autoimmune disorders

2 new IVX Health outpatient infusion centers open in Florida

More treatment centers for people with autoimmune disorders such as multiple sclerosis (MS) are now available in Florida, as IVX Health expands its footprint across the state with the addition of two outpatient infusion and injection centers in the Fort Lauderdale area. With the new locations in Pembroke…

STAT5 Protein Complex Implicated in MS Autoimmunity in Mice

A four-protein complex, or tetramer, of the protein STAT5 is involved in the development of multiple sclerosis (MS)-like autoimmune disease in mice, a new study shows. The findings point to this protein complex and its signaling pathway as a potential treatment in MS and other autoimmune conditions, scientists noted.

FDA to Review ANI’s Request for Cortrophin Gel Use

The U.S. Food and Drug Administration (FDA) has agreed to review ANI Pharmaceuticals’ supplemental new drug application for the approval of Cortrophin Gel to treat people with multiple sclerosis (MS) and other chronic inflammatory conditions, including rheumatoid arthritis. Purified Cortrophin Gel (repository corticotropin injection USP) is a purified…

Oxygen Sensor Protein Can Regulate B-Cell Anti-inflammatory Response in MS, Study Shows

Oxygen sensor proteins can regulate immune B-cell activity, preventing inflammation in autoimmune disorders such as multiple sclerosis, a study reports. The research, titled “Hypoxia-inducible factor-1α is a critical transcription factor for IL-10-producing B cells in autoimmune disease,” was published in Nature Communications. An autoimmune disease is one in…

Topas and Lily Are Partnering to Develop Therapies for Autoimmune Disorders

Topas Therapeutics and Eli Lilly and Company are teaming up to develop compounds that could be used to treat inflammatory and autoimmune diseases, such as multiple sclerosis and diabetes. The compounds, based on a Topas technology platform, will be aimed at restoring immune tolerance. Immune tolerance refers to the immune system being unresponsive to certain antigens — for instance, the body’s own proteins. Without immune tolerance, the body can generate an excessive immune response that prompts the immune system to attack healthy organs or tissue — a process called autoimmunity Under the multiyear agreement, Topas will receive research and development funding. It will also receive financial rewards from the success of any drug developed under the collaboration. The agreement will give Lilly the option to license all therapies created under the collaboration, and to develop them further. "We are excited to be working with Lilly to generate drug candidates using our proprietary technology," Timm Jessen, the CEO of Topas Therapeutics, said in a press release. "We expect this work to support the value of our approach" of triggering immune tolerance against antigens, he said. The fact that an important pharmaceutical company like Lilly is interested "in our technology, we believe, supports the strong commercial potential of our work." Topas develops compounds against autoimmune reactions — that is, situations in which the immune system attacks healthy parts of the body. It is already developing treatments for multiple sclerosis, type 1 diabetes, celiac disease, and other autoimmune disorders. While the majority of such therapies try to shut down the immune system, Topas’ approach is to trigger antigen-specific immune tolerance. This allows the body to regain control over an excessive immune response, while sparing the body's normal immunity. Topas links its compounds to tiny nanoparticles that liver sinusoidal endothelial cells can absorb. The liver cells are the first place where immune T-cells can learn what the body should not fight against. In studies of mice with multiple sclerosis, a single injection of nanoparticles containing peptides found in neurons triggered a potent protective effect, improving the disease's symptoms and blocking its progression. Peptides are components of proteins. "Lilly is committed to be an innovation leader in immunology," said Dr. Thomas F. Bumol, senior vice president of biotechnology and immunology research at Lilly. "Topas has a very novel approach to immune tolerance induction, which we would like to see successfully applied to certain disease-relevant antigens. We look forward to working together with Topas on their unique platform."

Lilly, Nektar Partner to Develop T-Cell Stimulator NKTR-358 for MS, Autoimmune Disorders

Eli Lilly and Nektar Therapeutics have established a development and commercial agreement for the investigational T-cell stimulator therapy NKTR-358 for the treatment of autoimmune disorders, including multiple sclerosis. NKTR-358, discovered and initially developed by Nektar, has the potential to modulate immune system responses to re-establish an immune balance in patients with autoimmune disorders. The treatment targets the interleukin 2 receptor complex (IL-2R) that is expressed on the surface of a subset of immune cells called regulatory T-cells, or Tregs. NKTR-358 activity stimulates the proliferation of Tregs, which in turn will regulate the activity of other immune cells that are uncontrolled and are responsible for the underlying mechanisms of autoimmune disorders. "We look forward to working with Nektar to study this novel approach to treating a number of autoimmune conditions," Thomas F. Bumol, PhD, senior vice president of biotechnology and immunology research at Eli Lilly, said in a press release. "NKTR-358 is an exciting addition to our immunology portfolio and reinforces Lilly's commitment to sustain a flow of innovative medicines in our pipeline." Bumol added. Under the agreement, Lilly and Nektar will continue to jointly develop NKTR-358. Nektar will be responsible for completing the ongoing Phase 1 clinical study; and Phase 2 clinical development costs will be shared by the two companies, with Lilly covering 75 percent of the costs and Nektar the remaining 25 percent. Nektar will have the option to take part of the Phase 3 development of NKTR-358 on an indication-by-indication basis. "We are very pleased to enter into this collaboration with Lilly as they have strong expertise in immunology and a successful track record in bringing novel therapies to market," said Howard W. Robin, president and CEO of Nektar. "Importantly, this agreement enables the broad development of NKTR-358 in multiple autoimmune conditions in order to achieve its full potential as a first-in-class resolution therapeutic." Based on the announced agreement, Lilly will pay an initial amount of $150 million to Nektar, which will also be eligible to receive up to $250 million from additional development and regulatory milestones. In the future, Nektar may also receive royalties from the product depending on its investment in NKTR-358’s Phase 3 development and future product sales. Lilly will cover all costs of global marketing of NKTR-358, and Nektar will have an option to co-promote the drug in the United States.

Stressful Environment Triggers Inflammatory Cells Linked to Autoimmune Diseases Like MS, Study Shows

A stressful microenvironment, characterized by low metabolites and low oxygen levels, triggers the generation of immune cells directly implicated in a variety of inflammatory diseases, such as multiple sclerosis (MS). The study, “Cellular Stress in the Context of an Inflammatory Environment Supports TGF-β-Independent T Helper-17 Differentiation,” was…

Immune System May Harbor Natural Way of Fighting MS, Other Autoimmune Diseases

A variant in the TYK2 gene, which encodes an immune system protein, may work to protect people from autoimmune disorders, including multiple sclerosis (MS), without overly depressing the body’s ability to fight opportunistic infections, researchers at the University of Oxford report. Their study, “Resolving TYK2 Locus Genotype-To-Phenotype Differences In Autoimmunity,” was published…

Selexis to Provide ImmuNext with Cell Lines for Research into Treatment for MS, Autoimmune Diseases

Selexis has entered into a commercial arrangement with ImmuNext, providing that company with access to research cell banks from its SURE technology Platform (a best-in-class cell line development technology). ImmuNext will use the cell banks in further developing its anti-CD40 ligand antibody, a potential therapeutic agent for chronic autoimmune disorders such as multiple sclerosis…