PROGRAMS

Firmonertinib

Mutational activation of the epidermal growth factor receptor (EGFR) is a common and early event in the development of non-small cell lung cancer (NSCLC) and confers oncogene dependency on the growth and proliferation of cancer cells. EGFR mutations are present in approximately 15% to 50% of NSCLC, with higher incidence in Asian populations. Patients with NSCLC harboring EGFR mutations are also particularly prone to the development of brain metastases, with approximately 70% developing central nervous system (CNS) metastases over the course of their disease. Despite initial clinical response to currently approved EGFR inhibitors, patients with advanced EGFR mutated NSCLC inevitably acquire resistance mechanisms and progress at some point during treatment; therefore, there is a need for more effective, tolerable treatments.

Firmonertinib (formerly furmonertinib) is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations.

Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted FDA Orphan Drug Designation for the treatment of non-small cell lung cancer with epidermal growth factor receptor mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations.

Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 1b study, which includes a cohort evaluating firmonertinib in patients with EGFR PACC mutations (FURTHER; NCT05364073). In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in partnership with Beijing InnoCare Pharma Tech Co., Ltd.

Firmonertinib is being developed in China by Allist Pharmaceuticals and in the rest of the world by ArriVent BioPharma.

ARR-002

We are partnered with Aarvik Therapeutics to advance a novel cancer therapeutic agent. As part of our agreement, Aarvik is responsible for the discovery and preclinical validation of the novel molecule, which is based on their unique modular platform that combines multiple target mechanisms. The ArriVent team will lead development and commercialization of the ARR-002 program.

Alphamab Partnership

We entered into a partnership with Alphamab Oncology for the discovery, development and commercialization of novel antibody drug conjugates (ADCs). The partnership will utilize the linker-payload platform and glycan-conjugation technology of Alphamab to identify promising ADC candidates for oncology indications. ArriVent has exclusive worldwide rights outside of the Greater China region for developing and commercializing the ADCs created through the partnership.