U.S. FDA Approved Forward IND application for clinical development of FWD1509

On January 7, 2021, the U.S. FDA Approved Forward IND application for clinical development of FWD1509, which is an innovative drug targeting for non-small cell lung canser(NSCLC) with EGFR exon20 insertion mutation. This clinical development will provide a novel approach to the treatment of NSCLC patients with EGFR exon 20 insertion mutations.


EGFR gene mutation is one of the main driving gene for NSCLC.  Currently, the 1st, 2nd and 3rd generations of EGFR-targeting drugs have been approved clinically. However for NSCLC patients with EGFR exon20 insertion mutation,  the clinical efficacy of existing drugs is still limited. There is no EGFR exon20 insertion mutation targeting drug up to now and effective treatment plan is desideratum for patients who suffering from such condition.


FWD1509 is a small molecule inrreversible oral inhibitor of EGFR. This candidate is highly suppressive for all kinds of EGFR exon20 insertion mutations, and has strong inhibitory activity to common mutations (L858R, exon19del) and drug-resistant mutation (T790M) of EGFR. At the same time, it's low inhibitory activity on wild-type EGFR had been proved, indicating a good safe therapeutic window. In addition, FWD1509 can effectively cross the blood-brain barrier (BBB) and thus be used to treat brain metastases in EGFR mutated NSCLC. In several preclinical studies, FWD1509 inhibited the proliferation of a variety of EGFR exon20 insertion mutations in lung cancer cells, demonstrating good safety and antitumor efficacy.

The phase I clinical trial of FWD1509 will be conducted simultaneously in China and the U.S. by the Chest Hospital affiliated to Shanghai Jiao Tong University and MD Anderson Cancer Center in the U.S.

"Compared with current chemotherapy methods, FWD1509 has great potential for NSCLC carrying EGFR exon20 insertion mutation. The rapid approval and promotion of the clinical development of FWD1509 not only enriched the clinical pipeline of Forward, but also strenghened our faith and confidence of rooting in China, accelerate the development of innovative drugs for Chinese and global patients. We will, as always, activately promote clinical research and atrive to bring more innovative drugs to the market as soon as possible to benefit more patients!" said Dr Chenggang Zhu, The founder and CSO of Forward.

"The realization of the approved clinical IND milestone of FWD1509 marks that Forward has entered a new stage of development after 5 years of entrepreneurial process. We appreciate all team members of the FWD1509 project for their tireless efforts, as well as WuXi Apptec and other partners for their support. Forward will always remain true to our original aspiration, and be committed to solving the clinical needs of cancer patients worldwide with innovative pharmaceutical products." said Dr Liangliang Xu, The founder and CEO of Forward.