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Cancer drug discovery company Sareum Holdings (LON:SAR) has been making good progress on all of its lead programmes, it told investors Wednesday.
The Checkpoint Kinase 1 (CHK1) programme, which is being carried out in partnership with the CRT Pioneer Fund, is targeting lung, pancreatic and other cancers. The company is awaiting approval to commence two trials, one of which will examine candidate CCT245737 in combination with other chemotherapies, while the other will assess it as a single anti-cancer agents in patients with various cancer types.
The Aurora+FLT3 programme is targeting acute myelogenous leukaemia (AML) and other blood cancers, with the pre-clinical development being funded entirely by the Hebei Medical University Biomedical Engineering Center (HMUBEC).
Development of a biomarker strategy to support future Phase 1 clinical trials has commenced and is making good progress, with the company successfully securing large quantities of material to support toxicology and safety pharmacology studies, which should be completed in 2016.
Toxicology studies, which will determine the initial doses to be used in the planned Phase 1 trial, have started.
On the autoimmune front, the company is working on a series of TYK2 (tyrosine kinase 2) inhibitors. It has not only achieved success in a psoriasis model, but the programme's lead compound, SAR-20347, has also been shown to reduce joint inflammation in a dose-dependent model in a rheumatoid arthritis model, where it has been shown to be more effective than a commonly-used steroid treatment.
The next steps are to evaluate SAR-20347 in disease models of inflammatory bowel disease (IBD), multiple sclerosis and lupus. New analogues have recently been synthesised and initial analysis indicates improved activity and selectivity over SAR-20347. These molecules will be evaluated in relevant disease models in due course, Sareum said.
Meanwhile, a study, assisted by funding of £140,000 from the Innovate UK Biomedical Catalyst Fund, is in progress to investigate the potential of Sareum's lead molecules to inhibit TYK2 signalling to treat T-cell acute lymphoblastic leukaemia (T-ALL) .
Trials so far have shown sufficient validation to warrant further investigation, and the next step will be to scale-up the synthesis of example lead compounds to study their effects in disease models. These studies will continue through to August 2016.
The company also released interim results, though these are not very meaningful for a drug discovery company that has yet to generate any revenue.
The company's loss before tax narrowed to £485,000 in the six months to the end of 2015 from £749,000, while the post-tax loss shrank to £485,000 from £659,000.
Cash at the end of the year was £335,000, down from £429,000 a year earlier, while the company's unspent investment in the CHK1 Project was £841,000 (2014: £447,000).
“We have made considerable progress in the last six months,” said Dr Tim Mitchell, chief executive officer of Sareum.
“With clinical trials for the CHK1 programme expected to start before our financial year end, we are swiftly moving towards our goal of becoming a clinical-stage development company," he added.
The company's nominated adviser (Nomad), WH IRELAND, said the interims were in line with expectations, while good progress is being made on all the drug programmes, particularly the lead CHK1.
“Another lead drug candidate, Aurora+FLT3 has begun toxicology studies under the watchful eyes of two Chinese CRO’s (both of whom adhere to Chinese/US FDA standards) and additional patents were secured in both the US and Europe. No cash commitment on Sareum’s part is required for further development of the latter drug candidate,” the broker noted.
The broker also mentioned that the reported cash balance of £0.3mln is to be bolstered by a research development (R&D) tax rebate of £0.2mln, and also by a £0.2mln milestone payment that is due from the CRT Pioneer Fund.
WH IRELAND said it would be leaving its full-year forecasts unchanged following the release of the interims; it is forecasting an adjusted loss before tax of £1.4mln and a loss per share of 0.1p.
This is not the sort of company to be valued on earnings per share, however, and WH IRELAND continues to see upside for the stock as it continues its journey towards becoming a clinical stage development company.
“Whilst all of Sareum’s pipeline drugs have demonstrated potential in vivo trials to date, particular focus will now rest on the lead candidate CHK1 to display its potential in the upcoming dual Phase I trials. We maintain our Speculative Buy recommendation and 1.0p target price,” the broker said.
Sareum's shares currently trade at 0.29p.