FWD1509 is a highly potent inhibitor of EGFR/HER2 exon20 insertion mutants. EGFR/HER2 exon20 insertions are the third most abundant mutations in NSCLC. Globally there are no fully approved drugs yet for either EGFR ex20ins or HER2 ex20ins patients.  The standard of care are still chemo-based therapies. FWD1509 provides a targeted solution to these patients. Preclinically FWD1509 showed strong inhibition of tumor growth of the heterogenous mutants. We are currently running phase 1/2 trials in both US (1) and China (2) to evaluate FWD1509’s safety and tolerability, and to observe its preliminary clinical activities. Consistent efficacy signals are observed in both HER2 and EGFR mutated patients in US and in China.


Program/TargetProg/Tgt
IndicationInd
DiscoveryDiscov
Lead
Optimization
Lead Opt
IND
Enabling
IND
Phase 1Ph 1
Phase 2Ph 2
CollaborationsCollab
FWD1509
NSCLC
FWD1509
(EGFR/HER2 Inhibitor)
NSCLC
Class I HDAC inhibition has been shown to dramatically enhance the efficacy of MEK inhibitors in Ras pathway driven melanomas by coordinately suppressing two DNA repair pathways. A potential clinical biomarker that predicts responsiveness has also been identified.

(1) Ph1/2 trial ongoing in US: NCT05068024.

(2) Ph1/2 trial ongoing in China: CTR20211750.