FOXO4

UTRECHT, The Netherlands--(BUSINESS WIRE)-- CLEARA Biotech B.V. (“Cleara” or the “Company”), a preclinical-stage biotechnology company focused on developing innovative, proprietary therapies for treating different pathologies of “scarred” cellular senescence, including late-stage cancer and chronic diseases, today announced that immunotherapy and oncology expert Dr. Nicholas J. Sarlis has been appointed as the company’s Chief Medical Officer (CMO) and Head of Clinical Development. Dr. Sarlis brings more than 25 years of clinical and pharmaceutical/biotechnology experience to his position at CLEARA, including leading multidisciplinary teams to advance early to late-stage clinical development programs in the biotechnology industry as well as approved drugs. This press release features multimedia. View the full release here: Nicholas J. Sarlis (Photo: Business Wire) Dr. Sarlis has (co-)managed the medical strategy supporting the launch of 6 globally marketed products, investigated 20 pipeline agents – progressing 11 of them along their clinical development path and lifecycle – and has participated as a site investigator in 38 studies and 2 registries. He is an experienced clinician, senior medical researcher and recognized pharmaceutical and biotech industry leader. Until recently, Dr. Sarlis led the Medical Content function within Amplity Health. Prior to that, and in reverse succession, Dr. Sarlis served as CMO of The Lynx Group and CMO of Sellas Life Sciences Group, Inc., where he led the clinical development of two peptide-based cancer vaccines. Before that, Dr. Sarlis served as Head of Medical Affairs at Incyte Corp. and held positions of increasing seniority at Sanofi, both in the US and France. Prior to his industry positions, he was a clinical faculty member at the MD Anderson Cancer Center and the US National Institutes of Health. Dr. Sarlis obtained his Doctor of Medicine and DrMedSci degrees from the University of Athens, Greece, and a PhD from Imperial College, University of London. Dr. Sarlis is certified by the American Board of Internal Medicine and the National Board of Physicians and Surgeons (US) and is an elected Fellow of the American College of Physicians and the Royal Society of Medicine (UK). Dr. Sarlis has published 135 articles and textbook chapters. Dr. Peter de Keizer, Managing Director and Founder of CLEARA, commented: "Dr. Sarlis is an internationally recognized physician-scientist with a proven ability in conducting clinical and translational research. He has broad connections throughout academic centers of excellence in oncology, and solid understanding of the regulatory environment, both in the EU and US.” He added: “CLEARA is in an advanced stage with its development candidate CL04183 for metastatic cancer. Dr. Sarlis adds exceptional strategic and practical leadership and guarantees our near future and long-term focus on progressing CL04183 and other compounds in our senescence pipeline to the clinic. I am honored and excited to welcome Dr. Sarlis both personally, as well as on behalf of our board and management team.” Dr. Sarlis remarked: “The study of the functional interaction between FOXO4 and p53 has a historical arc of almost 15 years and has led to the discovery of highly innovative synthetic peptides at CLEARA. Previous work has fundamentally fostered our understanding of the proapoptotic effects of such agents on ‘scarred’ cancer cells that remain viable and proliferating, even after exposure to chemotherapeutic and targeted agents, thus ushering a breakthrough technology with broad applicability. I am delighted to join CLEARA with the remit to spearhead the clinical program studying the effects of FOXO4-interacting peptides in a biomarker-selected patient population with chemo-resistant metastatic malignancies. I look forward to partnering with the company’s energetic and talented team to build our clinical development organization and advance this new therapeutic option for patients in need.” About CLEARA Biotech B.V. Cleara is a biopharmaceutical preclinical-stage company, spun out from University Medical Center Utrecht (UMCU), focused on developing therapies for treating different types of “senescent” cells. Cleara’s expertise lies in understanding the molecular and biological pathways that underlie these pathological phenotypes to exploit their weak spots for safe and selective clearance. Cleara’s lead program is focused on eliminating “scarred” cells, i.e., irreparably damaged cells hallmarked by the binding of the guardian proteins FOXO4 and p53, the latter of which is in a specifically modified form different from healthy cells. This subtype of senescence is particularly deleterious as it is metabolically active and disrupts neighboring cells. Using the native FOXO4 3D structure, Cleara optimized CL04183 specifically around binding modified p53. In doing so, CL04183 potently and selectively eliminates scarred cells with striking efficacy against metastases. Having both favorable tissue distribution and long-term safety profile, Cleara is gearing up for clinical translation of scarred metastatic cancer. Cleara is a platform-based company that utilizes knowledge against senescence subtypes and develops compounds to eliminate these in respective diseases. For more information, please visit

Company Also Appoints Seasoned Industry Executive, Dr. Angelos Stergiou, as Board of Directors Chairman in Advance of Lead Program Entering the Clinic UTRECHT, Netherlands--(BUSINESS WIRE)-- CLEARA Biotech B.V. (“Cleara” or the “Company”), a preclinical-stage biotechnology company focused on developing innovative, proprietary therapies for treating different pathologies of “scarred cellular” senescence, including late-stage cancer and chronic diseases, today announced that it closed a $2.5 million seed financing round earlier in the year, led by Apollo Health Ventures, with participation from Curie Capital B.V., ROM Utrecht Region and Longevity Tech Fund. The proceeds will be used to progress Cleara’s compounds toward clinical development and further build the Company’s developmental pipeline and management team. Cleara has optimized two lead developmental candidates, CL04177 and CL04183, that can eliminate scarred cancer cells found in several late-stage cancers and chronic diseases in humans. The Company is aiming to develop precision medicine tools that treat specific diseases with clear niche-directed, anti-senescent lead candidates, accompanied with associated biomarkers, around its FOXO4-based D-amino acid peptides and pipeline against subtypes of senescence. As senescent cells impair tissue function, identifying how these cells avoid apoptosis allows for the prospective design of anti-senescence compounds and will be critical to address whether homeostasis can be restored. Cleara scientists identified FOXO4 as having the potential to sequester active, phosphorylated p53, preventing nuclear translocation and induction of apoptosis in scarred senescent and cancer cells. Senescent/scarred cells, as well as a range of chemo-resistant and/or metastatic cancers, share features and unique biomarkers that Cleara has identified, making them highly selective targets for CL04177/CL04183. Designed and optimized based on an extensive (3D) structural, molecular and cellular understanding of cell scarring’s mechanism of action and how FOXO4 restrains this particular form of the cell guardian p53, both lead compounds potently counter viability of scarred cancer cells in 2D culture and 3D organoids, as well as strongly reduce the metastatic burden and infiltration in mouse in vivo models for metastatic colon cancer and triple-negative breast cancer. Furthermore, they show favorable pharmacokinetics and tissue distribution in mice, with an MTD that is well above their efficacious dose. Additionally, Cleara has appointed Dr. Angelos Stergiou, New York-based SELLAS Life Sciences’ President and Chief Executive Officer, as its Board of Directors Chairman. Dr. Stergiou is a preeminent leader in the biotechnology industry with more than 20 years of experience in immuno-oncology, drug development and health economics, as well as deep expertise in finance and corporate governance. “As Cleara’s vision is to develop novel, highly innovative approaches to combat life-threatening diseases, we look forward to further building the Company’s pipeline and advancing our preclinical studies,” said Dr. Peter de Keizer, Managing Director and Scientific Founder, Cleara. “At the same time, Dr. Stergiou’s deep expertise in cancer drug development and impressive track record of building companies will be invaluable to use as we scale our preclinical and regulatory efforts in the U.S. and EU to enter the clinic by 2024.” “Cleara’s novel FOXO4-based treatment approach, which harnesses the unique attributes of utilizing biomarkers and ability to eliminate biomarker-positive scarred cells, specific subsets of senescence, has the potential to be a disruptive treatment paradigm for many high-unmet-need cancer patient populations,” added Dr. Stergiou. “I look forward to working with the Board and management team as the Company continues to grow at such a pivotal time.” Dr. Marianne Mertens, Partner at Apollo Health Ventures, Cleara’s founding venture capital group and lead investor, concluded: “As we have worked closely with Cleara since its inception, playing a key role in the Company’s founding, Apollo Health Ventures has been extremely impressed with the progress achieved to date. We believe that the FOXO4-based approach, including the utilization of biomarkers, has great promise to develop safe and efficacious drugs in several diseases. We also look forward to benefiting from Dr. Stergiou’s biotech finance and operations knowledge, which will have an immediate and beneficial impact on our strategy to bring first- and/or best-in-class cancer drugs to patients.” About CLEARA Biotech B.V. Cleara is a biopharmaceutical preclinical-stage company, spun out from University Medical Center Utrecht (UMCU), focused on developing therapies for treating different types of “senescent” cells. Cleara’s expertise lies in understanding the molecular and biological pathways that underlie these pathological phenotypes to exploit their weak spots for safe and selective clearance. Cleara’s lead program is designed to generate disruptive, innovative and proprietary technology against “scarred cellular” senescence against late-stage cancer and chronic diseases. Cleara is a platform-based company that utilizes knowledge against senescence subtypes and develops compounds to eliminate these in respective diseases. For more information, please visit . View source version on businesswire.com: Contacts CLEARA Biotech B.V. info@clearabiotech.com Source: CLEARA Biotech B.V. View this news release online at: