Midatech Raises $9.7M to Fund Nano-based Insulin Candidate
By Nuala Moran
BioWorld International Correspondent
LONDON – Nanomedicine specialist Midatech Ltd. closed a £6.3 million (US$9.7 million) funding round as it confirmed the formal launch of its joint venture with MonoSol Rx, in which the two partners will develop a gold nanoparticle-based formulation of insulin, designed to be delivered via a patch that adheres to the inside of the mouth.
"This new money is the biggest investment in the history of the company. It allows us to expand our technology platform to support other products, with a focus on oncology," Storme Moore-Thornicroft, vice president corporate management, told BioWorld International.
MonoSol Rx, of Warren, N.J., and Midatech, of Abingdon, UK, first announced the plan to develop the insulin formulation just over a year ago. (See BioWorld International, Jan. 5, 2011.)
They have since completed preclinical studies in a diabetic primate model and in November 2011 started a Phase I in healthy volunteers that is due to report in the first half of this year.
"We have now formalized the joint venture and licensed the technology into it," Moore-Thornicroft said. The partners have also started to look for commercialization partners, and are scouting for a potential deal at the J.P. Morgan Healthcare conference in San Francisco this week.
"All the preclinical toxicology is very clear, and the Phase I safety trial is coming to an end. The main issue is to make sure the gold [nanoparticles] are OK and what they do in the body," Moore-Thornicroft said. While the joint venture will embark on preparations for Phase II, no studies will start until there is a partner.
A number of other companies have tried to develop oral formulations, but as yet there is no alternative to administering insulin by injection. Moore-Thornicroft said it will be necessary to demonstrate that stabilizing insulin on gold nanoparticles and delivering it buccally using MonoSol's PharmFilm is at least equivalent to injections.
"Over and above that we have the advantage that it's far more convenient," she said.
In addition to insulin, the joint venture, called MidaSol Therapeutics LP, is developing a nanoparticle-based version of glucagon-like peptide-1 (GLP-1) and another nanoparticle combining insulin and GLP-1.
In the preclinical studies of the insulin product in rhesus monkeys and pigs, therapeutic doses of insulin were delivered from PharmFilm patches adhered inside the cheek.
The water soluble gold nanoparticles have a diameter of less than 2 nm, meaning that once they have delivered the therapeutic payload, the particles are small enough to be excreted via the kidneys, which Midatech said reduces the likelihood of them accumulating somewhere in the body. The particles are also invisible to the host immune system, and their multiple ligands mean there can be multivalent or multidrug delivery from a single particle.
Midatech is able to engineer the gold nanoparticles to target specific cell types, and it is that property in particular that it now hopes to exploit with the new money. It will be possible to target nanoparticles linked to marketed chemotherapeutics directly to tumors at a higher concentration than is possible by other methods of administration, Moore-Thornicroft said.
"The ability to increase the payload and target it to the tumor site results in greater potency at a lower dose," she noted.
At present, those oncology programs are preclinical, with demonstrations that it is possible to conjugate chemotherapeutics to the nanoparticles and some early preclinical work in mice.
"We now plan to do the same as we have done with insulin: to advance an oncology product to market and then try and find a partner," Moore-Thornicroft said.
In addition to MidaSol Therapeutics, Midatech has a second joint venture with Immunotope Inc., of Doylestown, Pa., in which the gold nanoparticles will be used to deliver cancer antigens. The lead program of the joint venture, called SynTara, is a lung cancer vaccine.
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