SKB264 (MK-2870) is approved for clinical trials in the European Union

On June 19, 2023, Kelun-Biotech announced that the innovative TROP2-ADC (SKB264, also known as MK-2870), which is being developed in collaboration with MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA), in combination with pembrolizumab (KEYTRUDA®, MSD’s anti-PD-1 therapy) for Phase II clinical studies in select patients with a variety of advanced solid tumors, has been approved for clinical trials in the European Union. This is an international multicenter clinical study which is currently approved in multiple countries and territories, including China, the United States, Canada, Australia, and now the European Union, fully demonstrating the strength of Kelun-Biotech in conducting clinical studies on a global scale. MSD and Kelun-Biotech are working closely to continually advance the international development of SKB264.

At present, immune checkpoint inhibitors, mainly represented by anti-PD-1/PD-L1 therapies, have played an important role in treating cancer across a variety of tumors. In order to improve outcomes for patients, combination therapies are being explored, including combination with chemotherapy, targeted therapy, radiotherapy, other types of immunotherapy, and more.

ADCs specifically target tumor cells to deliver cytotoxic molecules that induce immunogenic cell death (ICD) and trigger innate and adaptive immune responses, allowing large numbers of T cells to infiltrate tumor cells and thereby improving immunotherapeutic efficacy. Clinical trial data in multiple cancer types have shown that anti-PD-1 therapies in combination with ADCs may be able to improve efficacy compared to either agent alone. TROP2 is highly expressed in a variety of epithelial-derived tumors and can promote tumor cell proliferation, invasion, and metastasis, and is a promising target for broad-spectrum anti-tumor therapy. TROP2-ADCs specifically target TROP2-expressing tumor cells to deliver cytotoxic effects, and have shown encouraging anti-tumor activity as monotherapy in several clinical trials, and has the potential to improve anti-tumor efficacy in combination with immune checkpoint inhibitors such as anti-PD-1/PD-L1 therapies.

About SKB264 (MK-2870)

SKB264 is an innovative ADC targeting TROP2 which was developed by OptiDC, a well-known international ADC R&D platform of Kelun-Biotech, using a proprietary payload-linker strategy (Kthiol design strategy) that achieves an optimized balance of ADC safety and efficacy by combining novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules with DAR of 7.4 (novel topoisomerase I inhibitors) [2].

SKB264 (MK-2870) has received 2 Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer and locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have failed EGFR-TKI therapy.

SKB264 (also known as MK-2870) is currently conducting Phase II and Phase III clinical trials of monotherapy/combination in multiple solid tumors. In China, the Phase III registrational clinical study of SKB264 monotherapy for patients with advanced or metastatic triple-negative breast cancer (TNBC) who have failed at least second-line therapy is progressing smoothly, and it is expected to become the first domestic TROP2-ADC approved for the Chinese market. Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant and EGFR-mutated non-small cell lung cancer (NSCLC) are also rapidly advancing. Several Phase II clinical studies of SKB264 in combination with pembrolizumab (KEYTRUDA®, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are ongoing. Kelun-Biotech has licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to research, develop, produce and commercialize SKB264 in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).

About Kelun-Biotech

Kelun-Biotech is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacture, commercialization and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries including China, Europe, and the United States.

References:
[1] Merck & Co., Inc. Investor Event at ASCO 2023
[2] Cheng Yezhe, et al. Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. Frontiers in Oncology. Vol 12, 2022.