Emily Schoenthaler is content producer for BioPharm International®.
Adaptin Bio has opened enrollment in a first-in-human Phase 1 trial of APTN-101, a bispecific T-cell engager built on the company's BRiTE platform designed to cross the blood-brain barrier and target EGFRvIII-positive glioblastoma. The trial, conducted with Duke University, will enroll up to 15 adult patients with WHO Grade IV malignant glioma.
This edition of The BioPharm Brief covers FDA approvals for Pasatru in fibrodysplasia ossificans progressiva and Genglycos in glycogen storage disease type Ia, along with a new bispecific CAR-T entering clinical development for large B-cell lymphoma.
Kirsten Detrick, chief representative, USA, at Basel Area Life Sciences Supercluster, discusses why emerging biopharmaceutical companies should incorporate market access and commercial considerations earlier and how Basel’s concentration of cross-functional talent can support product development and launch.
The FDA has approved Genglycos (pariglasgene brecaparvovec-opnr), a one-time AAV8 gene therapy, to reduce cornstarch dependence in patients eight and older with GSDIa, the first approved treatment to target the disease's underlying genetic cause.
AbelZeta Pharma has reclaimed global rights to prizloncabtagene autoleucel from Janssen and secured FDA clearance to begin US trials, positioning the anti-CD20/CD19 bispecific CAR-T for patients who relapse after existing CAR-T therapies.
This week’s BioPharm Brief covers positive phase 3 melanoma results for Merck and Moderna’s individualized neoantigen therapy, a personalized cancer vaccine manufacturing platform entering clinical use, and a new brain-penetrant antibody approach for glioblastoma.
AI tools that extract information from unstructured medical records could help oncology practices identify eligible clinical trial patients, surface care gaps, and compare treatment outcomes across real-world cohorts, according to Shaalan Beg and Eron Kelly of ConcertAI.
Real-time process analytics and digital manufacturing systems could generate the reliable data needed for artificial intelligence to deliver more predictive insights in biopharmaceutical manufacturing, according to Bryan Hassell, founder and CEO of Nirrin Technologies.
NTx Bio's NTxscribe CORE platform is being used by Baylor College of Medicine to manufacture mRNA for DOC1021, Diakonos Oncology's personalized dendritic cell vaccine, now dosing patients in a Phase 1 trial for refractory melanoma.
Today’s BioPharm Brief looks at a long-acting anti-VEGF therapy entering clinical trials, the first commercial use of imlifidase in Australia for kidney transplantation, and FDA Fast Track designation for a platelet-derived biologic for chronic sciatica.
Eyconis has dosed the first patients in OVERTURE, a phase 1b/2a first-in-human trial of EYC-0305, an investigational anti-VEGF antibody fragment designed for six-month or longer dosing intervals in wet age-related macular degeneration, marking the company's transition to clinical-stage status.
The FDA has granted Fast Track designation to C-1101, Consano Bio's investigational platelet-derived multi-protein biologic for chronic, painful lumbosacral radiculopathy, following the drug's recent IND clearance and as the company advances a Phase 1 trial evaluating the epidural injection.
Today’s BioPharm Brief looks at an oncology trial discontinuation, an AI-designed glioblastoma vaccine, and an expanded biosimilars collaboration.
Evaxion has added EVX-05, an AI-designed, off-the-shelf therapeutic vaccine targeting glioblastoma, to its pipeline, discontinuing the EVX-03 program as part of a broader R&D refocus while maintaining its cash runway into the second half of 2027.
OncoC4 has dosed the first patient in a phase 1 trial of ONC-783, a T-cell engager targeting neoCD24, a cancer-specific glycoform of CD24, positioning the subcutaneously administered candidate as a potential treatment across multiple solid tumor types.
Shanghai Henlius Biotech has entered a strategic collaboration with Sandoz covering up to 10 proposed monoclonal antibody and antibody-drug conjugate biosimilar assets, deepening the companies' existing oncology biosimilars partnership with initial deals worth up to $322 million.
The European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, Pfizer and Valneva's six-valent OspA-based Lyme disease vaccine candidate, beginning formal review of what could become the first Lyme disease vaccine available in Europe.
Fate Therapeutics has initiated RECLAIM-LN, a Phase 2 potentially registrational trial of its off-the-shelf, iPSC-derived CD19-targeting CAR T-cell candidate FT819, in patients with refractory lupus nephritis, following favorable Phase 1 safety and efficacy data.
Today’s BioPharm Brief covers NMPA approval of ivonescimab plus chemotherapy for first-line squamous NSCLC, a $175 million financing for Silence Therapeutics, and Infinimmune’s $75 million Series A for its human-derived antibody pipeline.
Infinimmune has closed a $75 million Series A financing co-led by Regeneron Ventures and Playground Global to advance its lead atopic dermatitis programs, IFX-101 (targeting IL-22) and IFX-201 (targeting IL-13), both derived from its Anthrobody platform for discovering fully human antibodies.
China's NMPA has approved ivonescimab plus chemotherapy for first-line advanced squamous non-small cell lung cancer, based on Phase III HARMONi-6 data showing the PD-1/VEGF bispecific antibody combination reduced the risk of death by 34% compared with a PD-1 inhibitor plus chemotherapy.
Today’s BioPharm Brief looks at new financing for multispecific antibody development, AbCellera’s $200 million public offering, and an expanded AI collaboration between Nucleai and Gilead focused on ADC development.
Boulevard Bio has emerged from stealth with $65 million in financing from Deerfield Management and early Phase 1 data for BLVD101, a bispecific BAFF/APRIL antibody for IgA nephropathy supporting once-quarterly dosing, alongside two additional multi-specific antibody candidates for B cell-driven autoimmune disease.
Nucleai has announced an ongoing translational research collaboration with Gilead Sciences applying AI-powered tissue analytics to support Gilead's global antibody-drug conjugate clinical development programs, generating candidate spatial biomarkers across multiple oncology indications.
SynaptixBio says rare disease biotech investment is increasing in the US following renewal of the FDA's Priority Review Voucher program, while UK-based rare disease companies continue to lack an equivalent incentive and remain dependent on public markets, private investment, or acquisition to secure capital.
Today’s BioPharm Brief covers rare disease investment, an FDA fast track designation for a Parkinson disease therapy, and phase 2 results for an siRNA treatment in polycythemia vera.
Stand Up To Cancer has awarded its Nina Nicolai Pancreatic Cancer Innovation in Collaboration Award to a research team developing a combination approach that pairs an engineered mRNA vaccine with KRAS G12D-directed TCR-T cell therapy, aiming to sustain antigen production and improve T-cell responses against pancreatic cancer.
Today’s BioPharm Brief looks at Akeso’s bispecific ADC and ivonescimab combination in breast cancer, Novo Nordisk’s AI partnership with AWS, and Ascletis’ once-monthly obesity candidates.
Ascletis has initiated two Phase I studies for its obesity pipeline: ASC36, a once-monthly amylin receptor peptide agonist, and ASC36_35FDC, a once-monthly fixed-dose co-formulation of ASC36 with its GLP-1R/GIPR dual agonist ASC35, following recent FDA IND clearances for both candidates.
Bristol Myers Squibb has selected Houston's Generation Park for a new $2.3 billion multi-modal manufacturing campus capable of producing small molecules, biologics, and antibody-drug conjugates, adding to a growing wave of large-scale US pharmaceutical manufacturing investment.
