Clinical Approval For Colombotide Skb264 (Mk-2870) In Combination With Oxitinib

Recently, Colambotai has received good news. On January 11, 2023, the Company's Phase II clinical study of its innovative TROP2-ADC (SKB264, MK2870) in combination with oxitinib for the first-line treatment of patients with EGFR-mutated non-small cell lung cancer (NSCLC) was granted a Notice of Clinical Trial by the National Drug Administration (NMPA).

In Asian populations, epidermal growth factor receptor (EGFR) mutations are the most common driver mutation in patients with lung adenocarcinoma, with an incidence of approximately 50%. Currently, EGFR tyrosine kinase inhibitors (EGFR-TKI) are the first-line standard of care for advanced NSCLC with EGFR mutations.

EGFR-TKIs have evolved through first-, second- and third-generation (oxitinib, etc.) drugs, and third-generation EGFR-TKIs have become the preferred treatment option due to better efficacy. However, the progression-free survival (PFS) of third-generation TKI is about 18-20 months, and drug resistance is inevitable after targeted TKI therapy for EGFR-mutated NSCLC, and continuous attempts to combine therapy to improve efficacy have become a direction of continuous exploration in the field of drug development.

TROP2 is overexpressed in EGFR-mutated NSCLC, and SKB264 (a novel ADC targeting TROP2) has shown encouraging anti-tumour activity in patients who have failed EGFR-TKI therapy. patients with EGFR mutated NSCLC.

About SKB264 (TROP2-ADC)
SKB264 is a new generation of antibody-coupled drug (ADC) combining a humanized monoclonal antibody targeting TROP2, an enzymatically cleavable Linker and a novel topoisomerase I inhibitor, which combines the specificity of a monoclonal antibody against a tumor cell surface target antigen with the efficiency of a cytotoxic drug.

Based on preliminary clinical data, SKB264 is currently in Phase II and Phase III clinical trials for multiple tumour types as a single agent/combination. eight new clinical studies (seven in China and one in the US) have been conducted with SKB264 since March 2022.

United States.
On 15 November 2022, a Phase II clinical study of SKB264 in combination with pablizumab for the treatment of patients with advanced solid tumours was approved.

China.
On 11 January 2023, a Phase II clinical study of SKB264 in combination with oxitinib in the first-line treatment of patients with EGFR-mutated non-small cell lung cancer was approved.

On 6 December 2022, a Phase II clinical trial (registration number: CTR20222948) was completed with first patient dosing for the evaluation of SKB264 monotherapy in selected advanced solid tumours.

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

On 14 July 2022, a Phase II clinical study of SKB264 in combination with pablizumab for the treatment of patients with advanced solid tumours was approved.

On 11 April 2022, a Phase II clinical trial of SKB264 in combination with or without KL-A167 (PD-L1 monoclonal antibody) for the first-line treatment of patients with non-surgically resectable, locally advanced, recurrent or metastatic TNBC was approved and patient recruitment is ongoing.
On April 7, 2022, SKB264 was approved for registration in a Phase III clinical study for the monotherapy of patients with advanced or metastatic TNBC who have failed at least second-line therapy, making it the first domestic TROP2-ADC to enter a registered clinical study, with patient enrollment underway. 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) with or without platinum was approved for the treatment of non-small cell lung cancer and patient enrollment is ongoing.

About Coloplast
CorenBotai is a holding company of Coren Pharmaceuticals, focusing on the development, manufacturing, marketing and international collaboration of biotech drugs and innovative small molecule drugs. Focusing on unmet clinical needs globally and in China, the company focuses on major disease areas such as oncology, autoimmunity, inflammation and metabolic diseases, building an international drug development and industrialisation platform and aiming to become a leading international player in the field of innovation. Significant progress has been made in the field of biotechnology drugs, including hot technologies for ADCs, monoclonal antibodies, dual antibodies and innovative small molecule drugs with new targets. The Company currently has more than 33 innovative projects for the treatment of major diseases such as oncology, autoimmunity, inflammation and metabolic diseases, of which 14 projects are in clinical studies in China and 3 projects are in clinical studies in the US.