Biopharma News

A phase 1 trial of mKRAS-VAX, an off-the-shelf synthetic peptide vaccine targeting mutant KRAS, safely stimulated durable, tumor-specific T-cell responses in 90% of high-risk individuals, with none of the 20 participants developing pancreatic cancer after a median follow-up of 16.5 months.

Keytruda improved progression-free survival versus chemotherapy in first-line dMMR advanced or recurrent endometrial cancer.

Nirrin Technologies founder and CEO Bryan Hassell discusses how simplifying protein quantitation could improve method transferability, support automation, and reduce bottlenecks across biologics development and manufacturing.

Umoja Biopharma has received FDA clearance of its IND application for UB-VV400, a CD22-directed in vivo CAR T-cell therapy candidate built on the company's VivoVec lentiviral platform, positioning it as the industry's first known in vivo CAR T program targeting CD22 for relapsed or refractory B-cell malignancies.

Updated clinical findings for brenetafusp highlight how T-cell receptor bispecific therapies may overcome key mechanisms of checkpoint inhibitor resistance while expanding immunotherapy to a broader range of solid tumors.

Allogene Therapeutics has published complete phase 1 data in the Journal of Clinical Oncology for ALLO-316, a CD70-targeted allogeneic CAR T therapy, showing a 31% confirmed response rate and durable remissions in patients with high CD70-expressing metastatic renal cell carcinoma.

ImmunoBrain has published phase 1b data in Nature Medicine and presented late-breaking results at AAIC 2026 for IBC-Ab002, an investigational anti-PD-L1 monoclonal antibody that met its primary safety endpoint and showed encouraging trends in biomarkers of neuronal and synaptic damage in patients with early Alzheimer's disease.

As part of our continuing coverage from the BIO International Convention 2026, Pharmaceutical Executive spoke with Martha Fowler, founder of Steer Bio, about the company's regenerative medicine platform, its lead program for cancer-related lymphedema, and how non-dilutive funding is supporting its path toward first-in-human studies.

Today's BioPharm Brief explores three developments in Alzheimer's disease and autoimmune research, including promising preclinical gene therapy data, a new FDA-approved at-home treatment option, and a licensing deal for a novel CD40L-targeting antibody.

The FDA has approved lecanemab-irmb (Leqembi Iqlik) a once-weekly subcutaneous autoinjector formulation, as an initiation dose for early Alzheimer's disease, making it the first anti-amyloid antibody offering at-home dosing across the entire treatment course, from initiation through maintenance.

Today's BioPharm Brief highlights three regulatory and clinical milestones, including an FDA RMAT designation for a regenerative therapy in osteoarthritis, promising rectal cancer data from GSK's AZUR-1 study, and a new perioperative treatment option for muscle-invasive bladder cancer.

The FDA has approved Padcev, a Nectin-4-directed antibody-drug conjugate, plus Keytruda as neoadjuvant and adjuvant treatment for muscle-invasive bladder cancer regardless of cisplatin eligibility, based on Phase III EV-304 data showing a 47% reduction in recurrence risk.

The FDA has granted Regenerative Medicine Advanced Therapy designation to Allocetra, Enlivex's macrophage-reprogramming cell therapy, for age-related symptomatic knee osteoarthritis in patients 64 and older, based on Phase I/IIa data showing durable pain and function improvements.

Opamtistomig, a PD-L1/4-1BB bispecific antibody from Nanjing Leads Biolabs, has been granted priority review by China's NMPA for advanced extrapulmonary neuroendocrine carcinoma, a rare and aggressive cancer with no globally approved therapy.

The FDA has approved subcutaneous Sarclisa Escena, administered via on-body injector, across all existing multiple myeloma indications for the IV formulation, making isatuximab the first anticancer monoclonal antibody available through both wearable injector and manual subcutaneous administration in the US.

Teva Pharmaceuticals has entered a global licensing agreement with Polpharma Biologics for exclusive commercialization rights to a proposed biosimilar of Ocrevus (ocrelizumab), the CD20-targeted monoclonal antibody used to treat relapsing and primary progressive multiple sclerosis.

Today's BioPharm Brief explores three very different paths toward innovation, from AI-guided precision medicine and a first-in-class autoimmune cell therapy to a late-stage clinical setback in transthyretin amyloid cardiomyopathy.

FT839, Fate Therapeutics' off-the-shelf, iPSC-derived CAR T-cell candidate co-targeting CD19 and CD38, has received FDA IND clearance and will advance into a phase 1/2 basket trial designed to treat multiple autoimmune diseases without conditioning chemotherapy.

CARDIO-TTRansform, the largest Phase III trial conducted to date in transthyretin-mediated amyloid cardiomyopathy, did not meet its primary composite endpoint for Wainua (eplontersen), though a monotherapy subgroup showed a nominally significant reduction in cardiovascular events.

Chemomab Therapeutics and Scipher Medicine will merge to advance nebokitug, a first-in-class anti-CCL24 monoclonal antibody, into a precision medicine Phase 2 trial in rheumatoid arthritis guided by Scipher's PrismRA test and AI Network Medicine platform.

Abu Dhabi is expanding its role in global biopharmaceutical manufacturing through strategic investments, advanced infrastructure, and international partnerships designed to accelerate biologics production, innovation, and supply chain resilience.

As part of BioPharm International's continuing coverage from the BIO International Convention 2026, Sara Jane Demy, CEO of Demy-Colton, discusses how artificial intelligence, global collaboration, and renewed investment could help improve drug development success rates and accelerate innovation.

As part of BioPharm International's continuing coverage from the BIO International Convention 2026, Sara Jane Demy discusses signs of renewed investment activity and why inclusive scientific leadership remains essential to advancing drug development.

Today's BioPharm Brief highlights advances in neurology, hematology, and nephrology, featuring new Alzheimer's disease biomarker data, an expanded pediatric approval for von Willebrand disease prophylaxis, and the first dual BAFF and APRIL inhibitor approved for IgA nephropathy.

Vaccinex will present new biomarker data from the Phase 1b/2 SIGNAL-AD trial of pepinemab — a humanized IgG4 monoclonal antibody targeting Semaphorin 4D — at AAIC 2026 in London on July 13, showing that SEMA4D blockade regulates glial biomarkers associated with disease progression in early Alzheimer's disease, while outlining plans for an enlarged Phase 2b SIGNAL-AD2 study.

The FDA has approved an expanded indication for Wilate (von Willebrand Factor/Coagulation Factor VIII Complex, Human) to include routine prophylaxis in children younger than 6 years with von Willebrand disease — the first FDA-approved option for this age group — based on phase 3 WIL-33 trial data showing significantly reduced bleeding episodes in young pediatric patients.

The FDA has granted accelerated approval to Trutakna, a recombinant fusion protein that simultaneously inhibits BAFF and APRIL, for adults with primary IgA nephropathy at risk for disease progression — marking the first approval of a dual BAFF/APRIL inhibitor in the US and a significant advance in the growing wave of targeted biologics for this immune-mediated kidney disease.

The annual gathering in San Diego showcased the industry's pivot toward complex molecules, flexible manufacturing, and human-based drug discovery — while candid conversations about capital access, deal strategy, and preclinical predictability reflected a sector navigating pressure with optimism.