SLAMF7

Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that 9 additional patients have entered its Expanded Access Program (EAP) with drug candidate CS1 in rare disease pulmonary arterial hypertension (PAH). In total, the EAP now includes 10 patients with the possibility of more patients being included in the coming months. The additional data collected on the patients in the EAP will strengthen the long-term safety and efficacy documentation of CS1 and support regulatory interactions for future clinical trials. “We are very pleased to see the high interest from patients and physicians to continue with the treatment of CS1 after the completed Phase IIa study,” said Sten R. Sörensen, CEO, Cereno Scientific. “From a drug development perspective, it is very valuable for us to be able to collect long-term clinical data on CS1 as we move forward with our plans for the next clinical program.” Drug candidate CS1 has been approved by the FDA for an Expanded Access Program as an extension of the Phase IIa trial in PAH. This program allows patients who have completed the Phase IIa trial to continue CS1 treatment if deemed suitable by physicians in the study. Through the recently entered collaboration with innovative medical company Fluidda, their non-invasive imaging technology called Functional Respiratory Imaging (FRI) will be used on certain patients enrolled in the EAP to visualize how long-term use of CS1 influences changes in pulmonary arteries. The EAP, an FDA-approved protocol, enables Cereno to obtain valuable long-term safety and efficacy data of CS1 in PAH patients supporting required regulatory interactions and planning future Phase IIb or pivotal Phase III trials. For further information, please contact: Tove Bergenholt, Head of IR & Communications Email: tove.bergenholt@cerenoscientific.com Phone: +46 732- 33 62 46 Sten R. Sörensen, CEO Email: sten.sorensen@cerenoscientific.com Phone: +46 73-374 03 74 About CS1 Drug candidate CS1 is an HDAC inhibitor (HDACi) that works through epigenetic modulation, being developed as a safe, effective and disease-modifying treatment for the rare disease pulmonary arterial hypertension (PAH). CS1 targets the root mechanism of the disease, aiming to reverse the pathological vascular remodeling of the small lung arteries. In a Phase IIa study, CS1 successfully met the primary endpoint of safety and tolerability. CS1 further showed compelling positive impact on exploratory clinical efficacy parameters over the 12-week treatment period. The Phase IIa data, together with preclinical data from the HDACi program, directly demonstrates the HDACi program’s dose-dependent positive impact on reverse remodeling in small lung arteries. This provides a basis of assumption that CS1 may act with disease-modifying capacity in PAH. In preclinical cardiovascular disease models, HDAC inhibitors have also shown anti-fibrotic, anti-inflammatory, pulmonary pressure-reducing, and anti-thrombotic effects. CS1’s unique efficacy profile aligns well with the underlying mechanisms of disease that drives the progression of PAH, positioning it to address the critical unmet need for more effective treatment options. The goal of CS1's development is to enhance and extend life for patients with PAH. CS1 is part of Cereno’s HDACi portfolio, untapping the potential of epigenetic modulation in rare cardiovascular and pulmonary diseases. CS1 has been granted orphan drug status in both the US and EU. CS1 has been approved by the FDA for an Expanded Access Program (EAP) as an extension of the Phase IIa trial in PAH, which enables Cereno to obtain valuable long-term safety and efficacy data of CS1 in PAH patients. Ten patients are currently enrolled in the program, which allows patients who have completed the Phase IIa trial to continue CS1 treatment if deemed suitable by physicians in the study. Through a collaboration with innovative medical company Fluidda, their non-invasive imaging technology called Functional Respiratory Imaging (FRI) will be used on certain patients enrolled in the EAP to visualize how long-term use of CS1 influences changes in pulmonary arteries. The data obtained by the EAP supports required regulatory interactions and planning future Phase IIb or pivotal Phase III trials. About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. Our innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full. Lead candidate CS1 is an HDACi that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for rare disease Pulmonary Arterial Hypertension (PAH). A Phase IIa trial evaluating CS1’s safety, tolerability, and exploratory efficacy in patients with PAH demonstrated that CS1 was safe, well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. HDACi CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 employs a multi-modal mechanism of action as an epigenetic modulator, targeting key unmet needs in patients with rare disease Idiopathic Pulmonary Fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Certified Adviser is Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com. Read PDF Share

“Currently 65 Antibodies Combinations Are Approved For Various Cancer Treatments” The treatment landscape for multiple myeloma ailment is a rapidly evolving field with ongoing research and clinical trials aimed at better understanding these conditions and developing effective therapies. Multiple myeloma is a group of hematological malignancies disorders characterized by the abnormalities in plasma cells, a type of white blood cell. With the rising incidence as well as prevalence of multiple myeloma year by year led to the development of novel combination therapies which can target these ailments. In the recent year, finding for the need of novel treatments led to the discovery of antibody combinations used for the treatment of multiple myeloma. The research and development of antibody combinations for the treatment of multiple myeloma begin when the monoclonal antibodies (mAbs), daratumumab (Darzalex) in addition elotuzumab (Empliciti), have aided to expand the treatment options for multiple myeloma and thereby led to great improvement in patient outcome. The mechanism used by these antibodies is to target the signaling lymphocytic activation molecule family 7 (SLAMF7)/ CD319 or CD38 that are frequently overexpressed in multiple myeloma cells. On the account of that reason, several antibody combinations, like Sarclisa (isatuximab-irfc), in combination with pomalidomide (Pomalyst) and dexamethasone, Sarclisa in combination with carfilzomib (Kyprolis) and dexamethasone, and Darzalex Faspro, Kyprolis, and Dexamethasone were approved in the 2020 and 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma. Download Research Insight: Since the discovery of antibody combinations involved for the treatment of multiple myeloma, there has been significant research into understanding the mode of action of antibody has been completed. Studies have focused on developing treatments that can prevent the abnormal aggregation of plasma cells or mitigate its toxic effects. Succeeding the approval of antibody combination, many clinical as well as translational research are being initiated in the arena with the intention to develop and innovative and advanced antibody combination treatment regimen which will aid to provide treatment for numerous patients suffering from multiple myeloma malignancies. Currently, numerous clinical researches are ongoing in the realm, few of which have reached the late stage of development that are being conducted by various pharma companies and hospitals such as Sanofi, Pfizer, Wuerzburg University Hospital, ClinAssess GmbH, Arbeitsgemeinschaft medikamentoese Tumortherapie, SWOG Cancer Research Network, National Cancer Institute (NCI), ECOG-ACRIN Cancer Research Group, Eastern Cooperative Oncology Group, European Myeloma Network, Karyopharm Therapeutics, GlaxoSmithKline, Janssen Research & Development, Alexion Pharmaceuticals etc. Apart from the involvement of various stakeholders from the giant pharma companies, the pipeline for sphere of antibody combinations for the treatment of multiple myeloma consist of monoclonal and bispecific antibodies targeting immune checkpoint receptors like anti PD-1, anti PD-L1, anti CTLA-4 along with BCMA, CD3, OX40, CD38, GPRC5D directed CD3 bispecific antibodies, interleukin- 6 receptor mAbs along with gamma secretase inhibitor. Presence of different types of therapeutic agents with antibody illustrates that the realm of antibody combinations to treat multiple myeloma is growing and it is expected that multiple novel combinations will be launch in the upcoming years. The vista of antibody combination therapy for the treatment of multiple myeloma is expanding at an incredible gait on the account of the rising growth of antibody combinations in the commercial market along with augmenting partnerships, increasing research, investments and collaborations in the domain. For instance, in January 2024, a researcher at Penn State Cancer Institute based in the US, stated that the bispecific antibodies plays a significant role for the treatment of in hematologic malignancies, particularly multiple myeloma. Despite the fact that chimeric antigen receptor (CAR)-T cell therapy have made surplus benefits to patients, yet the role of bispecific antibodies becomes progressively apparent in the difficult-to-treat population with multiple myeloma patients. Antibody combinations represent a significant breakthrough in the management of multiple myeloma. By targeting the key pathway and receptors such as SLAMF7/ CD319 or CD38 that are involved in progression of multiple myeloma, the therapeutic approach offer an effective and convenient way to increase effectiveness and reduce the side effects along with drug resistances. Despite some challenges, Antibody combinations clenches great promise in transforming the lives of those suffering from multiple myeloma, providing a beacon of aspiration to numerous individuals suffering from multiple myeloma. As research continues, the use of antibody combination therapies may become more refined and accessible treatment, further improving their role in multiple myeloma management.

DUBLIN, March 1, 2024 /PRNewswire/ -- The "In Vitro Diagnostic (IVD) Reagents Market by Type (Antibodies, Proteins, Oligonucleotides, Nucleic Acid Probes) Technology (Immunoassay, Biochemistry, Molecular Diagnostic, Microbiology, Hematology) Use (Clinical, RUO) End User - Global Forecast to 2030" report has been added to ResearchAndMarkets.com's offering. The global in-vitro diagnostics reagents market is projected to reach $75.67 billion by 2030, at a CAGR of 5.4% from 2023 to 2030. The growth of this market is driven by the increasing prevalence of infectious diseases, increasing funding for research activities, the rising adoption of advanced diagnostic technologies, the growth in proteomics and genomics research studies, and the growing number of clinical laboratories offering advanced diagnostic testing menus. Additionally, emerging economies and the growing demand for protein therapeutics and personalized medicines are expected to offer significant market growth opportunities. However, the stringent regulations for antigen-specific reagents restrain the growth of this market. Additionally, the high costs of reagents and the unfavorable reimbursement scenario pose a significant challenge to the market's growth. Based on type, the IVD reagents market is segmented into antibodies, purified proteins and peptides, oligonucleotides, nucleic acid probes, and other reagents. In 2023, the antibodies segment is expected to account for the largest share of the IVD reagents market. The large share of this segment is mainly attributed to the increasing R&D funding. For instance, According to Research America, investments in medical and health R&D by the U.S. has increased by 7.0% between 2019 and 2020. In 2020, the total medical and health R&D expenditure was USD 245.1 billion. Furthermore, the huge demand for antibodies in various biomedical & basic research are the factors contributing to the largest share of this segment. Based on technology, the IVD reagents market is segmented into immunoassay/immunochemistry, biochemistry/clinical chemistry, molecular diagnostics, microbiology, hematology, coagulation/hemostasis, urinalysis, and other IVD technologies. In 2023, the immunoassay/immunochemistry segment is expected to account for the largest share of the IVD reagents market. The large share of this segment is mainly attributed to the increasing use of immunoassays in infectious disease testing, the development of novel tests, and the rising demand for immunoassay-based tests. Further, the coronavirus (COVID-19) outbreak since December 2019 is expected to accelerate the growth of this segment owing to the national emergency declared and the requirement of various reagents for the kits and assay preparation. Based on the use, the IVD reagents market is segmented into clinical use, research use only (RUO), and analyte-specific reagents (ASR). In 2023, the clinical use segment is expected to account for the largest share of the IVD reagents market. The large share of this segment is mainly attributed to the growing need for the early detection of various epidemic and pandemic infections, the large volume of test samples diagnosed for clinical purposes, and initiatives undertaken by manufacturers to develop advanced IVD reagents drive the demand for IVD reagents for clinical use. Based on the end user, the IVD reagents market is segmented into IVD manufacturers, reference laboratories, academic institutes and research laboratories, and hospital laboratories. In 2023, the IVD manufacturers segment is expected to account for the largest share of the IVD reagents market. The large share of this segment is mainly attributed to the initiatives undertaken by IVD manufacturers and the increasing demand for pharmaceutical & biopharmaceutical products from emerging countries. In 2023, North America is estimated to account for the largest share of the IVD reagents market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Furthermore, in 2023, the U.S. is expected to account for the largest share of the IVD reagents market in North America. The market growth in the U.S. is attributed to the increasing prevalence of infectious diseases, growing preference for PoC testing and personalized medicine, and rising funds and investments for research reagents. Market Insights Drivers Increasing Prevalence of Infectious Diseases Increasing Funding for Research Activities Growth in Proteomics and Genomics Research Studies Growing Number of Clinical Laboratories Offering Advanced Diagnostic Testing Menus Restraints Stringent Regulations for Antigen-Specific Reagents Opportunities Growing Demand for Protein Therapeutics and Personalized Medicines Emerging Economies Challenges High Costs of Reagents and the Unfavorable Reimbursement Scenario Factor Analysis Regulatory Analysis U.S. Canada Europe China Japan India Latin America Middle East & Africa Porter's Five Forces Analysis Pricing Analysis Company Profiles (Business Overview, Financial Overview, Product Portfolio, and Strategic Developments) Thermo Fisher Scientific (U.S.) Becton Dickinson and Company (U.S.) Merck KGaA (Germany) Bio-Rad Laboratories Inc. (U.S.) Agilent Technologies Inc. (U.S.) Abcam plc (U.K.) Hologic Inc. (U.S.) InBios International Inc. (U.S.) SDIX LLC (U.S.) BioTechne Corporation (U.S.) Bio-Synthesis Inc. (U.S.) RayBiotech Inc. (U.S.) Sino Biological Inc. (China) Oy Medix Biochemica Ab (Finland) QIAGEN N.V. (Netherlands) Beckman Coulter Inc. (U.S.). Competition Analysis Overview Competitive Benchmarking Competitive Dashboard Industry Leaders Market Differentiators Vanguards Emerging Companies Market Share Analysis (2022) Thermo Fisher Scientific (U.S.) Merck KGaA (Germany) Becton, Dickinson and Company (U.S.) Scope of the Report: IVD Reagents Market Size & Trend Analysis - by Type Antibodies Antibodies Market, By Type Monoclonal Antibodies Polyclonal Antibodies Antibodies Market, By Target Cluster of Differentiation (CD) T-cell Receptor (TCR) Epidermal Growth Factor Receptor (EGFR) Other Targets Purified Proteins and Peptides Oligonucleotides Nucleic Acid Probes Other Reagents Notes: 1. Other targets include Nucleic BCMA, DLL/Notch, EpCAM, HER2, PDGFR?, Claudin 18.2, SLAMF7, and DKK1. B-cell maturation antigen (BCMA). 2. Other reagents include blocking agents, detergents, surfactants, wetting agents, buffers, stabilizers, purified water, dyes, standards and controls, enzymes, cell culture reagents, and anti-coagulants. IVD Reagents Market Size & Trend Analysis - by Technology Immunoassay/Immunochemistry Enzyme-linked Immunosorbent Assays (ELISA) and Enzyme-linked Immunospot Assays (ELISpot) Lateral Flow Assays (LFA)/Rapid Tests Western Blotting (WB) Immunofluorescence (IF) Functional Assays Immunoprecipitation (IP) Other Immunoassay Technologies Biochemistry/Clinical Chemistry Molecular Diagnostics Polymerase Chain Reaction (PCR) Hybridization Isothermal Nucleic Acid Amplification Technology DNA Sequencing & Next-generation Sequencing Microarray Other Molecular Diagnostic Technologies Microbiology Hematology Coagulation/Hemostasis Urinalysis Other IVD Technologies Note: 1. Other technologies include virus neutralization tests, agar gel immunodiffusion, and radioimmunoassay. 2. Other molecular diagnostic technologies include electrophoresis, ligase chain reaction (LCR), northern blot, and southern blot. 3. Other IVD technologies include anatomical pathology, histochemistry, and whole blood glucose monitoring. IVD Reagents Market Size & Trend Analysis - by Use Clinical Use Research Use Only (RUO) Analyte-specific Reagents (ASR) IVD Reagents Market Size & Trend Analysis - by End User Reference Laboratories IVD Manufacturers Academic Institutes and Research Laboratories Hospital Laboratories IVD Reagents Market Size & Trend Analysis - by Geography North America U.S. Canada Europe Germany France Italy U.K. Spain Switzerland Netherlands Rest of Europe Asia-Pacific China Japan India South Korea Australia Singapore Rest of Asia-Pacific Latin America Brazil Mexico Rest of Latin America Middle East & Africa For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets