[Edaily Reporter Kim Jinsoo ] #LigaChem Biosciences announced that its partner, Exsuda Therapeutics, is developing an antibody-drug conjugate(ADC) “IKS014 (LCB14)” being developed by its partner, Iksuda Therapeutics, at the “San Antonio Breast Cancer Symposium” (hereinafter “SABCS”), to be held in San Antonio, Texas, from the 8th to the 11th of next month.

IKS014 is a HER2-targeted ADC that utilizes LigaChem Biosciences’ proprietary ADC platform, “ConjuAll” technology. In particular, it is designed to deliver efficacy even in patients whose disease has recurred or who are refractory to treatment with “Enhertu” and other TOP1i-class ADCs, as it incorporates a payload with a different mechanism of action.

At SABCS, Iksuda will focus its presentation on results from a cohort of HER2-positive breast cancer patients with prior Enhertu treatment experience. This is an area of high unmet medical need, as there is currently no established standard of care for patients whose disease has progressed following Enhertu treatment.

According to the study, IKS014 achieved a partial response (PR) in 5 out of 10 evaluable HER2-positive breast cancer patients with a history of Enhertu treatment, resulting in an objective response rate (ORR) of 50%. These patients had received multiple prior treatments, with a median of 6 prior treatment lines (range: 2–12). Responses were also observed in patients who had experienced disease progression (PD) during Enhertu treatment, and sustained responses—including patients who maintained their response for 18 months or longer—were confirmed, indicating significant clinical relevance.

Grade 3 treatment-related adverse events (TRAEs) occurred in 15.2% of patients, and no Grade 5 adverse events or serious treatment-related adverse events (SAEs) were reported. The company stated that, compared to other HER2-targeted ADCs, Iksuda had a significantly lower incidence of high-grade TRAEs and showed no cases of high-grade pneumonia, interstitial lung disease (ILD), neutropenia, anemia, or gastrointestinal toxicity.

Park Se-jin, CEO of LigaChem Biosciences, stated, “IKS014 is the most advanced program utilizing the Conjuol platform technology.” He added, “The fact that its design—which incorporates a payload with a different mechanism of action from Enhertu—led to meaningful responses even in patients who had previously received Enhertu treatment demonstrates that we have clinically validated our competitiveness in overcoming the issue of payload resistance, which has become a major topic of discussion in the ADC industry.”