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- ISA Pharmaceuticals strengthens its Supervisory Board with the appointment of Professor Jan van de Winkel
October 17, 2011 - Leiden, The Netherlands, October 17th, 2011 – ISA Pharmaceuticals, a leader in the development of novel immunotherapeutic products for oncology and infectious diseases, today announced that Professor Jan van de Winkel has joined its Supervisory Board. “We are excited to have Jan van de Winkel strengthening our Supervisory Board. He complements an experienced and motivated team, the collective experience of which spans the biotechnological, pharmaceutical and financial areas. We expect ISA to benefit from his insights and expertise and look forward to interacting with Jan to further propel the company in the rapidly emerging field of immunotherapy.” says Gerard Platenburg, managing director of ISA Pharmaceuticals BV. Professor van de Winkel has built a distinguished track record in the pharmaceutical industry over the last 25 years. Currently, he serves as CEO of Genmab A/S, a leading company in antibody therapeutics. Prior to co-founding Genmab, Professor van de Winkel served as Scientific Director and Vice President of Medarex Europe. 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 vaccine against HPV-induced lesions. The company was founded in 2004 by Aglaia Oncology Fund and has its roots in the ground-breaking research of the internationally renowned tumor immunologist Professor Kees Melief. For more information, please contact Gerard Platenburg (+31 (0) 6 53439090) or visit our website at: www.isa-pharma.com
- FDA grants ISA Pharmaceuticals Orphan Drug Designation for the treatment of Vulvar Intraepithelial Neoplasia with its lead product ISA-HPV-SLP®
October 5, 2011 - Leiden, The Netherlands, October 5th , 2011 – ISA Pharmaceuticals BV, a leader in the development of immunotherapeutic products for oncology and infectious diseases, today announced that orphan drug designation has been granted to its lead compound for the treatment of vulvar intraepithelial neoplasia (VIN) by the Office of Orphan Products Development (OOPD) of the US Food and Drug Administration (FDA). Orphan drug designation is granted by the FDA to promote the development of products that may offer therapeutic benefits for diseases affecting less than 200,000 people in the USA. Orphan drug designations are based on several criteria that include rarity and seriousness of the condition, the lack of therapies and scientific merit of the proposed medicinal product. Orphan medicinal product designation provides opportunities for fee and tax reductions before and after marketing authorization and seven years of market exclusivity following drug approval in the US. EU orphan drug designation was previously also obtained by ISA potentially providing ten years of market exclusivity following drug approval in Europe. “Receiving the orphan drug designation from the EMA and now also the FDA has been very encouraging and confirms the validity of our scientific approach for the treatment of VIN and other HPV-induced lesions. Indeed, the recognition by these major regulatory organizations is exhilarating and strengthens our commitment. The orphan drug designation provides opportunities to stimulate the development of our program.” said Gerard Platenburg, managing director of ISA Pharmaceuticals BV.
- ISA Pharmaceuticals closes a License Agreement with Transgene aimed at the development of novel vaccines for TB
May 26, 2011 - ISA Pharmaceuticals B.V., a private, clinical stage company and leader in the development of immunotherapeutic products for oncology and infectious diseases, and Transgene (Euronext Paris: FR0005175080), a bio-pharmaceutical company specialized in the development of immunotherapeutic products, today announced the signing of an exclusive license agreement. Transgene will use ISA’s proprietary IP in Transgene’s program for developing novel vaccines to combat infectious diseases caused by mycobateria tuberculosis, such as TB. Under the terms of the agreement, ISA will receive an upfront fee and could receive payments on the achievement by Transgene of research and clinical milestones, as well as royalties on the sales of products resulting from the agreement. Financial details of the agreement were not disclosed. “We are very pleased to collaborate with Transgene, since we strongly believe that ISA’s IP combined with Transgene’s expertise in vaccine development will yield breakthrough products”, said Gerard Platenburg, CEO of ISA. About Transgene Transgene, a member of the Institut Mérieux Group, is a publicly traded French biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases and has five compounds in clinical development: TG4010 and JX-594/TG6006 having completed initial Phase II trials, TG4001 in Phase IIb trial, TG4040 in Phase II trial and TG4023 in Phase I trial. Transgene has concluded strategic agreements for the development of two of its immunotherapy products: an option agreement with Novartis for the development of TG4010 to treat various cancers; and, an in-licensing agreement with US-based Jennerex Biotherapeutics, Inc., to develop and market JX-594/TG6006, an oncolytic product. Transgene also has bio-manufacturing capacities for viral-based products. Additional information about Transgene is available at www.transgene.fr. 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. www.isa-pharma.com.
- ISA Pharmaceuticals and Prosensa receive Mibiton funding for peptide manufacturing facility
April 26, 2011 - Leiden, The Netherlands, April 26th , 2011 – ISA Pharmaceuticals B.V., a leader in the development of immunotherapeutic products for oncology and infectious diseases, today announced that Mibiton supports ISA and Prosensa to further enhance their respective technology platforms. The Shared Life Sciences facility includes a state-of-the art peptide manufacturing unit. ISA Pharmaceuticals is an innovative clinical stage company focusing on the development of immunotherapeutics. By using the breakthrough 'synthetic long peptides' (SLP®) technology, the company is developing novel treatments to treat cancer patients. ISA's lead compound in clinical development is an immunotherapeutic product to combat human papilloma virus-induced diseases in general and for cervical cancer and vulvar and anal intraepithelial neoplasias (VIN and AIN) in particular. According to CEO Gerard Platenburg, the peptide synthesis facility will enable ISA to further develop in-house synthesizing capabilities enabling the physical, chemical and biological characterization of (pre-) clinical drug leads. "This peptide synthesizing facility will significantly reduce our preclinical development track", he says. Prosensa is an innovative Dutch biopharmaceutical company focused on the discovery, development and commercialization of RNA modulating therapeutics correcting gene expression in diseases with largely unmet medical needs, in particular neuromuscular disorders. Prosensa's focus is on developing a treatment for Duchenne Muscular Dystrophy. 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. www.isa-pharma.com. About Mibiton The Mibiton Foundation with its main office in The Hague, The Netherlands, enables Dutch Life Sciences SMEs to exploit state-of-the-art facilities and equipment. With its three funding programs Share, Solo and Science the Mibiton foundation targets both collaborating SMEs and individual (start-up) Life Sciences companies which are not able to finance their facilities using commercial funding. The Mibiton Share program is co-funded by the Ministry of Economic Affairs, Agriculture and Innovation. The Mibiton Science program is co-funded by the Netherlands Genomics Initiative.
- ISA Pharmaceuticals embarks on EUR 4 million Cancer Vaccine development track awarded by CTMM
March 22, 2011 - ISA Pharmaceuticals embarks on EUR 4 million Cancer Vaccine development track awarded by CTMM Leiden, The Netherlands, March 15, 2011 – ISA Pharmaceuticals B.V., a leader in the development of immunotherapeutic products for oncology and infectious diseases, today announced that CTMM, an agency of the Dutch Ministry of Economic Affairs, has awarded ISA and partners a EUR 4 million grant to finance the further optimization of its SLP based platform. Gerard Platenburg, Chief Executive Officer of ISA said: “CTMM acknowledges, by this grant, the uniqueness of our platform and we are very pleased to further solidify the scientific basis of ISA. Grants under this special scheme are awarded to innovative projects with a strong commercial potential. This will be instrumental in further development of ISA.” For the development of new SLP based therapies it is crucial to further optimize e.g. dosing, and methods of administration. In this project ISA will collaborate with 4 renowned groups (LUMC, Leiden University, Utrecht University and Percuros B.V.) which are all specialized in the important areas of this project: immunology, chemistry, imaging, pharmacy and cancer therapy. 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. About Center for Translational Molecular Medicine Center for Translational Molecular Medicine (CTMM) is dedicated to the development of medical technologies that enable the design of new and "personalized" treatments for the main causes of mortality and diminished quality of life and the rapid translation of these treatments to the patient. CTMM is a public-private partnership that comprises a multidisciplinary group of parties – universities, academic medical centers, medical technology enterprises and chemical and pharmaceutical companies. For more information about CTMM, please visit www.ctmm.nl.
- ISA Pharmaceuticals awarded EUR 2.7 million (~ US$ 3,8 million) by Dutch government
March 7, 2011 - Leiden, The Netherlands, March 2, 2011 – ISA Pharmaceuticals B.V., a leader in the development of immunotherapeutic products for oncology and infectious diseases, today announced that AgentschapNL, an agency of the Dutch Ministry of Economic Affairs, has granted the company a credit under its new Innovation Credit scheme of EUR 2.7 million to finance the further clinical development of its lead immunotherapeutic SLP-HPV-01™. Gerard Platenburg, Chief Executive Officer of ISA said: “On the back of our recent round, we are very pleased to further solidify the financial basis of ISA. Credits under this special scheme are awarded to innovative projects with a strong commercial potential. This will be instrumental in financing late stage clinical development of our lead product.” ISA’s therapeutic lead product SLP-HPV-01™ is based on the company’s proprietary SLP® (Synthetic Long Peptide) concept and is indicated against Human Papilloma Virus (HPV) induced diseases such as cervical carcinoma, vulvar intraepithelial neoplasia (VIN), and cervical intraepithelial neoplasia (CIN). ISA has recently published in the New England Journal of Medicine positive results from a clinical phase II study with SLP-HPV-01™ to treat patients with HPV induced neoplasia. Vaccination of patients with high-grade Vulvar Intraepithelial Neoplasia (VIN) with SLP®-HPV-01 resulted in an 75% objective clinical response rate. 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. About AgentschapNL and the Innovation Credit schemeAgentschapNL is an agency of the Dutch Ministry of Economic affairs that promotes sustainable development and innovation with various financial instruments. The Innovation Credit (innovatiekrediet) scheme is aimed at supporting commercially attractive development projects with an interest-bearing loan of which repayment is waived if the project fails. For more information about AgentschapNL, please visit www.agentschapnl.nl
- Kees Melief, CSO of ISA, receives Netherlands most prestigious Cancer Award
December 9, 2010 - please check the press release (in Dutch) at: www.kwfkankerbestrijding.nl/Pages/nieuws-pagina.aspx?nieuwsid=11
- 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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