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DRUG:

BNT326

i
Other names: BNT326, YL202
Associations
Company:
BioNTech, MediLink
Drug class:
Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate
Related drugs:
Associations
4ms
A Study of YL202 in Selected Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2, N=200, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
BNT326
6ms
A Study of YL202 in Selected Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2, N=200, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
New P2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
|
HER-2 positive • ERBB3 expression
|
BNT326
1year
Preclinical development of YL202, a novel HER3-targeting antibody-drug conjugate (ADC) with novel DNA topoisomerase I inhibitor for treatment of solid tumors (AACR 2023)
GLP toxicity studies using cynomolgus monkeys showed that YL202 is well tolerated with calculated therapeutic index (TI, HNSTD/MED) of ~100 for repeat dosing. No lung or platelet toxicity findings were observed at doses up to the maximum tolerated dose (MTD).Based on these preclinical results, it demonstrates that YL202’s advanced ADC design results in an increased therapeutic margin, and YL201 could be further developed in HER3 positive cancer patients.
Preclinical
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 elevation
|
BNT326 • YL201
over1year
New P1 trial • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
|
EGFR mutation • HR positive • HER-2 negative • EGFR L858R • EGFR exon 19 deletion • HR positive + HER-2 negative
|
BNT326