kind and listed on the SIX Swiss Exchange on the day of the settlement of the tender offer. Johnson & Johnson will initially hold 16 percent of the shares of Idorsia Ltd and have rights to potentially increase to 32 percent through a convertible note.

On March 29, 2017 Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported financial results for the 12 months ended December 31, 2016 (Press release, Delcath Systems, MAR 29, 2017, View Source;p=RssLanding&cat=news&id=2257229 [SID1234518333]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights for the fourth quarter of 2016 and recent weeks include:

Fourth quarter 2016 revenue increased 54.0% to $0.7 million and full year 2016 revenue increased 18% to $2.0 million;
Fully established national reimbursement coverage in Germany under ZE system;
Significantly expanded the number of clinical sites for the Company’s global Phase 3 clinical trial for patients with hepatic dominant ocular melanoma (the FOCUS Trial);
Announced a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of a pivotal trial of Melphalan/HDS to treat patients with intrahepatic cholangiocarcinoma (ICC);
The American Journal of Clinical Oncology published a single-center retrospective review finding that the Company’s investigational percutaneous hepatic perfusion (PHP) with Melphalan/HDS offered promising results with a doubling of overall survival and significantly longer progression-free survival (PFS) and hepatic progression-free survival (HPFS) compared with other targeted therapies; and
Favorable data from two institutions were presented at the Regional Cancer Therapies Symposium and showed strong tumor response and overall survival with the Company’s investigational PHP therapy in patients with ocular melanoma that metastasized to the liver.
"Fiscal year 2016 was devoted to the advancement of our global FOCUS Trial in ocular melanoma liver metastases as well as other important clinical initiatives for our Melphalan/HDS as a treatment for primary and metastatic liver cancers, while at the same time we continued to facilitate the commercial availability of CHEMOSAT in Europe," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Office of Delcath.

"Our FOCUS Trial was initiated in January 2016 under an SPA with the FDA to evaluate Melphalan/HDS as a treatment for ocular melanoma that has metastasized to the liver. During the year we activated more than 20 leading U.S. and European cancer centers as participating clinical sites in this study. We plan to have approximately 40 sites activated by the end of summer 2017.

"In addition, we recently announced a new SPA with the FDA for the initiation of a pivotal trial for the use of Melphalan/HDS in patients with ICC. This new trial will enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe, with the primary endpoint of overall survival and secondary and exploratory endpoints including safety, progression-free survival, overall response rate and quality-of-life measures. We’ve designed this trial to be cost effective and intend to pursue it in a financially prudent manner. Given the sequential nature of the trial design, our investment in this study will be modest in 2017 as the Melphalan/HDS segment of the study will not occur until late in the year.

"In Europe, we continued to grow revenue and focus our efforts on obtaining favorable reimbursement in key markets. We believe our ZE national reimbursement in Germany, along with the continued presentation and publication of data supporting the use of CHEMOSAT by leading clinical experts validates our access efforts in other markets across Europe.

"During the year we also secured committed financing through a securities purchase agreement with an institutional investor to issue $35 million of senior convertible notes and common stock purchase warrants. Assuming all conditions are satisfied, we expect the quarterly releases of capital throughout 2017 will fund our clinical development plan through the end of the year, while also supporting our commercial activities in Europe.

"The commercial and clinical progress made throughout 2016 has been steady and we look forward to expanding access to our potentially life-saving PHP therapy for patients around the world afflicted with primary and metastatic liver cancer," concluded Dr. Simpson.

2016 Financial Results

Total revenue for 2016 of $2.0 million increased 18% from $1.7 million for 2015. Selling, general and administrative expenses for 2016 decreased to $9.4 million from $10.0 million in 2015. For 2016, research and development expenses increased to $8.4 million from $6.5 million in 2015. Total operating expenses for 2016 were $17.9 million compared with $16.5 million for 2015.

The Company reported a net loss for 2016 of $18.0 million or $10.59 per share based on 1.7 million weighted average common shares outstanding, compared with a net loss for 2015 of $14.7 million or $14.56 per share based on 1.0 million weighted average common shares outstanding. The increase is primarily due to a $14.3 million increase in interest expense primarily related to the amortization of debt discounts, a non-cash item, and a $1.4 million increase in operating expenses primarily related to increased investment in clinical trial initiatives. This was offset by a $12.2 million change in the fair value of the warrant liability, a non-cash item, and a $0.2 million improvement in gross profit due to higher sales.

Balance Sheet Highlights

As of December 31, 2016, Delcath had cash and cash equivalents of $4.4 million, compared with $12.6 million as of December 31, 2015. During 2016 the Company used $14.2 million of cash to fund operating activities. Delcath believes it has sufficient capital and access to committed capital to fund its operating activities through the first quarter of 2018.

(Filing, Annual, Rosetta Genomics, 2016, MAR 29, 2017, View Source [SID1234518386])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On March 29, 2017 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) reported business and financial highlights for the fourth quarter and year ended December 31, 2016 (Press release, Navidea Biopharmaceuticals, MAR 29, 2017, View Source;p=RssLanding&cat=news&id=2257395 [SID1234518381]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

2016 Top Highlights

Achieved $1 million in Lymphoseek (technetium Tc 99m tilmanocept) injection commercial milestones upon sale of 100,000th patient dose and receipt of European approval to manufacture a reduced-mass vial
Completed sale of Lymphoseek to Cardinal Health 414, LLC ("Cardinal Health 414") and received approximately $83 million in upfront payments including an advance of $3 million of future earnout payments, with up to $227 million in potential additional earnout payments through 2026
Initiated intravenous ("IV") dose escalation Phase 1 imaging/disease-finding study in rheumatoid arthritis ("RA") of ten cohorts with three dose cohorts completed with major escalations and imaging of active RA
Completed nine-subject cardiovascular imaging disease-finding study in HIV/CV patients and published clinical results in The Journal of Infectious Diseases
Awarded $1.8 million Fast-track Small Business Innovation Research ("SBIR") Grant for Manocept-based treatment for Kaposi’s Sarcoma ("KS")
Appointed Michael M. Goldberg, M.D., as President and Chief Executive Officer and Eric K. Rowinsky, M.D., as Chairman of the Board of Directors
Business and Product Development Update

This past year and first quarter of 2017 were positively transformative for us. We refocused Navidea from investing in developing the commercial infrastructure to sell its sole commercial imaging product to a late-stage development company focused on several very large imaging market opportunities, and through its Macrophage Therapeutics, Inc. ("MT") subsidiary successfully advanced a number of novel immunotherapy products through proof of concept studies in animals. In the process, we transformed our capital structure by paying down our high interest and very covenant restrictive debt. The Company has gone from losing close to $28 million in 2015 to a net loss of $14 million in 2016 to operating at cash flow positive projected for 2017 not including discretionary research projects. Furthermore the Company, which had no excess cash flow for discretionary, non grant related research, now has sufficient cash to advance all of our existing imaging and MT ongoing initiatives.

While transforming our business model, balance sheet and income statements, we made significant progress with our technology and pipeline. We are fortunate that both our imaging and therapeutic product candidates are based on the same drug delivery system that targets activated macrophages, even when an additional agent is chemically attached. In humans, we advanced two new delivery approaches and confirmed their utility when dosed subcutaneously or intravenously. In animals, we initiated development of an oral delivery formulation for our therapeutic product candidates.

Additionally, we confirmed that in humans we can target the classically-activated or M1 macrophage in patients with RA and atherosclerosis. This is a major advance, as the alternative activation state, or M2 macrophage, is well known to have significantly higher cell surface expression of the mannose receptor (CD206) than the M1 macrophage in the activated state. Clinical results clearly demonstrate sufficient CD206 expression on M1 activated macrophages to target this receptor with our technology. Our animal studies confirmed as well that targeting either M1 or M2 macrophages implicated in disease is feasible with the appropriate therapeutic linked to our delivery system. In animal models we verified the activity of our product candidates in both M1-based diseases as well as M2-based diseases. Finally, working with various academic groups we demonstrated that by targeting the host macrophage that acts as an incubator we can eliminate viral reservoirs containing Zika, dengue, human immunodeficiency virus ("HIV"), human herpesvirus 8 ("HHV8"), and other infectious agents such as leishmaniosis. We are also currently working with National Institutes of Health ("NIH")-funded labs, at no cost to Navidea, to explore our antiviral and anti-infective performance in appropriate animal models.

Financial Results

Revenues for the year ended December 31, 2016 were $22.0 million compared to $13.2 million for 2015. Navidea’s revenues for 2016 consisted of $17.0 million in sales of Lymphoseek, $3.1 million from various federal grants and other revenue, and $1.8 million related to license agreements, compared to $10.3 million, $1.9 million and $1.1 million, respectively, for 2015.

Operating expenses for the year ended December 31, 2016 were approximately $21.9 million compared to $30.0 million for 2015. Research and development expenses were $8.9 million during 2016 compared to $12.8 million during 2015. The net decrease was primarily a result of reductions in NAV4694, Lymphoseek and NAV5001 product development costs coupled with reduced headcount and related support costs, offset by increased Manocept diagnostic and therapeutic product development costs. Selling, general and administrative expenses were approximately $13.0 million for 2016 compared to $17.3 million for 2015. The net decrease was primarily due to reduced headcount and related support costs, contracted medical science liaisons, business development consulting services, market development expenses related to Lymphoseek, and investor relations, offset by increased legal and professional services.

Navidea’s loss from operations for the year ended December 31, 2016 was $2.2 million compared to $18.6 million for 2015. For the year ended December 31, 2016, Navidea reported a loss attributable to common stockholders of $14.3 million, or $0.09 per share, compared to a loss attributable to common stockholders of $27.6 million, or $0.18 per share, for the same period in 2015.

Revenues for the fourth quarter of 2016 were $3.4 million compared to $4.3 million for the same period in 2015. Navidea’s revenues for the fourth quarter of 2016 consisted of $2.3 million in sales of Lymphoseek and $1.0 million from various federal grants and other revenue, compared to $3.5 million and $541,000, respectively, coupled with $250,000 related to license agreements, for the same period in 2015. Additionally, approximately $2 million in sales of Lymphoseek to Cardinal Health 414 recorded in the third quarter of 2016 was accelerated to help facilitate the transaction that was ultimately closed in March 2017. Without acceleration of such, the related sales would have occurred in the fourth quarter of 2016.

Fourth quarter 2016 operating expenses were $5.5 million compared to $6.4 million for the fourth quarter of 2015. Research and development expenses were $2.4 million during the fourth quarter of 2016 compared to $2.6 million during the fourth quarter of 2015. The net decrease from 2015 to 2016 was primarily a result of reduced headcount and related support costs coupled with decreased NAV4694 product development costs, offset by increased Manocept diagnostic and Lymphoseek product development costs. Selling, general and administrative expenses were $3.1 million for the fourth quarter of 2016 compared to $3.8 million for the same period in 2015. The net decrease was primarily due to reduced headcount and related support costs, market development expenses related to Lymphoseek and investor relations, offset by increased legal and professional services.

Navidea’s loss from operations for the fourth quarter of 2016 was $2.4 million compared to $2.6 million for the fourth quarter of 2015. For the fourth quarter of 2016, Navidea reported a loss attributable to common stockholders of $3.9 million, or $0.02 per share, compared to a loss attributable to common stockholders of $2.5 million, or $0.02 per share, for the fourth quarter of 2015.

Detailed Highlights

Navidea and Cardinal Health 414
Completed sale of Lymphoseek to Cardinal Health 414 for lymphatic mapping, lymph node biopsy and the diagnosis of metastatic spread to lymph nodes for the staging of cancer in North America
Received approximately $83 million in upfront payments including an advance of $3 million of future earnout payments, with up to $227 million in potential additional earnout payments through 2026, $17.1 million of which is guaranteed over the next three years
CRG et al
Entered into a Global Settlement Agreement between the Company, MT, Capital Royalty Partners II L.P. and its affiliates ("CRG"), and Cardinal Health 414 in which Navidea repaid $59 million (the "Deposit Amount") of its indebtedness and other obligations outstanding under the CRG Term Loan.
Platinum et al
Concurrently with payment of the Deposit Amount to CRG, the Company also paid to Platinum Partners Credit Opportunities Master Fund, LP ("PPCO") an aggregate of $7.7 million in partial satisfaction of the Company’s liabilities, obligations and indebtedness under that certain Loan Agreement, dated July 25, 2012 (as amended) by and between the Company and Platinum-Montaur Life Sciences, LLC, which, to the extent of such payment, were transferred by Platinum-Montaur to PPCO. Approximately $1.9 million remains outstanding under the Platinum Loan Agreement.
U.S. Food and Drug Administration ("FDA")
Held several discussions/meetings with the FDA significantly expediting development and approval timelines for Manocept-RA disease-finding approaches to rheumatoid arthritis
Cardiovascular ("CV") Initiative
Completed nine-subject cardiovascular imaging disease-finding study in HIV/CV patients
Presented clinical results at CROI-2017 and published in the Journal of Infectious Disease
Additional planned studies include a large potential partner evaluating product in their proprietary animal models
Rheumatoid Arthritis
Completed 18-subject subcutaneous ("SC") Manocept RA study
Initiated RA intravenous ("IV") dose escalation Phase 1 imaging/disease-finding study of 10 cohorts with three dose cohorts completed with major escalations and imaging of active RA
Appointed strategic clinical and regulatory consulting firm to optimize clinical development plan for RA imaging candidate
Non-Alcoholic Steatohepatitis (NASH) Therapy
Completed three in vivo studies employing two Manocept conjugate agents and three different dosing regimens demonstrating effectiveness at preventing non-alcoholic fatty liver disease ("NAFLD") progression to NASH and NASH’s progression to liver cirrhosis
A poster presentation on certain of our NASH results will be presented at a meeting next week and will be posted on the MT website
Cancer Therapy
Completed three preclinical studies, two single agent and one in combination with a well-established therapeutic antibody (two confirmatory in vivo studies – murine human tumor model). All three studies confirmed a positive impact on the tumor progression and inhibition/tumor kill.
Cancer Imaging to Treatment
Colorectal Cancer and Liver Cancer – completed preclinical testing for the requirements to administer the Manocept imaging agent for colorectal cancer and colorectal cancer with synchronous liver metastases.
Cervical Cancer – completed a significant portion of the clinical testing for a new indication for imaging of metastatic disease (lymph node metastasis) in cervical cancer. Navidea’s portion of the study will be completed in Q1 2017.
Lipid Storage Disease (Neuro)
Initiated in vitro cell culture study in which Manocept conjugates demonstrated substantial protective effect of glial cells exposed to toxic metabolite
Anti-Infectives
Zika Virus – Initiated and completed four in vitro studies in human tissue demonstrating a highly effective reduction in Zika infectivity and antiviral activity by multiple Manocept conjugates
Dengue Virus – Initiated and completed four in vitro studies in human tissue demonstrating a highly effective reduction in dengue infectivity and antiviral activity by multiple Manocept conjugates
Leishmaniosis – Initiated and completed two in vivo studies demonstrating a highly effective targeting in Leishmaniosis infectivity and parasite activity by multiple Manocept conjugates
Cytomegalovirus ("CMV") – Held discussions with NIH/NIAID on testing of key Manocept conjugates in CMV infection and disease progression with preclinical studies to be initiated in H2 2017
Kaposi’s Sarcoma
Received NIH/NCI funding to support the therapeutic development of anticancer (Anti-KS) Manocept conjugates
Phase 1 of the grant completed and Phase 2 clinical protocols are IRB-approved with study initiation anticipated shortly
Human Herpes Virus 8 – The testing of Manocept agents against HHV8 are an integral part of the Kaposi’s Sarcoma therapy initiatives
Human Immunodeficiency Virus – The testing of Manocept agents against HIV is an integral part of the KS therapy initiatives
Completed Preclinical FDA requirements for IV administration of tilmanocept for all radio-diagnostic applications
Inflammatory Bowel Disease and Crohn’s Disease ("BD/C")
Initiated partnership with major pharma group to assess the efficacy of Manocept conjugates in appropriate in vivo models with results anticipated in the coming months.