Jiangsu Vcare's Next-Generation TRK Inhibitor VC004 Project Approved for Pivotal Phase II Clinical Trial
Published Time:
2023-11-01 17:18
Source:
Recently, the pivotal Phase II clinical study for Jiangsu Vcare Pharmaceutical Technology Co., Ltd.'s (Jiangsu Vcare) next-generation TRK inhibitor VC004 for treating NTRK fusion-positive solid tumors was approved by the NMPA. This clinical study will further evaluate the efficacy and safety of VC004 in patients with NTRK fusion mutations. Upon success, Jiangsu Vcare plans to submit an NDA in China.
VC004 is a next-generation TRK inhibitor independently developed by Jiangsu Vcare for the clinical treatment of solid tumors with NTRK fusion mutations. 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.
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 the favorable safety profile and 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 approval for this pivotal Phase II clinical trial signifies full recognition and positive affirmation of VC004's pre-clinical and clinical development progress. 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 is expected to provide a treatment option for patients with NTRK fusion mutations, addressing the unmet clinical need for anti-resistance therapy globally. As a next-generation therapeutic, VC004 demonstrates excellent clinical efficacy and safety. Currently, no next-generation resistance-overcoming inhibitor drugs 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.
Related News
23
2017
/
08
Jiangsu Vcare Was Honored as Jiangbei New Area Lingque Enterprise
In 2017, the list of “Lingque” enterprises in Jiangbei New District of Nanjing was announced and Jiangsu Vcare Pharmaceutical Technology Co., Ltd. was successfully selected into the list. “Lingque” enterprises project aim to select a group of innovative SMEs with high growth in Jiangbei district and provide the selected enterprises with one-stop support such as equity investment, emergency turnover, loan interest subsidy, R&D subsidies, and etc.. To be successfully selected into the “Lingque” enterprises program is an inspiration to the company. Vcare keep integrating various resources to quickly become bigger and stronger to contribute to the development of Jiangbei New Area.
View Details
15
2017
/
06
Jiangsu Vcare and Yangzhou Princechem Acquired Boya Chemical Company
The signing ceremony of Jiangsu Vcare Pharmaceutical Technology Co., Ltd. and Yangzhou Princechem Co., Ltd. acquiring Boya Chemical (Nantong) Co., Ltd. was held in the conference room of Jiangsu Vcare recently. Boya Chemical (Nantong) Co., Ltd. is located in Yangkou Chemical Industrial Park, Rudong Coastal Economic Development Zone, Jiangsu Province. The company covers an area of 70 acres and is a Hong Kong-owned enterprise. The goal of this acquisition is to build Boya Chemical into a raw material drug manufacturer that meets the standards of China, the United States and the European Union. After renovation, Boya Chemical will be a chemical raw materials production base of Yatai Group and solve the bottleneck problem of Vcare's raw material drug R&D and production. It’s believed that the acquisition will make a significant contribution to Vcare’s production and sales of intermediates and APIs.
View Details
06
2017
/
06
Leaders of Management Committee of Rudong Coastal Economic Development Zone Visited Jiangsu Vcare
Leaders of management committee of Rudong coastal economic development zone visited Jiangsu Vcare on June 1st, 2017. The delegation was received by the vice chairman Jun Qu, general manager Yongqiang Liu, and vice general manager Yanchun Gong of Vcare. The delegation visited the Vcare's chemical research center and drug research center. Mr. Liu introduced R&D progress and advanced equipment to the guests. During the discussion, Mr. Liu introduced the overall development plan of Yatai Group's pharmaceutical industry, and Vcare's development history and the future plan. Mr. Liu also introduced the progress of innovative drug Vicagrel and a series of generic drugs in detail. The leaders of Rudong coastal economic development zone introduced the planning of their park, local investment, environmental protection policies and etc., and expressed their confidence in the research and development prospects of Vcare.
View Details
15
2017
/
05
Leaders of Pukou District Economic and Trade Bureau Visited Jiangsu Vcare
Leaders of Pukou District Economic and Trade Bureau Visited Jiangsu Vcare on May 12, 2017. The general manager Yongqiang Liu received the delegation.
View Details
24
2017
/
04
Jiangsu Vcare Held Mountain Climbing and Tug-of-war Competitions
Jiangsu Vcare organized mountain climbing and tug-of-war activities recently. The mountain climbing competition was divided into men's and women's groups, and each group competed for top three. The venue was located in Laoshan National Forest Park. Everyone climbed the top after efforts. Four teams consisting of Vcare’s two R&D center members conducted a tug-of-war competition after going down the mountain and finally "Lingya team" won the top spot. Everyone had fun.
View Details
30
2017
/
03
Jiangsu Vcare Held the First Quarter Fire Drill
In order to further improve the safety awareness of new employees, Jiangsu Vcare held a fire-fighting exercise on March 30, 2017. New employees had a deeper understanding of fire extinguishers through on-site explanation of the types, inspection methods and instructions of fire extinguishers. Everyone learned about fire-fighting procedures and the use of appliances. The exercise provided a safety guarantee for everyone’s life and work.
View Details
Company Address:
No. 136, Huakang Road, Jiangbei New Area, Nanjing, P. R. China
Subsidiary NJVcare Website：
Scan to see
Copyright © JIANGSU VCARE PHARMATECH CO.,LTD.
苏公网安备32011202001742号
Powerby：www.300.cn nanjing.300.cn