Iksuda Therapeutics Gets FDA IND Approval for IKS014

Iksuda Therapeutics, a UK-based biotechnology firm specializing in antibody drug conjugates (ADCs), has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for IKS014. This approval allows Iksuda to expand its ongoing clinical trials of the drug in the United States, alongside existing trials in Australia and Singapore. IKS014 is being developed to treat patients with advanced HER2-positive solid tumors.

Currently, IKS014 is under investigation in an open-label phase 1 dose-escalation study. This trial aims to assess the safety and tolerability of increasing doses of IKS014 and to determine an appropriate dose for phase 2 trials. Early results from this study have revealed significant clinical activity across a range of tumor types, such as breast, ovarian, gallbladder, and oesophageal cancers. Notably, this includes patients who have not responded to previous treatments, like Enhertu. The FDA's approval for the expansion phase in the U.S. will facilitate further exploration of IKS014's efficacy in this crucial patient subgroup.

Dr. Dave Simpson, CEO of Iksuda Therapeutics, expressed that the FDA's clearance of IKS014's IND application marks a pivotal step in their goal to address unmet medical needs for patients with HER2-positive cancers, especially those who have exhausted existing treatment options. He shared the company's excitement about expanding their program to benefit more patients. The encouraging early clinical data, especially from patients who have relapsed after treatments with Kadcyla and Enhertu, indicates that IKS014 might offer a new treatment avenue for patients with limited existing options.

The initial phase of the phase 1 trial is nearing its end, with the objective of determining the recommended phase 2 dose for further study. The upcoming expansion phase will involve several patient groups, such as those with HER2-positive breast cancer who are resistant to or cannot tolerate Enhertu, patients with HER2-low breast cancer, and those with HER2-positive gastric cancer. With the IND approval, Iksuda can now recruit patients from multiple sites across the U.S., in addition to those in Australia, New Zealand, and Singapore. The completion of the phase 1 trial is projected for the second half of 2026.

IKS014 is designed as a potentially superior ADC, leveraging tumor-selective activation and release of the cytotoxic agent, monomethyl auristatin F (MMAF). Preclinical trials have shown it to exhibit robust activity in both high and low HER2-expressing tumors, with a better therapeutic index compared to other HER2-focused drugs. Iksuda obtained exclusive worldwide rights to IKS014, excluding Greater China and South Korea, from LigaChem Biosciences.

Iksuda Therapeutics is at the forefront of developing advanced ADCs aimed at treating challenging hematological and solid tumors. Their pipeline emphasizes prodrug DNA and protein alkylating payloads, coupled with stable conjugation chemistries like their proprietary PermaLink® platform. The company's ADC design concepts have been clinically validated to enhance the therapeutic index of this critical modality, aiming to improve outcomes for cancer patients.