Chinese biotechnology company DualityBio (HKEX:9606) announced on Monday that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310.
This designation is for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
DB-1310 is a novel ADC targeting HER3 developed using DualityBio's proprietary DITAC platform. First-in-human Phase I/IIa clinical trial data of DB-1310 demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumours who had failed standard therapies.
Actuate Therapeutics advances Ewing Sarcoma trial following positive Phase 1 results
Citius Oncology prices USD9.0m public offering
Innovent Biologics' Phase 1 anti-CLDN18.2 ADC (IBI343) results published in Nature Medicine
Varian launches IntelliBlate in Europe, expanding image-guided microwave ablation for cancer care
Imugene announces Azer-cel Phase 1b clinical trial data
CARsgen successfully defends European GPC3 CAR-T patent
IGI and AbbVie enter global licensing agreement for ISB 2001