GSK drug Nucala has expanded its FDA-approved uses to include maintenance treatment of chronic obstructive pulmonary disease that’s driven by eosinophils, a type of immune cell. The antibody drug will compete against the blockbuster Sanofi product Dupixent, which expanded its FDA approval to COPD last year.
The FDA approved Sanofi and Regeneron Pharmaceuticals drug Dupixent as a treatment for the inflammatory skin disorder chronic spontaneous urticaria. The regulatory decision comes two years after the agency turned down an application for the biologic drug in this indication.
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Ampersand Biomedicines’ map of all tissue in the human body reveals “addresses,” identifying markers on disease targets that are not found on healthy tissue. The company aims to improve the targeting of biologic drugs in order to reduce on-target, off-tissue toxicity.
Gilead Sciences is acquiring LEO Pharma’s oral small molecule inhibitors of STAT6, a protein key to two validated inflammation pathways. Other STAT6 drug developers include Kymera Therapeutics and Sanofi-partnered Recludix Pharma, which is presenting this week during the J.P. Morgan Healthcare Conference.
Sotyktu, which became the first TYK2 inhibitor to reach the market after its 2022 FDA approval in plaque psoriasis, now has positive data from two pivotal tests in psoriatic arthritis. Bristol Myers Squibb is trying to add new indications for the drug and stay ahead of competitors including Takeda Pharmaceutical.
The Teva Pharmaceuticals and Sanofi drug, duvakitug, showed statistically significant and clinically meaningful results in a Phase 2b study in ulcerative colitis and Crohn’s disease. The drug is part of an emerging class of therapies that target TL1A, a protein involved in signaling that drives inflammation.
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Bicara Therapeutics’ IPO raised $315 million for Phase 3 testing of a bifunctional antibody drug with potential to become a first-line treatment for head and neck cancers. Zenas BioPharma and MBX Biosciences also went public; all three companies upsized their IPOs.
Recent financing news includes several companies raising money to advance their research to the clinic. Here’s a look back at funding rounds from companies such as Outpace Bio, GRO Biosciences, and Confo Therapeutics.
Harvard spinout GRO Biosciences has a platform technology for engineering therapeutic proteins that won’t prompt an immune response against them. The startup’s lead program is a potential competitor to an Amgen gout drug acquired in a multi-billion dollar deal.
Alumis’s lead drug candidate blocks TYK2, an inflammation target that’s already addressed by Sotyktu, a Bristol Myers Squibb drug approved for plaque psoriasis. Alumis plans to begin two Phase 3 tests in this indication later this year.
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Brensocatib, a drug Insmed licensed from AstraZeneca, met the main goal of a Phase 3 test in non-cystic fibrosis bronchiectasis. Insmed plans to seek regulatory approvals in this indication while also continuing to develop the small molecule for other inflammatory disorders.
Johnson & Johnson’s Proteologix acquisition adds a pipeline of bispecific antibodies, including an experimental treatment for asthma and atopic dermatitis. It’s the latest M&A deal involving molecules addressing TSLP, a key signaling protein involved in inflammation.
Eli Lilly-partnered Lycia Therapeutics will use its Series C financing to continue developing its internal pipeline of protein-degrading drugs. The startup is working to reach the clinic with drugs for autoimmune and inflammatory disorders.
Contineum Therapeutics plans to spend most of its IPO cash on clinical testing of a lead drug candidate in development for idiopathic pulmonary fibrosis and multiple sclerosis. This small molecule blocks a competitive target pursued by several other companies, including Bristol Myers Squibb and AbbVie.
AbbVie is acquiring Landos Biopharma, whose lead drug is a small molecule that takes a novel approach to treating ulcerative colitis. Preliminary proof-of-concept data from a Phase 2 study are expected later this year.