Selvita SA

KRAKÓW, Poland, May 7, 2024 /PRNewswire/ -- Selvita S.A. [WSE: SLV] announced today completion of a strategic transaction in which it has acquired 100% of shares in PozLab. The closing of the transaction comes shortly after the announcement of the transaction on March 27, 2024. PozLab is a contract development and manufacturing organization ("CDMO") offering expert drug product development services and small pilot plant capabilities, including analytical, formulation, and process development competencies, followed by microbiological testing. Moreover, PozLab holds a GMP license for the manufacture of medical and investigational products. The Company currently employs over 80 dedicated subject matter experts and is located in state-of-the-art R&D facilities in Poznan, Poland, which offer approx. 1700 m2 of research space. The acquisition of PozLab substantially expands Selvita's capabilities in the rapidly growing pharmaceutical research sector. Selvita extends its value chain beyond preclinical research, enabling, in particular, the provision of small molecule drug manufacturing services for early-stage clinical trials. This strategic move enriches Selvita's portfolio with additional valuable competencies, positioning the company as a comprehensive solution provider in the pharmaceutical industry. We are very excited that as of today, PozLab is formally part of the Selvita Group. A lot of effort has gone into the completion of this transaction, and we are certain that it's a very important milestone for the development of Selvita's CDMO offer. I would like to extend a very warm welcome to our new colleagues in Poznan. It's wonderful to have them on board and I am looking forward to all the synergies this new relationship will bring - said Bogusław Sieczkowski, President of the Management Board of Selvita. About Selvita (SLV) Selvita is one of the leading preclinical contract research organizations in Europe, driven by a clear mission: to offer a comprehensive scope of services bridging the gap between early drug discovery and the clinical stage of drug development. Selvita provides comprehensive solutions supporting Clients and their drug discovery projects, across a broad range of therapeutic areas, specializing in infectious diseases, inflammation, fibrosis, and oncology. The Company offers a range of stand-alone or fully integrated drug discovery and development solutions spanning the entire value chain from early drug discovery to preclinical development both for small molecules and therapeutic antibodies. On top of that Selvita offers drug product development and contract testing studies. Selvita, established in 2007, operates globally with over 900 highly qualified employees, of which over 40% hold a PhD degree. The Company's research sites are in Krakow (HQ), Poznan and Wroclaw Poland, and Zagreb, Croatia. The international offices are located in Cambridge, MA, and San Francisco Bay Area, in the U.S., as well as in Cambridge, UK. Ardigen, a bioinformatics company harnessing advanced Artificial Intelligence methods for novel precision medicine, is part of Selvita Group portfolio of companies. The company employs over 150 professionals. Selvita is listed on the Warsaw Stock Exchange (WSE: SLV). For more information, please see . SOURCE Selvita S.A.

KRAKOW, Poland, Jan. 31, 2024 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today that the first patient has been dosed with the study drugs in a Phase II clinical trial investigating RVU120 in combination with venetoclax for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) – the RIVER-81 study (NCT06191263). The primary goal of the RIVER-81 study will be to evaluate safety and efficacy of RVU120 in combination with venetoclax in r/r AML patients who have failed prior venetoclax treatment. The RIVER-81 study is initially launching at clinical sites in Poland and Italy. Ultimately, the study will expand to other EU and non-EU countries, covering up to 50 clinical sites globally. The planned overall enrollment for the study is up to approx. 98 patients. The study is part of the RVU120 Development Plan presented in October 2023 and aligns with the company's cash runway to Q1 2026. Execution of the RIVER-81 study is supported with a PLN 62.3 mln grant from the Polish Medical Research Agency (ABM). In H1 2024, Ryvu plans to launch four Phase II RVU120 clinical studies and enroll over 100 patients across the studies by the end of the year. Ryvu aims to prioritize further development options in Q1 2025 based on the study outcomes. Clinical trials conducted in various hematological indications and treatment regimens (monotherapy and combination therapy) will contribute to the global RVU120 safety database, which would support potential future regulatory approvals. RVU120 is a selective, first-in-class dual CDK8/19 kinase inhibitor developed by Ryvu Therapeutics. RVU120 monotherapy has demonstrated positive clinical activity in a Phase Ib study, where 50% of evaluable patients with r/r AML or HR-MDS achieved clinical benefit, including a complete response, a morphologic leukemia-free state, multiple clinically significant blast reductions, hematologic improvements, and reduction of bone marrow fibrosis. Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics, said: - Considering the encouraging results from the Phase Ib study of RVU120 as monotherapy for patients with r/r AML and HR-MDS, along with compelling translational evidence of synergistic activity with venetoclax, we have launched the Phase II RIVER-81 study with optimism. AML patients who fail the current standard of care, consisting of venetoclax and a hypomethylating agent, have very few alternative treatment options and a poor prognosis. We are delighted to commence the new Phase II RVU120 study in Poland and Italy, with plans to expand to up to 50 clinical sites globally. Our goal is to bring meaningful clinical benefits to AML patients. Kamil Sitarz , Ph.D., Chief Operating Officer of Ryvu Therapeutics, said: - We have successfully confirmed the safety profile of RVU120, and our focus is now on substantiating its efficacy signals. With the activation of dozens of clinical sites globally, we aim to dose over 100 patients across four RVU120 Phase II studies by the end of 2024. Subsequently, and based on treatment outcomes, we will strategically prioritize further development paths. This progress aligns with the RVU120 development plan unveiled in October 2023, supported by secured financing until Q1 2026. RIVER-81 is a multicenter, open-label clinical trial that aims to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with AML who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent. The study is divided into two parts. Part 1 aims to identify safe and tolerated doses of RVU120 and venetoclax when used in combination, through dose escalation of both study drugs. In Part 2, the selected doses will be evaluated for both safety and efficacy in a larger group of patients. The study has received approval from the Competent Authorities in Poland and Italy following a clinical trial application in accordance with the European Union Clinical Trial Regulation (EU-CTR) 536/2014, as well as positive opinions from the respective Ethics Committees, enabling patient enrollment in both countries. Start-up activities in other EU and non-EU countries are currently in progress. RIVER-81 marks the commencement of the first of four planned RVU120 Phase II clinical studies, scheduled to launch in H1 2024. Following RIVER-81, Ryvu intends to initiate the RIVER-52 study (evaluating RVU120 as a monotherapy in patients with genetically defined subtypes of AML and in patients with HR-MDS). Upcoming plans also include the initiation of the REMARK study (conducted as an investigator-initiated trial, exploring RVU120 as a monotherapy for the treatment of patients with low-risk myelodysplastic syndromes; LR-MDS) and the POTAMI-61 study (evaluating both monotherapy and combination therapy for the treatment of patients with myelofibrosis; MF). About Ryvu Therapeutics   Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel small-molecule therapies that address emerging targets in oncology. Internally discovered pipeline candidates make use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, and immuno-oncology targets. Ryvu's most advanced programs include RVU120, a selective CDK8/CDK19 kinase inhibitor with potential to treat hematological malignancies and solid tumors, currently in Phase II development for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) in combination with venetoclax. Another clinical program, SEL24 (MEN1703), is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group. Ryvu Therapeutics has signed multiple partnering and licensing deals with global companies, including BioNTech, Exelixis, Menarini, and Merck. The Company was founded in 2007 and is headquartered in Kraków, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the sWIG40 index. For more information, please see . SOURCE Selvita S.A.

OXFORD, England and KRAKOW, Poland, June 5, 2023 /PRNewswire/ -- The University of Oxford and Selvita (WSE: SLV), one of the largest contract research organizations in Europe, announced an integrated drug discovery collaboration in the area of Parkinson's disease. While Parkinson's disease is the second most common neurodegenerative disease affecting ~7 million people worldwide, there are only symptomatic therapies available. At the molecular level, it is caused by the build-up of a small protein called alpha-synuclein which forms aggregates inside vulnerable neurons. The inability of cells to efficiently clear these aggregates may lead to the death of neurons and the emergence of characteristic symptoms of the disease. Professor George Tofaris and his Team at the University of Oxford have identified key protein disposal factors that affect alpha-synuclein aggregation, and could be important drug targets for disease modification. Taking advantage of Selvita's experience in the areas of protein degradation and neuroscience, Professor Tofaris and his team have worked with Selvita to develop promising prototype compounds that efficiently promote the clearance of alpha-synuclein aggregates. The project is now being continued with an aim to progress the compounds further along the drug discovery pipeline by improving their pharmacological properties and their efficacy. "There is extensive evidence from genetics and pathology implicating alpha-synuclein aggregates as the cause of Parkinson's. Therefore, promoting the ability of nerve cells to rid themselves of these aggregates is a rational therapeutic strategy in this group of diseases." – commented Professor George Tofaris, Professor of Neurology and Translational Neuroscience at the University of Oxford. "Combination of Selvita's drug discovery expertise and the world-class innovative research conducted at the University of Oxford, create this exquisite collaboration which holds an immense potential to address the urgent need for disease-modifying treatments to combat Parkinson's disease. We are very excited to continue working with Prof. Tofaris and his Team." – added Edyta Jaworska, Vice President Sales, Drug Discovery Europe and Asia at Selvita. Parkinson's disease Parkinson's disease is the second most common neurodegenerative disease affecting ~7 million people worldwide. Currently there are only partially effective symptomatic therapies but no treatments to stop or slow down the disease. Parkinson's primarily affects movement and posture due to the death of dopamine producing nerve cells. Poor smell, sleep or mood disturbance and other difficulties often start decades before the movement disorder and become more prominent as the disease progresses, with a significant impact on the quality of patients' and carers' lives. About the University of Oxford Oxford University () has been placed number one in the Times Higher Education World University Rankings for the sixth year running, and number two in the QS World Rankings 2022. At the heart of this success are the twin-pillars of our ground-breaking research and innovation and our distinctive educational offer. Oxford is world-famous for research and teaching excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research alongside our personalised approach to teaching sparks imaginative and inventive insights and solutions. Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988. Over a third of these companies have been created in the past three years. The University is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full-time jobs. About Selvita [SLV] Selvita is one of the largest preclinical contract research organizations in Europe, driven by a clear mission: to offer a comprehensive scope of services bridging the gap between early drug discovery and the clinical stage of drug development. Selvita provides comprehensive solutions supporting Clients and their drug discovery projects, across a broad range of therapeutic areas, specializing in infectious diseases, inflammation, fibrosis, and oncology. The Company offers a range of stand-alone or fully integrated drug discovery and development solutions spanning the entire value chain from early drug discovery to preclinical development. On top of that Selvita also offers analytical support of drug development and contract testing studies. Selvita, established in 2007, operates globally with almost 900 highly qualified employees, of which over 40% hold a PhD degree. The Company's research sites are in Krakow (HQ), Poznan, Poland, and Zagreb, Croatia. The international offices are located in Cambridge, MA, and San Francisco Bay Area, in the U.S., as well as in Cambridge, UK. Ardigen, a bioinformatics company harnessing advanced Artificial Intelligence methods for novel precision medicine, is part of Selvita Group portfolio of companies. The company employs over 160 professionals. Selvita is listed on the Warsaw Stock Exchange (WSE: SLV). For more information, please see . SOURCE Selvita