Vorinostat

Credit: Lightspring/Shutterstock.com A team of German scientists and biotech company Dynamic42 have jointly developed a ‘tumour-on-chip’ model of pancreatic ductal adenocarcinoma (PDAC), allowing insights into interactions between tumour cells and potential treatments. The team of scientists, led by Professor Nicole Teusch at the Institute of Pharmaceutical Biology and Biotechnology at Heinrich Heine University Düsseldorf, used biochips manufactured by Dynamic42 to create an in vitro model to study the efficacy of drugs in treating the cancer. “The collaboration with Dynamic42 has given us the opportunity to develop a state-of-the-art system that can significantly advance pancreatic cancer research. We are confident that this model will make a significant contribution to the development of new therapies,” said Teusch. Also based in Germany, Dynamic42 spun off from the University Hospital Jena in 2018. The biotech’s main offerings are its human organ-on-chip models and micro-physiological systems. Organ-on-chips have become an established method of studying disease pathogenesis, whilst tumour-on-chips, although promising, need more refinement before being a go-to preclinical model for cancer research. Professor Teusch and Dynamic42 set out their work in one of the most challenging cancers, with PDAC being the most common and lethal form of pancreatic cancer. A major cause of its fast disease progression is the presence of a highly fibrotic tumour microenvironment. The complex tumour microenvironment is also a reason why developing effective treatments against the disease is difficult. Results from the study, which were published in the Royal Society of Chemistry’s Lab on a Chip journal, demonstrate that the innovative chip could improve prospects at the preclinical stage of drug testing. Teusch and her team successfully developed the in vitro model that realistically simulates the tumour microenvironment seen in PDAC. The chip was integrated with PDAC spheroids, structures made of PANC-1 cells – a human pancreatic cancer cell line – and pancreatic stellate cells. This gives the model three-dimensional cell cultures, simulating tumour structure more accurately than two-dimensional counterparts. A key benefit of the tumour-on-chip developed by the team is that it allows dynamic administration of drugs or immune cells. The researchers tested the chip’s ability for drug testing by applying US Food and Drug Administration (FDA)-approved cancer therapy Zolinza (vorinostat), which is developed by MSD. After administrating the treatment for three days, PDAC spheroids were killed off without affecting vascular integrity. “This advanced PDAC model offers a powerful platform for identifying promising new drug candidates, thereby reducing the reliance on animal models and improving translational potential for clinical applications,” the authors said in the paper. Dynamic42 CEO and co-founder Dr Martin Raasch said: “This innovative model marks a turning point in preclinical cancer research. It enables us to precisely analyse the complex processes in the tumour microenvironment and accelerate new therapeutic approaches.”

GALASHIELS & MARLOW, England & BAAR, Switzerland--( BUSINESS WIRE )--Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co. Ltd., and Swixx BioPharma AG today announced that the Croatian National Health Insurance Fund (NHIF) and the Bulgarian Ministry of Health have both approved the reimbursement of POTELIGEO ® (mogamulizumab) for adult patients with mycosis fungoides (MF), and Sézary syndrome (SS). MF and SS are two subtypes of cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin’s lymphoma that presents and persists in the skin and can cause debilitating physical, emotional and social challenges. 1 MF—the most common CTCL subtype—accounts for approximately 60% of all CTCLs. 2 With an average time to diagnosis of 3-4 years, MF is typically characterised by skin symptoms including patches or plaques, skin redness and tumours. 3,4 SS is much rarer, accounting for around 5% of CTCLs, 5 and is more aggressive, causing severe itching, erythroderma, intense scaling of the skin and frequent hair loss. 6 Jeremy Morgan, President of Kyowa Kirin International, commented: “ I am delighted that the Croatian and Bulgarian authorities have agreed to reimburse POTELIGEO for MF and SS patients. Both decisions are important milestones for people impacted by these rare and challenging forms of CTCL, and with mogamulizumab now reimbursed in more than 20 countries across the EMEA region we remain as committed as ever to delivering life changing value for people impacted by under-diagnosed and under-served diseases, and making more people smile.” Poteligeo is distributed in Central and Eastern Europe by Swixx, on behalf of KKI. The two companies signed a Promotion and Distribution Agreement in October 2022. Under the terms of the agreement, Swixx will exclusively market, promote and distribute mogamulizumab in both Croatia and Bulgaria, among other countries. “ At Swixx, our mission is to unlock access to innovative medicines, and the recent reimbursement approvals in Croatia and Bulgaria mark significant progress in improving therapeutic options for patients with MF and SS in those markets,” said Dezso Martha, Chief Operating Officer of Swixx. “ We will continue working closely with health authorities, the scientific community, and Kyowa Kirin to expand access to this important medicine, ensuring better outcomes for patients across our Central and Eastern European countries.” With Croatian reimbursement effective as of 15 th November 2024, and Bulgaria’s Ministry of Health confirming reimbursement as of 2 nd January 2025, both decisions build on the inclusion of POTELIGEO ® (mogamulizumab) in the Polish Ministry of Health’s Drug Programme announced in July 2024 and the ongoing expansion of access to patients across Central and Eastern Europe (CEE). About Poteligeo (mogamulizumab) Mogamulizumab is a first-in-class humanised monoclonal antibody directed against CC-chemokine receptor 4 (CCR4), a protein consistently expressed on cancerous cells seen in both MF and SS. 7-9 Once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells. 10 About MF and SS MF and SS are two subtypes of CTCL, which is itself a rare form of non-Hodgkin’s lymphoma that presents and persists in the skin. 1 CTCL is treatable, but is not generally considered to be curable, and there has been a clear unmet need for novel treatment options. As well as the obvious impact of symptoms upon patients, there can be significant erosions to quality of life for those caring for an individual living with CTCL. 11 MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin. 12 These cancerous T cells consistently express a protein called CCR4, which enables them to move from the blood to the skin. 7-9 When these cancerous T cells move to the skin, this results in the visible early skin symptoms of red patches or plaques which can resemble psoriasis or eczema in the early stages of the disease. 6 Later, for some patients, skin involvement may evolve to include tumours or reddening of the majority of the skin’s surface (erythroderma). MF—the most common CTCL subtype—accounts for approximately 60% of all CTCLs 2 and is typically indolent, characterised by skin symptoms including patches or plaques, skin redness and tumours. 3,4 SS is much rarer, accounting for around 5% of CTCLs, 5 and is more aggressive, 6 with high levels of blood involvement. 5 It can cause severe itching, erythroderma, intense scaling of the skin and frequent hair loss. 6 CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis. 6 About Kyowa Kirin Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by severe and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions – Japan, Asia Pacific, North America, and EMEA/International. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com About Swixx BioPharma AG Swixx BioPharma is one of the fastest-growing, largest, intercontinental commercial platforms for the biopharmaceutical industry. Swixx operates subsidiaries across Central and Eastern Europe, Greece, Russia, several Eurasian countries, the Middle East, and via Biopas, a Swixx BioPharma company, in almost 20 Latin American countries. Swixx BioPharma Group has over 1,600 employees and sales likely to exceed a billion Euros in 2024. The company has gathered outstanding rare disease, oncology-hematology, specialty, vaccines and self-medication talent under one roof. For more information about Swixx BioPharma, please visit: www.swixxbiopharma.com References 1 Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204. 2 Willemze R, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714. 3 Scarisbrick, J, et al. The PROCLIPI international registry of early-stage mycosis fungoides identifies substantial diagnostic delay in most patients. Br J Dermatol. 2019;181(20):350–357. 4 Demierre M-F, et al. Significant impact of cutaneous T-cell lymphoma on patients’ quality of life. Cancer. 2006;107(10):2504-2511. 5 Trautinger F, et al. European Organisation for Research and Treatment of Cancer consensus recommendations for the treatment of mycosis fungoides/Sézary syndrome - Update 2017. European Journal of Cancer. 2017;77:57–74. 6 Lymphoma Coalition. Cutaneous lymphoma – a patient’s guide. Available at: https://lymphomacoalition.org/wpcontent/uploads/Cutaneous_lymphoma_-_patients_guide_-.pdf . Last accessed: January 2025. 7 Ferenczi K, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405–10. 8 Yoshie O, et al. Frequent Expression of CCR4 in Adult T-Cell Leukemia and Human T-cell Leukemia Virus Type 1-transformed T cells. Blood. 2002;99(5):1505–11. 9 Ishida T, et al. Clinical Significance of CCR4 Expression in Adult T-cell Leukemia/Lymphoma: Its Close Association With Skin Involvement and Unfavorable Outcome. Clin Cancer Res. 2003;9:3625–34. 10 Duvic M, et al. Mogamulizumab for the treatment of cutaneous T-cell lymphoma: recent advances and clinical potential. Ther Adv Hematol. 2016;7(3):171–174. 11 Williams et al (2020) – Health state utilities associated with caring for an individual with CTCL. Journal of Medical Economics. 2020; 23(10):1142-1150. 12 Scarisbrick JJ, Prince M, Vermeer MH, et al. Cutaneous Lymphoma International Consortium Study of Outcome in Advanced Stages of Mycosis Fungoides and Sézary Syndrome: Effect of Specific Prognostic Markers on Survival and Development of a Prognostic Model. J Clin Oncol. 2015;33(32):3766-3773.