agreement

March 22, 2018 News by Patricia Silva, PhD

Symbiotix Obtains Access to Harvard Material That Could Help It Develop MS Therapies

Symbiotix Biotherapies has gained access to Harvard University material that could help it develop treatments for autoimmune and inflammatory diseases like multiple sclerosis and inflammatory bowel diseases. It obtained access to the intellectual property, much of which deals with gut bacteria, under a licensing agreement with Harvard. Intellectual property typically includes…

November 29, 2017 News by Alice Melão, MSc

Alkermes, Biogen Partnering on Therapy for Relapsing Forms of Multiple Sclerosis

Alkermes and Biogen have begun working together on a compound known as ALKS 8700 as a potential treatment for relapsing forms of multiple sclerosis. Under the agreement, Alkermes will be responsible for obtaining regulatory approval of the drug, while Biogen will handle its marketing. ALKS is taken orally. The body quickly transforms it into a compound known as monomethyl fumarate that can counter MS. Aikermes designed it to have better features than Tecfidera (dimethyl fumarate) — in particular, fewer gastrointestinal side effects. The partnership gives Biogen worldwide marketing rights to ALKS 8700. Alkermes will receive a royalty on global sales. Aikermes is evaluating ALKS 8700's safety and effectiveness in what it has dubbed the EVOLVE-MS clinical trial program. It includes two Phase 3 trials that are comparing ALKS 8700 with Tecfidera in patients with relapsing-remitting MS, or RRMS. Preliminary results of the EVOLVE-MS-1 trial, which involved 580 patients, showed few gastrointestinal side effects from ALKS 8700. The most common adverse events in the first month of treatment were flushing, diarrhea, and a rash known as pruritus. Aikermes discussed the treatments safety, and patients' ability to tolerate it, at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris in October. The company is still recruiting participants for a second trial that will compare ALKS 8700 and Tecfidera's effect on the gastrointestinal system. The EVOLVE-MS-2 study will  be conducted at locations in several U.S. states and six sites in Poland. Alkermes expects to release initial findings from the trial in the first half of 2018.  

October 3, 2017 News by Alice Melão, MSc

MS Society, TG Therapeutics Partner to Advance Potential Oral Therapy for Progressive MS

Fast Forward, a non-profit subsidiary of the National Multiple Sclerosis Society, will give financial support to TG Therapeutics to advance TGR-1202 (umbralisib) into preclinical testing as a potential oral therapy for progressive forms of multiple sclerosis. The support, whose value was not specified, is part of a Sponsored Research Agreement between Fast Forward and the company. Research work will be led by Lawrence Steinman, MD, a professor of pediatrics, neurology, and neurological sciences at Stanford University. TGR-1202 is an orally administrated inhibitor that blocks a signaling enzyme called PI3K delta. Immune cells such as B-cells have high levels of this enzyme, which is thought to be important for cell proliferation and survival. "We look forward to evaluating umbralisib [TGR-1202]'s effect on our preclinical progressive MS models in hopes to move umbralisib closer to clinical development in MS," Steinman said. The approval of Ocrevus (ocrelizumab), by Genentech, to treat primary progressive and relapsing multiple sclerosis underscored the potential of B-cell-targeted therapies for MS patients. As a result, investigative drugs that also aim to bolster B-cell survival or activity, such as those being developed by TG Therapeutics, are an attractive approach to potentially treating patients. Another potential treatment by the company — an engineered antibody, TG-1101 — targets a specific sequence on the CD20 protein found on immune B-cells. This infusion therapy is now in two Phase 3 clinical studies for relapsing multiple sclerosis, ULTIMATE I and ULTIMATE II. Both are currently enrolling patients at sites in Kentucky, Tennessee, and New York.

August 25, 2017 News by Alice Melão, MSc

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."

July 25, 2017 News by Alice Melão, MSc

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.

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