Jiangsu Vcare's Next-Generation TRK Inhibitor VC004 Completes First Patient Enrollment in China's Pivotal Phase II Trial

　　Recently, Jiangsu Vcare Pharmaceutical Technology Co., Ltd. (Jiangsu Vcare) completed the first patient enrollment in the pivotal Phase II clinical trial (Registration Number: CTR20201703) in China for its self-developed next-generation TRK inhibitor, VC004. This clinical trial aims to further evaluate the efficacy and safety of VC004 in treating patients with NTRK gene fusion mutations.

　　Dr. Gong Yanchun, Co-founder and CEO of Jiangsu Vcare, stated: "VC004 is a next-generation TRK inhibitor prioritized by our company. With its unique mechanism of action and favorable safety profile, as well as significant clinical efficacy demonstrated in early clinical studies, we believe it has the potential to be the leading drug among similar next-generation TRK inhibitors. The completion of the first patient enrollment in this pivotal Phase II trial marks another significant milestone in VC004's clinical development. We will accelerate its subsequent clinical development process, expediting the exploration of its safety and efficacy in patients with NTRK fusion-positive solid tumors, striving to bring this resistance-overcoming TRK targeted therapy to cancer patients as soon as possible."

　　About VC004

　　VC004 is a Class I targeted agent independently developed by Jiangsu Vcare. As a next-generation TRK inhibitor, it's expected to provide a treatment option for patients with NTRK fusion mutations, addressing the unmet clinical need for anti-resistance therapy globally. Phase I clinical data show an ORR of 80-90% in patients with NTRK fusion-positive solid tumors, with the longest DOR reaching 24 months. Efficacy data collection is ongoing. Preliminary efficacy was also observed in patients with brain metastases and those previously treated with TRK inhibitors, with over 60% of brain metastasis patients showing varying degrees of tumor shrinkage, including one case where the lesion nearly disappeared. Currently, no next-generation resistance-overcoming inhibitors are marketed globally. VC004 has the potential to become a leading next-generation TRK inhibitor worldwide.

　　About NTRK Fusion-Positive Solid Tumors

　　NTRK gene fusions have been identified as oncogenic drivers in both adult and pediatric patients with a wide range of solid tumors. The NTRK genes (NTRK1, NTRK2, and NTRK3) encode the TRKA, TRKB, and TRKC receptors of the TRK family. These fusions act as drivers in multiple cancers and are found across numerous solid tumor types. Currently, NTRK fusion inhibitors show remarkable efficacy in the clinical practice, holding immense potential in the field of oncology. In China, NTRK gene fusion mutations are found in prevalent cancer types such as lung cancer, colorectal cancer, breast cancer, and thyroid cancer, especially high prevalence in certain rare cancers, including secretory breast carcinoma and salivary gland secretory carcinoma.