FDA Grants Fast Track Designation to IN10018 FAK Inhibitor for Ovarian Cancer

The FDA has granted a fast-track designation to IN10018, a selective ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor, for the treatment of platinum-resistant ovarian cancer, according to a press release by InxMed, Co. Ltd. 1

Early clinical data has found that IN10018 has a good safety profile and promising efficacy across a number of tumor types. Recent research suggests that FAK inhibitors in general are able to overcome the fibrotic barrier and immune tolerance, which boosts multi-modalities such as targeted therapy, chemotherapy, immune-therapy, and radiation therapy.

After ovarian cancer progresses and become platinum-resistant, very little treatment options are left. The overall survival for this population is 1 year. Both clinical and preclinical data suggest that IN10018 has promising efficacy when combined with chemotherapy for this patient population.

"This is an important milestone for InxMed. IN10018 is one of our critical assets to fulfill our "Best-in-Disease Combination" development strategy. We will leverage the advantage of Fast Track status and work closely with US FDA to speed up further clinical development. InxMed will fully accelerate global clinical development of IN10018 to better meet the patient's needs," said Zaiqi Wang, PhD, chairman and chief executive officer of InxMed, in a press release.

Currently, a phase 1 clinical trial is underway to assess the efficacy of the agent in patients with metastatic melanoma. The randomized, open-label study has an estimated enrollment of 52 participants. Primary end points include safety and tolerability as IN10018 as both a monotherapy and in combination with cobimetinib (Cotellic). Secondary end points include pharmacokinetics, overall response rate, disease control rate, duration of response, progression-free survival, and overall survival.2

During the study, patients will be assigned to 1 of 2 arms. In arm 1, patients will receive IN10018 as a monotherapy. In arm 2, they will receive it in combination with cobimertinib. A modified 3+3 design will be used.

In order to participate, patients must have confirmed metastatic uveal melanoma or metastatic NRAS-mutant melanoma, at least 1 measurable disease, an ECOG status of 0 or 1, and adequate organ function. Patients who have had major surgery within 28 days prior to the first study dose, prior radiation therapy within 14 days, prior FAK inhibitor treatment, known active central nervous system metastases, or has an active infection are not eligible to participate.

The study is recruiting in Florida, Massachusetts, New York, and Texas.

_REFERENCES:

_{1. InxMed's IN10018 Receives U.S. FDA fast track designation for the treatment of platinum-resistant ovarian cancer. News release. InxMed. August 15, 2021. Accessed August 16, 2021. https://prn.to/3g8L00x.}

_{2. IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma. ClinicalTrials.Gov. Accessed August 16, 2021. https://bit.ly/37MKwJ1.}