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- Bachem to supply ISA Pharmaceuticals with finished dosage forms immunotherapeutic HPV-SLP® for phase III clinical trials
June 2, 2010 - Bubendorf, Switzerland and Leiden, Netherlands, Bachem (SIX: BANB) and ISA Pharmaceuticals B.V. today announced the conclusion of an agreement for the manufacture of the active ingredients and the supply of finished dosage forms of ISA Pharmaceutical’s immunotherapeutic HPV-SLP® product. The company has successfully concluded a clinical phase II study with this product in patients suffering from human papillomavirus type 16 (HPV16) associated (pre-) malignant disorders. To date, ISA Pharmaceuticals had commissioned peptide production for clinical trials to its partner Leiden University Medical Center. Subsequent to the positive phase II results published in the New England Journal of Medicine*, ISA Pharmaceuticals now has chosen Bachem as a manufacturing and supply partner for the upcoming phase III program and the subsequent market introduction. Gerard Platenburg, CEO of ISA Pharmaceuticals, commented: “When entering phase III with our lead product, we want to work with the best in class to assure optimal technical and regulatory support in order to get our therapeutic HPV product to the market as soon as possible. Bachem is our partner of choice since it has a proven track record, as well as the skills and the range of services we need.” Anne-Kathrin Stoller, Vice President Marketing and Sales of Bachem AG, added: “We are very proud of having been selected by ISA Pharmaceuticals for this challenging project now entering phase III. It does not only prove our competence in manufacturing peptides but also the benefit of our Clinalfa® brand with its offer of finished dosage forms for clinical trials.” ISA’s therapeutic HPV product is based on the company’s proprietary SLP® (Synthetic Long Peptide) concept and is indicated against Vulvar Intraepithelial Neoplasia (VIN) with Cervical Intraepithelial Neoplasia (CIN), and cervical carcinoma as first follow up indications. In the frame of the agreement, Bachem will manufacture and provide to ISA Pharmaceuticals both the peptides as well as the Clinalfa® products. Further, Bachem will provide the necessary analytical and regulatory support required for phase III. * Gemma G. Kenter et al., New England Journal of Medicine, 361, 12 (2009) - Vaccination against HPV-16 Oncoproteins for Vulvar Intraepithelial Neoplasia.
About Bachem Bachem is an independent, technology-based, public biochemicals company providing full service to the pharma and biotech industry. Bachem is specialized in the process development and the manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients (APIs), as well as innovative biochemicals for research purposes. With headquarters in Bubendorf, Switzerland, and affiliates in Europe and the US, Bachem works on a global scale and holds a leading position in the field of peptides. For more information about Bachem, please visit www.bachem.com. About Clinalfa® Clinalfa® is Bachem's brand name for its sterile products to be used in approved clinical studies. The products are manufactured and released based on the requirements laid down in the relevant European Commission Directives. Clinalfa® products contain active substances manufactured and released according to ICH Q7. About ISA ISA Pharmaceuticals is dedicated to fighting cancer and infectious diseases by providing novel immunotherapeutics based on its proprietary SLP® technology to activate and employ the patient's own immune system. Its most advanced product is a highly efficacious therapeutic product against HPV-induced lesions. The company was founded in 2004 by Aglaia Oncology Fund and has its roots in the ground-breaking research performed by the group of the internationally renowned tumor immunologist Professor Kees Melief. R&D is performed in close collaboration with the Leiden University Medical Center, the Netherlands. For more information about ISA, please visit www.isa-pharma.com.
- ISA Pharmaceuticals announces NEJM publication on VIN phase II data
November 5, 2009 - New England Journal of Medicine Publishes a highly Successful Clinical Study by Leiden University Medical Center and ISA Pharmaceuticals B.V. with a therapeutic HPV vaccine in patients with premalignant vulvar lesions
SLP®-based therapeutic HPV vaccine to enter phase III clinical trials
Leiden, November 5th, 2009 - ISA Pharmaceuticals B.V., the Dutch clinical stage biopharmaceutical company focusing on the development of therapeutic vaccines, and Leiden University Medical Center (LUMC), announced today that the New England Journal of Medicine has published positive results from a clinical phase II study with the Synthetic Long Peptide (SLP®)-based therapeutic vaccine to treat patients with Human Papilloma Virus induced neoplasia (SLP-HPV-01). Vaccination of patients with high-grade Vulvar Intraepithelial Neoplasia (VIN3) with SLP®-HPV-01 resulted in an 75% objective clinical response rate.
VIN3, a high grade precursor stage of vulvar cancer, is caused by the Human Papilloma Virus (HPV). In this study, patients were injected subcutaneously with SLP®-HPV-01. By inducing a robust HPV specific immune response, ISA’s SLP®-HPV-01 vaccine was shown to induce an unprecedented high number of objective complete clinical responses, persisting for at least 24 months after treatment. The breakthrough is the use of synthetic long peptides. This ‘synthetic long peptide concept (SLP®)’ enables the activation of both cytotoxic T-cells (‘killer cells’) and T-helper cells, as a result of superior activation of the immune system. This phase II study is the first to document robust therapeutic activity with a vaccine for HPV and is an important step towards treatment of this devastating disease, for which as yet no successful standard therapy is available. Following this clinical proof-of-mechanism, ISA has started preparations for a phase III clinical study. In addition to its’ lead VIN program for which ISA obtained the orphan drug designation, the HPV-SLP® vaccine is under clinical evaluation in three additional HPV-induced disease indications among which is cervical cancer.
Gerard Platenburg, Chief Executive Officer of ISA, commented: "This first clinical phase II study successfully demonstrates that the therapeutic HPV-SLP®-vaccine, based on ISA’s proprietary SLP® technology, was able to induce a good clinical response in VIN3 patients. We are excited to have demonstrated clinical proof-of-mechanism and are progressing SLP®-HPV01 into Phase III trials in order to assess the broader benefits available to patients. SLP®-based vaccines hold great promise as an approach to create a novel class of exciting synthetic medicines and we are well positioned to exploit this opportunity.”
Professor dr. Gemma Kenter, together with her colleagues Prof.dr. Cornelis Melief and Dr. Sjoerd van der Burg, of the LUMC commented: “After more than 10 years of preparatory work we were greatly rewarded by this clinical effect. The statistically significant correlation between the immunological response and the clinical effect is unique in therapeutic vaccination strategies and it creates an excellent starting point for further expansion of activities. Not only with respect to the treatment of HPV-induced diseases but also with similar type of vaccines for other types malignancies or chronic infections”
Professor Olivera Finn, one of the pioneers of cancer immunology and president of the American Association of Immunologists, remarked in a commenting editorial that “the paper by Kenter et al. might herald the dawn of effective therapeutic vaccines”.
Contact details: Gerard Platenburg, CEO, platenburg@isa-pharma.com
- ISA Pharmaceuticals names Nigel Crockett Business Development director
July 9, 2009 - ISA Pharmaceuticals names Nigel Crockett Business Development director Leiden, July 9th, 2009 – ISA Pharmaceuticals B.V., the Dutch clinical stage biopharmaceutical company focusing on the development of therapeutic vaccines against cancer, today announced the further strengthening of its management team. Nigel Crockett has been appointed as the new business development director becoming responsible for the business strategic direction of the company. Nigel has over 20 years’ experience in the pharma-biotech sector and, as the Commercial Director at Astex Therapeutics, Nigel was responsible for more than 13 major collaboration and licensing deals in a period of just four years. During his commercial career to date he has executed over 30 major in- and out-licensing deals and has been involved in the completion of several company acquisitions, for Astex Therapeutics and for Cantab Pharmaceuticals. At the latter company he spent his early career as a researcher developing cervical cancer vaccines, having previously obtained his PhD (Molecular Biology) from Cambridge University in 1989 and a BSc (Chemistry) from the University of Manchester in 1986. Gerard Platenburg, Chief Executive of ISA, commented, "The appointment of Nigel strengthens our senior management team and is a reflection of our strategy to become a global leader in therapeutic SLP-based products. He brings to ISA a wealth of experience, which will greatly enhance our business development efforts.” About ISA ISA Pharmaceuticals is dedicated to fighting cancer and infectious diseases by providing novel ways based on its proprietary SLP® technology to activate and employ the patient's own immune system. Its most advanced product is a therapeutic vaccine against HPV-induced lesions. The company was founded in 2004 by Aglaia Oncology Fund and has its roots in the ground breaking research performed by the group of internationally renowned tumor immunologist Professor Kees Melief. R&D is performed in close collaboration with the Leiden University Medical Center, the Netherlands. For more information about ISA, please visit www.isa-pharma.com. Contact details: Gerard Platenburg, CEO, platenburg@isa-pharma.com
- Kees Melief, CSO of ISA Pharmaceuticals, receives prestigious Coley Award
June 5, 2009 - FOR IMMEDIATE RELEASE Scientific & Corporate Leaders in Immunology, Tumor Immunology to be Honored at Cancer Research Institute 23rd Annual Awards Dinner 2009 Grace and Coley Award Winners Announced May 29, 2009 -- The Cancer Research Institute, Inc. (CRI), a nonprofit organization dedicated to the development of immunological treatment, control, and prevention of cancer, announced today the winners of the 2009 William B. Coley Award for Distinguished Research in Basic and Tumor Immunology. Cornelis J.M. Melief, M.D., Ph.D., CSO of ISA Pharmaceuticals and professor at Leiden University Medical Center in The Netherlands, will receive the William B. Coley Award for Distinguished Research in Tumor Immunology for his novel insights into the relationship between tumors and the host’s immune system, in particular his description of certain key mechanisms of cytotoxic T lymphocyte recognition of tumor antigen and their subsequent activation, and for his development of innovative therapies that have been applied in the clinic or are being translated in the clinic based on improved insights into cell-mediated immunity. About the William B. Coley Award for Distinguished Research in Basic and Tumor Immunology This award was established in 1975 in honor of Dr. William B. Coley, a pioneer of cancer immunotherapy, whose daughter Helen Coley Nauts (1907-2001) founded the Cancer Research Institute. Award winners are nominated by CRI’s Scientific Advisory Council, the Academy of Cancer Immunology, and former Coley Award winners, including: Michael J. Bevan (2008), HHMI, University of Washington; Jeffrey V. Ravetch (2007), The Rockefeller University; Ian H. Frazer (2006), University of Queensland; James P. Allison (2005), The Ludwig Center/Memorial Sloan-Kettering Cancer Center; and Robert D. Schreiber (2001), Washington University School of Medicine. About the Cancer Research Institute The Cancer Research Institute (CRI) is the world’s only non-profit organization dedicated exclusively to the support and coordination of scientific and clinical efforts that will lead to the immunological treatment, control, and prevention of cancer. Guided by a world-renowned Scientific Advisory Council that includes five Nobel Prize winners and thirty members of the National Academy of Sciences, CRI supports cutting-edge cancer research at top medical centers and universities throughout the world. The Cancer Research Institute is ushering in a new era of scientific progress, hastening the discovery of effective cancer vaccines and other immune-based therapies that are providing new hope to cancer patients. www.cancerresearch.org | |
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