Kelun-Biotech Receives Approval for Clinical Trials of Dual-Payload ADC Drug SKB565
Chinese biopharmaceutical company Kelun-Biotech announced it has received approval from China's NMPA to begin clinical trials for its novel dual-payload ADC drug, SKB565. The drug is intended for the treatment of advanced solid tumors.
Kelun-Biotech, a biopharmaceutical company based in China, has announced that its investigational new drug application for SKB565 has been approved by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The approval allows the company to proceed with clinical trials for SKB565, a dual-payload Antibody-Drug Conjugate (ADC) being developed for the treatment of advanced solid tumors.
SKB565 utilizes Kelun-Biotech's proprietary OptiDC™ platform and features a dual-payload design. This design enables the targeted delivery of both toxins and immunomodulators directly to tumor tissue. Unlike conventional ADCs, which typically carry only toxins, SKB565 is designed with a dual antitumor mechanism. It aims to precisely target and kill tumor cells while simultaneously activating an immune response within the tumor microenvironment to enhance and potentially prolong antitumor efficacy.
Preclinical studies indicated that SKB565 demonstrated significant antitumor activity and a favorable safety profile, supporting its progression into clinical development. This advancement marks a milestone for Kelun-Biotech's "ADC + IO" (Antibody-Drug Conjugate plus Immuno-Oncology) strategy, aiming to combine the strengths of targeted drug delivery with immune system activation.
The company has a diversified pipeline of ADC candidates and is actively pursuing combinations with other therapeutic approaches. Kelun-Biotech focuses on developing innovative treatments for unmet medical needs in oncology and other major disease areas.