Ublituximab

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Coherus is resuming the supply of its Neulasta biosimilar after issues at a third-party labeling and packaging contractor caused delays in October. Production will resume this week. It has a backlog of around 120,000 units. Coherus first warned of supply delays in September. The biosimilar, branded as Udenyca, is approved to reduce infection in patients with low white blood cell count. Novavax has ended its Covid-19 vaccine supply agreement with the UK, the company said on Wednesday. The vaccine maker will return $10.3 million in quarterly installments over the next three years, totaling $123.8 million. Akebia Therapeutics disclosed in its third-quarter report that it has several ties with WuXi STA, a subsidiary of WuXi AppTec. The company has two contracts with WuXi and has the option to give 180 days notice to terminate them for any reason. One of the contracts ends in 2029 and the other in 2032. Charles River Laboratories reported a 1.6% drop in its total revenue for the third quarter of 2024 to $1.01 billion. But its manufacturing business increased 12% to $196.9 million because of heightened demand for its cell and gene therapy services, CEO James Foster said in an earnings call Wednesday. Charles River makes Vertex Therapeutics’ cell therapy Casgevy. The World Health Organization and its member states have allocated 899,000 doses of mpox vaccines to nine African countries. Around 85% of the doses will be supplied to the Democratic Republic of the Congo, which has the highest number of infections, according to a Wednesday release. CDMO AmplifyBio secured $50 million from investment capital provider Vitrian to bolster its manufacturing facility in New Albany, OH, according to a Tuesday release. Accord Healthcare received £50 million ($64.9 million) from the UK government to expand its facility in Fawdon, Newcastle upon Tyne, the company said Friday . It will build new manufacturing lines for an unnamed cancer drug and two autoimmune injectables. Around 50 new jobs will be added. Fujifilm Diosynth Biotechnologies has started the first phase of its factory expansion in Hillerød, Denmark, which will include adding six mammalian cell bioreactors, the company said Tuesday. The overall plan will be completed and operational by 2026. It will increase the facility to 51,500 square meters and add 2,200 new jobs. FujiFilm also said it signed a commercial manufacturing agreement with TG Therapeutics to make its therapy for relapsing forms of multiple sclerosis, according to a Monday announcement. Fujifilm will make Briumvi in Holly Springs, NC, which will be fully operational in 2025. Briumvi was FDA approved in December 2022. Evotec has sold an API manufacturing site in Halle, Germany, to Munich-based private equity firm Monacum Partners, the company said Tuesday. No financial details were disclosed. The CDMO Scorpius Holdings is partnering with Celltheon so it can offer cell line development and antibody discovery to its customers, according to a Monday announcement.

iStock, JHVEPhoto Oditrasertib, which blocks the inflammatory RIPK1 protein, earlier this year also failed a Phase II trial in amyotrophic lateral sclerosis, forcing the company to discontinue its development a few months later. Sanofi is discontinuing a Phase II multiple sclerosis study of its investigational RIPK1 blocker oditrasertib after the candidate failed to meet its primary and key secondary endpoints, according to an SEC filing on Thursday by partner Denali Therapeutics. Denali and Sanofi were evaluating oditrasertib in the mid-stage K2 study , a randomized, double-blinded and placebo-controlled trial that enrolled more than 170 patients with relapsing-remitting multiple sclerosis (MS), secondary progressive MS or primary progressive MS. The primary efficacy endpoint was oditrasertib’s effect on serum neurofilament light chain levels. No specific details were provided in Denali’s SEC document, nor did the company identify which particular secondary outcomes oditrasertib missed. The California biotech also did not address oditrasertib’s safety profile. Designed to be orally available, oditrasertib is an investigational inhibitor of the RIPK1 protein, which is a crucial signaling player in inflammatory and cell death pathways. In neurodegenerative diseases, RIPK1—along with other proteins from the same family— tends to be overactivated , leading to widespread inflammation and large-scale cell death in the brain. By targeting RIPK1, oditrasertib disrupts this pathological process, in turn preserving the integrity and function of the brain. Despite a promising mechanism of action, however, oditrasertib has had a challenging clinical showing recently. In April 2024, Sanofi announced plans to terminate a Phase II trial of oditrasertib in amyotrophic lateral sclerosis (ALS) after a disappointing mid-stage readout. A few months earlier, in February 2024, Sanofi and Denali announced that oditrasertib failed the Phase II HIMALAYA study in ALS , unable to significantly improve disease severity, as measured by the ALS Functional Rating Scale-Revised. Developing effective therapies for MS has proven difficult. In September 2024, another Sanofi asset, the BTK inhibitor tolebrutinib, failed to significantly improve relapse rates in two Phase III studies. Tolebrutinib redeemed itself a few weeks later by significantly delaying disability onset in patients with non-relapsing secondary progressive MS in a third Phase III trial. That same month, a study published in the peer-reviewed journal Neurology raised questions about the use of anti-CD20 antibodies in multiple sclerosis. According to its findings, there appear to be no significant difference in relapse or the progression of disability between patients who were given these therapies versus those who were untreated. The study focused on primary progressive multiple sclerosis, for which the only approved anti-CD20 therapy is Roche’s Ocrevus (ocrelizumab). Other agents in the same drug class are also approved for relapsing forms of MS, including Novartis’ Kesimpta (ofatumumab) and TG Therapeutics’ Briumvi (ublituximab).