Kelun-Biotech to present clinical updates for SKB264 at 2023 ESMO

Chengdu, China, August 10, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced that it will present the data from a Phase I/II clinical trial of the innovative TROP2-ADC (SKB264, MK-2870) jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc Rahway NJ USA) at the European Society for Medical Oncology (ESMO) Congress 2023 to be held in Madrid, Spain from October 20 to 24, 2023. The data will be presented in the form of an oral presentation and will focus on the treatment of previously-treated patients with metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In June of this year, SKB264 was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic HR+/HER2- breast cancer which has received at least second-line systemic therapy.

The abstract of this oral presentation is titled "SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): results from a phase I/II, single-arm, basket trial", and the presentation number is 380MO. Details of the abstract are expected to be released on the official website of the ESMO Congress on October 16, 2023, local time.

The ESMO Congress is the most prestigious and influential oncology conference in Europe. It brings together clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all around the world each year. By sharing the latest cutting-edge data, it provides unparalleled networking opportunities and high quality education for oncologists and other stakeholders.

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) [1].

SKB264 has received 3 Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer, locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have failed EGFR-TKI therapy and the treatment of locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer which has received at least second-line systemic therapy.

SKB264 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 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“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 and regions including China, Europe, and the United States. To learn more, please visit
http://kelun-biotech.com/.

References:

[1] 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

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