NANJING, China, Nov. 21,
2024 /PRNewswire/ -- InxMed Co., Ltd, a
clinical-stage biotechnology company developing innovative
therapies against cancer treatment resistance and metastasis,
announced that China National Medical Products Administration
(NMPA) has granted Ifebemtinib (IN10018) Breakthrough Therapy
designation (BTD) for the first-line (1L) treatment of non-small
cell lung cancer (NSCLC) with KRAS G12C mutation in combination
with garsorasib, a specific inhibitor of the KRAS G12C
mutation. This is the second BTD ifebemtinib received. In
April 2022, ifebemtinib was
granted its first BTD for the treatment of platinum-resistant
ovarian cancer (PROC) in combination with PEG-liposomal doxorubicin
(PLD).
Ifebemtinib is a highly selective, orally administered, small
molecule inhibitor for focal adhesion kinase, which has
demonstrated significant clinical synergies with targeted
therapies, immunotherapies, and standard chemotherapies.
The BTD is supported by the data from the Phase Ib/II study
evaluating the efficacy and safety of ifebemtinib in combination
with garsorasib for the 1L treatment of NSCLC with KRAS G12C
mutation (NCT06166836). The results of the clinical trial were
featured at the 2024 American Society of Clinical Oncology (ASCO)
Annual Meeting. The dual-oral regimen showed promising antitumor
efficacy with a well-tolerated safety profile in 1L
KRASG12C NSCLC. The
objective response rate (ORR) was 90.3% and the disease control
rate (DCR) was 96.8%. A total of 28 confirmed partial
responses (PRs) and two stable diseases (SDs) were reported from 31
efficacy evaluable patients. All treated patients have achieved a
follow-up visit of 9 months so far, and the median PFS has not been
reached at the time of this report.
Beyond KRAS G12C inhibitors, Ifebemtinib has also shown
significant therapeutic synergies when combined with a wide range
of standard and emerging cancer treatments, such as anti-PD-(L)1
antibodies, other RAS-targeted inhibitors, EGFR inhibitors, and
ADCs. InxMed is actively pursuing collaborations with innovating
partners globally。
InxMed is currently conducting a registrational trial in
platinum-resistant ovarian cancer in China, for which the
company plans to submit a New Drug Application to the NMPA in 2025.
InxMed also has multiple proof-of-concept trials ongoing in lung,
colorectal, melanoma, and pancreatic cancers, some of which will
progress into pivotal studies. Thus far, more than 600 subjects
have been treated with ifebemtinib, and a favorable safety and
tolerability profile has been observed.
About InxMed
InxMed Co. Ltd is a clinical-stage biotech company developing
innovative therapies against tumor treatment resistance and
metastasis. Established in 2018, InxMed has built an efficient
engine for clinical translational research driven by an in-depth
understanding of disease biology. InxMed's pipeline includes
several compounds targeting tumor defense mechanisms with highly
differentiated therapeutic candidates. For more information, please
visit en.inxmed.com.
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