Kuros Biosurgery Holding Ltd. closes merger with Cytos Biotechnology Ltd. which is renamed Kuros Biosciences Ltd.

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."

CytomX Announces Third Target Selection by Bristol-Myers Squibb, Triggering Milestone

On Jan. 20, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported the selection of a third target by Bristol-Myers Squibb in accordance with the companies’ strategic oncology collaboration established in May 2014, triggering a $10 million milestone payment (Press release, CytomX Therapeutics, JAN 20, 2016, View Source;p=irol-newsArticle&ID=2130651 [SID:1234511332]).

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"Our collaboration with Bristol-Myers Squibb has progressed very well and we are pleased to expand our collaborative work to a third target," said Sean McCarthy, D.Phil., President and Chief Executive Officer of CytomX. "We look forward to continuing to work closely with the BMS team to advance product candidates into development."

Investigational therapeutics developed with CytomX’s Probody platform are designed to be active in the tumor while sparing healthy tissue. By restricting activity to the tumor microenvironment, investigational Probody therapeutics directed against both validated and novel targets have been shown preclinically to enable anti-tumor efficacy with an enhanced safety window, relative to traditional antibody-based therapies.

About the Collaboration Agreement

Under the terms of the agreement which was entered into in May of 2014, CytomX granted Bristol-Myers Squibb exclusive worldwide rights to develop and commercialize Probodies for up to four oncology targets including CTLA-4, a clinically validated immune inhibitory checkpoint receptor. Bristol-Myers Squibb made an upfront payment of $50 million to CytomX in 2014 and provides research funding over the course of the research term. Upon the selection of the third and fourth targets, Bristol-Myers Squibb pays CytomX selection payments. CytomX is also eligible to receive additional preclinical payments and up to $298 million in future development, regulatory and sales milestone payments for each collaboration target, as well as tiered mid-single digit rising to low-double digit royalty payments on net sales of each product commercialized by Bristol-Myers Squibb.

Imugene Extends Partnership with The Medical University of Vienna to
Develop Cutting-Edge Mimotope Immuno-Oncology Platform

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

Peregrine Pharmaceuticals to Present at Two Upcoming Cancer Immunotherapy Conferences

On January 20, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body’s immune system to fight cancer, reported that members of the company’s scientific team will deliver podium presentations focused on the role of combination immunotherapies in the treatment of cancer at two upcoming immunotherapy conferences (Press release, Peregrine Pharmaceuticals, JAN 20, 2016, View Source [SID:1234508819]). Jeff T. Hutchins, Ph.D., Peregrine’s vice president, preclinical research, will speak at Immunotherapy World 2016, being held January 25-27, 2016 in Washington, D.C. Additionally, Bruce Freimark, Ph.D., research director, preclinical oncology at Peregrine, will present at GTCBio’s 8th Immunotherapeutics & Immunomonitoring Conference, being held January 25-26, 2016 in San Diego, CA.

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Details of the presentations are as follows:

Immunotherapy World 2016
Title: "Combination Immunotherapies – Opening the Gate: Increasing Tumor Infiltrating Activated T-Cells to Optimize and Expand the Benefits of Immune Checkpoint Therapies."

Presenter: Dr. Hutchins

Time/Date: Monday, January 25 at 3:40 p.m. Eastern time.

8th Immunotherapeutics & Immunomonitoring Conference

Title: "Blockade of Phosphatidylserine Enhances the Anti-Tumor Activity of Targeted Therapy and Immune Checkpoint Inhibitors by Reducing Immunosuppressive Cells in the Tumor Microenvironment."

Presenter: Dr. Freimark
Time/Date: Tuesday, January 26 at 10:00 a.m. Pacific time.

In his talk, Dr. Hutchins will discuss strategies for expanding the therapeutic benefit seen with immuno-oncology monotherapies to a broader range of patients using combination treatment approaches. Specifically, he will highlight the strategy of leveraging treatments capable of increasing the number and activity of T-cells in the tumor microenvironment to optimize the therapeutic benefit of immune checkpoint inhibitors such as anti-PD-1/anti-PDL-1 agents.

Dr. Hutchins will draw on the company’s experience in working with preclinical equivalents of bavituximab, Peregrine’s lead investigational phosphatidylserine (PS)-targeting immunotherapy candidate. PS-targeting antibodies have been shown to shift the immunosuppressive functions of immune cells in tumors, resulting in anti-tumor immune responses. Peregrine has generated results from multiple preclinical and clinical-translational studies demonstrating enhanced anti-tumor activity and immune activation when combining equivalent PS-targeting antibodies with conventional chemotherapy or checkpoint inhibitors such as anti-PD-1 agents.

Dr. Freimark will highlight data showing that blocking PS signaling in combination with immune checkpoint inhibitors promotes a localized, anti-tumor response. He will share research findings demonstrating that PS-targeting antibodies enhance the anti-tumor activity of anti-CTLA-4 and anti-PD-1 antibodies in models of melanoma and breast cancer and correlate with an increase in the infiltration of activated T-cells and the induction of adaptive immunity.

Both presentations will also highlight key recent research findings showing that PS-signaling pathway inhibitors demonstrate multiple signs of immune activation in low or negative PD-L1 tumors. This suggests that PS-targeting antibodies have the potential to show a clinical benefit in patients with low PD-L1 levels and who do not generally benefit from checkpoint treatment alone. The potential for bavituximab to improve the clinical outcome of checkpoint inhibitors will be evaluated as part of Peregrine’s ongoing clinical research collaboration with AstraZeneca. To this end, a global Phase II study of bavituximab in combination with AstraZeneca’s durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with previously treated squamous or non-squamous NSCLC is expected to begin during the first quarter of 2016.

About Bavituximab: A Targeted Investigational Immunotherapy
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab blocks PS and, in turn, is believed to remove this immunosuppressive signal and send an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.

Delcath Announces Initiation Of Phase 3 Trial Of Melphalan/HDS System For Treatment Of Hepatic Dominant Ocular Melanoma

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.