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.
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.
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.
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.
Oxford spinout Alethio Therapeutics closed a $90 million Series A to take ATX-011, a monoclonal antibody against the G6B receptor, into Phase 1/2a studies in essential thrombocythemia. It is also developing a G6B-targeted ADC for myelofibrosis.
T-Therapeutics closed an oversubscribed $133 million Series B backed by Eli Lilly, JJDC, and others. The funding will take its first T-cell receptor bispecifics in cancer and autoimmune disease into clinical trials.
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.
FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
Healthy-volunteer data show sustained TL1A suppression and a profile supporting infrequent subcutaneous dosing. Caldera also licensed a second bispecific, targeting IL-17 and TL1A, from Qyuns Therapeutics.
UCB will use Cradle’s AI-driven protein design platform in selected discovery projects, from hit generation through preclinical readiness, expanding its digital antibody engineering program.
Boehringer Ingelheim licenses six preclinical ADC and T-cell engager programs from Sino Biopharmaceutical in a deal worth up to $7 billion, Spyre Therapeutics drops anti-TL1A antibody SPY072 in rheumatic diseases after phase 2 misses and turns to hidradenitis suppurativa, and Biora Therapeutics gets ethics approval for a first-in-human trial of its BioJet oral adalimumab capsule.
The half-life-extended antibody failed its primary endpoints in two Phase 2 SKYWAY sub-studies, so Spyre is dropping it in rheumatic diseases and moving it into a combination trial in hidradenitis suppurativa.
A former CIA officer, Pacific Research Institute economists, and industry groups say Treasury's proposed COINS Act biotechnology restrictions are too broad, while the National Security Commission on Emerging Biotechnology backs the move. Comments are due December 7, 2026.
Today’s BioPharm Brief covers FDA’s final potency assurance guidance for cell and gene therapies, Lonza’s deal to acquire Merck KGaA’s US CDMO business, and Phase 2a data for Tiziana’s intranasal anti-CD3 antibody foralumab in progressive multiple sclerosis.
At AAPS PharmSci 360 2026, University of Iowa PhD candidate Siddhanth Hejmady explains how adding a payload or radiolabel to trastuzumab changes its behavior in bulk solution and at interfaces, and why developability teams should pair DLS with QCM-D.
In the Phase 2a INFORM-MS trial, Tiziana’s nasal foralumab reduced microglial activation on PET imaging at 50 µg in non-active secondary progressive MS, while the 100-µg dose showed no significant effect.
The deal adds five US sites and about 1,100 employees, more than doubling Lonza’s US network and filling a gap in US bioconjugation capacity the company flagged weeks earlier.
AAPS PharmSci 360 2026 in New Orleans centered on auditable AI, modeling-guided formulation, oral peptide delivery, high-concentration antibody suspensions, and the push toward $10-per-gram monoclonal antibodies.
The deal gives Fresenius options on biosimilars spanning monoclonal and bispecific antibodies, ADCs, and fusion proteins, starting with polatuzumab vedotin and teprotumumab, and could expand its portfolio from 29 to 66 molecules.
FDA set a May 1, 2027 target date for AMT-130, a one-time gene therapy that silences the huntingtin gene, and plans an advisory committee meeting.
FDA approves Sun Pharma’s Ilumya for active psoriatic arthritis, BioMarin licenses a subcutaneous Fabry enzyme replacement therapy from GC Biopharma and Hanmi, and Lonza expands bioconjugation capacity in Visp to meet rising ADC demand.
In an interview for BioPharm International’s AAPS PharmSci 360 2026 coverage, Nanoform’s Chris Worrall shares 18-month stability data for a 440 mg/mL trastuzumab suspension and explains how ultra-high-concentration formulations could shorten administration and support at-home injection.
The first-in-class molecule, licensed to Dianthus as DNTH212 outside Greater China, is designed to block type 1 interferon production and BAFF/APRIL-driven B-cell activity with a single drug.
The IL-23p19 inhibitor tildrakizumab becomes the third drug in its class approved for psoriatic arthritis, and the only one given exclusively by a healthcare provider.
In the final part of a three-part interview, Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team has cut monoclonal antibody costs toward $10 per gram and why process intensification will spread one unit operation at a time.
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.
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.
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.
