A smart path for novel biologics

Merck's GLP-1/glucagon co-agonist raised MASH resolution versus placebo at 52 weeks, but fibrosis and dose-response questions remain.

FDA granted RMAT and Fast Track designations to AbelZeta’s anti-CD20/CD19 CAR-T therapy prizlon-cel for relapsed or refractory large B-cell lymphoma. The company plans US studies after prior CAR-T therapy and in the second-line setting.

argenx agrees to acquire macrocyclic peptide developer Unnatural Products for up to about $1.15 billion, Johnson & Johnson’s pasritamig and JNJ-9401 bispecific regimen achieves a 73% PSA response in phase 1 in metastatic castration-resistant prostate cancer, and Janux Therapeutics’ TRBV6-targeted T-cell engager JANX011 shows deep B-cell depletion in healthy volunteers.

More monoclonal antibodies are moving from IV infusion to subcutaneous injection, but dose, volume, and viscosity still limit the switch. This FAQ covers the formulation science, the enabling technologies, what regulators require, and what remains unresolved.

argenx's acquisition of Unnatural Products adds macrocyclic peptides that could yield oral or long-acting treatments for immune-mediated diseases.

A single subcutaneous dose of Janux’s CD19-targeted T-cell engager JANX011 depleted more than 90% of B cells in three of five healthy volunteers at the top dose, with only Grade 1 cytokine release syndrome. Patient studies in immune thrombocytopenia and rheumatoid arthritis are planned for 2027.

Bimekizumab-bkzx (Bimzelx) produced ACR50 joint responses in 54.9% of psoriatic arthritis patients at week 24 vs 43.8% with risankizumab.

In a phase 1 study, Johnson & Johnson’s combination of pasritamig and JNJ-9401, two bispecific antibodies targeting KLK2 and PSMA, cut PSA by at least 50% in 73% of patients with metastatic castration-resistant prostate cancer. The regimen is now in phase 3.