InxMed Unveils Data on Enhancing ADC Therapeutic Window with Ifebemtinib and FIC ADC at 15th Annual World ADC

In Nanjing, China, on November 7, 2024, the biotechnology company InxMed Co., Ltd, which focuses on developing innovative treatments for tumor resistance and metastasis, revealed preclinical findings at the 15th Annual World ADC Conference in San Diego. They presented data on ifebemtinib (ifebe, IN10018), a selective oral inhibitor of focal adhesion kinase (FAK), which aims to enhance the efficacy and safety of Antibody-Drug Conjugates (ADCs), and IN30758, a pioneering ADC intended for treating various solid tumors, including those resistant to DXD.

The effectiveness of ADCs in targeting tumors is often compromised due to toxicity associated with exposure. Cancer-associated fibroblasts (CAFs) around tumor cells act as barriers, hindering the ADCs' effectiveness. The preclinical studies showed that ifebemtinib could reduce this fibrotic barrier, improve ADC penetration, and thus increase efficacy.

A notable challenge with some ADCs, like Enhertu, is interstitial pneumonitis, a serious and potentially fatal side effect. FAK activation was observed in patients suffering from this condition, similar to what was induced by Enhertu in mouse models. InxMed's research demonstrated that ifebemtinib could effectively prevent and treat Enhertu-induced interstitial pneumonitis in animal models.

Dr. Zaiqi Wang, the founder and Chief Executive Officer of InxMed, emphasized the potential of ifebemtinib to significantly improve the therapeutic window of ADCs by increasing their local exposure and reducing interstitial pneumonitis. He mentioned that clinical trials with rigorous designs would be conducted to translate these promising preclinical results into clinical success. Dr. Wang highlighted that ifebemtinib could become an ideal complementary partner for ADCs, potentially leading to groundbreaking strides in cancer treatment.

InxMed plans to submit an Investigational New Drug (IND) application for the combination of ifebemtinib with ADC to China’s Center for Drug Evaluation (CDE) in November 2024. The company is also forming partnerships with various ADC firms.

Additionally, InxMed presented data on IN30758, a first-in-class ADC for treating multiple solid tumors, including those resistant to DXD. This ADC targets an integrin family member overexpressed in most solid tumors. Preclinical trials showed that IN30758 has strong in vivo efficacy in CDX and PDX models of various cancers and is well tolerated in cynomolgus monkeys. The IND submission for IN30758 is expected in 2025.

Ifebemtinib is an orally administered, highly selective small molecule inhibitor of focal adhesion kinase. It has shown significant synergies with a wide range of therapeutic modalities, including chemotherapy, targeted therapies, and immunotherapies. In clinical settings, ifebemtinib has shown promising results in combination with these treatments. InxMed is currently conducting a registrational trial for ifebemtinib in platinum-resistant ovarian cancer in China and multiple proof-of-concept trials in lung, colorectal, melanoma, and pancreatic cancers. Over 600 patients have been treated with ifebemtinib, and it has demonstrated a favorable safety and tolerability profile.

Ifebemtinib has received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) and Fast-Track designation from the U.S. Food and Drug Administration (FDA). InxMed plans to submit a New Drug Application to the NMPA in early 2025.

Founded in 2018, InxMed Co., Ltd is a clinical-stage biotechnology company dedicated to developing therapies for tumor treatment resistance and metastasis. The company has established a robust platform for clinical translational research based on a thorough understanding of disease biology. InxMed's pipeline includes several compounds that target tumor defense mechanisms, featuring highly differentiated therapeutic candidates.