On February 28, 2018 Navidea Biopharmaceuticals (NYSE MKT: NAVB) ("Navidea" or "the Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call on March 8, 2018 at 4:30pm E.T. to discuss its financial results for the fourth quarter and full year 2017, in conjunction with the filing of its annual report on Form 10-K for the fourth quarter and full year results ended December 31, 2017 (Press release, Navidea Biopharmaceuticals, FEB 28, 2018, View Source [SID1234524252]).

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Michael Goldberg, President and Chief Executive Officer, and Jed Latkin, Chief Financial and Operating Officer of Navidea, will host the call and provide an update on recent developments and clinical progress. Management will be answering questions live immediately following the earnings announcement part of the call.

To participate in the call, please dial +1 646-828-8143 (toll-free) in the U.S. and Canada. The conference ID number is 1826783.

Event: FY+ 2017 Earnings and Business Update Conference Call
Date: Thursday, March 8th, 2018
Time: 4:30pm E.T.
U.S. & Canada Dial-in: +1 646-828-8143 (toll free)
Conference ID: 1826783

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On february 28, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age‐related macular degeneration, reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, Tracon Pharmaceuticals, FEB 28, 2018, View Source [SID1234524975]).

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Fourth Quarter 2017 and Recent Corporate Highlights

In February, TRACON’s partner, Santen Pharmaceutical Co. Ltd. (Santen), reported Phase I/II data for DE‑122 (carotuximab) in patients with refractory wet age-related macular degeneration (AMD) at the 15th Annual Angiogenesis, Exudation, and Degeneration meeting organized by Bascom Palmer Eye Institute. The study assessed the safety, tolerability and bioactivity of a single intravitreal injection of DE-122 at four dose levels in 12 subjects with wet AMD refractory to vascular endothelial growth factor (VEGF) inhibitors. Improvement was observed in mean change in central retinal subfield thickness (CST) based on the spectral domain optical coherence tomography (SD-OCT) suggesting bioactivity of DE-122 in these refractory wet AMD patients. No serious adverse events were reported. Based on these results, Santen previously advanced DE-122 into a Phase 2a randomized controlled trial assessing the efficacy and safety of intravitreal injections in combination with Lucentis (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD that continues to enroll subjects, and which resulted in TRACON receiving a $7.0 million milestone payment.

In January, initial data from the ongoing open-label, non-randomized Phase 1b/2 study of TRC105 and Nexavar (sorafenib) in patients with advanced hepatocellular carcinoma (HCC) were presented by Dr. Kanwal Raghav from the University of Texas MD Anderson Cancer Center at the 2018 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. Partial responses by RECIST 1.1 occurred in 25% (2 of 8) of evaluable patients and a reduction of 50% or greater in alpha fetoprotein (AFP) concentration occurred in 38% (3 of 8) of evaluable patients, including both partial responses. Reduction in AFP, a tumor marker expressed in patients with HCC, in early treatment may help identify a favorable response to treatment. Adverse events typical of each drug were observed but did not increase in frequency or severity when the drugs were administered concurrently. The 25% response rate seen in this trial is consistent with the 25% (5 of 20) response rate reported in a Phase 1/2 trial of TRC105 and Nexavar conducted by the National Cancer Institute and published in Clinical Cancer Research in 2017. The response rates observed in both trials compare favorably with the 2% and 3% response rates in HCC patients reported for single agent Nexavar in its pivotal studies. The trial is currently ongoing, and we expect to complete the enrollment of approximately 33 patients by the end of 2018.

In December, TRACON licensed development and commercialization rights outside of ophthalmology indications to TRC105 in China, Hong Kong, Macau, and Taiwan to Ambrx. Deal terms included a $3.0 million upfront payment to TRACON, up to $140.5 million in development and commercial milestones and potential high single digit to low teen royalties from net sales of TRC105 in the Ambrx territories. Ambrx is expected to file an IND later this year and to subsequently begin clinical development of TRC105 in China.

In December, Brian Daniels, M.D., was appointed to TRACON’s Scientific Advisory Board. Dr. Daniels was Senior Vice President at Bristol-Myers Squibb until 2014, where he chaired the development investment committee and oversaw the development of Sprycel (dasatinib), Ixempra (ixabepilone), Yervoy (ipilumumab), Empliciti (elotuzumab), and Opdivo (nivolumab). He is currently a venture partner at 5AM Ventures, and previously held senior level development-related positions at Merck and Genentech. In addition, Dr. Daniels previously served in multiple academic roles in the Department of Medicine at the University of California, San Francisco.

In November, the first patient was dosed in a Phase 1b clinical trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer. The Phase 1b clinical trial is an open-label, dose-escalation and expansion cohort study of TRC105 and Opdivo in patients with non-small cell lung cancer that have received prior chemotherapy. The primary objectives of the Phase 1b study are to assess the safety of TRC105 when dosed with Opdivo, determine its recommended Phase 2 dose and evaluate the response rate. The trial incorporates tumor biopsy testing to determine if there is a correlation of tumor myeloid cell infiltration with response, in order to allow for potential biomarker-directed therapy in lung cancer patients.

In November, TRACON presented updated data from the Phase 1b/2 study of TRC105 and Votrient (pazopanib) in patients with soft tissue sarcoma, including angiosarcoma, at the Connective Tissue Oncology Society (CTOS) annual meeting. Median progression-free survival (PFS) was 7.8 months in 13 VEGF inhibitor naïve angiosarcoma patients treated with the combination of TRC105 and Votrient using either 10 mg/kg weekly dosing or the hybrid dosing schedule of TRC105. The reported median PFS compares favorably to the median PFS of 3 months reported in a retrospective study of single agent Votrient in patients with angiosarcoma. In the 17 patients who received prior treatment for metastatic disease, treatment duration on TRC105 and Votrient exceeded the duration of the most recent prior therapy in 7 of 12 VEGF naïve angiosarcoma patients and 2 of 5 patients who received a VEGF inhibitor as part of their most recent prior therapy. Treatment with the combination of TRC105 and Votrient continued to be well-tolerated and allowed for dosing of the combination for more than two years in the two patients who experienced complete responses to treatment.

Enrollment continues in the Phase 1/2 trial of TRC253, TRACON’s product candidate for treating prostate cancer that was in-licensed from Janssen. The Phase 1/2 trial is designed to assess the safety, determine a recommended Phase 2 dose and assess response by prostate-specific antigen (PSA) levels. If Janssen opts to reacquire TRC253 prior to or following completion of the Phase 1/2 trial, TRACON is entitled to receive a $45.0 million opt-in payment, up to $137.5 million in potential milestone payments and a low single digit royalty.
"We achieved important progress across our pipeline and continued to position the Company well for long-term success during the fourth quarter and throughout 2017," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Most importantly, our pivotal Phase 3 TAPPAS trial of TRC105 in angiosarcoma continues to enroll well across sites in the U.S. and now Europe, with the key interim analysis projected for later this year. Moreover, our recent partnership with Ambrx expands the development and potential commercial opportunity of TRC105 into China."

Expected Additional 2018 Milestones

Completion of the dose escalation portion of the Phase 1/2 trial of TRC253 in patients with prostate cancer is expected in mid-2018.

Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta for patients with advanced or metastatic renal cell carcinoma is expected in mid-2018.

Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in the second half of 2018.

Presentation of data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected in the second half of 2018.
Fourth Quarter 2017 Financial Results

Cash, cash equivalents and short-term investments were $34.5 million at December 31, 2017, compared to $44.4 million at December 31, 2016.

There was no collaboration revenue for the fourth quarter of 2017 compared to $0.6 million for the fourth quarter of 2016.

Research and development expenses for the fourth quarter of 2017 were $4.6 million compared to $4.8 million for the fourth quarter of 2016.

General and administrative expenses for the fourth quarter of 2017 were $1.7 million compared to $1.9 million for the fourth quarter of 2016.

Net loss for the fourth quarter of 2017 was $6.6 million compared to a net loss of $6.3 million for the fourth quarter of 2016.
Investor Conference Call

The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its fourth quarter of 2017. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 1894785. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC253

TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F876L (also known as F877L) mutation. The AR F876L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR.

On February 28, MetaStat, Inc. (OTCQB: MTST), a precision medicine company developing novel anti-metastatic treatment solutions for patients with aggressive cancer, reported that positive results and the successful completion of the pilot research project with Celgene Corporation (Press release, MetaStat, FEB 28, 2018, https://ir.stockpr.com/metastat/company-news/detail/398/metastat-announces-positive-topline-data-showing-over-50-reduction-in-cancer-metastasis-from-preclinical-studies-evaluating-inhibition-of-the-mapkapk2-kinase-pathway [SID1234524308]). In preclinical models of aggressive breast cancer, data showed cancer cell invasion and metastasis was reversed through inhibition of a specific serine-threonine kinase responsible for activation of the MenaINV protein. Over-expression of the MenaINV protein isoform has been shown to play an important role in driving progression and metastatic dissemination in aggressive types of solid tumors.

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"We are very pleased to have successfully completed our research project that demonstrated a 50% or more reduction in distant metastasis in animal models of aggressive breast cancer," stated Douglas A. Hamilton, MetaStat’s President, CEO and Director. "These results confirm our pathway forward for development of MAPKAPK2 inhibitors selected for specificity against the Mena protein." MetaStat has received the final milestone payment of approximately $100,000 and completed its obligations under the pilot research agreement. MetaStat has received aggregate milestone payments of approximately $1 million from Celgene pursuant to the terms of the agreement.

Detailed results from these in vitro and in vivo studies will be submitted to a future medical conference and for publication.

On February 27, 2018 Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, reported that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Calaspargase Pegol (Cal-PEG; SHP663) (Press release, Shire, FEB 28, 2018, View Source [SID1234524260]). The investigational-stage compound is being reviewed as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2018 for Cal-PEG.

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Shire is developing SHP663 based on more than a decade of data, research and experience with ONCASPAR (pegaspargase), which is approved in the United States as a first-line treatment for patients with ALL.2 The mechanism of action of ONCASPAR is thought to be based on selective killing of leukemic cells due to the depletion of plasma asparagine, an amino acid that certain tumor cells depend on for growth and development.2 Asparagine depletion remains a cornerstone of ALL treatment regimens. Cal-PEG is also thought to be based on plasma L-asparagine depletion. The totality of the clinical trial data submitted to the FDA for review, as part of the BLA, included a comparable safety profile and efficacy outcomes to ONCASPAR. If approved, Cal-PEG could provide a treatment that has an extended shelf life beyond that of the current PEGylated asparaginase treatment, helping ensure availability to patients.

"Today’s FDA acceptance of the Cal-PEG BLA is an important milestone as we work to help address the unmet needs for rare and underserved cancers," said Andreas Busch, Ph.D., Head of Research and Development at Shire. "Developing Cal-PEG underscores our commitment to evolving the standard of care in ALL, including taking innovative steps to improve treatment options for patients."

The BLA filing is supported by data obtained in ALL patients treated with calaspargase pegol first-line as a component of a multi-agent chemotherapeutic regimen.

Acute Lymphoblastic Leukemia (ALL)
ALL is a cancer of the white blood cells and is characterized by an excess of lymphoblasts, an immature white blood cell. Lymphoblasts are normally found in the bone marrow but can be found in the blood and other locations in people with ALL. ALL accounts for about 75 percent of childhood leukemia in the U.S. and around 78 percent in Europe;1,3 however, it can be a curable disease.4

About Calaspargase Pegol
Calaspargase Pegol (Cal-PEG) is under review with the U.S. Food and Drug Administration (FDA) as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL).

About ONCASPAR
In the United States, ONCASPAR (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for first-line treatment of patients with acute lymphoblastic leukemia (ALL) and for the treatment of patients with ALL and hypersensitivity to native forms of L-asparaginase.2

Select Important Safety Information2
ONCASPAR is contraindicated in patients with a history of: serious allergic reactions to ONCASPAR, history of the following with prior L-asparaginase therapy: serious thrombosis, pancreatitis or serious hemorrhagic events.

ONCASPAR Warning & Precautions include:

Anaphylaxis and Serious Allergic Reactions – observe patients for 1 hour after administration; discontinue if serious allergic reactions occur
Thrombosis – discontinue if serious thrombotic events occur
Pancreatitis – evaluate for pancreatitis in patients with abdominal pain; discontinue in patients with pancreatitis
Glucose Intolerance – monitor serum glucose
Coagulopathy and Hepatotoxicity – perform appropriate monitoring

The most common adverse reactions with ONCASPAR (≥2%) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia and elevated transaminases. Hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) has been reported in patients exposed to ONCASPAR.

On February 28, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported positive interim results from the initial cohort of the Phase 1 clinical trial evaluating the Company’s new human antibody-based radioimmunotherapy ("RIT") product MVT-1075 for the treatment of pancreatic, colon and lung cancer (Press release, MabVax, FEB 28, 2018, View Source [SID1234524242]).

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Results from the first three patients dosed in the initial cohort of this dose escalation Phase 1 safety trial demonstrated that MVT-1075 is reasonably well tolerated and accumulates on tumor as evidenced by dosimetry measurements performed after the first dose. At this initial dose, two subjects met the criteria for stable disease (SD) and one met the criteria of progressive disease (PD) as measured using RECIST 1.1 criteria. Hematologic toxicities were manageable, and the Company is enrolling the first patient in the second cohort.

"We achieved our primary objectives in this early-stage clinical trial of our novel radioimmunotherapy product MVT-1075. We were able to establish safety at the first dose and generated our first clinical data with this product confirming targeting specificity and accumulation of the radiolabeled antibody on target lesions over time. The toxicities that emerged were expected and manageable. Having established safety at this first low dose level, we are now enrolling patients at the next planned dose and are optimistic that we will see impacts on tumor as we continue this study," commented David Hansen, MabVax’s President and Chief Executive Officer.

This Phase 1 first-in-human clinical trial is an open-label, multi-center study evaluating the safety and efficacy of MVT-1075 with CA19-9 positive malignancies in the U.S. The primary objective is to determine the maximum tolerated dose and safety profile in patients with recurring disease who have failed prior therapies. Secondary endpoints were to evaluate tumor response rate and duration of response by RECIST 1.1, and to determine dosimetry and pharmacokinetics. This dose-escalation study utilizes a traditional 3+3 design. The investigative sites include Honor Health in Scottsdale, Arizona and Memorial Sloan Kettering Cancer Center in New York City.

"We continue to believe that combining the clinically-demonstrated tumor targeting characteristics of our fully human HuMab-5B1 antibody and the commercially validated radionuclide, 177Lutetium, we can deliver a lethal dose of radiation to the targeted cancer cells," added Mr. Hansen.

The Company previously reported preclinical results for MVT-1075 at the 2017 Annual Meeting of the American Association of Clinical Research (AACR) (Free AACR Whitepaper), demonstrating marked suppression, and in some instances, regression of tumor growth in xenograft animal models of pancreatic cancer, potentially making this product an important new therapeutic agent in the treatment of pancreatic, colon and lung cancers. Supporting the MVT-1075 RIT clinical investigation are the Company’s successful Phase 1a safety and target specificity data which were reported at the annual meetings of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the Society for Nuclear Medicine and Molecular Imaging (SNMMI), including the clinical results for the Company’s MVT-5873 single agent therapeutic antibody and MVT-2163, an immuno-PET imaging agent. The combined results from 50 patients in the Phase 1a MVT-5873 and MVT-2163 studies, established safety and provided significant insight into drug biodistribution and an optimal dosing strategy, which the Company has incorporated into the MVT-1075 program.

For additional information about the Phase 1 MVT-1075 clinical trial, please visit clinicaltrials.gov, and reference Identifier NCT03118349.

About MVT-1075

MVT-1075 is a radioimmunotherapy product that combines established efficacy of radiation therapy with tumor specific targeting. It has the potential to deliver a more potent HuMab-5B1 based product. MVT-1075 uses small doses of the Company’s MVT-5873 antibody, coupled to a radioisotope to target pancreatic cancer cells and kill them.