Big Picture – A Deep Dive Examination of ValiRx Plc
ValiRx Plc Snapshot
Our Strategy & Vision
ValiRx is a biotechnology oncology focused company specialising in developing novel therapeutics for cancer and associated biomarkers. It aims to make a significant contribution in “precision” medicine and science, namely to engineer a breakthrough into human health and well-being, through the early detection of cancer and its therapeutic intervention.
The Company’s business model focuses on out-licensing therapeutic candidates during the development process. By aiming for early-stage value creation, the company reduces risk considerably while increasing the potential for realising value. The group is constantly in licensing discussions and actively explore collaborative opportunities with major players in the oncology field.
ValiRx’s four therapeutics drugs in development, which each have the potential for meeting hitherto unmet medical needs by existing methods, have worldwide patent filings and grants together with commercial rights and agreements. They originate or derive from Word class institutions, such as Cancer Research UK and Imperial College.
Until recently, cancer treatments have often relied on non-specific agents, such as chemotherapy. With the development of target-based agents, primed to attack specific cancer cells only, these can less toxic and more effective treatments are now possible. New drugs in this group—such as those in ValiRx’s pipeline development plans to greatly improve outcomes for cancer patients.
The Company’s leading anti-cancer therapeutic VAL201 is currently in clinical trials for the treatment of prostate cancer and potentially other indications of hormone induced unregulated growth including endometriosis. The Phase I/II trial has entered the concluding stages of it’s study at University College London Hospital (“UCLH”) and this follows the company receiving approval from the Medicines and Healthcare products Regulartory Agency (“MHRA”) to escalate VAL201 dosing. The curent cohort hs already received the escalated dose and UCLH continues to recruit suitable patients to complete the trial.
Progressing through the dose escalation and expansion stages, the study is then designed to investigate further safety and tolerability aspects as well as efficacy. Particular emphasis will be placed on evaluating the pharmacokinetics, pharmacodynamics and early assessment of anti-tumour activity in response to VAL201, using a variety of measurements including biomarkers, with biomarkers being key indicators in personalised medicine.
VAL201 selectively prevents tumour growth by specifically inhibiting the proliferation of tumour cells. As a result, tumour growth is suppressed and metastasis is significantly reduced. The approach is a targeted therapeutic with pre-clinical results that indicate that due to the specific nature of this treatment, this therapy is likely to be less toxic than many other therapeutic options. The VAL201 target is also associated with other cancers and there is significant potential for VAL201 to be used as a treatment for other hormone-induced cancers, such as breast and ovarian cancer, alongside endometriosis.
Endometriosis is a gynaecological medical condition in which cells from the lining of the uterus (endometrium) appear and flourish outside the uterine cavity lined by endometrial cells, which are under the influence of female hormones. These endometrial-like cells in areas outside the uterus (endometriosis) are influenced by hormonal changes and respond in a way that is similar to the cells found inside the uterus and symptoms often worsen with the menstrual cycle. The treatments chosen will depend on symptoms, age, and lifestyle plans. VAL201 has been shown though to reduce abnormal endometrial growth, whilst leaving other hormone-induced activities working normally. ValiRx’s initial in-vitro results show a reduction in endometrial lesion size directly related to dose and two generations of offspring produced by treated animals. This strongly suggests that the peptide does not affect fertility the same way other treatments do.
Lung Cancer and others
VAL401 is the reformulation of a generic drug that has over 20 years of clinical use for treatment of a chronic non-oncology disease in an oral capsule. The re-formulation allows the drug to access previously unexploited anti-cancer activity. VAL401 has completed a clinical Phase II trial for the treatment of late-stage non- small cell lung cancer with data from the completed trial indicating a palliative effect and an improvement of quality of life in the patients treated.
Progress of VAL401 through its clinical trials will follow an accelerated route to Market Authorisation through the use of prior clinical data gathered on the original generic drug. Pre-clinical efficacy data has been collected in non-small cell lung, pancreatic and prostate cancers. Pre-clinical toxicology has revealed no side effects beyond those expected from the parent drug, with both pre-clinical and clinical pharmacokinetc data allowing bridging from VAL401 to the historical full clinical data package on the parent. ValiSeek is currently in discussions with potential partners for starting the next clinical trial.
During 20 years of prior clinical use, the active drug has been safely administered long term (chronic use of over 2 year’s duration) with good compliance.
Other possible indications include prostate and pancreatic cancer.
GeneICE “rebellious gene” technology continues to show good progress in the pre-clinical phase – the programme currently benefits from a second Eurostars grant for up to €1.6 million.
Rebellious genes are genes that are overexpressed or are erroneously expressed when they should not be, e.g. in cancers, inflammatory conditions, Alzheimer’s and autoimmune diseases. ValiRx’s proprietary GeneICE forward, ValiRx will look to leverage upon TRAC’s market presence and grow the sales of this diagnostic business. The Company believes that together with clinical validation, revenues from TRAC will grow, which will support both the biomarker and therapeutic development businesses. ValiFinn, which is itself already generating revenues, is well placed to further develop as a service/licensing business.
VAL101 is a novel therapeutic based on the Company’s proprietary GeneICE (Gene Inactivation by chromatin engineering) 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. 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. ValiRx’s GeneICE technology enables the selective silencing or the shutting down of particular rebellious genes, thereby halting and reversing tumour growth.
Mr Oliver de Giorgio-Miller
Oliver has a wealth of experience in the management and commercial advancement of life science companies. He has worked for over 30 years with several global pharmaceutical and medical device companies including Schering AG, Hoffman la Roche, Intavent-Orthofix and Photo Therapeutics, a Cancer Research UK company and he has extensive experience advising a number of other early stage biopharmaceutical and medical device companies.
Dr Satu Vainikka
Chief Executive Officer
Satu has many years experience of the biotechnology industry, including extensive first hand experience of equity financing, business management and developing life science technology into commercial enterprises. Prior to her current role as CEO of Valirx, she was a founder, director and CEO of Cronos Therapeutics Limited.
In her past roles, Dr Vainikka has developed and exited successful business models, negotiated corporate and academic transactions, and raised funding for a number of companies. (Member of Remuneration Committee) Dr Satu Vainikka has gained the following qualifications and awards:
. MBA at Imperial College Business School 2000.
. PHD in signal transduction in oncology, University of Helsinki 1996.
. Prestigious “embo” fellowship for Postdoctoral research, at the imperial cancer research (Now CRC).
Dr George Morris
Chief Operations Officer
George has over 25 years’ experience in biological and medical research, and financial services. In the past he has worked for Guy‘s hospital medical school department of medicine, King’s college and University College London. As a Research Scientist, he is an author of numerous books and articles on refereed papers, approximately 70 abstracts, short reports and posters, and an inventor of multiple patents.
George was a founding member of the expert advisory panel, the ‘Biotechnology and Finance Forum’, set up jointly between the European Commission and the European Association of Securities Dealers. George involved in a number of conferences and workshops with the EU research and agricultural directorates and is an ‘expert’ to the Commission, and has been invited into several policy discussion groups.
George has worked with a variety of commercial, governmental organisations and financial institutions in the US, Europe and Australia and many consultancy projects covering various biotechnology and financial activities. He is regularly asked to chair or participate in conferences in his areas of experience, including acting as a ‘Venture Academy’ mentor. Has undertaken numerous continuing professional development courses covering finance and general management as well as in specific areas related to science & technology, statistics.
Mr Gerry Desler
Chief Financial Officer
Gerry is a chartered accountant, who qualified in 1968 with a City firm, before becoming a partner in 1970. Between 1985 to 1990 he was the Senior Partner. During his time in the City, he has specialised in consultancy work, much of it involving funding and venture capital.
He was involved in one of the first joint ventures in what was then the People’s Republic of China in 1980. Gerry was previously the Finance Director of Premier Management Holdings plc, an AIM listed company and is on the board of a number of private companies. Gerry also holds positions as Company Secretary at Prospex Oil and Gas Plc both Aim listed companies. (Member of Audit Committee).
Mr Kevin Alexander
Kevin is a qualified solicitor in England and an attorney in New York and he was a partner at major law firms in both London and the United States for over 25 years. Since leaving the law he has been involved in forming and managing various businesses, both private and public. Kevin is a director of Valirx Plc, and joined the board in September 2006. He has an MA in law from Cambridge University.
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