Xenome gets IND green light and $2 million

The US Food and Drug Administration has approved Brisbane-based Xenome’s Investigational New Drug (IND) submission for its Xen2174 pain killer.

The IND approval also triggers a second-tranche investment in Xenome of AUD$2m from the Queensland BioCapital Fund (QBF) at $0.25444 per share. This brings the total funds QBF has invested in Xenome to $6 million.

These funds, together with an AUD$3.2 million R&D Start grant which Xenome received last year from the federal government, will be used to advance the clinical development of Xen2174 and support additional drug discovery and development programs.

“The IND approval just adds a lot of weight in terms of potential negotiations. Although I think we have the funds to push further into clinical development. [We have] no immediate plans to partner the molecule.”

With IND approval in place, the unlisted biotech plans to begin a Phase I safety study in July this year. In the trials – which will take place at clinical research organisation CMAX in South Australia-- Xen2174 will be delivered intravenously to normal healthy individuals.

“Following up from that will be a Phase I/IIa study using bolus intrathecal injection in cancer patients – [which will take place] primarily in the US,” said Xenome CEO Tony Evans.

In animal models, Xen2174 has proved a more potent painkiller than morphine. It is a synthetic peptide which inhibits the transport of noradrenaline -- a nerve transmitter which amplifies messages between nerve cells. The resulting accumulation of noradrenaline in the nerve synapses responsible for down-modulating pain prevents pain signals from reaching the brain.

The peptide on which Xen2174 is based is the venom of marine cone shell Conus marmoreus, a native of Queensland's Great Barrier Reef.

Although Xen2174 has to be administered as either a bolus injection or a continuous infusion into the space around the spinal cord, Evans is confident that the drug will find a market because of the huge unmet need for chronic neuropathic pain.

Other investees in Xenome include Medica Holdings (ASX:MCA) with a 20.5 per cent holding, investment fund BioTech Capital (ASX: BTC) and UniQuest.