Vorinostat

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.

Study site selection and finalization of clinical trial agreement final step toward initiation of RVL-001 proof-of-concept clinical studies early next year BOSTON, Oct. 24, 2024 /PRNewswire/ -- Unravel Biosciences, Inc., ("Unravel"), an AI-enabled therapeutics company established to advance drugs for complex diseases, and the clinical research unit of the PECET of the University of Antioquia, certified in Good Clinical Practices by the Colombian Health Regulatory Authority ("INVIMA") and located in in Medellín, Colombia, today announced the finalization of a clinical trial agreement enabling PECET to be the designated study site for Unravel's RVL-001 proof of concept clinical trials for Rett syndrome (RTT) and Pitt Hopkins syndrome (PTHS). Unravel's proprietary BioNAV™ drug discovery platform identified RVL-001 as a potentially promising therapeutic drug for Rett Syndrome and PTHS. Building on previously announced initiatives by Unravel to initiate a proof-of-concept clinical trials of RVL-001 in Colombia for RTT as well as a collaboration by the Pitt Hopkins Research Foundation (PTHF) to conduct an extension study of RVL-001 in PTHS, today's agreement with PECET in Colombia formally establishes the clinical infrastructure for Unravel to rapidly evaluate BioNAV™ identified drugs in patients. "We are excited to collaborate with the highly skilled PECET team to accelerate therapeutics development for rare disease patients," said Richard Novak, Ph.D., Unravel Co-Founder and CEO. "By conducting multiple clinical trials in parallel at a single clinical trial site enables faster and less costly drug development to support more patients with unmet needs." RTT and PTHS are both rare neurogenetic disorders starting in early childhood that lead to debilitating cognitive, motor and autonomic disability. Despite one approved treatment for RTT, there remains a significant unmet need for novel treatments having meaningful efficacy and acceptable safety and tolerability. There are no known treatments for PTHS. In addition to Unravel's RVL-001 program for RTT and PTHS, the company has also initiated development work on RVL-002, a first-in-class novel molecule for Rett syndrome. Initiation of patient dosing for the RVL-001 trial in RTT and extension trial in PTHS are both anticipated in early 2025, with study startup activities including clinical trial material manufacturing and patient recruitment initiated earlier this year as previously announced. "We are pleased to be the designated clinical trial center for Unravel, it is a great challenge that we will take on with great enthusiasm to contribute to the search for solutions for this type of disease," said Iván Darío Vélez, Professor Emeritus of the University of Antioquia and founder of PECET. "PECET has extensive expertise conducting clinical studies with international biopharma sponsors including US to support worldwide registration and approval and we look forward to supporting Unravel in their development efforts". About Unravel Biosciences Unravel Biosciences revolutionizes drug development, uncovering disease-modifying targets from patient data powered by AI systems biology computation, rapid in vivo screening, and clinical validation of discovered targets with unprecedented efficiency. Unravel leverages its proprietary BioNAV™ foundational model of human health combining target and drug discovery, preclinical screening and patient stratification to find treatments for complex diseases. Unravel's platform has led to four clinical programs. Unravel's platform developed RVL001, a novel formulation to treat neurodevelopmental disorders, RVL002, a first-in-class new small molecule targeting mitochondrial metabolism, and RVL027, a molecule targeting a novel mechanism to treat dystonias. The rareSHIFT™ program provides platform access to foundation and biotech partners to accelerate and clinically derisk therapeutics using existing drugs as a key stepping stone to validating novel targets and mechanisms in real patient populations. and SOURCE Unravel Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED