TIDMVAL

RNS Number : 0820M

ValiRx PLC

19 January 2021

19 January 2021

("ValiRx", the "Company" or the "Group")

Patent Status Update

Notification of allowance of VAL201 for the treatment of metastatic cancer

and four other patents granted

London, UK - ValiRx plc ("ValiRx", AIM:VAL), a clinical stage drug development company, announces that its patent portfolio continued to build in 2020, with four patents granted during the last 12 months (see table below).

Additionally, in January 2021, the European Patent Office notified the Company of its intention to grant a patent which extends patent cover for VAL201 into metastatic cancer. These statements of protection are similar to those granted by the US patent office announced in November 2019 and creates a broad coverage of use of the peptide in an important area of oncology.

The patents granted during 2020 and the notice received by the European Patent Office in relation to VAL201 can be found below:

 
 Project   Patent Family      Patent Granted    Date Granted/allowance   Impact 
 VAL201    WO/2008/113770     JP6689430         April 2020               A new patent linked 
            Use of the                                                    to the previously 
            peptide against                                               granted Japanese patents 
            cancer                                                        to strengthen the 
                                                                          portfolio 
          -----------------  ----------------  -----------------------  -------------------------------- 
           WO/2014/177868     EP number         April 2021               Extends protection 
            Use of the         to be assigned                             for the use of VAL201 
            peptide against                                               into metastatic cancer 
            metastases 
          -----------------  ----------------  -----------------------  -------------------------------- 
 VAL301    WO/2013/064830     EP2773427         January 2021             This includes the 
            Use of the                                                    use in the treatment 
            peptide against                                               of endometriosis, 
            non-cancerous                                                 as well as other non-cancerous 
            proliferative                                                 conditions hormone-driven 
            conditions                                                    conditions (including 
                                                                          hyperplasia) 
          -----------------  ----------------  -----------------------  -------------------------------- 
 VAL401    WO/2014/049071     CN104797271       March 2020               The first Chinese 
                                                                          patent granted for 
                                                                          VAL401, granted claims 
                                                                          include the composition 
                                                                          of the formulation 
                                                                          and use in the treatment 
                                                                          of cancerous and non-cancerous 
                                                                          disease linked to 
                                                                          the mechanism of action 
          -----------------  ----------------  -----------------------  -------------------------------- 
                              JP6734346         August 2020              Covers the use of 
                                                                          VAL401 in the treatment 
                                                                          of lung cancer 
          -----------------  ----------------  -----------------------  -------------------------------- 
 

The full patent portfolio for each project can be found on the project pages of the Company's website: https://www.valirx.com/our-pipeline

Dr Suzy Dilly, Chief Executive Officer commented: "It is important for ValiRx to continue to build value in our product portfolio by protecting intellectual property. The patenting process involves rigorous scrutiny of the proposal, testing for novelty and utility before a patent is allowed to be granted. Granted patents provide protection of the intellectual value of our research and provide further evidence to potential partners of the value of our products.

"I am very pleased that we have continued to extend protection across our three core products through 2020 and into January of this year. This is an important component of value creation in the Company and a high priority for the Board."

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The Directors of the Company take responsibility for this announcement.

Ends

For further information please contact:

 
 ValiRx plc                                        Tel: +44 (0) 2476 796496 
                                                    www.valirx.com 
 Suzanne Dilly, CEO                                Suzanne.Dilly@valirx.com 
  Cairn Financial Advisers LLP (Nominated           Tel: +44 (0) 20 7213 
   Adviser)                                          0880 
   Liam Murray / Jo Turner / Ludovico Lazzaretti 
  Peterhouse Capital Limited (Sole Broker)          Tel: +44 (0) 20 7469 
   Duncan Vasey / Lucy Williams / Eran Zucker        0930 
  Optimum Strategic Communications                  Tel: +44 (0) 20 8148 
   Supriya Mathur/ Shabnam Bashir                    3040 
                                                     valirx@optimumcomms.com 
 

About ValiRx plc

ValiRx accelerates the development of treatments in oncology and women's health to improve patient lives. We provide the scientific, financial and commercial framework towards enabling rapid translation of innovative science into clinical development.

With our extensive and proven experience in research and drug development, we select and incubate promising novel drug candidates and guide them through an optimised process of development, from pre-clinical studies to clinic and investor-ready assets.

Integrating science and business

We connect diverse disciplines across scientific, technical and commercial domains, with the aim of achieving a more streamlined, less costly, drug development process. We work closely with our selected collaborators and leverage the combined expertise required for science to advance.

Lead candidates from our portfolio are out-licensed or partnered with investors through ValiRx subsidiary companies for further clinical development and commercialisation. https://www.valirx.com/

About VAL201

VAL201 is a short peptide being studied as a potential treatment for prostate cancer. The peptide structure is inspired by the naturally occurring androgen receptor and is designed to intercept and prevent the binding of the androgen receptor to SRC kinase - an enzyme implicated in cancerous cell growth pathways. By preventing the androgen-mediated activation of SRC kinase, VAL201 can potentially prevent cancerous cell proliferation (or growth) without interfering with other functions of either the androgen receptor or SRC kinase. This precision method, mimicking a natural process, proposes a high specificity of cancer treatment with a lower side effect profile. VAL201 was licensed from CRT (part of CRUK) and developed through preclinical development into this clinical trial in patients with advanced prostate cancer. The study was held at University College Hospital (UCLH), London.

About Prostate Cancer

Around 48,500 men are diagnosed with prostate cancer in the UK each year [1] . In men, it is the most common cancer in the UK. Prostate cancer is most common in older men. On average each year 35 out of 100 (35%) of new cases are in men aged 75 and over.

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identi ed by their use of terms and phrases such as "believe", "could", "should" "envisage", "estimate", "intend", "may", "plan", "potentially", "expect", "will" or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements re ect the Directors' current beliefs and assumptions and are based on information currently available to the Directors. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates.

Factors that could cause actual results to differ materially from those in the forward-looking statements include risks relating to unanticipated costs, liabilities or delays; failure or delays in research and development programs; the safety and efficacy of the Company's product candidates and the likelihood of clinical data to be positive and of such product candidates to be approved by the applicable regulatory authorities; unanticipated changes relating to competitive factors in the Company's industry; risks relating to the Company's capitalisation, resources and ownership structure, the availability of sufficient resources for company operations and to conduct or continue planned clinical development programs; the outcome of any legal proceedings; risks related to the ability to correctly estimate operating expenses; risks related to the ability to project future cash utilisation and reserves needed for contingent future liabilities and business operations; risks related to the changes in market prices of the Company's ordinary shares; the Company's ability to hire and retain key personnel; changes in law or regulations affecting the Company; international, national or local economic, social or political conditions that could adversely affect the Company and its business; conditions in the credit markets; risks associated with assumptions the Company makes in connection with its critical accounting estimates and other judgments.

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