Recently, Colombotai continued to get good news. On January 11, 2023, the company innovated the Phase II clinical study of TROP2-ADC(SKB264, MK2870) combined with ocitinib in the first-line treatment of EGFR-mutated non-small cell lung cancer (NSCLC) patients, and obtained the clinical trial notification from the National Medical Products Administration (NMPA).
Epidermal growth factor receptor (EGFR) mutations are the most common driver mutation in patients with lung adenocarcinoma in Asian populations, occurring in about 50% of patients. Currently, EGFR tyrosine kinase inhibitors (EGFR-TKI) are the first-line standard treatment for advanced NSCLC with EGFR mutations.
EGFR-TKI has undergone the continuous development of first-generation, second-generation and third-generation (oechtinib, etc.) drugs, and third-generation EGFR-TKI has become the preferred treatment for its better efficacy. However, the progression-free survival (PFS) of third-generation TKI is about 18-20 months, and drug resistance is inevitable after EGFR-mutated NSCLC targeted TKI therapy. Continuous attempts of combination therapy to improve efficacy have become the direction of continuous exploration in the field of drug research and development.
TROP2 was overexpressed in EGFR-mutated NSCLC, and SKB264, a novel Trop2-targeting ADC, showed encouraging antitumor activity in patients who had failed EGFR-TKI therapy. SKB264 combined with third-generation EGFR-TKI oechtinib, combined with a strong combination, has the potential to overcome or delay TKI resistance and bring better treatment options to patients with EGFR-mutated NSCLC.
About SKB264(TROP2-ADC)
SKB264 is a new generation of antibody conjugate drug (ADC), which is a combination of Colombote's proprietary intellectual property rights of humanized monoclonal antibody targeting TROP2, Linker, and a novel topoisomerase I inhibitor. Skb264 combines the specificity of monoclonal antibody against tumor cell surface target antigens with the high efficiency of cytotoxic drugs.
Based on preliminary clinical data, SKB264 is currently being tested in single-agent/combination Phase II and Phase III trials in multiple tumor species. Since March 2022, 8 new clinical studies have been conducted on SKB264 (7 in China and 1 in the United States) :
The United States:
On November 15, 2022, a Phase II clinical study of SKB264 in combination with Pabolizumab in patients with advanced solid tumors was approved.
China:
On January 11, 2023, a Phase II trial of SKB264 in combination with oechtinib for first-line treatment of EGFR-mutated non-small cell lung cancer was approved.
On 6 December 2022, a Phase II clinical trial (registration number: CTR20222948) completed its first patient dosing to evaluate SKB264 monotherapy in selected advanced solid tumors.
On August 18, 2022, a Phase II study of SKB264 alone or in combination with Pabolizumab, with or without chemotherapy, was approved to treat patients with advanced or metastatic non-small cell lung cancer (NSCLC).
On July 14, 2022, a Phase II clinical study of SKB264 in combination with Pabolizumab in patients with advanced solid tumors was approved.
On April 11, 2022, a Phase II trial of SKB264 in combination with or without KL-A167(PD-L1 mab) for first-line treatment of locally advanced, relapsed, or metastatic TNBC patients who are inoperable was approved, and patient enrollment is ongoing.
On April 7, 2022, SKB264 was approved to conduct a Phase III registered clinical study in patients with advanced or metastatic TNBC who had failed at least second-line therapy, becoming the first domestic TROP2-ADC to enter a registered clinical study, and patient recruitment is underway. SKB264 has been recognized by the NMPA Center for Drug Evaluation (CDE) as a breakthrough therapy for the treatment of locally advanced or metastatic triple negative breast cancer.
On March 31, 2022, a Phase II trial of SKB264 in combination with KL-A167(PD-L1 monoclonal antibody) with or without platinum-based treatment in non-small cell lung cancer was approved and patient enrollment is ongoing.
About Colombote
Colombo Tai is a subsidiary of Colombo Pharmaceutical, focusing on the research and development, production, marketing and international cooperation of biotechnology drugs and innovative small molecule drugs. Focusing on unmet clinical needs in China and around the world, the company focuses on major disease areas such as tumor, autoimmune, inflammatory and metabolic diseases, and builds an international drug research and development and industrialization platform, committed to becoming an international leader in the field of innovation. Great progress has been made in the field of biotechnology drugs, including ADC, monoclonal antibody, double antibody, and hot technologies of innovative small molecule drugs with new targets. At present, the company has more than 33 innovative projects for the treatment of tumor, autoimmune, inflammatory, metabolic diseases and other major diseases, of which 14 projects have entered clinical research in China and 3 projects have carried out clinical research in the United States.
