ValiRx continues its strong progress
With cancer worldwide being the second leading cause of death after heart disease,
ValiRx (VAL: AIM) aims to apply its technologies to modern medicine’s better understanding of cancer and to deliver improved and more targeted treatments for the disease.
The company aims to make a significant contribution in ‘precision’ medicine and science, through the early detection of cancer and its personalised therapeutic intervention. By so doing, ValiRx is striving to develop therapeutics that can substantially improve human health and well-being.
Currently, the company has four therapeutic drugs in development, two of which are in clinical trials. Both its clinical stage therapeutics and pre-clinical assets have demonstrated clear potential for addressing significant unmet medical need. The company has worldwide exclusive developmental and commercial rights and its compounds have worldwide patent protection.
Furthermore, the technologies and science lying behind the development programmes and therapeutics, originate or derive from Word class institutions, such as Cancer Research UK and Imperial College.
While established cancer treatments, such as surgery, radiation and chemotherapy, are still improving, recent exciting advances in the cancer arena today, lie in the development of novel and targeted therapies, otherwise known as ‘Precision Medicine’. This targeted, personalised medicine includes early stage diagnosis of every specific cancer, tailor-made therapeutic intervention and the careful monitoring of progress.
With the development of target-based agents, primed to attack only identified cancer cells, higher response rates for treatments, as well as less toxic and more effective outcomes, are now possible. New drugs in this group—such as those in ValiRx’s pipeline— promise to greatly improve outcomes for cancer patients.
RECENT CLINICAL TRIAL PROGRESS AND LATEST DEVELOPMENTS VAL401
ValiRx’s compound closest to Market Approved Application (MAA) is VAL401, which is a reformulated drug, Risperidone, with an established safety record derived from clinical studies and years of use in other medical areas. ValiRx’s subsidiary, ValiSeek, has completed its Phase II trial of VAL401 as an oral treatment of late stage non-small cell lung adenocarcinoma in a clinical study in Tbilisi, Georgia.
Positive VAL401 clinical data from the completed trial in December 2017 showed that the VAL401 treatment had a statistically significant improvement in overall survival for patients with non-small cell lung cancer compared to those receiving no treatment. The trial also demonstrated that the VAL401 treatment had a measureable improvement
INTRODUCING… VALIRX A clinical stage biotechnology company specialising in developing targeted novel treatments for cancer and associated biomarkers.
on patient quality of life and did not trigger any unwanted immune responses.
The company is currently in the process of filing the formal trial report to regulators and it is currently in advanced negotiations with a number of potential partners. Significant interest has been received from organisations in the UK, Europe, US and Asia including potential joint venture, licensing-out and co-development structures vis-à-vis the compound’s progression into a Phase III clinical study.
The VAL401 technology has received recent patent grants in the US and New Zealand. With its worldwide patent protection, allied to the trial’s very encouraging results, regarding both efficacy and its palliative effect on patients, VAL401 is on the cusp of a pivotal trial and the value inflection that would represent.
ValiRx’s other clinical-stage compound, VAL201, has the potential to treat hormoneinduced oncological conditions and abnormal growth in cells, including prostate, breast and ovarian cancers, as well as Endometrosis.
The compound is being trialled in patients with hormone-refractory prostate cancer at University College London Hospital and has in practise completed its Phase I study. VAL201 is a compound with a unique mechanism of action, which was first discovered by academics, partly with support from Cancer Research UK.
VAL201 has performed extremely well in its clinical trials and has confirmed to date, that beyond it being well tolerated and safe, it is efficacious and works. The compound had a major trial review of its protocol at the end of 2017, which the regulatory authorities subsequently approved.
This modification to the trial protocol allows the Company to escalate or accelerate the dosing regimen of the study, from 4mg to 16mg in a couple of steps; effectively seeing a substantial increase in the dose of VAL201 being administered to patients, which allows treatment to more speedily reach its full therapeutic potential and potential anti-cancer impact on patients.
The company is actively recruiting patients for the trial and is hopeful that data will begin to emerge by the yearend, although with the caveat that such an outcome does depend on the right subjects becoming available and with the appropriate commitment level and progression of the disease.
A major challenge experienced in any cancer treatment is the ability of cancer cells to seek new locations and to spread to other sites in the body. This is called metastasis. The ability of cancer cells to metastasize is, as a rule, very bad news for cancer sufferers, as it offers the cancer cells potential new places in the body for growth.
With this issue in mind, scientists at ValiRx have been very excited by what they have seen in a subset of the pre-clinical data obtained with VAL201, as it shows that the compound, when administered in cancer models, decreased metastatic growth by up to 50%. Since all cancers have the potential for metastatic growth, ValiRx believes that this treatment could potentially be used in several oncological indications, together with a specific cancer targeting treatment.
By good fortune, preclinical studies of VAL201 in a slightly different use, also suggested that the compound would work against a major gynaecological indication, namely Endometriosis. This is a medical condition in which cells from the lining of the uterus appear and flourish outside the uterine cavity. Endometriosis is excessively debilitating and it represents
one of the major causes of female infertility.
In preclinical studies, VAL201’s reformulation, which has been named VAL301, has been shown to reduce the endometrial lesions by up to 50%. The condition is not adequately served with current medications, as those medications are frequently poorly tolerated. However, due to VAL201’s safety profile and lack of any noticeable side effects, the compound is well placed as a potential treatment.
The compound has recently received a US patent grant for its use in Endometriosis and is currently in the final preclinical stage with an ambition to move into the clinic within the next twelve months dependant on funding and regulatory clearance.
The molecule VAL101 is based on a technology, which is called Geneice (‘Gene Inactivation by Chromatin Engineering’) and is licensed from Imperial College. All cells in our bodies contain the same genome and tissue differentiation requires well maintained, tuned specific gene activity regulation.
If this regulation system goes wrong or genes have unwanted mutations and are ‘rebellious’, problems such as cancerous growth or neurological indications and problems will occur.
The Geneice technology allows the design of molecules which find and bind these ‘rebellious genes’, thereby potentially reversing the problem. VAL101 is a molecule based on this technology and it is currently in preclinical trials.
The compound has been optimised after considerable reformulation and background work, funded by two prestigious Eurostars grants. ValiRx is now in discussions with European, US and Chinese organisations over ways to take the compound forward and more details on these discussions will emerge in the near future.
The Company’s business model focuses on in-licensing early stage drugs and technologies from Worldleading academic institutions, such as Cancer Research UK and Imperial College and maturing them to the point where they can be outlicensed to pharmaceutical partners or co-developed and taken to market. The model for biotechnology companies, like ValiRx, is to act as a specialised and experienced bridge between World-class academic science and big pharma.
Currently pharmaceutical companies are facing an increasing need for novel, more precise and effective therapies across a number of indications and accordingly, ValiRx strives to be in continuous discussions with these major players in the oncology field.
THE NEXT STAGE AND INTO THE FUTURE
Given the current industry climate, ValiRx believes that in view of the progress of these trials, the company’s therapeutic approaches are increasingly attractive to pharma partners, as a licensing opportunity or a co-development partner. The interest ValiRx has seen from potential partners to date has been very encouraging. Based on ValiRx’s history of out-licensing separate technologies, the company remains optimistic of a successful outcome to its talks and the crystallisation of substantial value for its assets.