Pan-Cancer Potential! Jiangsu Vcare’s Anti-Resistant TRK Inhibitor VC004 Capsule advances to NDA Preparation Phase
Published Time:
2025-01-26 18:06
Source:
In January 2025, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced that its self-developed next-generation anti-resistant TRK inhibitor VC004 capsule has officially entered the domestic NDA preparation phase, initiating pre-NDA communications with regulatory authorities. Marking this milestone, Jiangsu Vcare has joined the top tier of domestic self-developed drugs targeting this pathway at remarkable speed.
VC004 is clinically indicated for the treatment of NTRK fusion-positive solid tumors. It features a "tumor-agnostic" mechanism and has demonstrated outstanding efficacy and favorable safety in Phase I/II clinical studies.
The Phase I data were presented at the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024):
In treatment-naïve patients, the confirmed objective response rate (ORR) in the recommended Phase II dose (RP2D) expansion cohort was 73.1% [95% CI: 52.2–88.4]. Among three patients who had progressed on prior TRK-TKI therapy, two showed tumor shrinkage, with one achieving a partial response (PR, 39.6%).
Most patients experienced rapid onset and sustained clinical benefits, with the longest-to-date duration of response exceeding 36 months. Among six patients with baseline brain metastases, two exhibited intracranial lesion reductions of 61.8% and 25%, respectively, while two others showed complete disappearance of non-target lesions after four months of treatment.
Safety-wise, treatment-related adverse events (TRAEs) were predominantly Grade 1–2, with no fatal TRAEs reported. No new safety signals were observed compared to other drugs in the same class.
About VC004
VC004 is a Class 1 targeted anti-tumor drug, independently developed by Jiangsu Vcare. As a next-generation TRK inhibitor with a unique anti-resistance mechanism, it is poised to become a new treatment option for patients with NTRK fusion mutations. In China, the project is advancing with a single-arm Phase II trial as the pivotal study, while its Investigational New Drug (IND) application has been approved by the US FDA. Currently, no second-generation NTRK inhibitor matches the efficacy of first-generation drugs on NTRK-naïve patients and possesses second-generation anti-drug resistance activity, positioning VC004 as a front-runner in this category.
Related News
08
2024
/
07
Recently, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) reported positive results from its Phase II clinical trial of VC005 tablets, a second-generation selective JAK1 inhibitor, for the treatment of ankylosing spondylitis (AS).
View Details
02
2024
/
07
Jiangsu Vcare and Geneseeq Form Strategic Partnership for NTRK Companion Diagnostics
On July 2, 2024, Jiangsu Vcare and Geneseeq signed a strategic cooperation agreement in Nanjing’s Jiangbei New District. The collaboration will focus on the joint development and future commercialization of a companion diagnostic kit for the NTRK inhibitor VC004.
View Details
07
2024
/
06
Jiangsu Vcare Unveils Phase I Clinical Trial Results of TRK Inhibitor VC004 at 2024 ASCO
On June 2, 2024，Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) unveiled the Phase I clinical trial results of its self-developed next-generation TRK inhibitor, VC004, for the treatment of locally advanced/metastatic solid tumors at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
View Details
28
2024
/
04
Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced the completion of participants enrollment in its Phase I clinical trial for VC005, a second-generation selective JAK1 inhibitor developed as a topical gel formulation for the treatment of mild-to-moderate atopic dermatitis (AD). The trial included four cohorts of healthy volunteers and three cohorts of patients. The blinded analysis demonstrated promising efficacy and safety profiles for the drug.
View Details
20
2024
/
03
Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced the completion of Phase II clinical enrollment for its self-developed second-generation selective JAK1 inhibitor VC005 tablets in the treatment of moderate-to-severe atopic dermatitis (AD). Preliminary blinded analysis from the clinical trial demonstrated promising efficacy and safety profiles for VC005.
View Details
07
2024
/
02
I. Important Progress in Innovative Drug R&D ① Submitted NDA to US FDA for anti-platelet drug Vicagrel: If approved, it may benefit ~27.6M US patients with coronary heart disease/stroke. ② Completed 1st patient enrollment in China’s Phase II trial for anti-resistant TRK inhibitor VC004: Phase I data showed ORR of 80%-90% in NTRK fusion+ solid tumors and DOR up to 24 months. ③ Completed Phase II enrollment for 2nd-gen selective JAK1 inhibitor VC005 in ankylosing spondylitis: Preliminary blinded analysis showed favorable efficacy/safety. Additionally: VC004 gel approved for clinical trials; VC005 gel initiated China Phase I for atopic dermatitis; Multiple preclinical projects advanced in cardio-cerebrovascular, oncology, and autoimmune fields.
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.
Powerby：www.300.cn nanjing.300.cn