FDA Clears Forward’s Innovative FWD1509 For Ph1

EGFR gene mutation is one of the main driving genes of NSCLC (non-small cell lung cancer). Currently, there are first, second, and third generation EGFR targeted drugs approved for clinical use. However, for NSCLC patients with EGFR exon20 insertion mutation, the clinical efficacy of existing EGFR targeted drugs is limited. As of now, there are no approved targeted drugs for EGFR exon20 insertion mutation. The preferred clinical treatment strategy is still platinum-based combination chemotherapy. NSCLC patients with this type of EGFR exon20 insertion mutation urgently need effective treatment options. 

FWD1509 is an orally available small molecule EGFR irreversible inhibitor that can strongly inhibit various types of EGFR exon20 insertions, as well as having strong inhibitory activity against common EGFR mutations (L858R, exon19 del) and resistant mutations (T790M). At the same time, FWD1509 has low inhibitory activity against wild-type EGFR and has a good safety treatment window. In addition, FWD1509 can effectively penetrate the blood-brain barrier (BBB) and can be used to treat brain metastases of EGFR-mutated NSCLC. In multiple preclinical studies, FWD1509 can inhibit the proliferation of various EGFR exon20 insertion mutated lung cancer cells and demonstrate good safety and anti-tumor efficacy.

On January 7, 2021, Forward Pharma 's independently developed innovative targeted drug FWD1509 for treating EGFR exon20 insertion mutated NSCLC obtained the US FDA clinical trial application (IND) license. This clinical trial will provide a new treatment option for NSCLC patients with EGFR exon20 insertion mutations.

The Phase I clinical trial of FWD1509 will be carried out simultaneously in China and the United States. The clinical trial project will be undertaken by Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University and MD Anderson Cancer Center in the United States.

Dr. Zhu Chenggang, founder and chief scientific officer of Forward Pharma, said, "Compared with the current chemotherapy methods, FWD1509 has great potential for NSCLC patients carrying EGFR exon20 insertion mutations. The rapid approval and advancement of FWD1509 clinical development not only enriches Forward's clinical pipeline but also strengthens our belief and confidence in continuous acceleration of innovative drug development rooted in China for Chinese and global patients. We will continue to actively promote clinical research and strive to bring more innovative drugs to market as soon as possible to benefit more patients!"

Dr. Xu Liangliang, founder and CEO of Forward Pharma, said, "This milestone achievement of FWD1509's clinical approval marks Fosun's entry into a new development stage after five years of entrepreneurship. We would like to thank all members of the FWD1509 project team for their unremitting efforts and the strong support of our partners such as WuXi AppTec. Forward will always adhere to its original intention, focus on its main business, and devote itself to using our independently developed innovative drugs to solve the clinical needs of global cancer patients."

About Forward Pharma

Forward Pharma is an innovative pharmaceutical company that focuses on the independent research and development of drugs. It has a dual-platform approach that covers the entire drug development process, from target validation, drug discovery, early development, translational medicine research, preclinical studies, and clinical development. The company is headquartered in Nanshan, Shenzhen, with international operations and research teams in Shanghai and Shenzhen. Over the past seven years, relying on its self-built chemical small molecule and monoclonal antibody drug discovery platform, Forward Pharma has established a product matrix consisting of more than 10 Category 1 innovative drugs in over three major solid tumors and autoimmune diseases.