Belimumab

The new molecule was identified using Logica, a drug discovery solution that Charles River and Valo first launched in April 2022.\n The drug discovery pact between Charles River Laboratories, Valo Health and Flagship Pioneering is starting to bear fruit. Charles River and Valo’s molecule designing platform has yielded its first drug candidate, a small molecule intended to treat lupus and other as yet unidentified autoimmune diseases, the partners announced March 25.“The target [outside lupus] is confidential, but this is a small-molecule inhibitor program for a first-in-class target for autoimmune disease,” Julie Frearson, Ph.D., chief scientific officer of Charles River Labs, told Fierce Biotech in an email. “There are currently no drugs on the market that modulate this target.”Charles River and Flagship-backed Valo Health, along with the drug development arm of Flagship Pioneering, Pioneering Medicines, are now working to solidify the molecule as a preclinical asset.“We will deliver a high-quality, derisked preclinical candidate in a shorter timeline than conventional drug discovery efforts,” Frearson said, at which point Pioneering Medicines will take over development. The new molecule was identified using Logica, a drug discovery solution that Charles River and Valo first launched in April 2022. Logica combines Valo’s artificial-intelligence-driven computational platform, called Opal, with Charles River’s preclinical drug development expertise, the partners said.While not divulging too many details, we do know that this platform has initially identified a target for \"different forms of lupus,\" according to the release. This disease is primarily treated with off-label drugs or newer meds in the form of GSK\'s Benlysta and AstraZeneca\'s Saphnelo. The most common form of the disease is systemic lupus erythematosus (SLE), with other forms including lupus nephritis. There are already other pharmas vying for a bite of the lupus market, including Biogen\'s experimental litifilimab as well as AbbVie’s blockbuster immunology drug Rinvoq, which is in phase 3 testing for SLE, and Bristol Myers Squibb’s Sotyktu, which presented positive data in SLE at the start of last year. Logica is not limited to any single disease area, Frearson said, with its current portfolio of projects spanning multiple therapeutic areas. When the Charles River, Valo and Pioneering Medicines collaboration was first announced in February 2023, the partners said the goal was to pursue new drug candidates across a variety of targets.“We entered our collaboration with Charles River and Valo with a shared goal of accelerating the drug discovery process, and of expediting the development of critically needed therapies for patients with limited or no treatment options,” Luisa Salter-Cid, Ph.D., chief scientific officer of Pioneering Medicines, said in the release. “Logica’s early success in identifying a potential therapy for an autoimmune disease has built confidence in that shared goal.”

Payments to Biogen will be spread over six quarters. Credit: PeopleImages via Getty Images. Royalty Pharma has signed a deal to pay Biogen $250m to support the development of its late-stage experimental lupus medication litifilimab. In return, Royalty Pharma will receive undisclosed milestone payments if the drug meets certain regulatory goals, as well as mid-single-digit royalties on worldwide sales. Payments up to $250m to Biogen will be spread over six quarters, Royalty said in the announcement. Litifilimab, an anti-BDCA2 antibody, is being evaluated in Phase III trials for both systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). Biogen will use the funds to continue development, with trial results expected in 2026 and 2027. The market for SLE remains largely dominated by generic drugs, with few targeted biologics approved by the US Food and Drug Administration (FDA) in the last 50 years . These include GSK’s Benlysta (belimumab) and AstraZeneca’s Saphnelo (anifrolumab). The market for CLE, however, has seen even less innovation. CLE is a form of lupus that primarily affects the skin, leading to inflammation, rashes, and lesions, though it can sometimes be linked to SLE. Litifilimab showed promising results in the Phase II LILAC study (NCT02847598), where it significantly reduced skin disease activity in people with CLE compared to placebo as measured by the primary endpoint. If approved, the drug could generate up to $750m in global sales by 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology. This agreement expands Royalty’s portfolio, adding to a series of deals that the company has struck over recent years. This includes transactions with BridgeBio Pharma, ImmuNext, Cytokinetics and Agios Pharmaceuticals. Royalty’s deal with ImmuNext provided it with access to royalties and milestones on a drug to treat multiple sclerosis (MS) under development with Sanofi. Royalty also holds rights on Biogen’s MS medication Tysabri (natalizumab) and spinal muscular atrophy drug Spinraza (nusinersen), acquired through agreements with Ionis and Perrigo. The deal coincides with Biogen’s latest earnings report, in which the company exceeded Q4 2024 expectations due to cost-cutting measures and new product launches, including its Alzheimer’s drug Leqembi (lecanemab). However, Biogen expects reduced profits this year, citing currency fluctuations and competition in the MS market. The biotech also announced the discontinuation of four drug development programmes: a Phase II asset for diabetic peripheral neuropathic pain and three Phase I neurodegenerative disease candidates. Biogen hit the headlines last month when Sage Therapeutics rejected its $469m takeover offer, with the company’s board of directors unanimously concluding that the bid “significantly undervalues” the company. Made earlier this year, the proposal offered $7.22 per share, a 30% premium on Sage’s share price at the time. Sage responded by suing Biogen to “enforce a standstill agreement” between the two companies. Biogen currently co-markets Sage’s postpartum depression drug Zurzuvae (zuranolone).