Delhi, Sept. 19, 2024 (GLOBE NEWSWIRE) -- SKB264, also known as MK-2870, is an innovative antibody-drug conjugate (ADC) targeting TROP2, currently being developed by Kelun Biotech in partnership with MSD (Merck & Co., Inc.). Developed by OptiDC, Kelun Biotech's renowned international ADC R&D platform, SKB264 utilizes a proprietary payload-linker strategy called the Kthiol design. This strategy achieves an optimized balance of safety and efficacy by incorporating novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules, boasting a drug-to-antibody ratio (DAR) of 7.4 with topoisomerase I inhibitors.
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SKB264 is making strides in clinical development, currently undergoing Phase II and Phase III trials for various solid tumors. In China, a Phase III registrational clinical study is evaluating SKB264 as a monotherapy for patients with advanced or metastatic triple-negative breast cancer (TNBC) who have failed at least second-line therapy. This study is progressing smoothly, positioning SKB264 to potentially become the first domestic TROP2-targeting ADC approved in the Chinese market.
The ADC's development is further supported by two Breakthrough Therapy Designations (BTDs) granted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). These designations apply to its use in treating locally advanced or metastatic TNBC and EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have not responded to prior EGFR-tyrosine kinase inhibitor (TKI) therapies.
In addition to its monotherapy studies, SKB264 is also being evaluated in combination with established therapies, including pembrolizumab, an anti-PD-1 treatment, and KL-A167, an anti-PD-L1 antibody. These combination studies are crucial as they aim to enhance the therapeutic impact of SKB264 across various cancer types, offering new hope to patients with limited treatment options.
Kelun Biotech has secured exclusive rights for MSD to research, develop, produce, and commercialize SKB264 in territories outside Greater China, further amplifying the ADC's potential reach and impact on global cancer treatment.
As SKB264 approaches potential regulatory approval, its innovative design and promising clinical data underline a significant advancement in cancer therapy. By targeting TROP2, SKB264 not only showcases the evolution of ADC technology but also exemplifies the future of targeted cancer treatments, offering new avenues for patients battling aggressive malignancies. With its transformative potential, SKB264 stands poised to redefine treatment landscapes in oncology.
