Colonbotai SKB264 (MK-2870) combined with osimertinib was approved for clinical trials

On January 11, 2023, the company's innovative TROP2-ADC (SKB264, MK2870) combined with osimertinib first-line treatment of EGFR-mutant non-small cell lung cancer (NSCLC) patients Phase II clinical study obtained the National Medical Products Administration (NMPA) clinical trial notice.

In Asian populations, epidermal growth factor receptor (EGFR) mutations are the most common driver gene mutation in lung adenocarcinoma patients, occurring in about 50%. Currently, EGFR tyrosine kinase inhibitors (EGFR-TKIs) are the first-line standard of care for EGFR-mutant advanced NSCLC.

EGFR-TKI has undergone the continuous development of first, second, and third generation (osimertinib, etc.) drugs, and third-generation EGFR-TKI has become the preferred treatment because of its better efficacy. However, the progression-free survival (PFS) of third-generation TKI is about 18-20 months, and drug resistance after EGFR mutation NSCLC targeted TKI treatment is inevitable, and continuous attempts to improve the efficacy of combination therapy have become the direction of continuous exploration in the field of drug development.

TROP2 is overexpressed in EGFR-mutant NSCLC, and SKB264, a novel ADC targeting TROP2, has shown encouraging antitumor activity in patients who have failed EGFR-TKI therapy. SKB264 combined with third-generation EGFR-TKI osimertinib has the potential to overcome or delay TKI resistance, bringing better treatment options for patients with EGFR-mutant NSCLC.

About SKB264(TROP2-ADC)

SKB264 is a new generation of antibody conjugate (ADC) composed of humanized monoclonal antibody targeting TROP2, enzymatic cleavage Linker and novel topoisomerase I inhibitor with independent intellectual property rights, combining the specificity of monoclonal antibody to target antigens on tumor cell surface and the high efficiency of cytotoxic drugs.

Based on preliminary clinical data, SKB264 is currently undergoing phase II and III clinical trials of single-agent/combination therapy for multiple tumor types. Since March 2022, SKB264 has carried out 8 new clinical studies (7 in China and 1 in the United States):

United States:

On November 15, 2022, the phase II clinical study of SKB264 combined with pembrolizumab in patients with advanced solid tumors was approved for launch.

China:

On January 11, 2023, the phase II clinical study of SKB264 combined with osimertinib for the first-line treatment of EGFR-mutant non-small cell lung cancer patients was approved.

On December 6, 2022, a Phase II clinical trial (registration number: CTR20222948) completed the first patient dosing to evaluate SKB264 monotherapy for selected advanced solid tumors.

On August 18, 2022, a Phase II clinical study of SKB264 alone or in combination with pembrolizumab, with or without chemotherapy, for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) was approved.

On July 14, 2022, the phase II clinical study of SKB264 combined with pembrolizumab in patients with advanced solid tumors was approved for launch.

On April 11, 2022, the Phase II clinical trial of SKB264 with or without KL-A167 (PD-L1 monoclonal antibody) for the treatment of patients with inoperably resectable locally advanced, relapsed or metastatic TNBC was approved, and patient recruitment is ongoing.

On April 7, 2022, the Phase III. registered clinical study of SKB264 monotherapy in patients with advanced or metastatic TNBC who failed at least second-line therapy was approved for launch, becoming the first domestic TROP2-ADC to enter the registration clinical study, and patient recruitment is ongoing. SKB264 has been approved as a breakthrough therapy by the NMPA Center for Drug Evaluation (CDE) for the treatment of locally advanced or metastatic triple-negative breast cancer.

On March 31, 2022, a Phase II clinical trial of SKB264 in combination with KL-A167 (PD-L1 monoclonal antibody) plus or without platinum in the treatment of non-small cell lung cancer was approved, and patient recruitment is underway.

About Kolumberta

Kelun Botai is a holding subsidiary of Kelun Pharmaceutical, focusing on the research and development, production, marketing and international cooperation of biotechnology drugs and innovative small molecule drugs. Focusing on the unmet clinical needs of the world and China, the company focuses on major diseases such as tumors, autoimmunity, inflammation and metabolic diseases, builds an international drug research and development and industrialization platform, and is committed to becoming an international leading enterprise in the field of innovation. In the field of biotechnology drugs, including ADC, monoclonal antibody, bispecific antibody, hot technologies of innovative small molecule drugs with new targets, etc., significant progress has been made. At present, the company has more than 33 innovative projects for the treatment of major diseases such as tumors, autoimmunity, inflammation, and metabolic diseases, of which 14 projects have entered clinical research in China and 3 projects have carried out clinical research in the United States.