Tag: immunotherapy

Company News: ISA Pharmaceuticals Strengthens Patent Protection for its Lead Product ISA101

– Granted EU patent provides market exclusivity until 2028 –

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced it has been granted a European patent on its lead compound ISA101. The patent ensures market protection of ISA101’s active ingredient in Europe until 2028.

ISA101 is a therapeutic vaccine for the treatment of high-risk, HPV16-induced diseases. The vaccine consists of synthetic long peptides derived from the E6 and E7 oncogenic proteins of the HPV16 virus. This HPV strain is responsible, among others, for over 50% of human cervical cancers, more than 85% of HPV-positive head and neck cancers, and a variety of premalignant disorders.

The patent covers long peptides of the HPV-E6 protein, including a novel CD4+ epitope and provides exclusivity for the treatment of HPV-related diseases.

ISA101 is currently studied in the CervISA trial, a company-sponsored Phase I/II trial in cervical cancer and anal intra-epithelial neoplasia (AIN). Moreover, the vaccine has established clinical proof-of-concept by successfully completing a Phase II trial in vulvar intraepithelial neoplasia (VIN).

 

Company News: Three Peer-Reviewed Papers by ISA Pharmaceuticals Introduce Strategies to Improve Immunotherapy Against Cancer

–  Local Delivery of Checkpoint Control Antibodies Greatly Improve Efficacy and Safety

–  Promising Potential for Combinatorial Strategies

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced the publication of three peer-reviewed papers that demonstrate the benefit of local delivery of a checkpoint control antibody targeting CTLA-4 (cytotoxic T lymphocyte antigen-4) for the successful eradication of cancer and the reduction of side effects. The papers include a review that underlines the importance of strategies for combinatorial treatments to improve further the immunotherapy of cancer. ISA Pharmaceuticals is developing cancer immunotherapies along those lines, in particular its Synthetic Long Peptide (SLP®) vaccine ISA101 for the treatment of HPV-induced diseases, such as cervical cancer and head and neck cancer, and ISA203 for the treatment of various tumors including lung cancer, head and neck cancer, breast cancer and melanoma.

In a paper just published in Clinical Cancer Research [1], a team of scientists from Leiden University Medical Center (LUMC) and ISA Pharmaceuticals report that in preclinical mouse models of cancer, the injection of a CTLA-4 blocking antibody in a slow-release formulation close to the tumor is very effective in activating a systemic anti-tumor (CD8+) T cell response. CTLA-4 is a crucial immune checkpoint protein that down-regulates the body’s immune response. The low-dose local treatment (50μg subcutaneously in a slow-release vehicle) eradicates tumors, including distant tumors, as effectively as a high-dose systemic treatment (2×200μg intraperitoneally). The method also leads to a 1000-fold decrease of antibody levels in the serum, thereby reducing adverse events and the risk of autoimmunity.

These findings are supported by an increasing number of studies demonstrating that local targets, mainly present in the microenvironment of tumors and draining lymph nodes, are key players in tumor progression. As published in a second paper by researchers from LUMC and ISA, a review in the International Journal of Cancer [2], local immunotherapies have clear advantages over systemic treatments, both in their ability to shift tumor-promoting mechanisms towards effective tumor-eradicating immunity and in terms of reducing the risks of systemic administration.

In the third publication in Seminars in Immunology [3], current cancer immunotherapy approaches are reviewed, concluding that most standalone immunotherapeutic strategies either fail to affect progressive diseases and survival significantly – or only do so in a minority of patients. The authors support combinations of synthetic vaccines that stimulate tumor-specific T cell responses and adjuvants, immune-modulating antibodies, cytokines, or chemotherapy.

 


[1] Fransen MF et al. (2103), Clin Cancer Res, Published Online First June 20, 2013; doi: 10.1158/1078-0432.CCR-12-0781

[2] Fransen MF et al. (2013), Int. J. Cancer, 132: 1971–1976; doi: 10.1002/ijc.27755

[3] Arens R et al., (2013), Sem Immunol, Published Online First May 21, 2013;
doi: 10.1016/j.bbr.2011.03.031

Company News: ISA Pharmaceuticals Strengthens Management Team

–      Company hires Jan Fagerberg as Chief Medical Officer and Jens Hennecke as Chief Business Officer

–      Ronald Loggers becomes Acting Chief Executive Officer and Gerard Platenburg Chief Operating Officer

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced that it has appointed Dr. Jan Fagerberg, M.D., Ph.D., as Chief Medical Officer and Dr. Jens Hennecke, Ph.D., as Chief Business Officer and Advisor. Furthermore, Ronald Loggers, M.Sc., MBA, will step down from the Board of Directors and assume the role of Acting Chief Executive Officer, while Gerard Platenburg will become Chief Operating Officer.

Dr. Jan Fagerberg (51) is a board-certified clinical oncologist with more than 20 years of experience in clinical research and the development of oncology drugs. He joins ISA from Amgen where he was Vice President Global Development and Managing Director of Amgen Research (Munich) GmbH. During his career, Dr. Fagerberg has held senior executive positions at Amgen, Micromet, TopoTarget, and F. Hoffmann-La Roche. His responsibilities have included the global clinical development of blinatumomab (AMG 103), belinostat (PXD101), capecitabine (Xeloda), and clinical development programs of bevacizumab (Avastin) outside the U.S.. Dr. Fagerberg has extensive international regulatory experience, and was successful in obtaining 11 FDA and EMA approvals for Xeloda and Avastin. At Micromet, he also initiated the clinical development of several compounds in collaboration with global pharma companies. Jan Fagerberg received his M.D. (1988) and Ph.D. (1995) for work in clinically applied passive and active immunotherapy in cancer from the Karolinska Institute in Stockholm (Sweden).

Dr. Jens Hennecke (45) has a strong track record in business development, corporate development and licensing. He brings extensive experience in the negotiation and closing of corporate alliances. Prior to joining ISA and building his own business development advisory franchise, he was Senior Vice President Business Development at Micromet, Inc., where he managed the company’s business and corporate development, intellectual property and information technology departments. He also played a key role in establishing partnerships with major pharma companies, and in Micromet’s acquisition by Amgen in 2012. Prior to joining Micromet in 2001, Dr. Hennecke was a post-doctoral researcher at Harvard University. He holds a B.Sc. in biology from the University of Göttingen, Germany, and a Ph.D. from the ETH Zurich, Switzerland.

Before becoming Acting Chief Executive Officer, Ronald Loggers (45) had been on the Supervisory Board of ISA since 2009. He is currently also Managing Director at Multifund B.V., a family-owned investment company. Prior to that, he worked seven years for HAL Investments B.V., five years for McKinsey & Company and one year for Fokker Aircraft B.V. He brings extensive managerial, investment and financing experience. Ronald obtained an MBA from INSEAD (France) and an M.Sc. in Chemical Engineering from Delft University of Technology (The Netherlands).

Gerard Platenburg (48) joined ISA Pharmaceuticals in an executive role in 2009 and helped to mature ISA’s organization into its current form. He has over 20 years of experience as an executive in the biotech industry. He gained experience in several innovative biotech companies, amongst others Pharming and Prosensa, which he co-founded and grew into a clinical-stage company. Gerard holds a degree as a chemist/molecular biologist from the University of Leiden, The Netherlands.

The management team will consist of Ronald Loggers (Acting Chief Executive Officer), Gerard Platenburg (Chief Operating Officer), Prof. Kees Melief (Chief Scientific Officer), Jan Fagerberg (Chief Medical Officer) and Jens Hennecke (Chief Business Officer).

Company News: Provecs Medical Signs Vaccine Collaboration with Bernhard Nocht Institute for Tropical Medicine

Hamburg-based immunotherapeutics company Provecs Medical this week announced the signing of a collaboration with the prestigious German Bernhard Nocht Institute for Tropical Medicine (BNI). The partners will design and evaluate novel vaccine candidates based on Provecs Medical’s technology platform. Indications are four undisclosed infectious diseases, three of them transmitted by insects.

Provecs Medical uses a proprietary adenoviral vector technology to achieve the targeted expression of multiple signaling molecules relevant for the immune system in the microenvironment of a disease site. Please click here for further information.