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ValiRx primed for a pivotal year

Proactive takes a closer look at an innovative drugs company that has largely flown under the radar
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BigPicture
The company operates as a virtual business, outsourcing most of its activities
  • Two clinical-stage drugs 
  • Partners identified for phase III trial in lung cancer
  • Read-out of phase II data from prostate trial later this year

What the company does

The company blurb tells us it’s a clinical-stage science company, focusing on developing cancer treatments. What that doesn’t describe adequately is the business model. ValiRx Plc (LON:VAL) operates as a virtual business, outsourcing most of its activities. Its strategy is to develop its drug candidates through the early clinical pathway and then seek a partner to complete the development and regulatory submissions, taking the product on to commercialisation.

It has three prospective products – two in the clinic, and one headed to the clinic.

VAL401, for lung cancer, is the most advanced of ValiRx’s pipeline of candidates. It is a reformulation of a generic drug. The reboot allows the 401 to access previously unexploited anti-cancer activity. VAL401 has completed a phase II trial in people in people in the late stage of the disease. Data indicated a palliative effect and an improvement of quality of life.

VAL201 is currently in phase II clinical trials assessing its potential as prostate cancer drug. It is also being developed to combat hormone-induced unregulated growth including endometriosis.

VAL101 is based on the ValiRx’s GeneICE platform. It acts to target and switch off the gene that expresses Bcl-2, a protein that is implicated in about half of all carcinomas (skin, liver and kidney cancers). Pre-clinical studies have established VAL101’s efficacy in prostate, ovarian and pancreatic cancers and it may also have anti-tumour activity against orphan oncologic indications.

On May 2 ValiRx unveiled a double deal – an acquisition and an outline joint-venture agreement. The company said it was buying for a nominal sum patents and intellectual property formerly owned by a Finnish company called FIT Biotech. In the same announcement shareholders were told ValiRx had signed a letter of intent with corporate financier Alpha Blue Ocean outlining the terms of a therapeutic and diagnostic-based collaboration.

Inflexion Points

- ValiRx’s joint-venture company ValiSeek has found US and European partners to take lung cancer treatment VAL401 into phase III trials. The search is now on for external funding for the study.

- VAL201 has been shown to be safe and well tolerated during phase I/II trials and, crucially, there was “primary evidence” of the drug’s activity in prostate cancer. The results from the trial are expected at the end of the first-half, which will be followed by data analysis and the publication of the full findings if the clinical assessment.

- VAL301 is essentially a riff on VAL201 and is based on the same mode of action. However this pre-clinical version of the drug is being assessed as a potential treatment for the hugely debilitating gynaecological condition, endometriosis. In pre-clinical studies, the compound has been shown to reduce endometrial lesions by up to 50%.

Blue Sky

Harman & Co’s respected veteran life sciences analyst, Dr Martin Hall, said recently: “ValiRx appears to be under-appreciated by the market. Reasons for this include the lack of institutional shareholders and a continuing need for more capital to advance its clinical programmes, thereby building value.

“On the back of clinical progress, the company is attracting potential commercial partners to help pay for the costs of late-stage development. This should be the catalyst needed to attract institutional investors into the company.”

 

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