In short
TVB-2640 is an investigational drug designed to inhibit fatty acid synthase (FASN), an enzyme found in many cancer types. It is not yet authorised as a medicine. One completed Phase 1 trial (2023-505180-36-00) studied its pharmacokinetics in 48 people with normal or impaired liver function, while a first-in-human Phase 1 study in patients with solid tumours was planned to recruit 131 participants.
Key points
- TVB-2640 is an investigational fatty acid synthase (FASN) inhibitor, not yet approved as a medicine.
- One completed Phase 1 trial assessed the drug in 48 participants with normal or impaired hepatic function.
- The hepatic impairment trial used a 50 mg oral dose and measured pharmacokinetic parameters such as AUC and Cmax.
- A separate first-in-human Phase 1 study in solid tumours was planned to enrol 131 patients across the US and UK.
- FASN is found in breast, ovarian, prostate, colon, and pancreatic cancers and non-Hodgkin lymphoma.
- The tumour study was designed with 3-week treatment cycles and an expected duration of 2 years.
What is TVB-2640?
TVB-2640 is an investigational drug designed to inhibit the enzyme fatty acid synthase (FASN). It is a small-molecule substance that has not yet received marketing authorisation and remains under investigation in clinical research. The drug was developed by 3V Biosciences, the sponsor of the first-in-human study. The therapeutic area could not be specified in the registry data for the completed hepatic impairment trial.
How does TVB-2640 work?
TVB-2640 is designed to inhibit fatty acid synthase (FASN), an enzyme involved in the production of fatty acids within cells. FASN is found in many cancer types, including breast, ovarian, prostate, colon, and pancreatic cancers, as well as non-Hodgkin lymphoma, and has been associated with increased patient death. By blocking FASN, TVB-2640 aims to interfere with a process that cancer cells may rely on for growth.
Which conditions is TVB-2640 used or studied for?
- Solid tumours — a first-in-human Phase 1 study was planned to test escalating doses of oral TVB-2640 in patients with various solid tumours.
- Impaired hepatic function — a completed Phase 1 trial investigated how the drug behaves in people with mild, moderate, or severe liver impairment compared to those with normal liver function.
How is TVB-2640 given?
TVB-2640 is given orally. In the completed hepatic impairment trial, participants received a 50 mg oral dose. The first-in-human study in solid tumours was also designed to use oral TVB-2640 in escalating doses, with treatment given in cycles of 3 weeks.
What do the clinical trials show?
One completed Phase 1 trial (2023-505180-36-00) assessed the pharmacokinetics (PK) of TVB-2640 — how the drug is absorbed, distributed, and eliminated in the body — after multiple oral doses in 48 participants. The trial compared people with mild, moderate, or severe hepatic impairment to healthy volunteers with normal liver function. The primary outcomes measured were the area under the concentration-time curve during a dosing interval at steady state (AUC0-tau, a measure of total drug exposure) and the maximum observed plasma concentration at steady state (Cmax,ss, the highest drug level in the blood), both for total and unbound TVB-2640.
A separate first-in-human Phase 1 study in patients with solid tumours was planned to recruit 131 patients across approximately 10 sites in the US and UK, with an expected duration of 2 years. The study was designed to test escalating doses of oral TVB-2640, with patients able to receive as many 3-week cycles as they could tolerate.