Tag: ISA Pharmaceuticals
Company News: ISA Pharmaceuticals Initiates Phase I/II Clinical Trial With ISA101 in Women with Cervical Cancer
– Therapeutic vaccine against Human Papilloma Virus type 16 (HPV16) tested together with chemotherapy in women with HPV16-positive advanced or recurrent cervical cancer –
ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced the initiation of a Phase I/II clinical study of its lead candidate ISA101 in women with HPV16-positive advanced or recurrent cervical cancer, eligible for standard chemotherapy with carboplatin and paclitaxel (CervISA study). The first patient was vaccinated this month.
ISA101 is a synthetic long peptide (SLP®) vaccine for the treatment of diseases induced by human papilloma virus (HPV) type 16, such as cervical cancer, ano-genital premalignant and malignant lesions, and head and neck cancer.
The open-label, multicenter CervISA study is designed to determine the safety and immune-modulating effects of ISA101 at different doses with or without pegylated interferon alpha in combination with carboplatin and paclitaxel.
Patients will receive up to six standard chemotherapy cycles (paclitaxel 175 mg/m2 and carboplatin AUC 6 every three weeks) and three vaccinations at different dose levels during the same period. Half the women at each dose level will also receive pegylated interferon alpha. Primary endpoints of the trial are safety and HPV-specific immune responses. The secondary endpoint is antitumor efficacy according to RECIST 1.1.
Virtually all cervical cancers are caused by HPV infections, with HPV16 being responsible for about 50-60% percent of all cases.
Company News: ISA Pharmaceuticals Establishes Advisory Board
– Renowned Specialists to Support Development of ISA’s Advancing Pipeline –
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced the establishment of an advisory board of seasoned executives and scientists. Five world-renowned specialists will bring strong clinical, regulatory, scientific and business expertise to assist ISA in developing and implementing its corporate and R&D strategy.
The members of ISA’s advisory board are:
Alex Eggermont, M.D., Ph.D., is General Director of the Institut de Cancérologie Gustave Roussy (IGR, Villejuif) and a Professor of Surgical Oncology at Rotterdam’s Erasmus University (Netherlands). Prof. Eggermont specializes in preclinical and clinical / translational oncology, and is a specialist in immunotherapy research and the treatment of melanomas and sarcomas.
Ulrich Granzer, Ph.D., is a pharmacist and founder of Granzer Regulatory Consulting & Services. In addition, he is a founding member and President of the Board of the German Association of Regulatory Affairs (DGRA). He has long-standing experience in all regulatory aspects of the pharmaceutical industry from his time at Glaxo (now GSK), BASF, Pharma / Knoll, and Bayer. At Bayer, as Vice President of Global Regulatory Affairs he was responsible for all regulatory aspects of the development and submission of projects worldwide. Dr. Granzer’s expertise in regulatory affairs extends to both U.S. (FDA) and European (EMA) regulatory authorities.
Drew M. Pardoll, M.D., Ph.D., is a cancer immunologist and an Abeloff Professor of Oncology, Medicine, Pathology and Molecular Biology and Genetics at the Johns Hopkins University School of Medicine. He is also Director of Cancer Immunology at the Sidney Kimmel Comprehensive Cancer Center. Dr. Pardoll specializes in cancer immunology and cancer immunotherapy and has contributed to the development of many immunotherapies.
Sjoerd H. van der Burg, Ph.D., is a Professor in Experimental Cancer Immunology and Therapy at the Department of Clinical Oncology of the Leiden University Medical Center. He has extensive experience in tumor immunology and the immunotherapy of cancer, in particular the development of therapeutic vaccine strategies and the adoptive transfer of ex-vivo expanded T cells. He is specialized in the immunomonitoring of human T cell responses and is the current Chair of the Association for Cancer Immunotherapy Immunoguiding Program (CIP).
Mark Krul, Ph.D., is a co-founder of ISA Pharmaceuticals and a co-founder and Managing Partner at Aglaia BioMedical Ventures, a Dutch venture firm focusing on oncology. He is a molecular biologist and immunologist with over 20 years of experience in anti-cancer drug development, among others as a Research Manager at the European Cancer Center and as Head of the Department of Molecular Virology at the National Institute of Public Health and Environmental Protection in the Netherlands. Mark Krul has a strong track record in founding, managing and financing early-stage oncology companies. Mark Krul will chair ISA’s advisory board.
Company News: ISA Pharmaceuticals Presents Novel Data at the European Cancer Congress 2013 – Strong Synergies Between Cancer Vaccine ISA101 and Chemotherapy
– Chemotherapy improves immune response to therapeutic vaccine against Human Papilloma Virus type 16 (HPV16) –
ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced that it had presented novel data on its lead compound ISA101 at this year´s European Cancer Congress (ECCO-ESMO-ESTRO) in Amsterdam, The Netherlands.
In a preclinical mouse model of cancer, chemotherapy with cisplatin increased the therapeutic response to subsequent vaccination with an HPV16 synthetic long peptide (SLP®). While cisplatin or HPV-SLP® treatment alone increased survival, long-term survival was only achieved by combining chemotherapy with the vaccine.
These findings are further supported by a Phase I toxicity / immunogenicity study in 18 women with advanced or recurrent cervical cancer eligible for chemotherapy. Concurrent with standard chemotherapy (including carboplatin and paclitaxel), 12 patients received ISA101, a therapeutic cancer vaccine consisting of 13 synthetic long peptides from the E6 and E7 oncoproteins of HPV16. The control group (n=6) did not receive vaccination. The study demonstrates that chemotherapy doe s not cause lymphodepletion or suppression of cellular immune responses in patients. Patients showed shifts in leukocyte composition associated with increased dendritic cell function and improved memory T cell responses to common recall antigens. Patients treated with chemotherapy and ISA101 exhibited robust and sustained HPV16-specific proliferative T cell responses.
Company News: ISA Pharmaceuticals Initiates Phase I/II Clinical Trial of ISA101 in Patients with Anal Intraepithelial Neoplasia (AIN)
Therapeutic vaccine against Human Papilloma Virus type 16 (HPV16) tested in HIV-positive male patients
ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed, fully synthetic therapeutic vaccines against cancer and persistent viral infections, today announced the initiation of a Phase I/II clinical study of its lead candidate ISA101 in HIV-positive men suffering from anal intraepithelial neoplasia (AIN). The study is supported by ZonMw, the Dutch Organisation for Health Research and Development, and is being conducted in The Netherlands.
ISA101 is a synthetic long peptide (SLP®) vaccine for the treatment of diseases induced by human papilloma virus type 16 (HPV16), such as cervical cancer, ano-genital premalignant and malignant lesions, and head and neck cancer.
The open-label, dose-response study will be conducted in 30 HIV-positive male patients suffering from HPV16-positive high-grade AIN, who failed previous treatment. In the first dose escalation part of the trial, patients will be vaccinated with ISA101 in three dosing cohorts three times at three-week intervals, either with or without administration of peg-interferon-α on the day of vaccination. An additional group of 15 patients will be treated with the optimal ISA101 schedule. Primary clinical endpoints will be toxicity and safety as well as regression of lesions at 3, 6 and 12 months. Secondary endpoints are regression of lesions at 18 months and HPV16-specific immunity in the blood.
AIN is caused by infection with high-risk papilloma viruses (HPV) and known as a cancer precursor lesion that can lead to the development of anal cancer. AIN of any grade has been reported to be present in 63–81% of HIV-positive men, and high-grade disease (AIN 2 or 3) in 25–52%. The majority (approximately 60%) of high-grade AIN is caused by HPV16. Incidence of anal cancer has increased significantly since 1997 in both men and women, and especially in HIV-positive men. This is assumed to be a result of the significantly prolonged life span of HIV-positive patients. Therefore, early diagnosis and treatment of AIN is important to prevent malignancy. At present, there is no systemic treatment.