TRIM21

AliveDx has received the CE Marks for its automated, multiplexed MosaiQ CENP-B microarray immunoassay, MosaiQ AiPlex CTD microarray immunoassay, and multiconstituent MosaiQ AiPlex CTD Quality Controls The close-up image of the microarray. (Credit: AliveDx) AliveDx, previously known as Quotient, has received CE mark approvals for three of its automated and multiplexed MosaiQ solutions, under the European Union’s (EU) In-Vitro Diagnostic Regulation (IVDR). The company’s MosaiQ Centromere Protein B (CENP-B) microarray, MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassay, and its MosaiQ AiPlex CTD Quality Controls have been granted the CE mark. Its MosaiQ solutions include a fully automated, high throughput instrument platform, unique planar multiplexed microarray technology, and a smart image analysis algorithm. The CE mark of the MosaiQ tests will enable rapid diagnosis of Connective Tissue Diseases (CTD) in the EU and other geographies that recognise the CE mark. It allows the company to provide laboratories and hospitals with in-vitro diagnostics solutions that improve workflow and faster turnaround time to diagnose and treat autoimmune diseases. AliveDx CEO Manuel Méndez said: “This approval confirms the MosaiQ solution flexibility to address various disease areas and simplify testing algorithms. I am thankful and proud of the AliveDx team and partners for achieving this milestone. “We look forward to expanding our portfolio in the near future. We are committed to empowering diagnostic insights, transforming patient care, and innovating for life.” The MosaiQ AiPlex CTD microarray immunoassay is designed to detect auto-antibodies to native, double-stranded DNA, Sm, U1RNP, SS-A (Ro-60), Trim-21 (Ro-52), SS-B, SCL-70, Jo-1, Sm/RNP, Centromere Protein B and Ribosomal P. It aids diagnosis of multiple CTD, including Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome, Scleroderma, Polymyositis, and Mixed Connective Tissue Disease (MCTD). The MosaiQ CENP-B microarray immunoassay is designed for the detection of auto-antibodies to only Centromere Protein B. The MosaiQ CENP-B and AiPlex CTD immunoassays are intended for use on AliveDx’s fully automated high-throughput MosaiQ microarray platform. Last year, AliveDx secured the CE mark for its MosaiQ Extended Immunohematology (IH) Microarray, which improves workflow and reduces costs for laboratories and clinicians.

AliveDx receives three IVDR CE Marks for its automated, multiplexed MosaiQ® solution, enabling faster diagnosis of Connective Tissue Diseases (CTD) - The MosaiQ CENP-B microarray immunoassay designed for the detection of Auto-antibodies to Centromere Protein B - The MosaiQ AiPlex CTD microarray immunoassay designed as an aid in diagnosis of Connective Tissue Diseases - The multiconstituent MosaiQ AiPlex CTD Quality Controls EYSINS, Switzerland, Oct. 30, 2023 /PRNewswire/ -- AliveDx is proud to announce it has received three CE Marks for: Its MosaiQ Centromere Protein B (CENP-B) microarray, its MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassays and its MosaiQ AiPlex CTD Quality Controls. By launching its Autoimmune testing portfolio in the European Union and other CE Mark recognizing geographies, the company is providing laboratories and hospitals with a novel in-vitro diagnostics solution to enable improved workflow and faster time to diagnosis and treatment of patients suffering from Autoimmune diseases. The company is pursuing an ambitious plan to rapidly expand its clinical immunology portfolio. The MosaiQ solution combines a fully automated, ease to use, high throughput instrument platform, proprietary planar multiplexed microarray technology, and a smart image analysis algorithm to enable faster turn-around times for complex diagnostics pathways. Economic and Clinical Value through multiplexed testing with MosaiQ AiPlex CTD microarray The new CE-Marked MosaiQ AiPlex CTD microarray immunoassay is designed to detect Auto-antibodies to native, double-stranded DNA, Sm, U1RNP, SS-A (Ro-60), Trim-21 (Ro-52), SS-B, SCL-70, Jo-1, Sm/RNP, Centromere Protein B and Ribosomal P. Hence it aids in the diagnosis of multiple Connective Tissue Diseases, including Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome, Scleroderma (Systemic Sclerosis, SSc), Polymyositis/Dermatomyositis, and Mixed Connective Tissue Disease (MCTD). "We are excited to receive the CE Mark for our initial clinical multiplexed microarrays. This approval confirms the MosaiQ solution flexibility to address various disease areas and simplify testing algorithms. I am thankful and proud of the AliveDx team and partners for achieving this milestone. "We look forward to expanding our portfolio in the near future. We are committed to empowering diagnostic insights, transforming patient care, and innovating for life," said Manuel O. Méndez, Chief Executive Officer of AliveDx. Follow us on LinkedIn and X or visit for more information. About AliveDx At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster disease detection to shorten the time to diagnosis. Alba – our blood bank reagents portfolio – and MosaiQ® – one of the first multiplexing and multimodality automated testing platforms – are designed to make laboratories more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life. ©AliveDx Holdings Finance Company Ltd, 2023. MosaiQ is a trademark or registered trademark of AliveDx Holdings Finance Company Limited or its subsidiaries in various jurisdictions. Menus and capabilities are subject to change. Not all methods may be available in all territories. Subject to regulatory clearance. SOURCE AliveDx

NANTES, France--(BUSINESS WIRE)-- Regulatory News: OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) presents scientific updates in oral and poster presentations selected for international conferences: at the Antibody Engineering & Therapeutics Europe 2023 Conference in Amsterdam, Netherlands (June 7), at the FOCIS 2023 Annual Meeting (June 20-23), the 4th Annual Cytokine-Based Drug Development Summit 2023 (June 27-29) and at the 3rd Annual Tumor Myeloid-directed Therapies Summit 2023 (July 18-20) in Boston, US. The communications feature the latest research on pre-IND programs for BiCKI®-IL-7 (bifunctional therapy targeting PD-1 and IL-7), CLEC-1(1) (new myeloid immune checkpoint) in immuno-oncology and for OSE-230 (first pro-resolutive monoclonal antibody) in chronic inflammation. Dr Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented: “We are very proud to share our latest scientific advances on our innovative pre-IND research programs with the international scientific community. The progress made on our next-generation immunotherapies in immuno-oncology and immuno-inflammation demonstrate our continued commitment to delivering first-in-class treatments for patients in high need for new therapeutic options. We are looking forward to progressing these programs with strategic partners into clinical stage”. Dr Aurore Morello, Head of Research of OSE Immunotherapeutics, said: “The latest data featured in our communications highlight the value and therapeutic potential of our pre-IND assets. BiCKI®-IL-7, our bispecific anti-PD1/IL-7 program, presents an innovative cytokine approach, selectively targeting tumor-specific T-cells to improve the quality and durability of memory T-lymphocyte responses. CLEC-1, developed in academic collaboration with Dr Elise Chiffoleau’s team at the Center for Translational Research in Transplantation and Immunology (1) in Nantes, acts as a new myeloid immune checkpoint and the CLEC-1/new ligand TRIM21 axis as a new target for cancer immunotherapy. These latest data further support the preclinical evaluation of monoclonal antagonist antibodies targeting CLEC-1. OSE-230, our most advanced pre-IND program, stands as the first pro-resolutive agonist monoclonal antibody, capable of clearing chronic neutrophil infiltrates and inhibiting the pathogenic NETosis (2) process and fibrosis”. BICKI®-IL-7 PROGRAM IN IMMUNO-ONCOLOGY ANTIBODY ENGINEERING & THERAPEUTICS EUROPE 2023 - JUNE 7, AMSTERDAM Presenter: Aurore Morello, PhD., Head of Research of OSE Immunotherapeutics “Anti-PD1/IL7v Cis-activated Stem-like T cells Expressing TCF1” Human tumor-specific T cells expressed PD1. Stem-like TCF1+ T cells are key for the efficient and durable response of anti-PD1 mAbs in clinic (3). Stem-like TCF1+ co-express PD1 and CD127 and an anti-PD1/IL7v bifunctional molecule preferentially cis-target and expand the proliferation and survival of stem-like TCF1+ T cells without inducing their exhaustion in vitro in human chronic stimulation and exhaustion assays as well as in-vivo in tumor bearing mice. 4TH ANNUAL CYTOKINE-BASED DRUG DEVELOPMENT SUMMIT 2023 - JUNE 27-29, BOSTON Day: Pre-Conference Workshop Day Time: 9:00 am Presenter: Nicolas Poirier, PhD, CEO and CSO of OSE Immunotherapeutics Seminar: “Going Beyond IL-2 to Explore Different Possibilities for the Development of Cytokine-Based Drugs” Although the IL-2s have been the forefront of research within the field of cytokine-based drugs, many interleukins and interferons beyond IL-2 are becoming increasingly relevant. The applications of these cytokines are vast and their different mechanisms of action open up the field to more R&D and an endless number of possibilities to tackle the various diseases affecting the world. Join this workshop to: Discuss the progress of novel technologies on IL-7, IL-12, IL-18, IL-15 and more. Understand the different mechanisms and mode of action employed by these cytokines. Explore the TNF super family and interferons. Understand clinical evaluation of non-alpha IL-2 and IL-15 cytokine therapies and implications for future drug development. Discover how anti-PD1/IL7v bispecific selectively expand and maintain stemness of TCF1+ stem-like T cells. CLEC-1 PROGRAM IN IMMUNO-ONCOLOGY 3RD ANNUAL TUMOR MYELOID-DIRECTED THERAPIES SUMMIT 2023 - 18-20 JULY, BOSTON Day: Day Two Time: 9:30 am Presenter: Nicolas Poirier, PhD, CEO and CSO of OSE Immunotherapeutics “CLEC-1 is a Novel Inhibitory Myeloid Receptor Sensing Cell Death & Limiting Tumor Antigen Cross-Presentation” Details: The orphan receptor CLEC-1 interacts with Trim21 over-expressed during cell death. CLEC-1 inhibitory function limits T-cell cross-priming. Positive preclinical efficacy with antagonist anti-CLEC1 mAb. OSE-230 PROGRAM IN INFLAMMATION DISEASE FOCIS 2023 ANNUAL MEETING - 20-23 JUNE, BOSTON Date: June 20 Presenter: Vanessa Gauttier, Researcher, OSE Immunotherapeutics Tu 220 - “Agonist anti-ChemR23 mAb inhibits NETosis and neutrophil-mediated inflammation” (1) Collaborative academic program between OSE Immunotherapeutics and Dr Elise Chiffoleau’s research teams (Center for Research in Transplantation and Translational Immunology (CR2TI), UMR1064, INSERM, Nantes University at Nantes University Hospital, ). (2) NETosis is a program for formation of neutrophil extracellular traps (NETs), which consists of modified chromatin decorated with bactericidal proteins from granules and cytoplasm. Recent research has highlighted that neutrophils, and in particular NETs that can be released upon activation, have central roles in the initiation and perpetuation of systemic autoimmune disorders and trigger complex and chronic inflammatory responses that lead to organ damage and fibrosis. (3) Connolly K A et al. Sci Immunol. 2021, A reservoir of stem-like CD8+ T cells in the tumor-draining lymph node preserves the ongoing anti-tumor immune response ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation. The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors. OSE-279 (anti-PD1): ongoing Phase 1/2 in solid tumors or lymphomas (first patient included). OSE-279 is the backbone therapy of the BiCKI® platform. OSE-127 - lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics). FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); Phase 1 ongoing in the US (sponsor Veloxis Pharmaceuticals, Inc.). OSE-172/BI 765063 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway) developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results in monotherapy and in combination, in particular with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing clinical trial in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC). OSE Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapeutics: BiCKI® platform focused on immuno-oncology (IO) is a bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. BiCKI-IL-7 is the most advanced BiCKI® candidate targeting anti-PD1xIL-7. Myeloid platform focused on optimizing the therapeutic potential of myeloid cells in IO and immuno-inflammation (I&I). OSE-230 (ChemR23 agonist mAb) is the most advanced candidate generated by the platform, with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: Click and follow us on Twitter and LinkedIn Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on May 2, 2023, including the annual financial report for the fiscal year 2022, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. View source version on businesswire.com: Contacts OSE Immunotherapeutics Sylvie Détry sylvie.detry@ose-immuno.com +33 1 53 198 757 Nicolas Poirier Chief Executive Officer nicolas.poirier@ose-immuno.com French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 6 07 768 283 Source: OSE Immunotherapeutics SA View this news release online at: