BioPharm International, December 2018 Issue (PDF)

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.

A real-world study found evolocumab cut fatal or nonfatal heart attack risk 20% vs ezetimibe in adults with ASCVD and prior statin use.

FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.