Iksuda Therapeutics (Iksuda), a U.K.-based developer of antibody-drug conjugates (ADCs), has successfully completed the first cycle of therapy with IKS014 in the first patient enrolled in a phase 1 study aimed at treating advanced HER2-positive solid tumors.

This information was provided by the company's partner, LegoChem Biosciences, headquartered in Korea.

This achievement comes in the wake of phase 1 clinical trial data obtained through Fosun Pharma, a Chinese pharmaceutical and healthcare company. Fosun Pharma is now progressing FS-1502 (IKS014) through phase 2 and phase 3 trials in China.

The open-label interventional study, identified as NCT05872295, is designed to evaluate the safety and tolerability of increasing doses of IKS014, with the aim of determining the recommended dosage for phase 2. 

The phase 2 study will further explore the safety, pharmacokinetics/pharmacodynamics, and efficacy of IKS014 at the recommended phase 2 dosages. 

Patient enrollment is currently underway at five predetermined locations in Australia, and the phase 1b trial is anticipated to deliver results in the second half of 2025.

Dr. Dave Simpson, Chief Executive Officer of Iksuda Therapeutics, said, “The dosing of the first patient in our phase 1 trial of IKS014 signifies a major milestone for Iksuda, signifying our transition into a clinical-stage company.”

This trial of IKS014 could potentially offer improved treatment options for patients afflicted with HER2+ solid tumors, he added. 

In January, the South Korean biopharmaceutical firm Celltrion substantially increased its ownership stake in Iksuda, bringing it to 47.05 percent. This strategic maneuver firmly established Celltrion as the primary shareholder in the company.