In short
H-CYS(SS)-GLU-VAL-SER-GLN-LEU-LEU-LYS-GLY-ASP-ALA-CYS(SS)-OH, also known as TAX2, is an investigational protein-based substance being developed by Apmonia Therapeutics. It is currently being studied in a first-in-human Phase 1/2 trial involving 48 patients with advanced or metastatic ovarian cancer, colorectal cancer, pancreatic cancer, or cutaneous melanoma who have exhausted all treatment options. The substance has no marketing authorisation and is given by intravenous infusion.
H-CYS(SS)-GLU-VAL-SER-GLN-LEU-LEU-LYS-GLY-ASP-ALA-CYS(SS)-OH, referred to as TAX2, is an investigational protein-based substance developed by Apmonia Therapeutics. It is being evaluated in a first-in-human clinical trial for patients with certain advanced solid tumours.
Key points
- TAX2 is an investigational protein-based substance with no marketing authorisation.
- It is being studied in a Phase 1/2 first-in-human clinical trial.
- The trial includes 48 patients with relapsed or refractory advanced solid tumours.
- Conditions studied include ovarian cancer, colorectal cancer, pancreatic cancer, and cutaneous melanoma.
- The trial is currently authorised and recruiting.
- TAX2 is given by intravenous infusion.
What is TAX2?
TAX2 is an investigational protein-based substance classified under the therapeutic area of neoplasms (cancers). It is not yet authorised as a medicine and is being developed by Apmonia Therapeutics. The full chemical name is H-CYS(SS)-GLU-VAL-SER-GLN-LEU-LEU-LYS-GLY-ASP-ALA-CYS(SS)-OH, and it is also known by the development code TAX2.
How does TAX2 work?
The available registry data does not provide details on the specific mechanism of action of TAX2. As an investigational protein-based substance, it is being studied to understand its safety, tolerability, pharmacokinetics (how the drug moves through the body), pharmacodynamics (how the drug affects the body), and preliminary anti-tumour activity.
Which conditions is TAX2 studied for?
- Relapsed/refractory advanced ovarian cancer (aOC) — ovarian cancer that has returned or not responded to previous treatment and has spread.
- Metastatic colorectal cancer (mCRC) — colorectal cancer that has spread to other parts of the body.
- Metastatic pancreatic cancer (mPC) — pancreatic cancer that has spread beyond the pancreas.
- Cutaneous metastatic melanoma (MM) — melanoma skin cancer that has spread to other areas.
How is TAX2 given?
TAX2 is formulated as a solution for injection and is given by intravenous infusion, meaning it is delivered directly into a vein.
What do the clinical trials show?
One clinical trial is currently authorised for TAX2. It is a Phase 1/2, first-in-human, open-label, dose-escalating study with a safety expansion cohort. The trial plans to enrol 48 patients.
The Phase 1 part focuses on determining the number of patients who experience dose-limiting toxicities (DLTs), which are side effects severe enough to prevent increasing the dose. The Phase 2a part evaluates safety and tolerability at the recommended Phase 2 dose (RP2D), based on the frequency and number of patients with adverse events (AEs).
The trial also measures pharmacokinetics, pharmacodynamics, and preliminary anti-tumour activity. Eligible patients are those with relapsed or refractory advanced or metastatic ovarian cancer, colorectal cancer, pancreatic cancer, or cutaneous melanoma who have exhausted all treatment options.