We are proud to announce that IKS014, IKSUDAs HER2-directed ADC, has been awarded The Most promising ADC to Watch at the 16^th World ADC convention, San Diego, held on November 3-6, 2025.

World ADC is considered the premier global conference for end-to-end ADC innovation & success, and is the world’s largest, definitive and longest standing ADC forum. This year it was attended by around 1,300 delegates including upcoming and established innovators, commercialization parties and drug manufacturing companies in the field.

The 12^th annual World ADC awards are intended to reflect and recognize the long-term contributors, novel and innovative programs, and upcoming pioneers who have gone above and beyond to ensure the continued success of the field and helped progress ADCs towards standard-of-care treatments.

IKS014 was selected based on excellent data from the most recent data-cut of the ongoing Phase 1 clinical trial.

Phase 1 Part I (dose escalation) has now been completed in around 70 patients with HER2+ and HER2-low solid tumors with a median number of prior therapies of 4, and is now in Part II (Dose Expansion) in sites in the US, Australia, NZ and Singapore. The recommended dose for Part II is 105 mg/m² (approximately 2.8 mg/kg).

Good tolerability profile

At the last cut-off date (end July, n = 62), it was associated with good tolerability, with only low-grade ocular toxicities (largely dry eye) and pneumonitis, with no cases of thrombocytopenia, neutropenia or ILD. The incidence and severity of GI toxicities such as nausea, vomiting and diarrhoea was significantly lower than other HER2-directed ADCs. This best-in-class profile replicates the data seen in studies in China where the ADC is developed as FS-1502 and is nearing BLA submission.

Promising anti-cancer activity

Anti-tumor activity was observed across all dose levels and in various tumor indications including breast, oesophageal, gall bladder, ovarian, endometrial, gastric/ GEJ cancers and NSCLC.

In 11 patients with advanced breast cancer treated with doses of ≥ 90 mg/m² (2.3 mg/kg), responses were observed in 7 (ORR 64%), including all 4 patients who had HER2+ disease, 3 of which had previously received Enhertu.  

In 10 patients with advanced HER2+ oesophageal adenocarcinomas, responses were observed in 5 (ORR 50%) including one complete response.

IKS014 has the potential to become the first choice HER2-therapy post Enhertu, replacing Kadcyla and other HER2-targeting agents as appropriate. In cancers such as oesophageal adenocarcinomas, it may have the potential to become the HER2-ADC of choice. Based on data to date, IKSUDA is excited to progress this program through Dose Expansion.