InxMed's Ifebemtinib Gets Breakthrough Status in China for KRAS G12C NSCLC

NANJING, China, Nov. 21, 2024 -- InxMed Co., Ltd, a biotech enterprise focused on the development of pioneering treatments for cancer resistance and metastasis, has announced that the China National Medical Products Administration (NMPA) has awarded Breakthrough Therapy designation (BTD) to Ifebemtinib (IN10018) for first-line treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation. This therapy is paired with garsorasib, a specific inhibitor targeting the KRAS G12C mutation. This marks the second BTD for ifebemtinib, following an initial designation in April 2022 for its use in treating platinum-resistant ovarian cancer (PROC) combined with PEG-liposomal doxorubicin (PLD).

Ifebemtinib is an orally administered, highly selective small molecule inhibitor of focal adhesion kinase. It has shown substantial clinical synergy when used with targeted therapies, immunotherapies, and standard chemotherapy regimens. The recent BTD is based on data from a Phase Ib/II clinical study assessing the effectiveness and safety of ifebemtinib in combination with garsorasib for the first-line treatment of NSCLC with KRAS G12C mutation (NCT06166836). Results from this trial were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, revealing that the combination therapy exhibited promising antitumor effects with a manageable safety profile. The study reported an objective response rate (ORR) of 90.3% and a disease control rate (DCR) of 96.8%. Out of 31 evaluable patients, there were 28 confirmed partial responses (PRs) and two instances of stable disease (SD). All patients had undergone at least a nine-month follow-up, with the median progression-free survival (PFS) yet to be determined.

Beyond KRAS G12C inhibitors, ifebemtinib has exhibited significant therapeutic potential when paired with a variety of standard and innovative cancer treatments, including anti-PD-(L)1 antibodies, other RAS-targeted inhibitors, EGFR inhibitors, and antibody-drug conjugates (ADCs). InxMed is proactively seeking collaborations with innovative partners worldwide.

InxMed is also advancing a registrational trial in China for platinum-resistant ovarian cancer, with plans to submit a New Drug Application (NDA) to the NMPA in 2025. Additional proof-of-concept trials are ongoing for lung, colorectal, melanoma, and pancreatic cancers, some of which are expected to advance into pivotal studies. To date, over 600 patients have been treated with ifebemtinib, which has demonstrated a favorable safety and tolerability profile.

About InxMed:
Established in 2018, InxMed Co., Ltd is a clinical-stage biotechnology company focused on developing breakthrough therapies aimed at overcoming tumor treatment resistance and metastasis. The company has a robust pipeline of compounds targeting tumor defense mechanisms, with several highly differentiated therapeutic candidates.