On January 22, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or the "Company"), reported that an abstract discussing the immunologic effects of PV-10 on colon cancer cells has been accepted for presentation at the 11th Annual Academic Surgical Congress to be held February 2-4, 2016, at the Hyatt Regency in Jacksonville, Florida (Filing, 8-K, Provectus Pharmaceuticals, JAN 22, 2016, View Source [SID:1234508843]).

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The abstract, titled "PV-10 Induces Potent Immunogenic Apoptosis in Colon Cancer Cells," will be presented by Dr. A.V. Maker. It is co-authored by N. M. Kunda, J. Qin, G. Qiao working out of the University Of Illinois At Chicago, Division Of Surgical Oncology, Department Of Surgery, College Of Medicine, Chicago, IL, USA. The team of authors also includes B. Prabhakar of the University Of Illinois At Chicago, Department Of Microbiology & Immunology, College Of Medicine, Chicago, IL, USA. Dr. Maker belongs to both Departments.

The presentation is scheduled for 7:30-9:30 am on Tuesday, February 2, 2016, in City Terrace 5 at the Hyatt Regency in Jacksonville. The abstract can be found at: View Source

About the Academic Surgical Congress

The Academic Surgical Congress is organized by the Association for Academic Surgery (AAS) and the Society of University Surgeons (SUS). The purpose of the AAS is: to stimulate young surgeons and surgical scientists to pursue careers in academic surgery and support them in establishing themselves as investigators and educators; to provide a forum for senior surgical residents, fellows and junior faculty members to present papers on subjects of clinical, laboratory or educational research; and to facilitate the development of young surgeons and surgical scientists as investigators and educators. Its additional mission is to inspire and develop young academic surgeons. The SUS exists to advance the art and science of surgery by (1) the encouragement of its members to pursue original investigations both in the clinic and in the laboratory; (2) the development of methods of graduate teaching of surgery with particular reference to the resident system; (3) free and informal interchange of ideas pertaining to the above subjects.

On January 21, 2016 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer, reported the presentation of preclinical data and participation in an expert panel at Immunotherapy World 2016 being held January 25-27, 2016 in Washington, DC (Press release, Verastem, JAN 21, 2016, View Source;p=RssLanding&cat=news&id=2131222 [SID:1234508838]).

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"Over the past couple of years, exciting data have emerged from several research groups demonstrating the importance of FAK inhibition in the immuno-oncology arsenal," said Dr. Jonathan Pachter, Verastem Head of Research. "Our presentation next week at Immunotherapy World 2016 will provide an overview of preclinical research to date demonstrating how FAK inhibition increases influx of cytotoxic T cells into tumors while reducing immuno-suppressive and stromal density barriers to anti-tumor immune attack. This creates a more favorable tumor microenvironment for the antitumor effects of immune checkpoint inhibitors and potentially other immunotherapies. Preclinical models have demonstrated extended survival with the combination of our FAK inhibitor with anti-PD-1 therapy, and we plan to test this hypothesis clinically in several tumor types and combinations in 2016. The first of such clinical trials was recently started at Washington University of Saint Louis in patients with advanced pancreatic cancer."

The Washington University of Saint Louis clinical trial is evaluating Verastem’s focal adhesion kinase (FAK) inhibitor VS-6063 in combination with Merck’s PD-1 inhibitor pembrolizumab and gemcitabine/Nab-paclitaxel in patients with pancreatic cancer. This clinical study is supported by a growing body of preclinical research suggesting that focal adhesion kinase (FAK) inhibition, when combined with PD-1 inhibitors, increases the anti-tumor activity of these immunotherapeutic agents. As published in the journal Cell (24 Sept 2015), FAK inhibition has been shown to increase cytotoxic (CD8+) T cells in tumors and decrease immunosuppressive T regulatory cells leading to full tumor regression. This is the first of several combination clinical trials Verastem expects to initiate this year.

Details for the Immunotherapy World 2016 events are as follows:

Oral Presentation

Title: FAK Inhibitors induce T cell-mediated tumor regression: Prospects for combination with checkpoint inhibitors

Date and time: Monday, January 25, 2016, 3:00 pm ET

Session: Focus Session 3: Next generation approaches to Immuno-oncology: Investigative Therapies, Tools and Tech

A copy of the oral presentation will be available following the presentation at http://bit.ly/R3M6wc

Expert Panel

Title: Moving beyond the first generation of immunotherapies

Date and time: Monday, January 25, 2016, 3:30 pm ET

Session: Focus Session 3: Next generation approaches to Immuno-oncology: Investigative Therapies, Tools and Tech

About Focal Adhesion Kinase

Focal Adhesion Kinase (FAK) is a non-receptor tyrosine kinase encoded by the PTK-2 gene that is involved in cellular adhesion and metastatic capability. VS-6063 (defactinib) and VS-4718 are orally available compounds designed to target cancer stem cells through the potent inhibition of FAK. Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research has demonstrated that FAK activity is critical for the growth and survival of cancer stem cells. VS-6063 and VS-4718 are currently being studied in multiple clinical trials for their ability to improve patient survival through the targeting of cancer stem cells, potentiation of an immune response against cancer cells and reduction of the stromal density encapsulating a tumor.

On January 20, 2016 Kuros Biosciences Ltd. (SIX:KURN formerly CYTN) ("Kuros") reporting the closing of the acquisition of Kuros Biosurgery Holding Ltd. and the change of name of the combined company to Kuros Biosciences Ltd (Press release, Kuros Biosciences, JAN 20, 2016, View Source [SID1234516803]). Starting 20 January 2016 all 508’432’244 Kuros Biosciences Ltd. shares are listed and freely tradable under the ticker symbol KURN on the SIX Swiss Exchange under the International Reporting Standard and include all former 108’015’276 Cytos Biotechnology AG shares, which remain listed and freely tradable under the unchanged ISIN number (CH0011025217).

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Christian Itin, Chairman of Kuros Board of Directors, stated: "We are pleased with the successful closing of the business combination and welcome our new shareholders. Kuros’ product candidates address important markets in wound care and bone regeneration. We are excited about the potential to create long-term value for shareholders."

Didier Cowling, CEO of Kuros, commented: "Kuros has a diversified and clinically tested product pipeline with significant revenue potential in attractive markets. This combination provides us with access to the public capital markets and thereby achieves a key step in Kuros’ development."

On 20 January 2016: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported the extension of a partnership with the Medical University of Vienna to discover and develop new mimotope-based immunotherapies against validated and new oncology targets (Press release, Imugene, JAN 20, 2016, View Source [SID:1234509852]).

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A mimotope is a small molecule, often a peptide, which mirrors the structure of an epitope, the specific target to which an antibody binds. Because of this property it induces an antibody response similar to the one elicited by the epitope. Mimotope vaccines can trigger B-cells to produce antibodies cross reactive with the native epitope they recognise.

Imugene will own the Intellectual Property in the mimotope vaccines generated under the partnership as well as the right to use the platform to generate additional mimotope vaccines independent of the University. In addition, Imugene is entitled to access additional mimotope vaccines of interest to it.

Professor Dr Ursula Wiedermann, Chief Scientific Officer of Imugene said "This is particularly exciting since mimotope cancer vaccines are set to be part of the next wave of the immunooncology revolution in cancer therapy. This project will position Imugene competitively in immuno-oncology research, expanding its pipeline and will efficiently transform Imugene into a multi-asset biopharmaceutical company." Executive Chairman Mr Paul Hopper said "Imugene has secured a strategic license and entered into a research collaboration with the Medical University of Vienna which greatly extends the company’s oncology franchise and pipeline. Thanks largely to the strong relationships being developed between Imugene and the Medical University of Vienna and Prof. Wiedermann on the HER-Vaxx program, we are now able to actively participate in this paradigm shifting research underway at the Medical University of Vienna and systematically develop cutting edge drug candidates. Work has commenced and we look forward with anticipation to developments in this area. Whilst being cautious about the early stage of the program, what is particularly exciting is the potential to discover mimotopes for vaccination against cancer targets offering the opportunity to further develop the current treatment concepts of best selling drugs." "This collaboration gives Imugene the opportunity to build on our unique and promising pipeline of immuno-oncology B-cell vaccines. This innovative approach to cancer therapy will ensure

On January 20, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces the initiation of a Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) for the treatment of patients with hepatic dominant ocular melanoma (OM) (Press release, Delcath Systems, JAN 20, 2016, View Source;p=RssLanding&cat=news&id=2130649 [SID:1234508818]).

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The FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the FOCUS Trial) will evaluate the safety, efficacy and pharmacokinetic profile of Melphalan/HDS versus best alternative care in 240 patients with OM. The primary endpoint is a comparison of overall survival between the two study arms; secondary and exploratory endpoints include progression-free survival, overall response rate and quality of life measures. The FOCUS Trial is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), and per the SPA is the only Phase 3 trial required for submission of a New Drug Application.

In the trial’s treatment phase, patients randomized to the Melphalan/HDS arm will receive up to six treatments at intervals of six to eight weeks for up to 12 months. Tumor response will be assessed in both study arms every 12 weeks until evidence of hepatic disease progression. For patients progressing to the follow-up phase, disease assessment scans will continue every 12 weeks for up to two years. The FOCUS Trial will be conducted at leading cancer centers in the United States and Europe.

Under the terms of the SPA, at least 50% of patients will be treated in the U.S. The Moffitt Cancer Center in Tampa, Fla. has been activated as a participating center and Jonathan Zager, M.D., FACS, Professor of Surgery in the Cutaneous Oncology and Sarcoma Departments and a Senior Member at Moffitt Cancer Center, is serving as the trial’s principal investigator.

"I am particularly pleased to serve as principal investigator in this very promising study as I have treated patients with Melphalan/HDS through both formal clinical research and compassionate use since 2007," said Dr. Zager. "Our experience at Moffitt with Melphalan/HDS in patients with hepatic dominant ocular melanoma has shown significant potential. We are pleased to be taking a leadership role in the FOCUS Trial, and look forward to verifying the potential for Melphalan/HDS in this life-threatening cancer with no effective treatment options."

"We believe the FOCUS Trial puts us on the fastest path to a regulatory submission in the U.S. and initiation of this trial is a landmark event for Delcath," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We are delighted to be working with the Moffitt Cancer Center and look forward to activating a number of other premier cancer centers as clinical sites in the coming months. Our goal is to have an interim analysis, which we expect to occur in the second half of 2017. We look forward to bringing this potentially life-saving therapy to patients suffering with hepatic ocular melanoma."

"The FOCUS Trial will utilize an improved Melphalan/HDS product/procedure that addresses safety issues raised in our previous Phase 3 study. Based on our commercial experience in Europe, and the bolus of clinical data recently presented and published, we are optimistic that the FOCUS Trial will demonstrate a compelling benefit/risk profile and that the study’s objectives will be met," added Dr. Simpson.