Olokizumab

Interleukin-6 (IL-6) is a 26-kDa secretory protein composed of 184 amino acids and two N-glycosylation sites, as well as four cysteine residues in the mature IL-6. IL-6 is a multifunctional cytokine that acts on multiple biological systems and organs. Bone marrow cells, such as macrophages and dendritic cells, produce IL-6 after Toll-like receptors (TLR) detect pathogens at sites of infection or tissue injury. IL-6 is essential for the proliferation of myeloma cells and the survival of plasma cells in the adaptive immune response because it induces the ability of plasma cells to differentiate and produce antibodies. Initially defined as B-cell-stimulatory factor 2 (BSF-2), IL-6 promotes the synthesis of immunoglobulins through activated B cells, and its complementary deoxyribonucleic acid (DNA) was successfully cloned in 1986. It was later found that IL-6 is a prototype cytokine with pleiotropic biological effects on immune responses, acute-phase responses, and hematopoiesis. IL-6 is rapidly produced in response to infection or tissue injury and contributes to host defense. On the other hand, overproduction of IL-6 is associated with the development of acute and life-threatening complications such as systemic inflammatory response syndrome (SIRS) and cytokine-release syndrome (CRS). IL-6 is a major cytokine in the cytokine storm, seen in some patients undergoing chimeric antigen receptor (CAR) T cell therapy.  IL-6 plays a key role in the pathogenesis of diseases such as rheumatoid arthritis, steatorrhea, inflammatory bowel disease, diabetes, vitiligo, psoriasis and multiple sclerosis. IL-6 Competitive LandscapeAccording to the data provided by Patsnap Synapse-Global Drug Intelligence Database: the following figure shows that as of 20 Sep 2023, there are a total of 53 IL-6 drugs worldwide, from 119 organizations, covering 131 indications, and conducting 2004 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications, organizations, clinical trials, clinical results, and drug patents related to this target. The analysis of the current competitive landscape and future development of target IL-6 reveals a strong focus on this target by various companies in the pharmaceutical industry. Bristol Myers Squibb Co., Roche Holding AG, and Johnson & Johnson are among the companies with the highest stage of development on this target. Multiple drugs have been approved for indications such as rheumatoid arthritis, multiple myeloma, and COVID-19. Small molecule drugs, monoclonal antibodies, and molecular glues are progressing rapidly under the current targets. The United States, China, and European Union are the leading countries/locations in the development of IL-6 targeted therapies. China has shown significant progress in this area, with multiple approved drugs. The analysis of the current competitive landscape and future development of target IL-6 indicates a promising future for the development of therapies targeting IL-6 and its associated indications. Approved for Market IL-6 Inhibitors: SiltuximabSiltuximab is a monoclonal antibody drug that targets IL-6, a protein involved in various diseases. It has been approved for use in multiple therapeutic areas, including neoplasms, immune system diseases, hemic and lymphatic diseases, endocrinology and metabolic disease, other diseases, infectious diseases, and respiratory diseases. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. The drug has shown efficacy in treating Castleman Disease, a rare disorder of the lymph nodes, as well as its variant, Multi-Centric Castleman's Disease. It has also been investigated for its potential in treating schizophrenia, diabetes mellitus type 1, large granular lymphocytic leukemia, and even COVID-19. Siltuximab was developed by EUSA Pharma, Inc., and it received its first approval in the United States in April 2014. The drug has also been approved in China. Its approval in both countries indicates its potential global impact. In terms of regulations, Siltuximab falls under the category of overseas new drugs urgently needed in clinical settings and has been designated as an orphan drug. This designation is given to drugs that treat rare diseases and provides certain incentives to the manufacturer, such as market exclusivity and financial benefits. Overall, Siltuximab is a monoclonal antibody drug that targets IL-6 and has shown promise in various therapeutic areas. Its approval in the United States and China, as well as its designation as an orphan drug, highlight its potential in addressing unmet medical needs. Further research and clinical trials may reveal additional indications and expand its usage in the field of biomedicine. IL-6 inhibitors that have entered the NDA/BLA stage: OlokizumabOlokizumab is a monoclonal antibody drug that targets IL-6, a protein involved in immune responses. It is being developed by UCB SA, a pharmaceutical company. The drug is primarily intended for the treatment of Rheumatoid Arthritis, a chronic inflammatory disorder that affects the joints. However, it is also being investigated for its potential use in COVID-19, the respiratory disease caused by the novel coronavirus. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. In terms of therapeutic areas, Olokizumab is being explored for its efficacy in treating various infectious diseases, respiratory diseases, immune system diseases, as well as skin and musculoskeletal diseases. This suggests that the drug has a broad range of potential applications beyond its primary indication for Rheumatoid Arthritis. In terms of its development stage, Olokizumab has reached the NDA/BLA stage globally. NDA stands for New Drug Application, which is the final step in the drug approval process in the United States. BLA stands for Biologics License Application, which is the equivalent process for biologic drugs. This indicates that the drug has completed clinical trials and is currently under review by regulatory authorities for potential approval. In China, Olokizumab has reached Phase 3, which is the final stage of clinical trials before seeking regulatory approval. This suggests that the drug is progressing well in its development in China and may soon be available for patients in this market. Overall, Olokizumab is a monoclonal antibody drug that targets IL-6 and is being developed by UCB SA. It has shown promise in the treatment of Rheumatoid Arthritis and is also being investigated for its potential use in COVID-19. With its broad therapeutic areas and advanced development stages, Olokizumab has the potential to address unmet medical needs in various disease areas and may provide new treatment options for patients.

Russia-based R-Pharm Group announced a new rheumatoid arthritis (RA) drug, olokizumab, has been found to offer significant benefits to patients. Findings from the Phase III CREDO study were presented at the British Society of Rheumatology Annual Conference. The results showed significant improvements to the signs and symptoms of RA patients compared to those in the placebo and methotrexate group, not only in biologically naïve patients, but also among the difficult to treat population with active RA inadequately controlled by TNF-α inhibitor therapy, the company announced. Olokizumab is a monoclonal antibody specific for the interleukin-6 (IL-6) cytokine. It targets the IL-6 ligand rather than the receptor, and selectively blocks the final assembly of the signaling complex, the company announced. Olokizumab is the first direct inhibitor of interleukin-6 (IL-6) authorized for commercial use for this indication. Treatment with olokizumab was well-tolerated and consistent with the established safety profile of anti-IL-6 agents, the company announced. In May 2020, olokizumab received a market authorization from Russia’s Ministry of Health under the trade name "Artlegia." R-Pharm is currently establishing GMP-certified olokizumab production at facilities in France and Germany to enable prompt approval of the drug in the American and European markets. Elsewhere around the globe: IcanoMAB – Germany-based IcanoMAB received positive regulatory advice for the clinical development path of its anti-IL-1R7 antibody in late-stage COVID-19. IcanoMAB has published the pre-clinical proof-of-concept for the anti-IL-1R7 antibody that blocks the signal transduction of the interleukin-18 (IL-18) receptor. Recently, the company secured positive regulatory advice for its clinical development plan in late-stage COVID-19. IcanoMAB is currently entering discussions with interested parties for a development partnership of its anti IL-1R7 antagonist antibody. Memo Therapeutics – Switzerland’s Memo Therapeutics announced its COVID-19 antibody MTX-COVAB has shown efficacy against both the original virus as well as the UK variant (B.1.1.7). Memo is now preparing MTX-COVAB for clinical evaluation. Using its microfluidic, single-cell molecular cloning and screening technologies to enable antibody repertoire mining and antibody discovery, Memo can discover novel antibodies at unprecedented speed, efficiency and sensitivity derived from recovered patient samples. This approach has enabled the company to also identify a very promising antibody candidate against the South African variant (B.1.351). Sphere Fluidics – U.K.-based Sphere Fluidics, which develops single cell analysis systems, announced it has enhanced the capability and performance of its Cyto-Mine System. The updated design provides improvements that will help streamline workflows, reduce costs, increase throughput, and enable high-value clones to be captured in a single run, the company said. Cyto-Mine is an automated platform which integrates single cell screening, sorting, dispensing, imaging and clone verification. The new electronics design improves system performance, reliability, and stability, while the updated software features help to provide a better user experience, reduce user-instrument interaction, and allow for more robust data analysis. Holborn – Also based in the U.K., AI Solutions company Holborn will launch a dedicated business unit in India dubbed Holborn Wells India. Holborn said the launch is in response to an increasing need for “high-quality and cost-effective molecular In Vitro Diagnostics (IVD) in the country due to ongoing COVID-19 concerns.” Holborn Wells India will develop and deliver IVD products for infectious diseases by leveraging data and innovative diagnostic capabilities, with continued pressure on the nation’s health service as a result of the pandemic accelerating the need for operational capacity. Holborn Wells India already signed a deal with an Indian-based company to produce Holborn Wells’ IVD products in order to assist until a fully operational manufacturing location can be established. Milestone Pharmaceuticals – Canada’s Milestone Pharmaceuticals Inc. announced an exclusive license and collaboration with Shanghai-based Ji Xing Pharmaceuticals. The companies will develop and commercialize the investigational drug etripamil in patients with paroxysmal supraventricular tachycardia (PSVT) and additional cardiovascular conditions in Greater China. Under terms of the deal, Milestone will receive an upfront cash payment consisting of $15 million and a $5 million equity investment. In addition, Milestone is eligible to receive up to $107.5 million in milestone payments and royalties on future sales of etripamil in Greater China. BioMed X – Germany’s BioMed X extended its collaboration agreement with Merck. Under terms of the new agreement, Merck will start up to six additional research projects at the BioMed X Institute, building on ongoing research projects in the fields of oncology and autoimmunity. The next joint global crowdsourcing project will explore mechanisms of immune senescence and mitochondrial dysfunction in regulatory T cells and other T cell subsets that are shared in human autoimmunity and aging, BioMed X announced. Evolve Biologics – Canada-based Evolve Biologics Inc. selected DPR Construction to act as the General Contractor for construction of its new state-of-the-art commercial facility to be built in Texas. The new facility will produce plasma-derived therapeutics, initially Intravenous Immunoglobulin (IVIG) and Human Serum Albumin (HSA), using Evolve’s innovative and proprietary technology, PlasmaCap EBA. The company expects to break ground this summer. Owlstone Medical – Breath biopsy company Owlstone, based in the U.K., announced agreements with Functional Gut Clinic (FGC) and Functional Gut Diagnostics (FGD), leading providers of smart solutions for the diagnosis of gut health problems. The partnership will combine Owlstone’s expertise in breath-based testing with FGC and FGD’s leadership in digestive health, to strengthen the provision of efficient and high-quality at-home breath testing through a UK Lab Services Agreement and accelerate development of future breath tests in digestive health through a Collaboration Agreement. BD -- BD (Becton, Dickinson and Company) will build a €165 million ($200 million USD) high-tech manufacturing facility in Spain. When operational, the company said the site will employ up to 600 jobs by 2030. Construction is expected to begin later this year. The site will initially have a workforce of 150 people and encompass an area of 86,000 square feet. When fully operational in 2030, the facility will have an area of 323,000 square feet. Galapagos NV – Belgium-based Galapagos announced that the first patient has been enrolled in the FILOSOPHY Phase 4 European real-world outcomes study. The goal of the FILOSOPHY study is to advance understanding of the effectiveness and safety of filgotinib as it is used with patients with rheumatoid arthritis (RA) in clinical practice. Basilea Pharmaceutica International – Switzerland-based Basilea was awarded $2.7 million from CARB-X to develop a novel class of antibiotics to treat Gram-negative bacterial infections. Gram-negative bacteria, often called ‘superbugs’ because they have developed resistance at an alarming pace to existing antibiotics, kill an estimated 700,000 people each year around the world.