Phase 2B trials of a generic fast-tracked immunity-boosting cancer therapeutic IRX-2 will be conducted after the biotech company IRX Therapeutics has successfully raised $31.6 million to finance these trials. The randomised head and neck cancer trials will include 200 patients and will be conducted in clinical centres across the US and Western Europe.
IRX-2 is a late-stage development compound that could potentially become a useful weapon in the fight against cancer. It is being developed as a neo-adjuvant regimen for the treatment of head and neck squamous cell carcinoma. This particular oncology indication is prevalent in a large patient population with approximately 500,000 incidents per year, worldwide. IRX-2 could fill an unmet medical need in those suffering from this cancer.
IRX-2 ups the immune response of cancer patients and helps their defence systems better recognise and respond to tumours. The therapy also helps patients immunise themselves against their cancer.
“Our approach can be categorized as a generic boost to the immune system,” an IRX spokesman said. “It’s not in the category of a targeted therapy; it’s not gene therapy; it potentially has broader applicability – so we’d pursue other indications if we had another dollar lying around.”
The therapy works to restore the patient's immune response by correcting both dendritic and T-cell defects. It has a cell-developed biologic with multiple cytokines that activate multiple arms of the body's immune system.
The drug has already completed Phase 1 and Phase 2 studies but since the Phase 2 study was a small, unrandomised trail, efficacy conclusions could not be drawn from it. Hence, the company has been working towards generating funding to conduct a large randomised trial and determine the efficacy of the IRX-2 regimen.
IRX Therapeutics is hoping to partner out or sell the company once this trial's complete. It may also raise money to conduct costly Phase 3 trials internally. The company has managed to raise $100 million since its launch in 1994 but Phase 3 trials will require at least another $100 million.
Source: Meghana Keshavan, MEDCITY News
Image Credit: IRX Therapeutics
