NANJING, China, Oct 18, 2022 -- InxMed Co., Ltd, a clinical-stage biotechnology company dedicates on developing innovative therapies targeting drug resistance for hard-to-treat solid tumors, is pleased to announce that the clinical data from an open-label, phase Ib trial evaluating the efficacy and safety of IN10018, a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), alone or in combination with cobimetinib (Cobi, an approved mitogen-activated protein kinase [MEK] inhibitor from Roche) in patients with Uveal Melanoma (UM) and NRAS-mutant melanoma. The clinical data is being presented in the form of poster at the Society for Melanoma Research (SMR) 19th International Congress from October 17-20, 2022 (Abstract #: P-141). The released data showed that IN10018 in combination with Cobi demonstrated promising antitumor activities and acceptable safety profile in patients with metastatic melanoma. InxMed has entered into a global clinical collaboration with Roche to evaluate IN10018 in combination with Cobi before.

This phase Ib study is to evaluate the safety, tolerability, and antitumor activities of IN10018 alone or in combination with Cobi in patients with UM or NRAS-mutant melanoma. The study is ongoing at 8 centers (US/AUS). As of Jun 30, 2022, a total of 45 patients with UM or NRAS-mutant melanoma were enrolled, and 93% of them had prior immune checkpoint inhibitors (ICIs) treatment. IN10018 100 mg QD either as monotherapy or in combination with Cobi 60 mg per label was determined as the recommended phase 2 dose (RP2D).

IN10018 in combination with Cobi showed an acceptable safety profile and promising antitumor activities in patients with UM or NRAS-mutant melanoma. In patients with UM, a median progression-free survival (mPFS) of 2.73 month was reported in 10 efficacy evaluable patients for IN10018 monotherapy. For IN10018 in combination with Cobi, a mPFS of 6.52 months was reported. In patients with NRAS-mutant melanoma, a mPFS of 2.79 months was observed in 7 efficacy evaluable patients with 1 PR for patients treated with IN10018 monotherapy. For IN10018 in combination with Cobi, a total of 5 PRs and 5 SDs were reported in 13 evaluable subjects. The ORR was 38.5% (5/13), the DCR was 76.9% (10/13), and the mPFS was 5.45 months. Notably that 93% of all enrolled patients have received prior immune related therapy.

FAK is a non-receptor tyrosine kinase that plays an important role in cell adhesion, migration, and regulation. It’s expression is up-regulated in multiple tumor types. Researchers have found that inhibiting the FAK signaling pathway in preclinical models can effectively reverse previously failed chemotherapy and targeted therapy caused by drug resistance and enhance the response and efficacy of immunotherapy against solid tumors.

InxMed started the global clinical development program for IN10018, as one of the most advanced FAK inhibitors. Clinical trials currently underway in the US, China and Australia with multiple hard to treat indications. IN10018 received fast track designation from the U.S. Food and Drug Administration (FDA) in August 2021, and breakthrough designation from China National Medical Products Administration (NMPA).

InxMed is going to initiate a triple combination of IN10018, Cobi and atezolizumab for treatment of Nras melanoma. ClinicalTrials.gov Identifier: NCT04109456, enrollment is ongoing. For more information, please visit http://en.inxmed.com/