On January 21, 2016 Asterias Biotherapeutics, Inc. (NYSE MKT: AST), reported that it has completed the transfer of its manufacturing processes to produce AST-VAC2 to Cancer Research UK (Press release, BioTime, JAN 21, 2016, View Source [SID:1234508832]). Schedule your 30 min Free 1stOncology Demo! AST-VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) AST-VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumor cells, but rarely found in normal cells. The modified form of telomerase permits enhanced stimulation of immune responses to the protein. The AST-VAC2 dendritic cells instruct the immune system to generate responses against telomerase which will target tumor cells.
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To accelerate clinical development of AST-VAC2, Asterias has an ongoing partnership with Cancer Research UK and Cancer Research Technology, the charity’s development and commercialization arm, to execute the first clinical trial of AST-VAC2. As part of this partnership, Cancer Research UK will perform cGMP manufacture of AST-VAC2 at their Biotherapeutics Development Unit. In preparation for cGMP production, Asterias developed the production process for AST-VAC2 to support the transfer and further scale-up in Cancer Research UK’s manufacturing facility for the Phase 1/2 clinical study. To that end, Asterias has completed transfer of the AST-VAC2 manufacturing process information to Cancer Research UK. Cancer Research UK is now verifying and scaling up the production of AST-VAC2 in their facility in preparation for pilot and full cGMP campaigns. Upon successful completion of AST-VAC2 production campaigns, Cancer Research UK’s Centre for Drug Development ("CDD") will submit a Clinical Trial Authorisation application to the UK regulatory authorities for a Phase 1/2 clinical trial in non-small cell lung cancer, which will be sponsored, managed and funded by CDD. The clinical trial will examine the safety, immunogenicity and activity of AST-VAC2 and position the immunotherapy to be tested for numerous clinical indications.
"Transfer of the manufacturing process for AST-VAC2 marks an important milestone in our partnership with Cancer Research UK and is a critical step towards initiating the first clinical trial of AST-VAC2," said Pedro Lichtinger, Chief Executive Officer of Asterias. "The program with Cancer Research UK will assess the safety and activity of AST-VAC2 and serve as a foundation for further clinical development in lung and other cancers."
"The design of AST-VAC2 affords three unique properties to this dendritic cell immunotherapy," stated Jane S. Lebkowski, Ph.D., President of R&D and Chief Scientific Officer of Asterias. "Being produced from pluripotent stem cells, AST-VAC2 can be manufactured at batch-scale and be available on-demand for patient use. Second, the telomerase protein in AST-VAC2 is specifically engineered to target the two major pathways stimulating T cell immune responses, inducing more robust and durable cellular immune responses to telomerase. Lastly, the non-patient specific, allogeneic, nature of AST-VAC2 could potentially provide signals to further amplify immune responses."
"Based on its mode of action, AST-VAC2 is likely to be synergistic with immune checkpoint inhibitors and other adoptive immunotherapies that are being used for treatment now," stated Katy Spink Ph.D., Chief Operating Officer of Asterias. "The combination of the immunostimulatory activity of AST-VAC2 with the drugs that downregulate inhibitors of immune responses could provide a very powerful tool for the treatment of multiple cancers."
Dr. Nigel Blackburn, Cancer Research UK’s director of drug development, said: "This drug could potentially treat most tumour types as it targets the telomerase protein – which is faulty in 95 per cent of all cancers. The treatment’s design means it could also boost the effects of other immunotherapies and be used in combination.
"Lung cancer is the biggest cancer killer so we desperately need to find new treatments for the disease. And we’re pleased to be working with Asterias Biotherapeutics to develop this new treatment and to test it in clinical trials for non-small cell lung cancer for the first time."
Author: [email protected]
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.