Ipilimumab - Step Forward for the Field
On June 7, 2010, the Cancer Research Institute announced its celebration of a significant new breakthrough in the treatment of melanoma. Results from a large, randomized, multicenter phase 3 clinical study, published in the New England Journal of Medicine, confirm that the new treatment, a monoclonal antibody targeting the Cytotoxic T-Lymphocyte Antigen-4 (CTLA-4) named ipilimumab, confers a significant survival advantage to patients with pre-treated advanced melanoma. This is the first study in advanced melanoma to demonstrate a survival advantage in history. The story has also received a great deal of attention in the media. See: CNN, NY Times, Wall Street Journal, Forbes
The landmark trial has other important implications for the field beyond establishing the effectiveness of this particular cancer immunotherapy. Axel Hoos, M.D., Ph.D., co-chairman of the executive committee of the CRI Cancer Immunotherapy Consortium and medical lead for ipilimumab at Bristol-Myers Squibb, said ipilimumab investigation represents a significant advance in how clinical studies of cancer immunotherapies are conducted and evaluated.
A New Framework for Immuno-Oncology
"The existing paradigm for evaluating the effectiveness of new cancer treatments is informed by experience with chemotherapy," Hoos said. "The chemotherapy paradigm does not entirely account for the biology and unique mechanisms of action of cancer immunotherapy."
To address this issue, the CRI Cancer Immunotherapy Consortium, in collaboration with international partner organizations, immunologists, and clinical oncologists around the world, spearheaded the development of a new operating framework for the emerging discipline of immuno-oncology. It provides new tools, development principles, and structure and possibly gained credibility for the field.
Contained within the new framework are a clinical development paradigm and improved endpoints, which may allow clinicians to more effectively investigate immunotherapies in clinical trials. "This offers a better defined path forward for the field to enable more successful development of immunotherapies in the future," Hoos said.
Dr. Hoos recently presented the new immuno-oncology framework during his keynote address to the Active Immunotherapeutics Forum in Barcelona, Spain, June 21-23 and will also present at the conference on "Unlocking the Potential of Cancer Vaccines" in Cambridge, Massachusetts, June 29-30.
A summary of the CRI Cancer Immunotherapy Consortium immuno-oncology framework is available here.
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The Minimal Information About T cell Assays (MIATA) Project proposes to generate recommendations on the minimum information required to allow an objective and thorough interpretation of published results from immunological T cell assays.
Thanks to the active involvement of more than 80 scientists from various fields, the MIATA modules, which aim to establish a reporting framework for T cell assays in scientific publications, have been updated. The new modules, described in the document MIATA Version 1 are listed under "Current MIATA Modules" on the project-related Web site: www.miataproject.org, and are subject to a second round of consultation.
Please get involved in shaping the MIATA modules by reviewing the current available version and sending your feedback to input@miataproject.org.
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The fifth proficiency panel testing round of the CIC Immunoassay Working Group is in preparation and will commence later this year. The panel for intracellular cytokine staining will address the biggest challenge for this assay: the gating strategy. This gating panel will be rolled out later this summer. All other panel testing programs (Elispot, multimer staining, and possibly Luminex) will begin this fall.
Please look for detailed email announcements in the coming weeks. If you would like more information, or to express your interest in participating, please contact the panel program leader, Sylvia Janetzki: sylvia@zellnet.com.
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Welcome New Members
The Cancer Immunotherapy Consortium welcomes its newest members: APEIRON Biologics AG, Hoag Hospital, Immudex, and Pfizer.
APEIRON Biologics AG
Apeiron Biologics AG is a privately financed biotech company in Vienna, Austria. As its main project Apeiron has developed recombinant human Angiotensin Converting Enzyme 2 (APN01) as a biotherapeutic up to Phase I clinical trials. Target indications for APN01 are diseases with an imbalance of the Renin Angiotensin System and insufficient natural ACE2 activity, such as ARDS and a variety of other diseases including cancer. In January 2010, this project was exclusively licensed to GlaxoSmithKline. Presently, Apeiron predominantly works on a preclinical project in cancer immunotherapy (target Cbl-b to enhance the capabilities of immune cells to combat cancer) and is in the process of compiling a broad and mature portfolio in cancer immunotherapy. This is based on the extensive 25+ years experience of Apeiron's CEO Hans Loibner in applied cancer immunotherapy, working both with big Pharma and as founder and CEO of the biotech company Igeneon. Dr. Loibner also was a founding member of the Cancer Immunotherapy Consortium.
Hoag Hospital
Hoag Memorial Hospital is a not-for-profit community hospital located in Orange County, California. Its Cancer Center and programs are nationally recognized and accredited by the American College of Surgeons. In particular, Hoag’s Cell Biology Lab has a twenty-year history of treating cancer patients with a variety of cancers with patient-specific, cell-based therapies. Its areas of interest are focused on providing cancer patients with autologous tumor cell lines or activated immune cell therapies
Immudex
Immudex is a company specializing in detection of antigen-specific T cells. Immudex manufactures and sells MHC Dextramer™ reagents for research use to customers all over the world. These reagents are used for monitoring of antigen-specific T cells by flow cytometry and immunohistochemistry. In addition, Immudex has two venture-driven diagnostic products and a vaccine in development, all based on the unique Dextramer™ technology.
Pfizer
Pfizer Oncology is committed to the discovery, investigation, and development of innovative treatment options to improve the outlook for cancer patients worldwide. Its strong pipeline, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers, including breast, lung, prostate, sarcoma, melanoma, and various hematologic cancers. Pfizer Oncology has biologics and small molecules in clinical development and more than 200 clinical trials underway. By working in collaboration with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time.
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Save the Date: 18th Annual Cancer Research Institute Symposium
This fall, the Cancer Research Institute will host the 18th annual conference in its International Cancer Immunotherapy Symposium Series. Chaired by CRI Scientific Advisory Council Director, Lloyd Old, M.D., and Emil Unanue, M.D., of Washington University, the meeting will be held October 6-8, 2010, in New York City and will focus on "Multiple Functions of CD4 T cells in Autoimmunity, Infectious Disease, and Cancer."
CD4 T cells play critical and diverse roles in controlling the immune response. Since the mid-1980s, researchers have identified a growing repertoire of CD4 T cell subsets and have made great progress in elucidating their different functions and regulation. It is now known that, while some, such as Th1, Th2 and Th17, are involved in promoting immune response, others, such as regulatory T cells (Tregs), engage in immune suppression. The specific roles that these cells play in autoimmunity, infectious disease, and cancer, however, remain unclear. Further characterizing CD4 T cell types and defining their precise functions and relationships to disease states will present key challenges moving forward. The 2010 CRI Symposium will address these and other challenges facing basic research and clinical development in the field today.
Sponsorship and underwriting opportunities for the 18th Annual CRI Symposium are available. For more information, please contact Leslie Salter at lsalter@cancerresearch.org.
More event details, including a list of confirmed speakers and guidelines for registration, will be made available soon on the 2010 Symposium Web site.
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Cancer Research Institute 24th Annual Awards Dinner
CRI held its 24th Annual Awards Dinner on Wednesday, June 16, 2010. The 2010 Oliver R. Grace Award for Distinguished Service in Advancing Cancer Research was presented to Andrew Witty, chief executive officer of GlaxoSmithKline, who was honored for his company’s many important contributions to the development and delivery of new immune-based therapies to combat infectious diseases and cancer, and for GSK’s world-leading efforts to research and develop a new class of immune-based cancer therapeutics. American fashion designer Michael Kors also received the 2010 Grace Award for his commitment to promoting awareness and raising funds for cancer research. On this occasion, the Institute also presented the 2010 William B. Coley Award for Distinguished Research in Tumor Immunology. The award was shared by Wolf Hervé Fridman, M.D., Ph.D., and Jérôme Galon, Ph.D., of the Cordeliers Research Centre, and Haruo Ohtani, M.D., of Mito Medical Center, for their fundamental contributions to our understanding of the prognostic significance of infiltrating T lymphocytes (TILs) in cancer patients.
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Antigenics, Inc.
Encouraging Data Presented on Oncophage® Vaccine at International Conference on Brain Tumor Research and Therapy
(May 20, 2010) Antigenics recently announced that data from a multi-center Phase I/II clinical trial of Oncophage (vitespen) for recurrent high-grade glioma (brain cancer) was presented at the International Conference on Brain Tumor Research and Therapy. The study was conducted by the Brain Tumor Research Center at the University of California, San Francisco (UCSF).
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Karolinska Institute
New Cancer Vaccine Strangling Tumor Blood Supply
(May 24, 2010) A DNA vaccine that prevents blood supply to tumors has been developed by researchers at the Karolinska Institute. New results show that the vaccine slows the growth of breast cancer tumors in mice. For a cancerous tumor to grow beyond a few millimeters it is required to have the ability to stimulate formation of new blood vessels to ensure the tumor's access to oxygen and nutrients. A drug that blocks blood vessel growth is therefore a potentially effective therapy against tumor diseases.
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Merck KGaA
Merck KGaA Resumes Stimuvax® Clinical Program in Lung Cancer
(June 17, 2010) Merck KGaA and its U.S. affiliate, EMD Serono, Inc. recently announced that they are resuming their Stimuvax® (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer (NSCLC), which includes the Phase III studies, START and INSPIRE. Treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.
"Merck remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients. We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists and their patients," said Dr. Wolfgang Wein, Executive Vice President, Oncology of the Merck Serono division.
This announcement follows a decision by the U.S. Food and Drug Administration (FDA) to partially lift the clinical hold it placed on the Investigational New Drug (IND) application for BLP25 liposome vaccine in March 2010 and allow the START trial to be resumed.
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Oxford Biomedica, Cardiff University
Oxford Biomedica Announces Collaborative Phase I/II Study to Evaluate TroVax in Mesothelioma
(June 24, 2010) Oxford BioMedica, a leading gene therapy company, is pleased to announce that it has entered a collaboration with a team of cancer immunologists led by Dr. Zsuzsanna Tabi at Cardiff University and in partnership with Dr. Jason Lester, an oncologist at Velindre Cancer Centre in Cardiff, to evaluate TroVax® in a Phase I/II study in mesothelioma. The study will be funded by the June Hancock Mesothelioma Research Fund (JHMRF) and Oxford BioMedica will provide TroVax®, its therapeutic cancer vaccine. The study aims to examine the effect of TroVax® in combination with first-line chemotherapy agents Alimta and cisplatin as a treatment against mesothelioma. This study follows a feasibility project undertaken by Dr. Tabi and her team, which was also funded by the June Hancock Mesothelioma Research Fund.
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Share Your Updates
Does your company have news to share about important advancements in the development of cancer vaccines? If so, please forward news releases and announcements to consortium-news@cancerresearch.org.
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OTHER NEWS
Celldex Therapeutics
Celldex Therapeutics Presents Positive Results from Phase I/II Advanced Breast Cancer Study with CDX-011 at 46th Annual ASCO Meeting
(June 5, 2010) Celldex Therapeutics, Inc., announced mature results from a Phase I/II study evaluating CDX-011 in advanced stage breast cancer patients at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). CDX-011 is an experimental antibody-drug conjugate (ADC) directed against glycoprotein NMB (GPNMB) and linked to a potent cancer cell-killing drug, monomethyl-auristatin E (MMAE).
Mature data from this study of CDX-011 show a progression free survival (PFS) rate at 12 weeks of 35% of patients, which is a positive outcome for a heavily treated advanced breast cancer population with very limited treatment options. "The results in triple negative disease are especially encouraging," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "A subset analysis using a newly optimized diagnostic assay for GPNMB showed that patients with strong stromal or tumor cell expression of GPNMB may be most likely to respond to CDX-011."
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Cleveland Clinic
Cleveland Clinic Researchers Develop Prototype Vaccine to Prevent Breast Cancer
(May 30, 2010) A first-of-its-kind vaccine to prevent breast cancer has shown overwhelmingly favorable results in animal models, according to a study by researchers at Cleveland Clinic’s Lerner Research Institute. The researchers found that a single vaccination with the antigen α-lactalbumin prevents breast cancer tumors from forming in mice, while also inhibiting the growth of already existing tumors. Enrollment in human trials could begin next year. If successful, it would be the first vaccine to prevent breast cancer. The research was published online May 30 and in the June 10 issue of Nature Medicine.
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ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics Granted Orphan Drug Status for ICT-107
(June 11, 2010) ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC) announced recently that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for ICT-107, the company’s dendritic cell-based cancer vaccine candidate which targets glioblastoma multiforme (GBM). As a result of the orphan drug status, ImmunoCellular will be eligible to receive a number of benefits, including access to grant funding for clinical trials, tax credits, accelerated FDA approval, and allowance for marketing exclusivity after drug approval for a period of up to seven years. U.S. orphan drug designation is granted to companies with products aimed at treatment of a rare disease or condition that affects fewer than 200,000 Americans.
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Northwest Biotherapeutics, Inc.
Exceptional Survival Data, Lower Costs Key to the Competitive Advantage of DCVax® - Northwest Biotherapeutics’ Vaccine for Multiple Cancers
(June 7, 2010) Northwest Biotherapeutics, Inc. (NWBT), developer of the DCVax® personalized cancer vaccine, today announced the release of a new detailed report by Pharmaceuticals and Biotech Analyst Dr. Navid Malik of the London-based Matrix Group.
As part of an in-depth review of the history and competitive landscape of what he calls the "cancer vaccine revolution," Dr. Malik concludes that "NWBT has generated some of the most striking data on survival and delayed time to progression in both brain cancer and prostate cancer that we have seen from any product in the market or in clinical development." Citing both "high dendritic cell purity" and "the single-batch bulk manufacturing process," as "key advantages of NWBT's technology which have not yet been appreciated by the market," he concludes that this gives DCVax® a "competitive advantage…versus virtually all of the other personalized cancer vaccine players."
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ABOUT THE CANCER IMMUNOTHERAPY CONSORTIUM
Consortium Mission and Vision
Cancer Immunotherapy Consortium scientists and clinicians, industry leaders, and governmental regulatory representatives interact and collaborate with one another to accelerate the discovery and development of effective cancer vaccines and other immunotherapies. Through annual conferences, member communications, and coordinated research initiatives, the Consortium addresses the networking, clinical, and regulatory needs of academic scientists, corporations, and organizations working in this promising area of biomedicine.
The following important goals form the core of the Consortium's activities:
- Host scientific conferences and workshops dedicated to cancer immunotherapy to facilitate knowledge exchange and establish community-wide consensus on key issues
- Form alliances with partner academic and industrial organizations across the globe to further advance progress in the field
- Facilitate dialogue with regulatory bodies, such as the U.S. Food and Drug Administration, to provide a comprehensive understanding of the regulatory climate and help develop needed standards for evaluating cancer immunotherapies
- Conduct initiatives that will seek to harmonize measurement of the immune response in immunotherapy clinical trials and establish surrogate biological markers
- Publish and promote results from collaborative initiatives carried out by CIC members and the wider cancer immunotherapy community
The Consortium's membership of industrial and academic leaders across the United States and Europe complements the CRI/LICR Cancer Vaccine Collaborative's international network of academic clinical and laboratory centers. Working in parallel under the Cancer Research Institute, the two programs encompass all points along the cancer vaccine and immunotherapy development spectrum, from laboratory and clinical discovery, reagent production, and immune response monitoring, to therapeutic product development and approval.
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Cancer Immunotherapy Consortium Members
- Alphavax
- Antigenics Inc.
- APEIRON Biologics AG
- Argos Therapeutics
- Association for Immunotherapy of Cancer (CIMT)
- BN ImmunoTherapeutics
- Baylor Institute for Immunology Research
- BIOCANCER
- Bristol-Myers Squibb
- Cancer Trials Australia
- Cardiff University School of Medicine
- Celldex Therapeutics, Inc.
- Center of Molecular Immunology
- Centre de Lutte Contre le Cancer
- City of Hope
- CureVac GmbH
- Dana-Farber Cancer Institute
- Dartmouth Medical School
- Deeley Research Centre/British Columbia Cancer Agency
- Dendreon
- Duke University Medical Center
- ERYtech Pharma
- Fondazione IRCCS Istituto Nazionale dei Tumori
- Fred Hutchinson Cancer Research Center
- The George Washington Cancer Institute
- Hoag Hospital
- IBT Laboratories
- Immatics Biotechnologies GmbH
- Immudex
- Inovio Biomedical Corporation
- IRX Therapeutics
- Johannes Gutenberg-Universität Mainz
- Johns Hopkins University School of Medicine
- Krankenhaus Nordwest
- Leiden University Medical Center
- Loyola University Medical Center, Chicago
- Ludwig-Maximilians Universität München
- Mabtech AB
- MannKind Corporation
- Max-Planck Institute für Infektionsbiologie
- McMaster University
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- Memorial Sloan-Kettering Cancer Center
- Merck KGaA
- Mercy Cancer Center
- Mie University
- Moffitt Cancer Center
- National Cancer Center Hospital
- New York University School of Medicine
- Okayama University Medical School
- Osaka University
- Oxford Biomedica
- Paterson Institute for Cancer Research, University of Manchester
- Pfizer
- The Rockefeller University
- Roswell Park Cancer Institute
- Swedish Institute for Infectious Disease Control
- Transgene
- Trimed Biotech GmbH
- University Hospital Lausanne
- University Hospital Zürich
- University Medical Center Hamburg-Eppendorf
- University of Antwerp
- University of Crete
- University of Erlangen-Nürnberg
- University of Heidelberg
- University of Minnesota Cancer Center
- University of Oxford
- University of Pennsylvania School of Medicine
- University of Pittsburg Cancer Institute
- University of Texas MD Anderson Cancer Center
- University of Tübingen
- University of Virginia Health System
- University of Wisconsin Carbone Cancer Center
- University of Zurich
- US Military Malaria Vaccine Program
- Vanderbilt University Medical Center
- Walter Reed Army Institute of Research
- Washington University School of Medicine
- Weill Medical College of Cornell University
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Join the Cancer Immunotherapy Consortium
Companies and academic institutions interested in becoming a member of the Cancer Immunotherapy Consortium should email consortium@cancerresearch.org for a membership application.
Cancer Immunotherapy Today
Volume 7, Number 3
June 2010
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Cancer Immunotherapy Consortium
Cancer Research Institute
One Exchange Plaza
55 Broadway, Suite 1802
New York, NY 10006
Phone: (212) 688-7515
Fax: (212) 832-9376
Email: consortium@cancerresearch.org
CIC Web site
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