Midatech’s drug delivery technology has not always worked out – witness the failure of its oral insulin MTD101 two years ago. But the UK company has decided that developing new ways of delivering old drugs is a better bet than speciality pharma.
Last week the group offloaded its US business, which comprises supportive therapies for cancer patients, to a private equity firm for £19m ($25m). Midatech will use the cash to develop its projects for cancer and rare diseases, but with its candidates still at an early stage it will need either funds or partners to get across the finish line.
The company’s new chief executive, Craig Cook, is unfazed, telling Vantage that Midatech’s lead project, MTD201, could challenge a stalwart Novartis drug used for carcinoid tumours and acromegaly, and help the UK group generate interest from bigger players.
They could be giants
Novartis’s sandostatin long-acting release (SLAR) has been available since 1997, but sold $1.6bn last year and is forecast to still be the Swiss group’s fourth-biggest drug in 2024. MTD201 has the same active ingredient, octreotide. Also like the incumbent, it employs microspheres for sustained delivery.
That is where the similarities end, according to Mr Cook. The method used to produce SLAR is inefficient and leads to microspheres of varying sizes, he says. As well as generating waste – particles that are too big or small have to be removed – this means that the drug must given via a large needle, and that clinical performance can be inconsistent.
“SLAR has got a lot of the active ingredient sitting on the surface of the spheres. Once it’s administered it just dumps the dose and there’s a massive burst,” says Mr Cook. Midatech’s production method, which involves printing microspheres, is more consistent, he adds, allowing it to be given via a smaller needle and leading to a more reliable clinical profile. “We don’t have that burst at all.”
Midatech will obviously have to prove its claims. The group reported proof-of-concept data in August, and will soon meet the FDA to confirm its plans for a registrational trial.
To get approval it could either show non-inferiority to SLAR in a study in healthy volunteers, or aim to prove superiority in a trial in patients, Mr Cook says. When asked which path is preferable, he replies: “We’d take the quickest to market initially, which is equivalence, and then in parallel we’d develop a superior product as a follow-on.”
Data for a non-inferiority claim could be available by the second half of next year.
Even if MTD201 succeeds, Midatech will have its work cut out competing with Novartis. This is where a partner could come in handy. “If we did decide to think about out-licensing, that could include large pharma, it could be generics companies, or even Novartis itself,” Mr Cook says, adding that the Swiss company could see MTD201 as a lifecycle management play.
“We could decide to focus on adenocarcinoids ourselves and let a partner take acromegaly,” he adds.
At least Midatech does not have to worry about being undercut by generic versions of SLAR: while Novartis’s product-specific patents have now expired, several technology patents still hold, Mr Cook says.
“Independent of the patent side, the know-how and technical bit is also very difficult,” he adds. “We know that companies are trying to do this, and none of them have succeeded.”
More cash needed
Midatech has two other projects in the clinic: MTX110, a liquid form of the multiple myeloma drug panobinostat, which the company is testing as an intratumoural injection in the brain cancers diffuse intrinsic pontine glioma and glioblastoma; and MTX102, which comprises proinsulin linked to gold nanoparticles, and is designed to harness T regulatory cells and damp down the autoimmune reaction seen in type 1 diabetes.
With all this R&D activity the UK group will need to top up its funds fairly soon – the money raised through the US speciality pharma sale should take it into the second quarter of next year, Mr Cook says.
“Between now and then we will be looking for additional sources of funding, either dilutive equity funding, or preferably non-dilutive funding such as licensing deals.”
With final data from the proof-of-concept trial of MTD201 due in October, Midatech will have to hope that there is enough promise there to attract a partner.