The Promise
Merck TROP2 ADC meets phase 3 endpoints in endometrial cancer
Merck has reported positive phase 3 data for sacituzumab tirumotecan, or sac-TMT, an investigational TROP2-directed antibody-drug conjugate being developed with Kelun-Biotech, in advanced or recurrent endometrial cancer. In the global TroFuse-005 trial, sac-TMT met its dual primary endpoints of overall survival and progression-free survival compared with physician’s choice chemotherapy in patients whose disease had progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy. The result marks the first positive phase 3 readout from Merck’s broader TroFuse program, which includes 17 ongoing global phase 3 trials across multiple tumor types. Source
Microbiotica reports phase 1b data for melanoma microbiome co-therapy
Microbiotica has reported positive phase 1b results for MB097, a once-daily oral live biotherapeutic product made up of nine commensal bacterial strains, in advanced melanoma. The MELODY-1 trial evaluated MB097 in combination with pembrolizumab in patients with advanced melanoma who had primary resistance to anti-PD-1 therapy, with all primary and secondary objectives met.
MB097 was administered safely with pembrolizumab, with no serious adverse events related to the microbiome therapy. Patients benefiting after the initial six-month treatment period have entered an extension study, and Microbiotica says the results support larger controlled studies in a broader melanoma population. Source
Akeso anti-CD47 antibody combination shows phase 2 AML survival signal
Akeso has reported phase 2 data for ligufalimab, its next-generation humanized IgG4 anti-CD47 monoclonal antibody, in frontline acute myeloid leukemia. The randomized, double-blind, placebo-controlled AK117-206 trial evaluated ligufalimab in combination with azacitidine and venetoclax in treatment-naïve AML patients who were ineligible for intensive chemotherapy. Ligufalimab has FDA orphan drug designation for AML, and the data will be presented at EHA 2026. Source
Regeneron LAG-3 combination misses phase 3 melanoma endpoint
Regeneron has reported that a phase 3 trial of fianlimab, an investigational LAG-3 inhibitor antibody, in combination with cemiplimab, its PD-1 inhibitor antibody, did not reach statistical significance for the primary endpoint of progression-free survival in first-line unresectable locally advanced or metastatic melanoma. The study compared two dose levels of the combination against pembrolizumab monotherapy in patients aged 12 years or older who had not received prior systemic treatment for advanced disease. Source
The Process and the Product
Dual-pressure CHO selection system boosts antibody productivity
Researchers have developed a dual-pressure selection system for Chinese hamster ovary (CHO) cells that could improve monoclonal antibody manufacturing. The platform combines disruption of the tyrosine biosynthesis pathway with knockout of the glutamine synthetase gene, creating a tyrosine-glutamine auxotrophic system designed to increase productivity while avoiding some limitations of conventional single-marker selection strategies.
In high-density fed-batch and semi-perfusion cultures, the dual-pressure cells showed higher cell-specific productivity than single-pressure tyrosine or glutamine synthetase systems. Under nutrient-restricted semi-perfusion conditions, productivity increased 1.59-fold versus the tyrosine system and 5.04-fold versus the GS system, with improved glucose use and reduced lactate and ammonia accumulation. The authors also report better control of the antibody light-chain/heavy-chain ratio, a key factor in monoclonal antibody yield. Source
Bispecific antibody architecture shapes manufacturability
A comparative study of five bispecific antibody formats has shown that molecular architecture can strongly affect CHO cell culture performance, product quality, downstream recovery, and antigen binding. Researchers evaluated symmetric and asymmetric bispecific antibody designs, including heavy-chain and light-chain scFv fusions, a dual-variable domain immunoglobulin, and a knobs-into-holes asymmetric format, using antibodies designed to bind Zika virus and the mouse transferrin receptor. The findings suggest that heavy-chain scFv fusion may offer a more manufacturable route for some bispecific antibody programs, while more complex formats may require additional process optimization. Source
High-concentration mAbs bring new manufacturing challenges
A new review has examined the manufacturing and formulation challenges facing high-concentration monoclonal antibodies, which are increasingly used to support subcutaneous delivery and at-home administration. The review focuses on developments from 2019 to 2025 and highlights how the push to replace lengthy intravenous infusions with smaller-volume injections has created new demands across downstream processing, formulation, fill-finish, packaging, and analytical characterization.
At concentrations of 50–200 mg/mL, monoclonal antibodies are more prone to elevated viscosity, aggregation, opalescence, phase separation, and protein–protein interactions, all of which can complicate ultrafiltration/diafiltration, sterile filtration, mixing, and final filling. The authors point to approaches such as single-pass tangential flow filtration, forward osmosis, optimized excipient systems, low-shear filling technologies, predictive modeling, and process analytical technologies as important tools for managing these risks. They argue that high-concentration mAb manufacturing will require closer integration of protein engineering, formulation design, process development, and real-time analytics to maintain quality while improving patient convenience. Source
The Patient
FDA finalizes guidance on pregnancy safety studies for drugs and biologics
The FDA has issued final guidance for industry on postapproval pregnancy safety studies, outlining methods for collecting safety data on drugs and biologics used during pregnancy. The guidance is intended to help generate clearer information for product labeling, supporting treatment decisions for pregnant patients and healthcare providers when clinical trial data at approval are limited.
The guidance recommends approaches including pregnancy registries, complementary real-world data studies, and descriptive analyses based on individual case reports. FDA says postapproval safety studies may require input from specialists in obstetrics, pediatrics, genetics, statistics, and other fields, and should be used alongside established scientific standards and other agency guidance on observational research, real-world data, pharmacovigilance, and postmarket requirements. Source
FDA approves first golimumab biosimilars
The FDA has approved IMMGOLIS and IMMGOLIS INTRI, the first biosimilars to Johnson & Johnson’s golimumab biologics Simponi and Simponi Aria. IMMGOLIS, a subcutaneous TNF blocker, is approved for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate and adults with moderately to severely active ulcerative colitis. IMMGOLIS INTRI, an intravenous formulation, is approved for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate. The products were developed by Bio-Thera Solutions, which will handle manufacturing and supply, while Accord BioPharma will lead exclusive U.S. commercialization. Source
FDA approves ctDNA-guided Tecentriq use in bladder cancer
The FDA has approved Genentech’s Tecentriq and Tecentriq Hybreza as adjuvant treatments for adults with muscle-invasive bladder cancer who have circulating tumor DNA molecular residual disease after cystectomy. The approval uses Natera’s Signatera CDx personalized MRD assay to identify patients with detectable ctDNA after surgery, creating the first approved ctDNA MRD-guided therapy approach. The decision was based on the phase 3 IMvigor011 study, in which Tecentriq reduced the risk of disease recurrence or death by 36 percent and the risk of death by 41 percent in patients with detectable ctDNA MRD identified through serial testing within one year of cystectomy. Source
Business Bulletin Board
LOTTE expands antibody manufacturing deal with Ottimo Pharma
LOTTE Biologics has expanded its antibody development and manufacturing collaboration with Ottimo Pharma, a biotech developing PD-1/VEGFR2 dual-paratopic antibodies. The agreement builds on a manufacturing partnership signed last year and will support Ottimo’s biparatopic antibody candidate OTP-01 as it moves toward launch readiness. Under the expanded collaboration, LOTTE’s Syracuse Bio Campus in New York will support commercial process development and characterization activities for OTP-01. Source
Bora to acquire MacroGenics manufacturing operations for $122.5 million
Bora Pharmaceuticals has agreed to acquire MacroGenics’ GMP manufacturing operations, including its CDMO business, for $122.5 million, plus up to $5 million in contingent consideration tied to future customer orders. The transaction includes a biologics drug substance manufacturing facility in Rockville, Maryland, and an associated warehousing center in Frederick, Maryland, with Bora also set to sign a long-term CDMO service agreement with MacroGenics after closing. Source
Oorja Bio launches with $30 million to advance IPF therapy
Oorja Bio has launched as a clinical-stage biopharmaceutical company with $30 million in Series A financing from founding investor Westlake BioPartners. The company will use the funding to advance ORJ-001, a first-in-class peptide therapeutic for idiopathic pulmonary fibrosis, and build a broader pipeline for fibrotic and cardiopulmonary diseases. Source
InMed and Mentari merge to advance migraine antibody pipeline
InMed Pharmaceuticals and Mentari Therapeutics have entered an all-stock merger agreement to create a public company focused on migraine prevention therapies. The combined company will operate as Mentari Therapeutics and will advance two antibody programs: MT-001, an anti-PACAP monoclonal antibody, and MT-002, a potentially first-in-class anti-CGRP/PACAP bispecific antibody. The merger is accompanied by an oversubscribed $290 million private placement. Source
Lonza and Oxford Nanopore launch mRNA QC sequencing workflow
Lonza and Oxford Nanopore Technologies have launched a direct RNA sequencing solution designed to modernize GMP quality control testing for mRNA therapeutics. The approach combines Oxford Nanopore’s nanopore-based direct RNA sequencing with machine learning analysis and dedicated workflows to measure multiple critical quality attributes in a single test. The companies say the sequence-agnostic approach is intended to support scalable mRNA manufacturing, faster release testing, and improved quality control strategies across the mRNA product lifecycle. Source
Thermo Fisher expands bioanalytical capacity with Sweden lab
Thermo Fisher Scientific has opened a new bioanalytical and biomarker laboratory in Gothenburg, Sweden, expanding the global capabilities of its PPD clinical research business. Source
For this week’s cell and gene therapy news – including pivotal Duchenne AAV data from REGENXBIO, extended phase 3 results for Candel’s adenoviral prostate cancer immunotherapy, preconditioning-free CAR-T in pemphigus vulgaris, CNS-targeting AAV platform advances, CRISPR epigenetic silencing, armored CAR-T for glioblastoma, DNA-guided RNA targeting, and new moves to strengthen advanced therapy trial delivery and manufacturing – click here.
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