The BioPharm Brief: Weight Loss, Biosimilars, and In Vivo Therapy

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Here’s what we have today.

First, Novo Nordisk’s CagriSema delivered positive phase 3 results. In the REIMAGINE 5 trial, CagriSema produced 12.4% weight loss compared with 9.1% for tirzepatide in adults with type 2 diabetes, while also meeting the trial’s non-inferiority endpoint for HbA1c reduction. In a separate trial, CagriSema produced 21% weight loss in adults with overweight or obesity. The company has already filed an NDA with FDA, with a decision expected in the fourth quarter. Read the full CagriSema story

Next, a notable development for biosimilars in Europe. Biocon’s pertuzumab biosimilar, Pebrilzo, received a positive CHMP opinion under EMA’s newly adopted tailored clinical development approach. The recommendation makes Pebrilzo the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the pathway, which can allow developers to establish biosimilarity without a dedicated comparative efficacy study when analytical, pharmacologic, and pharmacokinetic evidence is sufficient. Read the full Biocon story

And in cell therapy, Vironexis is reporting early results from an unusual approach. Its investigational VNX-101 is designed to turn the patient’s own liver into a “biofactory” that produces a CD19/CD3 T-cell engager after a single infusion. All three antibody-naive patients with relapsed or refractory ALL in the reported group achieved MRD-negative complete responses, with the first patient maintaining that response through day 260. The data are early, but the company says the results provide clinical evidence for a one-time, systemically delivered in vivo therapy. Read the full Vironexis story

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Key takeaways

• CagriSema posts positive Phase 3 results, with 12.4% weight loss versus 9.1% for tirzepatide in adults with type 2 diabetes.
• Biocon’s pertuzumab biosimilar advances in Europe under the EMA’s new tailored clinical development pathway.
• Vironexis reports complete responses with a one-time in vivo therapy in patients with relapsed or refractory acute lymphoblastic leukemia.