Business Trends– category –
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Business Trends
MAGEA11-Recruiting PROTACs: Cancer-Selective BET Degradation
npj Drug Discovery Overview Researchers have developed the first PROTAC that recruits the tissue-specific E3 ligase scaffolding protein MAGEA11 to achieve cancer-restricted protein degradation. Lead compound 105B degrades BET proteins in... -
Business Trends
FDA Gene Editing Guidance: BLA Process and IFS for Rare Diseases
Pharmaceutical Technology (PharmTech) USA Overview The FDA has issued draft guidance allowing biologics license applications (BLAs) for individualized genome editing products to add patient-specific variants without new clinical trials. ... -
Business Trends
XmAb819: Phase 1 Dose Selection and ccRCC Development Roadmap
Yahoo Finance (Business Wire) USA Overview Xencor has selected 400 mcg/kg as the proposed IV recommended Phase 3 dose (RP3D) for XmAb819, showing a 45.5% cORR and 82% 6-month PFS estimate. The company plans to discuss an accelerated FDA ... -
Business Trends
ZW191 Phase 1 Data: FRα-Targeting ADC Efficacy in PROC Patients
BioSpace Canada Overview Zymeworks presented Phase 1 data for ZW191, showing a 64.5% confirmed objective response rate (cORR) at the 6.4 mg/kg dose in patients with high-grade serous platinum-resistant ovarian cancer (PROC). The ADC demo... -
Business Trends
Ascletis Oral Peptide Pipeline: Once-Weekly Obesity Treatment Specs
BioPharma APAC China Overview Ascletis Pharma has reported preclinical data for a once-weekly oral peptide pipeline targeting obesity and metabolic diseases, with the lead candidate ASC36o entering Phase 1 trials in the U.S. The pipeline... -
Business Trends
Sofusa Holdings: Lymphatic Drug Delivery Platform and 2027 FDA Timeline
BioSpace USA Overview Sofusa Holdings has relaunched as an independent clinical-stage company focusing on a nanotechnology platform for precision lymphatic targeting. The DoseConnect platform demonstrated efficacy in rheumatoid arthritis... -
Business Trends
IDE849 (SHR-4849): Phase 1 DLL3-ADC Data for SCLC and NEC
PR Newswire(IDEAYA Biosciences) USA Overview IDEAYA Biosciences reported updated Phase 1 data for IDE849, a DLL3-directed ADC, showing a median overall survival (OS) of 17.4 months in second-line small cell lung cancer (SCLC). The resu... -
Business Trends
KRAS-mutant CRC therapy: LNP-mediated RNAi and 5-FU synergy
bioRxiv Overview Researchers developed a lipid nanoparticle (LNP)-based RNA interference strategy using a single siRNA sequence to target KRAS G12D, G12V, and G13D mutations in colorectal cancer (CRC). The approach suppresses cellular pr... -
Business Trends
Cereblon Allosteric Inhibition: VVD-105917 and Cys287 Targeting
bioRxiv USA Overview Researchers have identified a cryptic allosteric pocket at Cys287 of cereblon (CRBN) that can be targeted by covalent ligands to inhibit protein degradation. The lead compound, VVD-105917, traps CRBN in an inactive o... -
Business Trends
Canary Cure CCT-217: siRNA-LNP Approach for Pediatric Obesity
BioXconomy USA Overview Canary Cure is developing CCT-217, an siRNA-LNP therapeutic targeting CB1R and ZFP423 genes to treat Prader-Willi syndrome and pediatric obesity. Preclinical mouse models demonstrate significant weight loss and in...