Phase 2 trial – Talk Bio

BioNTech and Bristol Myers Squibb Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig in Advanced Triple-Negative Breast Cancer

21 hours ago talkbio0Tagged Antibodies, Bispecific, BioNTech, BNT327, BREAST-01, disease control rate, Gene Expression, Myers Squibb, ORR, PD-L1, PD-L1xVEGF-A, Phase 2 trial, Progression-Free Survival, pumitamig, ROSETTA, SABCS, TNBC, Triple Negative Breast Neoplasms

BioNTech; Bristol Myers Squibb; pumitamig; BNT327; PD-L1xVEGF-A bispecific antibody; Phase 2 trial; triple-negative breast cancer; TNBC; confirmed ORR; disease control rate; progression-free survival; PD-L1 expression; ROSETTA BREAST-01; SABCS

Structure Therapeutics’ oral obesity drug shows competitive early data vs Novo and Lilly; Ascletis reports early obesity results

2 days ago talkbio0Tagged ASC41, Ascletis, eli lilly, Glucagon-Like Peptide 1, GSBR-1290, Obesity, Oral cavity, Ozempic, Phase 2 trial, safety profile, Structure Therapeutics, Wegovy, Weight Loss, Weight-Loss Agents, Zepbound

Structure Therapeutics; GSBR-1290; oral GLP-1; obesity pill; weight-loss drug; Novo Nordisk; Eli Lilly; Wegovy; Ozempic; Zepbound; Ascletis; ASC41; ASC42; phase 1 trial; phase 2 trial; weight reduction; safety profile

Jazz and Zymeworks Bispecific Antibody Zanidatamab Delivers Practice-Changing Results in Stomach Cancer Study

3 weeks ago talkbio0Tagged Antibodies, Bispecific, erbB-2 Receptor, gastroesophageal adenocarcinoma, Jazz, Malignant neoplasm of stomach, orphan drug designation, Overall Survival, Pharmacotherapy, Phase 2 trial, Phase 3, practice-changing, Progression-Free Survival, Zanidatamab, Zymeworks

Jazz Pharmaceuticals; Zymeworks; zanidatamab; bispecific antibody; HER2; gastroesophageal adenocarcinoma; stomach cancer; phase 2 trial; phase 3 HERIZON-GEA-01; overall survival; progression-free survival; chemotherapy; practice-changing; Orphan Drug designation

AnaptysBio Halts Phase 2 Ulcerative Colitis Trial; Lyell Immunopharma Secures CAR-T Rights

4 weeks ago talkbio0Tagged AnaptysBio, CAR-T therapy, Clinical Failure, Clinical Trials, Discontinuation (procedure), Lyell Immunopharma, News [Publication Type], Phase 2 trial, Rheumatoid Arthritis, Rosnilimab, Ulcerative Colitis

AnaptysBio; rosnilimab; ulcerative colitis; Phase 2 trial; clinical failure; trial discontinuation; Lyell Immunopharma; CAR-T therapy; licensing deal; biotech news; rheumatoid arthritis

Terns Ditches Obesity Pill After Phase 2 Letdown, Shifts Focus to Cancer Pipeline

2 months ago talkbio0Tagged liver enzyme elevation, Metabolic Diseases, Myeloid Leukemia, Chronic, Neoplasms, Obesity Drug, Phase 2 trial, Product containing glucagon-like peptide 1 receptor agonist (product), TERN-601, TERN-701, Terns, Weight Loss

Terns Pharmaceuticals; TERN-601; obesity drug; GLP-1 receptor agonist; Phase 2 trial; weight loss; liver enzyme elevation; oncology; TERN-701; chronic myeloid leukemia (CML); metabolic disease

Metsera’s New Obesity Data Raises Efficacy Profile, Key Side Effect Questions for Pfizer After Acquisition

2 months ago talkbio0Tagged aspects of adverse effects, Effectiveness, Glucagon-Like Peptide 1, MET-097i, Metsera, Obesity, Pfizer, Pfizer acquisition, Phase 2 trial, Weight Loss

Metsera; Pfizer; obesity drug; MET-097i; GLP-1; side effects; efficacy; Phase 2 trial; weight loss; Pfizer acquisition

Novartis Acquires Tourmaline Bio for $1.4B to Bolster Cardiovascular Pipeline with Promising Phase 2 Drug

3 months ago talkbio0Tagged Acquisition, Anti-Inflammatory Agents, Antibodies, C-reactive protein, Cardiovascular Diseases, Chronic Kidney Diseases, interleukin-6, Novartis, pacibekitug, Phase 2 trial, Tourmaline Bio

Novartis; Tourmaline Bio; acquisition; $1.4 billion; pacibekitug; cardiovascular disease; anti-inflammatory; IL-6 antibody; ASCVD; phase 2 trial; C-reactive protein; chronic kidney disease

Servier Supercharges Neuro Pipeline with $450M Deal for Fragile X Syndrome Candidate

3 months ago talkbio0Tagged Acquisition, Bioscience, deal, Fragile X Syndrome, Infrequent, Kaerus, KER-0193, orphan drug designation, pediatric drug designation, Phase 2 trial, Servier

Servier; Kaerus Bioscience; KER-0193; Fragile X syndrome; neurology pipeline; $450 million deal; orphan drug designation; rare pediatric drug designation; Phase 2 trial; acquisition

Scholar Rock’s SMA drug helps Zepbound patients retain muscle in phase 2 trial

6 months ago talkbio0Tagged apitegromab, GDF8 protein, human, Inhibitor, Lean Mass, muscle preservation, Obesity, Phase 2 trial, Scholar Rock, Spinal Muscular Atrophy, Weight Loss, Zepbound

Scholar Rock; apitegromab; SMA drug; Zepbound; tirzepatide; muscle preservation; obesity; weight loss; phase 2 trial; lean mass; myostatin inhibitor

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

6 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay