Novacea Inc. and Kudos Pharmaceuticals announced that Novacea has licensed from Kudos the North American rights to develop and commercialize AQ4N, a novel proprietary hypoxic cell-activated agent with broad potential in a variety of cancers.
The agreement grants Novacea an exclusive license to the North American (US, Canada and Mexico) development and commercialization rights for AQ4N in all indications in exchange for development milestones and royalty payments. Kudos will continue to develop AQ4N in Europe and other markets outside North America. The two companies will work together to coordinate worldwide development of a broad range of cancer indications and jointly manufacture the compound. No financial terms of the deal were disclosed.
"The acquisition of rights to this promising clinical-stage product candidate further expands Novacea's portfolio of anti-cancer agents," said Brad Goodwin, CEO of Novacea. "We believe AQ4N has significant potential and we intend to leverage our existing expertise in hematology and oncology to move forward expeditiously with its development for a broad range of potential indications."
"The collaboration with Novacea will prove very effective in bringing additional expertise and resource to bear in the development of this exciting new cancer treatment," said Barrie Ward, CEO of Kudos Pharmaceuticals. "The collaboration is expected to enhance a route to market approval."
As a first-in-class hypoxic cell-activated anti-tumour therapy, AQ4N represents a new approach to cancer treatment. The drug is considered inactive when administered and is selectively converted into its active cytotoxic form, known as AQ4, once it reaches hypoxic tumour cells (cells that are oxygen starved), reducing potential systemic toxicity. AQ4 is a potent topoisomerase II inhibitor and DNA intercalator.
More than two million patients each year are estimated to present with tumours in the US and Europe. The large majority of these tumours have hypoxic components, which are relatively resistant to standard anti-cancer treatment, including radiotherapy and chemotherapy. As a result, a specific agent like AQ4N that can treat the hypoxic fractions should enhance the overall efficiency of cancer cell killing and reduce tumour recurrence.
Preclinical data demonstrate that AQ4N markedly enhances the effects of radiation and chemotherapy when administered in combination with either treatment. Data further suggest anti-tumour activity as a monotherapy. The agent is currently being evaluated in a Phase 1 clinical trial in combination with radiation in esophageal cancer. Sixteen patients have been treated to date and AQ4N has been well tolerated, with no serious drug-related adverse events reported.