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As part of BioPharm International’s AAPS PharmSci 360 2026 coverage, Nanoform’s Chris Worrall explains why stability and viscosity have kept antibody formulations below 200 mg/mL, and how a low-temperature particle engineering process and non-aqueous suspensions could support ultra-high concentrations.

Lilly’s retatrutide more than doubles Ozempic’s weight loss in a phase 3 head-to-head trial, Iovance’s lifileucel reaches a 52% response rate in a biomarker-selected lung cancer subgroup, and FDA issues draft guidance on licensing individualized genome editing products.

DAX-044 aims to confine IL-12 activity to tumors and avoid the toxicity that has limited IL-12 therapy, with phase 1 testing expected in 2027.

Updated phase 2 IOV-LUN-202 data show Iovance’s TIL cell therapy lifileucel produced a 24.6% response rate in previously treated non-squamous metastatic NSCLC, rising to 52.0% in KRAS and HER2 wild-type patients, as the company launches a biomarker-enriched registrational cohort.

The proposed FDA guidance would let sponsors add patient-specific gene editing variants to approved BLAs via in vitro data, with comments due November 27, 2026.

In the 80-week phase 3 TRANSCEND-T2D-2 trial in adults with type 2 diabetes, Eli Lilly’s GIP/GLP-1/glucagon triple agonist retatrutide lowered A1C by 2.2% and body weight by up to 20.9%, compared with 1.8% and 9.4% with Ozempic 2 mg.

Genmab’s petosemtamab plus pembrolizumab cuts the risk of death by 50% in phase 3 head and neck cancer, AbbVie submits a BLA for etentamig in relapsed or refractory multiple myeloma, and Benitec reports interim data for BB-301 gene therapy in OPMD-related dysphagia.

Direct-to-Biology workflows move crude reaction mixtures straight into assays, giving hit-to-lead teams earlier data to guide series selection.

The EGFR×LGR5 bispecific antibody met both primary endpoints, overall survival and objective response rate, at the first interim analysis of LiGeR-HN1 in first-line PD-L1-positive recurrent or metastatic head and neck cancer.

Long-term phase 2 data presented at ESMO 2026 show 3SBio’s tivunatamig plus chemotherapy extended progression-free survival vs tislelizumab plus chemotherapy in squamous and non-squamous NSCLC.

All 9 patients treated with BB-301 gene therapy met formal response criteria for improved swallowing in an ongoing OPMD trial.

Etentamig cut the risk of progression or death by 60% vs standard therapies in the phase 3 CERVINO trial of triple-class exposed myeloma.

Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team cuts monoclonal antibody costs without cutting purification steps, and why the $10-per-gram target could make antibodies viable for infectious disease and global access.