Immunology

The drugmaker announced positive topline results from its two Phase III trials of zasocitinib, a TYK2 inhibitor, in plaque psoriasis.

Clinical Data Readout: As a worldwide first mover, InnoCare’s BTK inhibitor orelabrutinib has hit its monotherapy primary endpoint of SRI-4 response rate at 48 weeks in a China-only Phase IIb trial in systemic lupus erythematosus.

With two late-stage lupus assets finishing recruitment and a newly acquired nephrology franchise running three concurrent Phase III programs, Biogen is making its most significant commitment yet to immunology beyond its legacy MS business.

The US FDA approved Uplizna (inebilizumab) for generalized myasthenia gravis, an increasingly crowded market. Amgen believes it can compete due to the CD19-targeting antibody’s durable efficacy with twice-yearly dosing.

Deal Snapshot: The biotech is joining forces with the Versant Ventures-backed startup, paying $50m upfront to apply its macrocycle peptide platform to immunological diseases.

Approval of Gobivaz across the 30-country EEA introduces long-awaited competition to Simponi, though the partners have yet to confirm a commercial launch date.

Byterna, Starna, Vivacta and DeliNova ride surging investor sentiment on in vivo CAR-T assets to secure venture funding.

In a world-first, Beijing Mabworks has scored a Phase III clinical win for its novel anti-CD20 antibody in the treatment of primary membranous nephropathy. However, multiple global contenders including Roche are threatening to come from behind in the race.

Investors and healthcare philanthropists have launched a new women’s health fund – aiming to be the largest of its kind – with an ambitious goal to not just finance innovation, but to build a sustainable market around it.

Eight $1bn+ alliances were penned in September, and four exceeded $2bn. In the top alliance by deal value, Monte Rosa Therapeutics will apply its AI-enabled QuEEN platform for the discovery and development of novel molecular glue degraders for immune-mediated diseases.

The drugmaker is joining the rush to acquire an in vivo CAR-T therapy developer as concerns mount about whether the health care system can accommodate cell therapies’ dramatic growth.

While some big pharma companies have exited cell and gene therapy, Novartis, Astellas, Gilead’s Kite and AstraZeneca’s Alexion are diving back in, executives said at ARM’s Cell and Gene Meeting on the Mesa.