Sargramostim

Strategic initiative to address Ukraine’s urgent need for radiation countermeasures Hemafund’s infrastructure ensures secure storage and rapid deployment of emergency treatments Collaboration may potentially generate over $100 million in value for both parties Haifa, Israel – March 5, 2025 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that it has signed an exclusive collaboration agreement with Hemafund Ltd. (“Hemafund”), a Ukrainian umbilical cord blood bank with clinical and research laboratories and facilities specializing in cell preservation and cryostorage (the “Collaboration” or the “Collaboration Agreement”). This Collaboration aims to establish a strategic initiative for stockpiling, distribution, and potential clinical advancement of Pluri’s innovative PLX-R18 cell therapy (“PLX-R18”) as a countermeasure against Hematopoietic Acute Radiation Syndrome (“H-ARS”) in Ukraine. Subject to certain conditions, the Collaboration Agreement will be effective for an initial period of three years and can be extended by the parties for an additional period of three years. Pursuant to the Collaboration Agreement, Pluri will produce and supply PLX-R18 as a potential treatment for H-ARS following nuclear radiation exposure. Hemafund will leverage its infrastructure and expertise in biostorage, logistics, and regulatory processes to support local distribution and ensure compliance with Ukrainian and European biobank standards. The parties will seek funding to build the necessary capacity of PLX-R18 and expect to enter into a specific separate definitive agreement once such funding becomes available. This Collaboration comes in response to recent escalations, including a recent Russian drone strike on the Chernobyl nuclear power plant, which caused a fire in the containment shell. Although the blaze was extinguished without an increase in radiation levels, the incident underscores the critical need for effective and readily available radiation countermeasures in the region. As part of this Collaboration, Pluri and Hemafund will work toward securing external funding to build an initial capacity of 12,000 doses of PLX-R18, ensuring preparedness for radiation-related emergencies. The PLX-R18 doses will be stored and managed by Hemafund, leveraging its state-of-the-art biobank infrastructure and logistics network to enable rapid deployment in case of need. The Collaboration, if successful, could potentially generate over $100 million in value for both parties, based on the estimated cost per dose and the projected stockpile of 12,000 doses, which is expected to be sufficient to treat 6,000 individuals (as each patient is expected to require two doses). The calculation of 12,000 doses is based on the actual availability of countermeasures in the U.S. Strategic National Stockpile for the U.S. population. This approach aligns with established preparedness measures designed to ensure the availability of countermeasures against H-ARS in response to public health emergencies[1]. H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as those which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by a dose-dependent bone marrow suppression, leading to severe neutropenia, thrombocytopenia, anemia, and a heightened risk of mortality. Strategic Goals of the Collaboration: Stockpiling and Distribution: Hemafund will establish secure storage and facilitate the logistics of PLX-R18 delivery to medical institutions across Ukraine. Regulatory and Compliance Support: The Collaboration will seek necessary approvals from Ukraine’s Ministry of Health and ensure adherence to regional regulations for PLX-R18 use. Clinical Advancement: Pluri and Hemafund will explore opportunities for clinical trials to register the PLX-R18 as a radiation countermeasure. Public and Private Funding: This Collaboration aims to attract government and private sector funding to support the development and accessibility of PLX-R18 in Ukraine and potentially other regions. “As a company committed to leveraging cell-based technology for humanity’s greatest challenges, we see this Collaboration as a proactive measure to ensure our PLX-R18 therapy is readily available where it is needed,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “We believe that Hemafund’s deep-rooted expertise in Ukraine’s biotech landscape makes them an ideal partner to facilitate local accessibility, storage, and regulatory integration of our solution.” Yaroslav Issakov, Founder of Hemafund Ltd., added, “We are excited to combine our efforts with Pluri to address this urgent medical need together. We believe that our state-of-the-art cryostorage facilities and logistics network position us well to support the introduction of PLX-R18 as a potential vital tool for radiation emergency preparedness in Ukraine. While we hope such treatments remain precautionary, our goal is to stand ready to distribute this potential therapy in the event of an emergency.” About Hemafund Hemafund is a family cord blood bank, located in a biotechnological complex in Ukraine, and specializing in the preservation of umbilical cord blood, placenta, and umbilical cord tissues. The company also provides long-term cryostorage services for human cells and tissues, with a focus on stem cell preservation. Hemafund operates a comprehensive facility that includes facilities such as clinical diagnostic laboratories, processing laboratories, and cryostorage facilities, and is a member of the international Cord Blood Association, coordinating a nationwide program for the application of cord blood in Ukraine. Learn more at https://international.hemafund.com/ About PLURI Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter). Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the potential benefits of the Collaboration and each party’s obligation pursuant to the Collaboration Agreement, the potential for PLX-R18 to be used for the potential treatment of H-ARS, the potential doses required and potential revenue to be derived from the Collaboration, the potential for both parties to secure necessary funds to build the necessary capacity of PLX-R18 and the expectation of the parties to enter into a separate definitive agreement when such funds become available. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. 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Media Contacts Investors: investor.relations@pluri-biotech.com Israel Media: Or Erez at Or.Erez@gitam.co.il U.S. Media: Jennifer Ringler at jringler@quantum-corp.com 1 HHS boosts stockpile of products to treat acute radiation syndrome | HHS.govBARDA Awards $37.6 million Contract to Sanofi to Supply Leukine® (sargramostim) for Potential Public Health Emergency | Business WireGoLocalProv | U.S. Shells Out $290M to Stockpile Radiation Sickness Pills — Made by Amgen OUR STORY OUR TECHNOLOGY OUR VERTICALS PARTNERS MEDIA & EVENTS INVESTORS & ESG OUR STORY OUR TECHNOLOGY OUR VERTICALS PARTNERS MEDIA & EVENTS INVESTORS & ESG Pluri Biotech Ltd., Matam Park Building 5, Haifa 3508409, Israel Israel +972-74-7108600 USA +1-347-9732098 info@pluri-biotech.com Terms of use Use of the Pluri Web Site General Pluri Biotech Ltd., on its behalf and on behalf of its related companies, including without limitations, its parent company, Pluri Inc. 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Privacy and Data Protection Policy and Notice Last updated on 13 January 2025 Pluri Biotech Ltd. and its affiliates and related companies (“Pluri”, “we”, “our” or the “Company”, and their cognates) respects the privacy of its research partners, academic affiliate representatives, investors, clinical studies participants, employees, vendors and sites and website visitors, and others of whom we collect information, and is committed to protecting the personal information you may share with us (these and any others with respect to whom we collect personal data, shall collectively be referred to as “you”, “user”, or “data subject”). Pluri develops platforms to manufacture cell-based products aimed at improving human well-being, increasing sustainability, and addressing significant global challenges (the “Services”). This policy and notice (the “Privacy Policy”) explains the types of information we may collect from you, that we may receive about you or that you may provide in the course of your interest or in our Services, transactions, conferences or when you use our platforms or services or visit our website. We are transparent about our practices regarding the information we collect, use, maintain and process and describe our practices in this policy and notice. Please read the following carefully to understand our practices regarding your personal data and how we will treat it. For the purposes of EU General Data Protection Regulation ( “GDPR”), the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of 2020 (“CCPA”) other US State privacy laws, and any other applicable data protection and privacy laws, Pluri is usually a data controller (or ‘owner’) in relation to the personal data collected and processed through our Services or provided to us by our research partners. Summary: we collect various categories of personal data in order to meet our contractual obligations, and also to meet various legitimate interests, such as service improvement, fraud prevention and marketing. We collect data about you in connection with your transactions with us, or in processing data for our research partners. We also collect data about our visitors and website visitors. One type of data collected is non-identifiable and anonymous information (“non-personal data”). We also collect several categories of personal data (“Personal Data”), as described below. Personal Data which is being gathered consists of any details which are personally identifiable and which are provided consciously and voluntarily by you, or by an organization you represent or are associated with or through your use of our website and registration to and use of our Services (as described below), by email, or other ways in which you communicate and interact with us. This generally includes your name (first and last), email address, phone number, postal address, position and organization name and other information you may choose to provide to Pluri directly and willingly through your use of our Services. Additionally, we may obtain data related to the geographic location of your laptop, mobile device or other digital device on which the Pluri website or platform are used. You do not have any legal obligation to provide any information to Pluri, however, we require certain information in order to perform contracts, or to provide any services. If you choose not to provide us with certain information, then we may not be able to provide you or your organization with some or all of the services. By contacting us or submitting requests for information or support via the website, email etc., Pluri will collect details, including also your name, phone number and personal or company email you provided, country, professional details and other information provided by you. Pluri may use this information to offer Pluri’s services and support. When participating in clinical research conducted by us or in collaboration with our research partners, we collect the necessary information, including health-related data. Summary: we collect Personal Data when you or your organization send it to us, or when a vendor, distributor or other research partner sends it to us so; we collect Personal Data through our website and Services, and through our interactions with you. We collect Personal Data required to provide Services when you register interest, or when you provide us such information by entering it manually or automatically, or through your use of our facilities, website and Services, in the course of preparing a contract, or otherwise in engaging with us. We also may collect Personal Data when you call us for support, in which case we collect the information you provide us. On our website, we collect technical and behavioral information such as the user’s Internet protocol (IP) address used to connect your device to the Internet, your uniform resource locators (URL), operating system, type of browser, browser plug-in types and versions, screen resolution, time zone setting, the user’s ‘clickstream’ on our website, the period of time the user visited the platform etc. We also We likewise may place cookies on your browsing devices (see ‘Cookies’ section below). Summary: we process Personal Data to meet our obligations, protect our rights, and manage our activities. We will use Personal Data to provide and improve our services to you or to our research partners and others and meet our contractual, ethical and legal obligations. All Personal Data will remain accurate complete and relevant for the stated purposes for which it was processed, including for example: Processing which is necessary for the performance of a contract to which you are a party or in order to take steps at your request prior to entering into a contract: Carrying out our obligations arising from any contracts entered into between you or your employer or organization and Pluri or Pluri’s research partners and/or any contracts entered into with Pluri and to provide you with the information, products, support and services that you request from Pluri and its research partners; Verifying and carrying out financial transactions in relation to payments you make in connection with the Services. Processing which is necessary for the purposes of the legitimate interests pursued by Pluri or by a third party of providing an efficient and wide-ranging service to research partners: Notifying you about changes to our service; Collecting data from various publicly available sources, including commercially licensed databases to develop and improve our Services; Contacting you to give you commercial and marketing information about events or promotions or additional services offered by Pluri which may be of interest to you, including in other locations; Soliciting feedback in connection with the services; Tracking use of Pluri services to enable us to optimize them. For security purposes and to identify and authenticate your access to the Services. Processing which is necessary for compliance with a legal obligation to which Pluri is subject: Compliance and audit purposes, such as meeting our reporting obligations in our various jurisdictions, anti-money laundering, and for crime prevention and prosecution in so far as it relates to our staff, research partners, facilities etc; If necessary, we will use Personal Data to enforce our terms, policies and legal agreements, to comply with court orders and warrants and assist law enforcement agencies as required by law, to collect debts, to prevent fraud, infringements, identity thefts and any other service misuse, and to take any action in any legal dispute and proceeding; We aggregate and de-identify Personal Data (i.e., use your data in a way which no longer allows to identify you) to analyze and improve our Services, and to conduct research, and for other similar purposes. We may share non-personal aggregated information with third parties, as described below. Summary: we share Personal Data with our service providers, research partners and academic institutions, group companies, and authorities where required. We transfer Personal Data to: Research partners, Academic institutions and Collaborators. We transfer or receive Personal Data from our various partners in order to facilitate joint research projects, enhance the quality and scope of our studies, and ensure the accuracy and reliability of our findings. This data exchange enables us to conduct collaborative research and development activities, fulfill contractual obligations with research partners and collaborators, comply with regulatory requirements applicable to clinical studies and research and advance scientific discoveries and innovations in line with our mission. Third Parties. We transfer Personal Data to third parties in a variety of circumstances. We endeavor to ensure that these third parties use your information only to the extent necessary to perform their functions, and to have a contract in place with them to govern their processing on our behalf. These third parties include business partners, suppliers, affiliates, agents and/or sub- contractors for the performance of any contract we enter into with you. They assist us in providing the services we offer, processing transactions, fulfilling requests for information, receiving and sending communications, analyzing data, providing IT and other support services or in other tasks, from time to time. These third parties also include analytics and search engine providers that assist us in the improvement and optimization of our platform, website, and our marketing. We periodically add and remove third party providers. At present services provided by third-party providers to whom we may transfer Personal Data include also the following: – Website and platform analytics, including Google Analytics; – Expression and language measurement services; – Document management and sharing services; – Ticketing and support; – On-site and cloud-based database services; – CRM software; – Data security, data backup, and data access control systems; – Project management systems; – Our lawyers, accountants, and other standard business software and partners. In addition, we will disclose your Personal Data to third parties if some or all of our companies or assets are acquired by a third party including by way of a merger, share acquisition, asset purchase or any similar transaction, in which case Personal Data will be one of the transferred assets. Likewise, we transfer Personal Data to third parties if we are under a duty to disclose or share your Personal Data in order to comply with any legal or audit or compliance obligation, in the course of any legal or regulatory proceeding or investigation, or in order to enforce or apply our terms and other agreements with you or with a third party; or to assert or protect the rights, property, or safety of Pluri, our research partners, or others. This includes exchanging information with other companies and organizations for the purposes of fraud protection and credit risk reduction and to prevent cybercrime. For purposes of the California Consumer Privacy Act as amended (“CCPA”) or other US privacy state laws, Pluri does not “sell” or “share” personal information, nor do we allow any personal information to be used by third parties for their own marketing. However, we use analytics tools and other technologies (as described above), which may be construed as a “sale” under privacy laws to which you may opt- out of. For avoidance of doubt, Pluri may transfer and disclose non-Personal Data to third parties at its own discretion. Summary: we store your Personal Data across multiple locations globally We store your Personal Data in databases owned or controlled by us, or processed by third parties on our behalf, by reputable cloud-service providers (see the following section regarding international transfers). Summary: we transfer Personal Data within and to the EEA, USA, Israel and elsewhere, with appropriate safeguards in place. Personal Data may be transferred to, and stored and processed at, a destination outside its origin. EU data may be transferred outside the European Economic Area (EEA). This includes transfer to Israel, a jurisdiction deemed adequate by the EU Commission, and to the USA, which may be deemed adequate under certain circumstances but not always. Where your Data is transferred outside of the EEA, we will take all steps reasonably necessary to ensure that your Data is subject to appropriate safeguards, including entering into contracts that require the recipients to adhere to data protection standards that are considered satisfactory under EU law and other applicable, and that it is treated securely and in accordance with this Privacy Policy. Transfers to Israel are made based on an adequacy ruling by the EU Commission. Transfers to the USA are made based either on an adequacy ruling to members of the data privacy framework, or based on the Standard Contractual Clauses published by the EU Commission. For more information about these safeguards, please contact us as set forth below. We may transfer your Personal Data outside of the EEA, in order to: – Store or backup the information; – Enable us to provide you with the services and products and fulfill our contract with you; – Fulfill any legal, audit, ethical or compliance obligations which require us to make that transfer; – Facilitate the operation of our group businesses, where it is in our legitimate interests and we have concluded these are not overridden by your rights; – Collaborate with our research partners across multiple jurisdictions. Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business and activities. Pluri will retain Personal Data it processes only for as long as required in our view, to provide the Services and as necessary to comply with our legal and other obligations, to resolve disputes and to enforce agreements. We will also retain Personal Data to meet any audit, compliance and industry practices. Data that is no longer retained may be anonymized or deleted. Likewise, some metadata and statistical information concerning the use of our services are not subject to the deletion procedures in this policy and will be retained by Pluri. We will not be able to identify you from this data. Some data may also be retained on our third-party service providers’ servers until deleted in accordance with their privacy policy and their retention policy, and in our backups until overwritten. Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business. Summary: with your consent, we place cookies on your device. You control our use of cookies through a cookie management tool on our website, or through your device and browser. 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LEXINGTON, Mass., Jan. 9, 2025 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) today announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services to fund a phase 2 study in patients with sepsis to assess the safety and enable dose selection of LEUKINE (sargramostim, rhu GM-CSF). The partners also will evaluate monocyte human leukocyte antigen-DR (mHLA-DR) and other biomarkers of immune status that could enable more precise identification of patients with sepsis who could benefit from LEUKINE treatment in addition to standard of care. Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection, characterized by altered immune homeostasis.1 It represents a critical unmet public health need urgently requiring safe and effective therapeutics guided by biomarkers to enable precise treatment approaches to reduce morbidity and mortality.2,3 In 2017, 1.7 million sepsis cases were reported in the US and 48.9 million cases were reported globally resulting in 11 million deaths.21 Since much of the morbidity and mortality from chemical, biological, radiological and nuclear (CBRN) threats is due to sepsis, the availability of a host-directed therapy to treat sepsis utilizing validated biomarkers to inform treatment would greatly enhance health security. Leukine is currently held for use by ASPR-Strategic National Stockpile (SNS) for the treatment of hematopoietic acute radiation syndrome (H-ARS) as a host-directed therapy. The PTx-BARDA partnership seeks to enhance patient care through restoration of immune homeostasis in patients with sepsis exhibiting a persistent immune suppressed state. Research shows that patients with sepsis with persistent immune suppression are unable to mount a sufficient immune response and experience significant mortality.2,4,5 The clinical study will further evaluate the safety of LEUKINE in these critically ill patients and seeks to confirm the utility of mHLA-DR as a marker to identify sepsis-associated immune dysregulation.2,6-10 Additional promising biomarkers of immune status in patients with sepsis also will be evaluated. Under a prior collaboration, BARDA and PTx supported the establishment of a Laboratory Developed Test (LDT) for mHLA-DR, which will be utilized in this collaboration. "We are grateful to BARDA for their support of this program, which has the potential to advance medical care for patients with sepsis by evaluating potential tools for measuring immune status to inform targeted immunomodulatory therapy," stated John L. McManus, President, Health Security and Critical Care of Partner Therapeutics, Inc. In small randomized clinical trials in critically ill patients with severe sepsis or septic shock, LEUKINE has been shown to promote immune homeostasis, as measured by a rapid and sustained improvement in mHLA-DR expression, as well as other markers of innate and adaptive immune function.7,11-16 The observed changes in immune status were accompanied by improved clinical outcomes including 28-day survival and resolution of infection. GM-CSF helps maintain immune homeostasis via innate and adaptive responses, and promotes tissue repair mechanisms.2,7,17 While classically known for promoting differentiation of bone marrow (BM) precursor cells, and stimulating proliferation, differentiation, and maturation of myeloid cells, GM-CSF also induces mHLA-DR and plays important roles in antigen presentation, T-cell activation, and myeloid cell survival and function.7,17-19 HLA-DR is part of the heterodimeric major histocompatibility complex class II (MHC II) on monocytes and is a measure of the cells' capacity for antigen-presentation. MHC II regulates monocytes' crosstalk with T helper cells, enabling the activation of the adaptive immune system.4,20 This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50124C00061. REFERENCES Singer M et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA. 2016;315(8):801-810. doi: 10.1001/jama.2016.0287 Cajander S et al. Profiling the dysregulated immune response in sepsis: overcoming challenges to achieve the goal of precision medicine. Lancet Resp Med. 2023;12(4):305-322. doi: 10.1016/S2213-2600(23)00330-2 Shankar-Hari M et al. Reframing sepsis immunobiology for translation: towards informative subtyping and targeted immunomodulatory therapies. Lancet Resp Med. 2024;12(4):323 – 336. doi: 10.1016/S2213-2600(23)00468-X Venet F, Monneret G. Advances in the understanding and treatment of sepsis-induced immunosuppression. Nat Rev Nephrol. 2018 Feb;14(2):121-137. doi: 10.1038/NRNEPH.2017.165 Lindell RB, Meyer NJ. Charting a course for precision therapy trials in sepsis. Lancet Respir Med. 2024 Apr;12(4):265-267. doi: 10.1016/S2213-2600(24)00070-5 Monneret G, Lepape A, Voirin N, Bohé J, Venet F, Debard A-L, Thizy H, Bienvenu J, Gueyffier F, Vanhems P. 2006. "Persisting Low Monocyte Human Leukocyte Antigen-DR Expression Predicts Mortality in Septic Shock." Intensive Care Medicine 32 (8): 1175–83. doi: 10.1007/S00134-006-0204-8 Meisel C, Schefold JC, Pschowski R, Baumann T, Hetzger K, Gregor J, Weber-Carstens S, et al. 2009. "Granulocyte–Macrophage Colony-Stimulating Factor to Reverse Sepsis-Associated Immunosuppression." American Journal of Respiratory and Critical Care Medicine 180 (7): 640–48. doi: 10.1164/RCCM.200903-0363OC Venet F, Lukaszewicz AC, Payen D, Hotchkiss R, Monneret G. Monitoring the immune response in sepsis: a rational approach to administration of immunoadjuvant therapies. Curr Opin Immunol. 2013 Aug;25(4):477-83. doi: 10.1016/J.COI.2013.05.006 Morris AC, Datta D, Shankar-Hari M, Stephen J, Weir CJ, Rennie J, Antonelli J, et al. 2018. "Cell-Surface Signatures of Immune Dysfunction Risk-Stratify Critically Ill Patients: INFECT Study." Intensive Care Medicine 44 (5): 627–35. doi: 10.1007/S00134-018-5247-0 Tremblay JA, Peron F, Kreitmann L, Textoris J, Brengel-Pesce K, Lukaszewicz AC, Quemeneur L, Vedrine C, Tan LK, Venet F, Rimmele T, Monneret G, et al. A stratification strategy to predict secondary infection in critical illness-induced immune dysfunction: the REALIST score. Annals of Intensive Care 2022 12:76. doi: 10.1186/S13613-022-01051-3 Rosenbloom AJ, Linden PK, Dorrance A, Penkosky N, Cohen-Melamed MH, Pinsky MR. 2005. "Effect of Granulocyte-Monocyte Colony-Stimulating Factor Therapy on Leukocyte Function and Clearance of Serious Infection in Nonneutropenic Patients." CHEST 127 (6): 2139–50. doi: 10.1378/CHEST.127.6.2139. Hall, MW., Knatz NL, Vetterly C, Tomarello S, Wewers MD, Volk HD, Carcillo JA. 2011. "Immunoparalysis and Nosocomial Infection in Children with Multiple Organ Dysfunction Syndrome." Intensive Care Medicine 37 (3): 525–32. doi: 10.1007/S00134-010-2088-X Spies C, Luetz A, Lachmann G, Renius M, von Haefen C, Wernecke K-D, Bahra M, Schiemann A, Paupers P, Meisel C. 2015. "Influence of Granulocyte-Macrophage Colony-Stimulating Factor or Influenza Vaccination on HLA-DR, Infection and Delirium Days in Immunosuppressed Surgical Patients: Double Blind, Randomised Controlled Trial." Edited by Sachin Yende. PLOS ONE 10 (12): e0144003. doi: 10.1371/JOURNAL.PONE.0144003 Pinder EM, Rostron Aj, Hellyer TP, Ruchaud-Sparagano M-H, Scott J, Macfarlane JG, Wiscombe S, et al. 2018. "Randomised Controlled Trial of GM-CSF in Critically Ill Patients with Impaired Neutrophil Phagocytosis." Thorax 73 (10): 918–25. doi: 10.1136/THORAXJNL-2017-211323 Hassan SA, Alamed Z, Syed U, Nadeem MT, Khushdil A. The Effect of Granulocyte-Macrophage Colony-Stimulating Factor on Neutropenia and Mortality in Neonatal Sepsis. Pak Armed Forces Med J 2023; 73(6): 1644-1647. doi: 10.51253/PAFMJ.V73I6.7456 Vacheron CH, Lepape A, Venet F, Monneret G, Gueyffier F, Boutitie F, Vallin H, Schwebel C, Maucort-Boulch D, Friggeri A; GRID Study Group. Granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients presenting sepsis-induced immunosuppression: The GRID randomized controlled trial. J Crit Care. 2023 Dec;78:154330. doi: 10.1016/J.JCRC.2023.154330 Dougan M, Dranoff G, Dougan SK. GM-CSF, IL-3, and IL-5 Family of Cytokines: Regulators of Inflammation. Immunity. 2019 Apr 16;50(4):796-811. doi: 10.1016/j.immuni.2019.03.022 Mathias B, Szpila BE, Moore FA, Efron PA, Moldawer LL. 2015. "A Review of GM-CSF Therapy in Sepsis." Medicine 94 (50): e2044. doi: 10.1097/MD.0000000000002044 Joshi I et al. Utility of monocyte HLA-DR and rationale for therapeutic GM-CSF in sepsis immunoparalysis. Front Immunol. 2023;14:1130214. doi: 10.3389/fimmu.2023.1130214 Shi Y, et al. Granulocyte-macrophage colony-stimulating factor (GM-CSF) and T-cell responses: what we do and don't know. Cell Res. 2006;16(2):126-133. doi: 10.1038/sj.cr.7310017 Rudd KE, Johnson SC, Agesa KM, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7 ABOUT LEUKINE LEUKINE (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast. The product is commercially available in the United States and accessible through a named patient program operated by Tanner Pharma Group outside of the United States. LEUKINE is indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). Important Safety Information for LEUKINE (sargramostim) Contraindications Do not administer LEUKINE to patients with a history of serious allergic reaction, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factor, sargramostim, yeast-derived products, or any other component of LEUKINE. Warnings and Precautions Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. If a serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy, and institute medical management. Discontinue LEUKINE permanently for patients with serious allergic reactions. LEUKINE can cause infusion-related reactions that may be characterized by respiratory distress, hypoxia, flushing, hypotension, syncope, and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease; dose adjustment or discontinuation may be needed. LEUKINE should not be administered simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy. Edema, capillary leak syndrome, and pleural or pericardial effusions have been reported in patients after LEUKINE administration. LEUKINE should be used with caution in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure. Such patients should be monitored. Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE administration, particularly in patients with a history of cardiac arrhythmia. Use LEUKINE with caution in patients with preexisting cardiac disease. If absolute neutrophil count (ANC) > 20,000 cells/mm3 or if white blood cell (WBC) counts > 50,000/mm3, LEUKINE administration should be interrupted, or the dose reduced by half. Monitor complete blood counts (CBC) with differential twice per week. Discontinue LEUKINE therapy if tumor progression, particularly in myeloid malignancies, is detected during LEUKINE treatment. Treatment with LEUKINE may induce neutralizing anti-drug antibodies. Use LEUKINE for the shortest duration needed. Avoid administration of solutions containing benzyl alcohol (including LEUKINE for injection reconstituted with Bacteriostatic Water for Injection, USP [0.9 % benzyl alcohol]) to neonates and low birth weight infants. Drug Interactions Avoid the concomitant use of LEUKINE and products that induce myeloproliferation. Monitor for clinical and laboratory signs of excess myeloproliferative effects. Adverse Reactions Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported at a higher frequency than in placebo patients are: In recipients of autologous bone marrow transplantation (BMT)–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder In recipients of allogeneic BMT–abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin In patients with AML–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema ABOUT PARTNER THERAPEUTICS Partner Therapeutics, Inc. (PTx), an integrated biotechnology company, focuses on development and commercialization of late-stage therapeutics to improve health outcomes in treatment of cancer and other serious diseases. The company believes in delivering products and supporting medical teams with the purpose of achieving superior outcomes for patients and their families. Visit MEDIA CONTACT [email protected] SOURCE Partner Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED