TIDMVAL
RNS Number : 0135P
ValiRx PLC
15 February 2021
15 February 2021
("ValiRx", the "Company" or the "Group")
Extension of Collaboration Agreement
London, UK - ValiRx plc (AIM:VAL), a clinical stage drug
development company, announces today that it has entered into a new
agreement with Physiomics plc ("Physiomics")(AIM:PYC), the oncology
consultancy using mathematical models to support the development of
cancer treatment regimens and personalised medicine solutions. The
new agreement supersedes the agreement between Physiomics and the
Group which was announced on 13 September 2011.
Under the terms of the new agreement, ValiRx will benefit from
Physiomics' experience in modelling the effects of prostate cancer
treatment, as well the use of the latest version of its Virtual
Tumour(TM) technology, which will be applied to derive valuable
information from the additional data generated by the completed
clinical trial of VAL201. Physiomics will also support ValiRx in
modelling the use of the VAL201 peptide in endometriosis (VAL301)
and Coronavirus (BC201).
Physiomics has developed a quantitative systems pharmacology
approach that uses pre-clinical and clinical data to model the
activity of a drug candidate. This data can be used to explore the
mechanism of action, disease impact and optimal dosing
strategies.
Physiomics will receive a fee (capped at GBP6m) of 6% of any
future net revenues that may be received by ValiRx relating to its
commercialisation of VAL201 and its derivatives in any indication,
including prostate cancer, endometriosis and treatment for
Coronavirus infection. Eligibility for part of this fee will be
conditional on completion of an agreed program of work by
Physiomics that builds on the work already carried out under the
2011 agreement. This program of work will start on 15 February 2021
and is required to be carried out by 15 November 2021. In
recognition of the collaborative nature of this new agreement,
Physiomics will also be offered a seat on the ValiRx scientific
advisory board.
Dr Suzy Dilly, Chief Executive Officer of ValiRx, commented: "I
am pleased to be able to expand our collaboration and the scope of
work being carried out by Physiomics. Enhancing the scientific
understanding of our results using cutting edge technology ensures
we maximise the value of the data we have collected. This will help
in the design and execution of future clinical trials and support
discussions with potential new partners. We expect that outputs
from the application of Physiomics' technology will be incorporated
into scientific publications presenting the results from the VAL201
clinical trial."
Dr Jim Millen, Chief Executive Officer of Physiomics, added: "We
are delighted to be working once again with ValiRx on a programme
of work that replaces and extends that originally agreed in 2011.
Since the time of the original agreement, Physiomics has gained
significant additional experience in the modelling of prostate and
other cancers and we will be aiming to generate new insights which
can improve development outcomes."
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 0930
Zucker
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) in 2010 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 the VAL201-001 clinical trial
The clinical trial: "A Phase I/II, Dose Escalation Study to
Assess the Safety and Tolerability of VAL201 in Patients with
locally Advanced or Metastatic Prostate Cancer and Other Advanced
Solid Tumours" opened to recruitment in December 2014 and closed in
January 2020.
Patients were scheduled for treatment of a once weekly injection
of VAL201 in 3 week cycles for a maximum of 6 cycles. A total of 12
patients received at least 1 dose of VAL201.
Patients were eligible if they were: Adult men (over the age of
18) with incurable locally advanced or metastatic prostate cancer
who had relapsed following radiotherapy treatment, are in 'watchful
waiting' or where a policy of intermittent hormone therapy had been
decided. Patients were expected to have no or only mild symptoms
relating to their prostate cancer. (ClinicalTrials.gov identifier:
NCT02280317)
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.
About VAL301
VAL301 is the use of the VAL201 peptide for the treatment of
endometriosis. VAL301 presents an opportunity to suppress
hormone-driven cellular growth in the absence of outright hormone
suppression. By interrupting only the hormone driven cell growth
while sparing the other hormone activities, the infertility and
related side effects are expected to be avoided.
Currently in preclinical testing, this theoretical benefit will
be looked for in future trials.
Endometriosis is a gynaecological medical condition in which
cells from the lining of the uterus (endometrium) appear and grow
outside the uterine cavity. This growth fluctuates in a pattern
alongside the menstrual cycle, under the influence of female
hormones.
These misplaced endometrial-like cells are influenced by
hormonal changes and respond in a way that is similar to the cells
found inside the uterus; hence symptoms often worsen with the
menstrual cycle.
The treatments chosen will depend on symptoms, age, and
lifestyle plans, currently centring around pain relief and hormone
suppression; the latter leading to potential infertility and bone
weakening side effects.
About BC201
BC201 is a combination of the peptide ingredient of VAL201 with
complementary active components to dampen this excessive immune
response and consequently improve severe symptoms of Covid-19.
The theoretical action of the peptide is two-fold: by blocking
the Androgen Receptor mediated activity of SRC Kinase, the peptide
is postulated to down-regulate the expression of TMPRSS2 a
transmembrane protein believed to be required for Coronavirus cell
entry; and by directly dampening the immune response.
About Physiomics
Physiomics plc (AIM: PYC) is an oncology consultancy using
mathematical models to support the development of cancer treatment
regimens and personalised medicine solutions. The Company's Virtual
Tumour(TM) technology uses computer modelling to predict the
effects of cancer drugs and treatments to improve the success rate
of drug discovery and development projects while reducing time and
cost. The predictive capability of Physiomics' technologies have
been confirmed by over 80 projects, involving over 40 targets and
70 drugs, and has worked with clients such as Merck KGaA, Astellas,
Merck & Co and Bicycle Therapeutics.
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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END
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