Today's BioPharm Brief explores three different ways biopharma companies are advancing precision medicine, from next generation bispecific antibody drug conjugates and myeloid engager immunotherapy to stem cell derived neuron replacement for Parkinson's disease.
Kenai Therapeutics has completed enrollment in the Phase 1b/2a REPLACE trial of RNDP-001, an allogeneic iPSC-derived dopaminergic neuron replacement therapy for idiopathic Parkinson's disease, with safety and preliminary efficacy data expected in 2027 — representing a significant step toward a potential disease-modifying cell therapy for a condition affecting more than 10 million people worldwide.
LTZ Therapeutics has received FDA IND clearance for LTZ-232, a first-in-class bispecific antibody designed to activate tumor-associated macrophages to phagocytose EpCAM-positive colorectal cancer cells — a novel myeloid-engaging approach aimed at overcoming the immunologically cold tumor microenvironment that has historically limited immunotherapy in this setting.
Biocytogen and Whitehawk Therapeutics have announced a global collaboration combining Biocytogen's RenLite bispecific antibody discovery platform with Whitehawk's CPT113-based ADC linker-payload technology to generate bispecific ADC candidates with differentiated tumor-targeting profiles — with Whitehawk targeting new ADC INDs within 12 to 24 months.
The European Commission has approved Tepkinly in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma after at least two prior systemic therapies, based on Phase 3 EPCORE FL-1 data showing a 79% reduction in risk of disease progression or death — marking the first bispecific antibody-based combination regimen approved in Europe for this indication.
The FDA has approved a label expansion for Casgevy, the first CRISPR-based gene therapy, lowering the eligible age from 12 to 2 years in sickle cell disease — a move that significantly broadens the potential patient population and marks another milestone in the clinical maturation of CRISPR-based genomic medicine.
Three-year follow-up data from Agenus' Phase 2 trial of botensilimab plus balstilimab in refractory microsatellite-stable metastatic colorectal cancer show a 33% overall survival rate at three years — with evidence of a plateau on the Kaplan-Meier curve beyond two years — representing an unprecedented durability signal in a tumor type historically resistant to immune checkpoint therapy.
Today's BioPharm Brief explores three distinct ways researchers are engineering the immune system, from a first-in-human bispecific T-cell engager for ovarian cancer and the FDA's first regulatory T-cell immunotherapy to promising vaccine data against antibiotic-resistant Shigella.
92Bio, Inc. has dosed the first patient in a Phase 1 trial of NTB-928, a fully human bispecific T-cell engager targeting FOLR1 and CD3, designed to selectively kill FOLR1-overexpressing ovarian cancer cells while sparing normal tissue — addressing a key limitation of prior FOLR1-directed therapies in platinum-resistant ovarian cancer.
A phase 2 controlled human infection trial has found that two doses of WRSs2, a live-attenuated oral vaccine candidate against Shigella sonnei, achieved 89% protection — the highest efficacy reported for any Shigella vaccine candidate — with no serious adverse events, advancing a century-long quest for a licensed vaccine against the diarrheal pathogen.
From a potential first at home treatment for thyroid eye disease to progress in lymphoma and a first in class antibody entering the clinic for kidney fibrosis, today's BioPharm Brief highlights three developments advancing biologic drug development.
The FDA has accepted Sarepta's supplemental New Drug Applications seeking to convert casimersen (Amondys 45) and golodirsen (Vyondys 53) from accelerated to traditional approval in Duchenne muscular dystrophy, with a PDUFA target action date of February 28, 2027, backed by ESSENCE confirmatory trial data and years of real-world evidence.
The FDA has granted priority review to Genentech's sBLA for Enspryng (satralizumab), an IL-6 receptor-targeting monoclonal antibody, as a potential first at-home subcutaneous treatment for thyroid eye disease, based on Phase III SatraGO data showing significant proptosis reduction, with an FDA decision expected by October 15, 2026.
ADC Therapeutics has completed enrollment of 100 patients in the Phase 1b LOTIS-7 trial evaluating loncastuximab tesirine-lpyl plus the bispecific antibody glofitamab in relapsed/refractory diffuse large B-cell lymphoma, with full data expected in Q4 2026 following earlier results showing an 89.8% overall response rate.
Eisai highlights next-generation Alzheimer's research, Talawar Therapeutics secures $285 million to advance a first-in-class bispecific antibody, and the FDA approves a new biologic for thyroid eye disease.
52-abstract package includes first reported real-world at-home subcutaneous administration data and phase 2 combination findings with anti-tau antibody.
New York-based biotech enters Nasdaq through JATT II merger, betting IL-13 × IL-18 dual blockade can break the efficacy ceiling in I&I
Jeff Talbot of Roseman University of Health Sciences discusses how Las Vegas is positioning itself as a growing life sciences hub by offering cost-effective laboratory space, access to capital, and a flexible environment for biotech startups and emerging companies.
This episode explores a first-in-class antibody entering the clinic for kidney fibrosis, the world's first approved bispecific ADC, and a major acquisition that strengthens AbbVie's immunology pipeline.
Mediar Therapeutics has dosed the first participants in a Phase 1 trial evaluating MTX-439, a first-in-class monoclonal antibody targeting SMOC2 for fibrosis associated with chronic kidney disease. The study marks the company's third anti-fibrotic program to enter clinical development and highlights growing interest in fibrosis-directed biologics.
China's National Medical Products Administration has approved izalontamab brengitecan (iza-bren) for recurrent or metastatic nasopharyngeal carcinoma, making it the first bispecific antibody-drug conjugate to receive regulatory approval anywhere in the world.
AbbVie has entered a definitive agreement to acquire Apogee Therapeutics for $10.9 billion, adding zumilokibart, a subcutaneous half-life extended IL-13 monoclonal antibody in Phase 3 development for atopic dermatitis, asthma, and eosinophilic esophagitis.
Innovent advances a trispecific antibody into phase 3 multiple myeloma testing, Bionyra enters the crowded TL1A race in inflammatory bowel disease, and Insilico Medicine partners with SK Biopharmaceuticals to apply AI to neuroimmune and CNS drug discovery.
Innovent Biologics has dosed the first patient in TriadicMM-1, a pivotal phase 3 trial evaluating IBI3003, a GPRC5D/BCMA/CD3 trispecific antibody, for relapsed or refractory multiple myeloma — marking the second trispecific antibody globally to reach pivotal phase 3 development in this setting and the first with independent intellectual property rights in China.
Newly launched Bionyra Pharma has raised $165 million in Series A financing and secured exclusive global rights to two TL1A-targeting biologics from China's TrueLab Biopharmaceutical — an anti-TL1A monoclonal antibody and a TL1A×IL-23p19 bispecific antibody — in a deal worth up to $985 million, positioning the company to compete in an IBD drug class already drawing attention from Merck, Roche, and the Sanofi/Teva partnership.
Japan's Ministry of Health, Labour and Welfare has approved the subcutaneous formulation of isatuximab (Sarclisa) across multiple myeloma treatment lines, making it the second country after the European Union to greenlight the administration route change backed by Phase 3 IRAKLIA trial data — with a US decision now expected by July 23, 2026.
The FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously on June 18, 2026 that the benefits of mFLUSIVA (mRNA-1010) outweigh its risks for adults 50 and older, positioning Moderna for a potential approval by August 5 that would make the vaccine the first mRNA-based seasonal influenza product licensed in the US.
Today's BioPharm Brief covers an FDA filing acceptance for Roche's Lunsumio and Polivy combination in lymphoma, a pediatric expansion for Merck's CAPVAXIVE vaccine, and a key advisory committee meeting for Moderna's mRNA-based flu vaccine.
During an interview with BioPharm International, Cencora experts Andrea Zobel, senior manager of dangerous goods, and Marco Hogenboom, senior director of specialty logistics, highlighted the unique regulatory, logistical, and educational challenges associated with delivering radiopharmaceutical therapies to patients worldwide.
The FDA has accepted Roche's supplemental BLA for a chemotherapy-free combination of mosunetuzumab (Lunsumio VELO) and polatuzumab vedotin (Polivy) in adults with relapsed or refractory large B-cell lymphoma, based on Phase 3 SUNMO trial data showing a 59% reduction in the risk of disease progression or death compared to standard salvage chemotherapy.
