KANDOVA - A Two-Part Phase Ib/IIa Study to Evaluate the Safety and Tolerability of KAND567, in Combination With Carboplatin Therapy, and to Determine the Recommended Phase II Dose (RPIID) of KAND567: An Open-Label, Multicenter Dose Escalation Study With an Expansion Cohort in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The study is a multicenter, Phase Ib/IIa, open-label, dose-escalation study to evaluate the safety and tolerability of orally administered KAND567 in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND567 in combination with carboplatin in subjects with recurrent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
In Part 1, dose escalation will be based on the recommendation of the Safety Review Committee (SRC) after review of the emerging safety and tolerability information. The SRC is also mandated to modify the dose levels within the dose range (125 to 625 mg BID), as well as the schedule to maintain subject safety and best serve the objectives of the study. Once the RPIID has been identified in Part 1, the SRC may recommend to the Sponsor to start Part 2.
An expansion cohort will be enrolled in Part 2 of the study to further evaluate the RPIID (approximately 20 subjects; may range from 6 to 24 subjects, depending on Part 1). If the number of subjects with confirmed CX3CR1 expression in tumor cells is below 50%, an additional 15 subjects may be included in Part 2 of the study.

开始日期2023-04-26

申办/合作机构

Novakand Pharma AB

ISRCTN18402242

/ Completed临床2期IIT

A Phase IIa, randomized, two-arm parallel-group, placebo-controlled, double-blind, multi-centre trial to evaluate the safety, tolerability, anti-inflammatory and cardio-protective effects after intravenous and oral administration of KAND567 in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention

开始日期2021-11-15

申办/合作机构

The Newcastle upon Tyne Hospitals NHS Foundation Trust

NCT06012565

/ Terminated临床2期

KAND567 Versus Placebo in Subjects Hospitalized With COVID-19. A Phase II, Randomized, 2-Arm Parallel-Group, Double-blind Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics

The study is a phase II, randomized, 2-arm parallel-group, double-blind study to explore the efficacy, safety, tolerability and pharmacokinetics of KAND567 versus placebo in COVID-19 subjects in need of oxygen treatment.
The target was to include forty (40) subjects with diagnosed COVID-19 for participation in the study. If at screening all criteria for study participation were fulfilled and informed consent signed, the subject was enrolled and randomized into one of the two arms. After randomization, the subjects were to receive KAND567 or placebo treatment for 7 days.
After the treatment period the subjects returned to ordinary clinical follow-up, but a study follow-up visit was to be planned for Day 21 and 90.

开始日期2020-10-11

申办/合作机构

Novakand Pharma AB

100 项与 Rugocrixan 相关的临床结果

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项与 Rugocrixan 相关的文献（医药）

2025-12-01·Food and Waterborne Parasitology

CX3CL1/CX3CR1 involved modulation of microglial activation and eosinophilic meningoencephalitis in angiostrongyliasis

Article

作者: Chen, An-Chih ; Huang, Shiang-Suo ; Wang, Yi-Hsin ; Chen, Ke-Min ; Lai, Shih-Chan ; Lu, Cheng-You

Angiostrongylus cantonensis typically infects humans through the ingestion of contaminated food or water containing the larvae. A. cantonensis is a neurotropic parasitic nematode that causes eosinophilic meningitis in humans. Upon invasion of the CNS, A. cantonensis larvae elicit a pronounced immune response, rapidly activating microglia and triggering the release of pro-inflammatory cytokines. The CX3CL1/CX3CR1 axis has been implicated in maintaining chronic microglial activation, which could exacerbate neuroinflammation. However, the precise role of this signaling pathway in angiostrongyliasis remains poorly understood. This study aims to elucidate the mechanistic role of CX3CL1/CX3CR1 signaling in microglial activation and neuronal degeneration in CNS infections caused by A. cantonensis. We analyse the expression and downstream regulatory proteins using Western blotting and evaluate neuronal degeneration by Fluoro-Jade C staining in BALB/c mice infected with A. cantonensis. Infected mice showed a marked increase in the expression of Iba-1, CX3CL1, and CX3CR1, indicative of pronounced neuroinflammation. Concurrently, infection led to elevated p-tau accumulation and reduced NeuN expression, suggesting significant neuronal damage. Pharmacological inhibition of CX3CR1 using AZD8797 mitigated these effects by downregulating CX3CL1/CX3CR1 signaling and attenuating neuronal degeneration. Further analysis revealed that the CX3CL1/CX3CR1 axis activates the Nrf2/JNK/HO-1 pathway, contributing to oxidative stress and neuroinflammatory cascades. These findings establish the CX3CL1/CX3CR1 axis as a crucial regulator of microglial activation and neuroinflammation in A. cantonensis infection. Targeting this pathway can offer a viable therapeutic strategy to mitigate inflammation of the CNS and prevent neurodegenerative consequences.

2025-09-01·NEUROPHARMACOLOGY

“Maladaptive stress-coping behavior in CX3CR1-deficient mice: Impact of adolescent stress and alcohol exposure on neuroimmune responses and inflammation”

Article

作者: Sánchez-Marín, Laura ; Martín-Chaves, Laura ; Popova, Olga ; Serrano, Antonia ; Sánchez-Quintero, María José ; Rodríguez de Fonseca, Fernando ; Medina-Vera, Dina ; Jiménez-Navarro, Manuel F ; Rodríguez-Capitán, Jorge ; Gavito, Ana L ; Díaz-Ottaviano, María ; Pavón-Morón, Francisco Javier

The CX₃CL1/CX₃CR1 chemokine axis regulates synaptic pruning, plasticity, and stress-related behaviors, influencing resilience or vulnerability to psychiatric disorders. Adolescence, a critical period for neuroimmune development, increases susceptibility to stressors. This study investigated how adolescent restraint stress and alcohol exposure affect stress-coping behavior, neuroimmune signaling, and systemic inflammation in adult wild-type (WT) and CX₃CR1 knock-out (KO) mice. Eighty-one male and female WT and KO mice were assigned to control (non-stressed, saline-treated), stress (stressed, saline-treated), alcohol (non-stressed, alcohol-treated), and stress + alcohol (stressed, alcohol-treated) groups. Behavioral responses were evaluated using the tail suspension test. Hypothalamic gene expression of CX₃CL1/CX₃CR1, corticotropin-releasing hormone (CRH), and neuropeptide Y (NPY) systems was analyzed alongside plasma corticosterone, adrenocorticotropic hormone (ACTH), CX₃CL1, and inflammatory mediators. Adolescent stress-but not alcohol-increased plasma CX₃CL1 levels, which inversely correlated with immobility time in WT mice. KO mice displayed higher baseline immobility than WT mice, whereas stress and/or alcohol paradoxically reduced immobility. These behavioral effects were reproduced by pharmacological inhibition of CX₃CR1. Additionally, KO mice showed disrupted hypothalamic expression of multiple genes in the CRH pathway and Npy1r, attenuated corticosterone responses to stress, and abolished ACTH-corticosterone correlation, suggesting HPA axis dysregulation. KO mice also exhibited exacerbated inflammatory responses to stress and alcohol, including elevated IL-17A/F, IL-11, and IFN-β1 levels. CX₃CR1 deficiency disrupts neuroimmune homeostasis, leading to maladaptive stress-coping behaviors and heightened inflammatory reactivity. These findings underscore the protective role of the CX₃CL1/CX₃CR1 axis in neuroinflammatory regulation and stress resilience, supporting CX₃CR1 as a potential therapeutic target in stress-related disorders.

2025-09-01·MOLECULAR NEUROBIOLOGY

TREK- 1 Ameliorates Secondary Brain Injury by Regulating Inflammatory Microenvironment via CX3 CL1-CX3 CR1 Pathway After Intracerebral Hemorrhage

Article

作者: Liu, Yang ; Fang, Yongkang ; Zhu, Suiqiang ; Zhu, Zhou ; Xu, Yuan ; Zheng, Xiaolong ; Wang, Wei ; Jiang, Na ; Sadike, Dilinuer ; Wang, Yao ; Xie, Minjie ; Xu, Feng

Neuroinflammation plays a pivotal role in the pathogenesis of secondary brain injury (SBI) after intracerebral hemorrhage (ICH). TREK-1 is a background potassium channel, and its role in regulating neuroinflammation after ICH remains unclear. In this study, ICH models were induced in wide-type (WT) and TREK knockout mice via intra-striatal administration of collagenase. Additionally, WT ICH mice were treated with the TREK-1 agonist ML67-33. Immunofluorescence, western blot, quantitative real-time PCR, enzyme-linked immunosorbent assay, and RNA-sequencing were performed to determine the role and the mechanism of TREK-1 in regulating neuroinflammation after ICH. The results indicate that TREK-1 deficiency exacerbated microglia/macrophages activation and pro-inflammatory polarization, as well as the influx of inflammatory cytokines and peripheral inflammatory cells compared to WT ICH mice. Conversely, activation of TREK-1 attenuated the inflammatory response and SBI post-ICH. These effects may be mediated through the CX3CL1-CX3CR1 pathway, as validated by specific inhibitors AZD8797. This study identified TREK-1 as a crucial modulator in alleviating SBI by regulating the inflammatory microenvironment via the CX3CL1-CX3CR1 pathway.

项与 Rugocrixan 相关的新闻（医药）

2023-01-26

·PRNewswire

Myocardial Infarction (MI) Market is Projected to Grow at a Minimal CAGR of 1.61% During the Study Period (2019-2032) | Assesses DelveInsight

Considering the expected launch of new upcoming therapies and greater integration of early patient screening, it can be safely assumed that the MI market will undergo a paradigm shift in the present decade holding new prospects and opportunities for those planning to carve out their niche during the forecast period [2022–2032] LAS VEGAS, Jan. 26, 2023 /PRNewswire/ -- DelveInsight's MI Market Insights report includes a comprehensive understanding of current treatment practices, MI emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. Key Takeaways from the MI Market Report As per DelveInsight analysis, the MI market size in the 7MM was approximately USD 21 billion in 2021 According to the assessment done by DelveInsight, the estimated total MI diagnosed prevalent cases in the 7MM was approximately 15 million in 2021 Leading MI companies such as AstraZeneca, Boehringer Ingelheim and Eli Lilly and Company, Amgen, Novartis, Idorsia Pharmaceuticals, Faraday Pharmaceuticals, CSL Behring, Immediate Therapeutics, Mitsubishi Chemical Group, Kancera, Bayer, Recardio, Mesoblast, and others are developing novel MI drugs that can be available in the MI market in the coming years The promising MI therapies in the pipeline include FARXIGA/FORXIGA (dapagliflozin), JARDIANCE (empagliflozin), Olpasiran (AMG860), Pelacarsen (TQJ230), Selatogrel, FDY-5301, CSL112, IMT-358, CL2020, MEDI6570, KAND567, Asundexian, Dutogliptin, MPC-25-IC , and others In November 2022, Amgen presented end-of-treatment data from its Phase II OCEAN (a)-DOSE study of olpasiran during the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions and simultaneously published in the New England Journal of Medicine As per the Q32022 investor presentation of AstraZeneca data, readouts from the Phase III (DAPA-MI) trial of FARXIGA/FORXIGA is anticipated by 2H 2023. With an estimated key regulatory submission acceptance after 2023 In June 2021, Idorsia announced the initiation of the Phase III registration study "SOS-AMI" to evaluate the efficacy and safety of self-administered SC selatogrel in suspected AMI In September 2020, the FDA granted Fast Track designation for the development of JARDIANCE to prevent hospitalization for heart failure and reduce the risk of mortality in patients with and without diabetes who have had an acute MI In July 2020, AstraZeneca was granted Fast Track designation in the US for the development of FARXIGA to reduce the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in adults following an AMI or heart attack Discover which therapies are expected to grab the major MI market share @ MI Market Report. MI Overview MI is pathologically defined as myocardial cell death caused by prolonged ischemia. The first ultrastructural changes are diminished cellular glycogen, relaxed myofibrils, and sarcolemmal disruption, which can be seen as early as 10-15 minutes after the onset of ischemia. Symptoms of MI include chest pain, which may initially manifest as a sensation of tightness or pressure. The pain usually radiates to the left arm, but it can also radiate to the lower jaw, neck, right arm, back, and upper abdomen. Sweating, nausea, vomiting, and fainting may accompany chest pain. The typical clinical features, ECG findings, and elevation of cardiac biomarkers are used for MI diagnosis. Cardiovascular catheterization is required for definitive diagnosis and serves diagnostic and therapeutic purposes. All patients suspected of having ACS should be considered for emergency revascularization; other MI treatment options include anticoagulation, antiplatelet therapy, statin therapy, and other adjunctive measures. MI Epidemiology Segmentation DelveInsight estimates that there were approximately 15 million diagnosed prevalent cases of MI in the 7MM in 2021. Among EU4 countries, Germany had the highest number of diagnosed prevalent cases of MI, while Spain had the lowest prevalent population among the 7MM. The MI market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Diagnosed Prevalent Cases Gender-specific Prevalence Type-specific Prevalence Download the report to understand which factors are driving MI epidemiology trends @ MI Epidemiological Insights. MI Treatment Market The goals of initial MI treatment are to relieve pain, immediately identify ST changes via 12-lead EKG, initiate reperfusion (if the patient is a candidate), and assess and treat hemodynamic abnormalities. Oxygen, nitroglycerin, and morphine sulfate are the most effective pain relievers. Reperfusion therapy is indicated for patients with ST-segment elevation or a new LBBB with symptoms lasting 12 hours or less. MI treatment may be divided into two paths depending on whether the patient has a STEMI or an NSTEMI. The pharmacologic MI treatment is further subdivided into several groups of medications that improve survival, reduce recurrent ischemic events, and provide symptomatic relief. Following the primary MI treatment, a multimodal regimen of therapies is used. To classify the disease, rapid diagnostic tests and serial biomarker analysis are used to begin MI treatment. The current MI market has been segmented into different commonly used therapeutic classes based on the prevailing MI treatment pattern across the 7MM, which exhibits minor variations in the overall prescription pattern. The major classes covered in the forecast model are antiplatelet agents, anticoagulants, vasodilators, beta-blockers, lipid-lowering drugs, Angiotensin-converting enzyme (ACE) inhibitors, ARBs (Angiotensin-II receptor Blockers), and calcium channel blockers. In recent years, it has been demonstrated that pre-hospital thrombolysis has a role in the management of patients seen early after symptom onset in comparison/association with patients who had primary coronary intervention or elective primary coronary intervention. This is an important issue that is still being researched to prevent cardiac arrest, large scares, and again limit the transition to heart failure and improve the survival rate after AMI. To know more about MI treatment guidelines, visit @ MI Management. MI Pipeline Therapies and Key Companies FARXIGA/FORXIGA (dapagliflozin): AstraZeneca JARDIANCE (empagliflozin): Boehringer Ingelheim and Eli Lilly and Company Pelacarsen (TQJ230): Novartis Olpasiran: Amgen Selatogrel: Idorsia Pharmaceuticals FDY-5301: Faraday Pharmaceuticals CSL112: CSL Behring IMT-358: Immediate Therapeutics CL2020: Mitsubishi Chemical Group MEDI6570: AstraZeneca KAND567: Kancera Asundexian: Bayer Dutogliptin: Recardio MPC-25-IC: Mesoblast Learn more about the FDA-approved drugs for MI @ Drugs for MI Treatment. MI Market Dynamics The dynamics of MI market is anticipated to change in the coming years. The growing emphasis on secondary preventive measures to avoid recurrent/new events, lifestyle changes, and the growing number of smokers and cases of obesity, diabetes, hypertension, and others, are expected to fuel MI market growth. Moreover, heart attacks and strokes are major cost drivers in the 7MM healthcare system. The volume of the MI market is enormous. The patient is receiving multiple therapies at the same time. The smallest portion of the patient share can provide pharmaceutical companies with options worth millions of dollars in the MI market. However, several factors are likely to affect the growth of the MI market. Women appear to be underdiagnosed with MI, despite being at higher risk because medical training for healthcare professionals and public information has emphasized the identification of symptoms that typically affect men. This highlights the importance of gender differences in developing strategies for early MI detection and tailored secondary prevention after MI, which should result in a higher rate of MI detection in women. Moreover, off-label therapies and generics account for the majority of the current MI market because they are less expensive and more easily accessible to patients, thus, causing a dip in the MI market growth. Hence, all these factors mentioned above will hamper the MI market growth in the future. Scope of the MI Market Report Therapeutic Assessment: MI current marketed and emerging therapies MI Market Dynamics: MI market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, MI Market Access and Reimbursement Discover more about MI drugs in development @ MI Clinical Trials. Table of Contents Related Reports MI Pipeline MI Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key MI companies, including CSL Behring, Immediate Therapeutics, Mitsubishi Chemical Group, Kancera, Bayer, Recardio, among others. MI Epidemiology Forecast MI Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted MI epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Myocarditis Pipeline Myocarditis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myocarditis companies, including Cantargia AB, Cardiol Therapeutics, Apitope, among others. Dilated Cardiomyopathy Pipeline Dilated Cardiomyopathy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key dilated cardiomyopathy companies, including Longeveron, Bristol Myers Squibb, Berlin Cures, Tenaya Therapeutics, Cardior Pharmaceuticals, among others. Cardiac Biomarkers Testing Market Cardiac Biomarkers Testing Market Insight, Competitive Landscape, and Market Forecast – 2027 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key cardiac biomarkers testing companies, including Beckman Coulter, Inc, Siemens Healthcare GmbH, Abbott, among others. Dilated Cardiomyopathy Epidemiology Dilated Cardiomyopathy Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted dilated cardiomyopathy epidemiology in the 7MM. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Blogs Upcoming Cardiovascular Diseases Drugs Key Companies in the Cardiology Segment Heart Failure Market Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Connect with us on: LinkedIn | Facebook | Twitter. Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services. Logo - Contact Us: Shruti Thakur [email protected] +1(919)321-6187 SOURCE DelveInsight Business Research, LLP

临床3期快速通道

2020-07-14

·BioSpace

Biopharma Update on the Novel Coronavirus: July 15

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 15, 2020. News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays. FDA Actions Spike Proteins on Surface of COVID-19 : FDA scientists have identified on the SARS-CoV-2 spike proteins, specific areas causing the virus to trigger protective antibody responses. This finding could help inform researchers about vaccine development. EUAs: The FDA has issued EUAS for the following: electroCore, Inc. ( GammaCore Sapphire Non-invasive Vagus Nerve Stimulator ) Circadiance ( SleepWeaver Prevent CPAP Mask ) Coronavirus Treatment Acceleration Program (CTAP) : The FDA posted an updated CTAP webpage. The revised webpage includes a dashboard of critical statistics related to the development of COVID-19 therapeutics. Warning Letters: The FDA issued warning letters to Health Beauty Love and Kegan Wellness for selling products with false or misleading claims that their products can prevent or treat COVID-19. Temporary Compounding : The FDA added dexamethasone sodium phosphate to the list of drugs approved for temporary compounding during the COVID-19 pandemic. Diagnostics Update : To-date the FDA has authorized 179 individual EUAs, which include 148 molecular tests, 29 antibody tests and 2 antigen tests. Diagnostics IDbyDNA’s Explify platform for metagenomics analysis is transforming highly sophisticated research-only laboratory tools into practical diagnostics tools for routine hospital use. Now physicians can determine not just whether a patient has COVID-19, but also – in the same test – whether that patient has other respiratory pathogens that are exacerbating illness. Genetic Technologies provided an update on the development of its Polygenic Risk Scores (PRS) test for COVID-19. The company has submitted to the Patent Office in Australia, a provisional patent for its test. The test is intended to predict the severity of COVID-19 disease using a combination of genetic and clinical information. VolitionRx announced results from two proof-of-concept studies of Nu.Q assays for COVID-19. The studies were conducted at University Hospital Liege, Belgium and the German Heart Center in Munich, Germany, with the goal of confirming whether circulating nucleosomes could act as a potential prognostic marker for COVID-19 disease severity. The test results did show a correlation with more severe COVID-19 cases. AXIM Biotechnologies announced the development of NeuCovix TM . The company’s test is a rapid diagnostic test that can measure levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2. Testing Therapies, Antivirals and Vaccines In mid-May, Moderna released positive interim data from its Phase I trial of mRNA-1273, its mRNA vaccine against SARS-CoV-2, the virus that causes COVID-19. It was in a press release and although the company shares rocketed, critics immediately took aim at what they felt was a lack of data. But now Moderna and researchers involved in the study from the National Institute of Allergy and Infectious Diseases (NIAID) and clinical trial centers published the data in The New England Journal of Medicine . The bottom line was the trial showed promising safety and immune response in all the patients involved in the trial. Stockholm, Sweden-based biotech company Kancera AB recently received approval from the Swedish Medical Products Agency to initiate a clinical trial of KAND567, which blocks the Fractalkine receptor that plays a major role in triggering the body’s inflammatory process. Fractalkine is the only known member of the CX 3 C chemokine family. It is a cytokine protein implicated in numerous areas of hyper-inflammation including, potentially, COVID-19. There is talk that positive news will soon be released on the trials of Oxford and AstraZeneca’s COVID-19 vaccine. The date is planned to be published in the Lancet . Nanobodies derived from llamas have neutralized the SARS-CoV-2 spike in the lab, effectively neutralizing the virus, according to research from the UK’s Rosalind Franklin Institute. NeoImmuneTech, announced the FDA cleared the company’s Investigational New Drug (IND) application. The company will study NT-17 for the treatment of adults with mild COVID-19. Biopharmaceutical company Medicago announced today that it has begun its Phase I clinical trial for its plant-derived COVID-19 vaccine candidate. It has already administered the first doses of the candidate in healthy human subjects, and the company intends to initiate a Phase II/III trial this coming October. Rigel Pharmaceuticals, Inc. launched a trial to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of COVID-19 pneumonia. Fostamatinib, marketed in the U.S. as Tavalisse, is a treatment for adult chronic immune thrombocytopenia. By inhibiting SYK, a key mediator of immunoreceptor signaling in a host of inflammatory cells, fostamatinib may inhibit the infiltration and activation of monocytes and neutrophils in the lungs that are prominent in COVID-19. Israel-based Can-Fite BioPharma plans to Investigational New Drug Application to evaluate piclidenoson for the treatment of COVID-19 infected patients with moderate symptoms. Piclidenoson is an A3 adenosine receptor (A3AR) agonist. Bold Therapeutics announced it has in vitro data showing that it’s lead therapeutic candidate, BOLD-100 successfully inhibits life SARS-CoV-2 within a therapeutic range. Company Actions In a sobering message , Ken Frazier , Merck’s chief executive officer, is reminding the world that vaccine development takes time, typically a decade, and hoping for a viable vaccine against the novel coronavirus by the end of December is premature. In an interview with the Harvard Business Review , as reported by Reuters , Frazier warned that the first vaccines against COVID-19, should they meet the 50% efficacy threshold set by the U.S. Food and Drug Administration, may not have as broad of an impact as hoped. Frazier said the vaccines may not have the qualities that are necessary to be deployed rapidly and on a large enough scale as hoped. In hopes of a late-stage COVID-19 vaccine candidate hitting the 50% efficacy threshold set by the U.S. Food and Drug Administration , U.S. drugmakers who have partnered with the U.S. government could begin to manufacture doses of a preventative treatment by the end of summer, Reuters reported. Other Industry News According to several studies, the risk of contracting COVID-19 or developing a serious case of the disease may be greater depending on blood type. In general, studies have shown that people with Type O blood appear to be more protected than those with Type A, who are seemingly more vulnerable, according to NBC News. In the first securities fraud prosecution involving COVID-19 testing, the US Department of Justice charged the president of Arrayit Corporation with one count of securities fraud and one count of conspiracy to commit healthcare fraud. They charged Mark Schena with submitting more than $69 million in claims for allegedly unnecessary medical laboratory allergy and COVID-19 tests.

疫苗临床1期临床结果上市批准信使RNA

2020-07-14

·BioSpace

Kancera’s Unique Approach to COVID-19: Attack the Fractalkine System

Thomas Olin, chief executive officer of Kancera, took time to discuss the company, the Fracktalkine pathway and the upcoming clinical trial. Thomas Olin, chief executive officer of Kancera, took time to discuss the company, the Fracktalkine pathway and the upcoming clinical trial. Because a major feature of COVID-19 infections is the cytokine storm, numerous biopharma companies are testing drugs that control the immune system’s hyper-response in the disease. Fractalkine is the only known member of the CX 3 C chemokine family. It is a cytokine protein implicated in numerous areas of hyper-inflammation including, potentially, COVID-19. Stockholm, Sweden-based biotech company Kancera AB recently received approval from the Swedish Medical Products Agency to initiate a clinical trial of KAND567, which blocks the Fractalkine receptor that plays a major role in triggering the body’s inflammatory process. Thomas Olin, chief executive officer of Kancera, took time to discuss the company, the Fracktalkine pathway and the upcoming clinical trial. Kancera is located in the Karolinska Science Park in Stockholm and its key staff have a background with AstraZeneca, Pharmacia and the Karolinska Institute. The focus of the company for the last five years has been on cancer and immunomodulation, said Olin, and its most advanced projects are KAND567 and KAND145, focused on targeting hyperinflammation by blocking the Fractalkine system. The Fractalkine receptor is expressed on monocytes and macrophages, natural killer (NK) cells and T-cells. “The ligand fractalkine is expressed in a membrane bound form on endothelial cells and a soluble form,” Olin said. “The membrane-found form acts as an adhesion molecule and the soluble as a chemo-attractant. Together, this ligand/receptor of the fractalkine system regulates attraction and infiltration of immune cell into tissues triggering inflammation and repair.” Olin noted that historically, the fractalkine system was thought to be primarily involved in resolution of inflammation and repair. But recent research suggests that the “fractalkine system drives both chronic and acute inflammatory disease in people and, potentially, blocking the system can cause remission in hard-to-treat autoimmune disease.” It has now been shown that the fractalkine system triggers hyperinflammation after acute tissue damage and severe viral infection. The upcoming Phase II clinical trial is expected to begin in the third quarter of this year with results in the fourth quarter 2020 and first quarter 2021. The trial will study 40 patients, half treated with KAND5467 and the other a placebo. KAND567 is an oral medication taken via capsule twice a day for seven days. Follow-up health checks will be performed after completion and 90 days later. Olin said KAND567 has an advantage over some of the antibody approaches because it is a small molecule, which can reach “damaged areas characterized by flow and exposure is easier to modulate short term, which could be the key to balancing processes that drive inflammation and repair.” The study followed results from the Phase Ib program, which was conducted in Finland. In early March, the company presented positive data from that trial in the form of good tolerability and a favorable safety pro intravenous treatment. The early work on KAND567 was intended for acute myocardial infarction. This data supported the drug’s safety pro also demonstrated that the drug’s activity could decrease the infiltration of monocytes carrying the fractalkine receptor into the vasculature. And those high fractalkine levels, Olin said, are markers of poor prognosis. It is the circulating monocytes that are likely the cause of that poor prognosis because they express high levels of fractalkine receptors and are attracted to regions of inflammation caused by the release of CX3CL1, a soluble fractalkine ligand. In non-COVID-19 patients in the clinic, elevated fractalkine levels have been noted in acute respiratory distress syndrome (ARDS) and in sepsis. As a result of the ongoing COVID-19 pandemic, the company decided in May to focus its development of KAND567 on infectious diseases. Part of that process was to cut staff in its preclinical research areas, which would decrease the company’s cost base by about SEK 8 million a year (Slightly under $1 million U.S.). It also is focused on taking KAND145, its preclinical drug candidate, into the clinic. “In early May, we announced a patent application for KAND567 and KAND145 for the treatment and prevention of hyperinflammation in viral infections, and shortly thereafter we submitted an application to the Swedish Medicines Agency to conduct a Phase II clinical study documenting the potentially protective effect of the drug candidate KAND567 in patients with COVID-19,” Olin said in an earlier statement . “The study is intended to be conducted in collaboration with Capio St. Görans Hospitals and the Science for Life Laboratory (SciLifeLab). By opening up this new area of use for fractalkine inhibitors, we hope to contribute to the treatment of severe viral infections caused by COVID-19 and other viruses that cause the same type of hyperinflammation.” The Phase II trial will be at one clinical site, Capio St. Görans Hospital and led by clinical investigators Mantas Okas and Mats Wistrand. The center had treated more than 4,000 COVID-19 patients as of the end of May. Peter Brodin, with the SciLifeLab and Karolinska Institute will perform analysis of the patients’ genetic and immunological pro the trial. The focus will be on COVID-19 patients with hypoxia who have not cleared the initial infection and are either in the earlier stages of the hyperinflammatory response or at risk of developing it. They will be able to define that patient group on the basis of several factors, including the C-reactive protein (CRP) level, and by oxygen saturation. Patients with less than 94% oxygen saturation or who require one to six liters of supplemental oxygen per minute in order to maintain oxygen saturation levels between 93% and 96% will be eligible for the trial. KAND-567 was originally developed by AstraZeneca for multiple sclerosis. Kancera picked it up while still in preclinical studies and planned it for immuno-oncology indications. Then, a trial with UK clinical collaborators suggested fractalkine was involved in the hyperinflammation that comes after percutaneous coronary intervention, or coronary angioplasty after a myocardial infarction. That trial is still on the table but planned for some time in 2021. In addition to the coronary study, Olin said the drugs have applications for “spinal cord injury: diminishing neural cell death in the acute phase of the injury and thereby preserving mobility” and “autoimmune diseases, e.g. Cohn’s: Eisai have published data showing complete remission in hard to treat patients following treatment with fractalkine targeted antibody.”

临床2期临床1期临床结果

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
输卵管癌	临床2期	丹麦	Novakand Pharma AB	2023-04-26
输卵管癌	临床2期	挪威	Novakand Pharma AB	2023-04-26
输卵管癌	临床2期	瑞典	Novakand Pharma AB	2023-04-26
卵巢上皮癌	临床2期	丹麦	Novakand Pharma AB	2023-04-26
卵巢上皮癌	临床2期	挪威	Novakand Pharma AB	2023-04-26
卵巢上皮癌	临床2期	瑞典	Novakand Pharma AB	2023-04-26
复发性铂耐药性原发性腹膜癌	临床2期	丹麦	Novakand Pharma AB	2023-04-26
复发性铂耐药性原发性腹膜癌	临床2期	挪威	Novakand Pharma AB	2023-04-26
复发性铂耐药性原发性腹膜癌	临床2期	瑞典	Novakand Pharma AB	2023-04-26
急性心肌梗塞	临床2期	英国	Novakand Pharma AB	2021-11-15

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


FRACTAL (ESC2024)	临床2期	急性心肌梗塞 fractalkine receptor CX3CR1	71	KAND567	簾鹽獵構觸築蓋鹹顧繭(鏇鬱餘選淵遞積襯遞膚) = Throughout the 3-month follow-up period, 23 (62%) patients from the KAND567 arm as compared to 24 (71%) patients in the placebo arm had reported adverse events. 壓艱遞觸廠壓糧鹹醖鹹 (憲廠蓋積簾製窪願壓醖 ) 更多	积极	2024-09-02
				Placebo
FRACTAL (ESC2024)	临床2期	急性心肌梗塞 troponin	71	KAND567	鏇鏇淵醖壓積糧獵襯衊(製襯構積壓獵艱鏇餘淵) = 夢窪網蓋襯憲積鹽構廠壓積衊繭鏇餘艱繭構衊 (獵觸蓋鹽壓醖繭觸積簾 )	积极	2024-09-01
				Placebo	鏇鏇淵醖壓積糧獵襯衊(製襯構積壓獵艱鏇餘淵) = 鏇夢遞廠顧膚積選鹹艱壓積衊繭鏇餘艱繭構衊 (獵觸蓋鹽壓醖繭觸積簾 )
ISRCTN18402242 (FRACTAL, NEWS)	临床2期	ST段抬高心肌梗死	71	KAND 567	鹽願艱觸夢觸製廠膚餘(壓膚淵鑰壓壓範繭糧齋) = 鬱醖鏇鹹積築獵鏇網鑰鬱顧網鏇夢簾餘鏇繭醖 (淵艱襯糧積獵憲憲築糧 ) 更多	积极	2024-02-06
				安慰剂	簾壓觸齋繭窪糧齋淵範(糧觸範鏇鹽鏇獵構艱餘) = 願齋憲繭鏇膚願鹹艱願夢醖願簾艱觸膚遞壓構 (廠網選鬱襯築鏇製獵襯 )