TIDMSALV
RNS Number : 7437E
SalvaRx Group plc
22 October 2018
SalvaRx Group plc
("SalvaRx" or "the Company")
Intensity Therapeutics Update
The Company notes the following announcement that will be
released today by Intensity Therapeutics, Inc. ("Intensity"), in
which it has an indirect equity holding of 8%.
The announcement is set out below without material changes or
adjustments.
Intensity Therapeutics Announces Preliminary Data from Clinical
Study of INT230-6 in Advanced Solid Tumors
-- Intratumoral injections of INT230-6 were well tolerated with
no drug-related serious adverse events or dose-limiting
toxicity
-- Increases in circulating CD8 and CD4 T-cells and evidence of
abscopal responses in non-injected tumors observed
WESTPORT, Conn., October 22, 2018 - Intensity Therapeutics,
Inc., a clinical-stage biotechnology company developing proprietary
immune cell-activating cancer treatments, today announced
preliminary data from a Phase 1/2 clinical study demonstrated that
INT230-6, the Company's novel lead product candidate designed for
direct intratumoral injection, was well tolerated in patients with
advanced solid tumors. The data were presented in a poster session
on Saturday at the European Society for Medical Oncology (ESMO)
2018 Congress in Munich, Germany.
INT230-6 is comprised of two proven, potent anti-cancer agents
and a unique molecule that causes rapid drug dispersion throughout
tumors and diffusion into cancer cells. In preclinical studies,
INT230-6 demonstrated the ability to thoroughly saturate and kill
injected tumors and induce an adaptive immune response that attacks
non-injected tumors.
"We are pleased to share the first clinical data emerging from
Intensity's study evaluating INT230-6 in patients with different
types of solid tumors. This early data indicates that INT230-6 can
be safely injected into several different types of superficial and
deep tumors, and the vast majority of the active components stay
inside the tumor," said Ian B. Walters, MD, Chief Medical Officer
of Intensity.
The presenting author and a study investigator, Anthony
El-Khoueiry, MD, Associate Professor of Clinical Medicine and phase
I program director at the University of Southern California Norris
Comprehensive Cancer Center, said, "We have treated 20 patients in
the study thus far, and the intratumoral injections of INT230-6
have been well tolerated. Most patients experienced mild to
moderate transient local pain and swelling. Even at low doses, we
are seeing some anti-tumor effects in injected tumors, as well as
some evidence of immune activation in the blood. There are also
early signs of anti-tumor effects in distal untreated tumors."
Dr. Walters added, "The study will continue to enroll patients
with difficult-to-treat tumors as we explore higher doses. We look
forward to adding more North American sites, as well as new centers
outside the U.S. and Canada. In addition, we plan to move into
combination arms with an anti-PD-1 antibody and begin Phase 2
expansion cohorts next year."
About INT230-6
INT230-6, Intensity's lead product candidate designed for direct
intratumoral injection, is comprised of two proven, potent
anti-cancer agents and a penetration enhancer molecule that helps
disperse the drugs throughout tumors and diffuse into cancer cells.
INT230-6 is being evaluated in a Phase 1/2 clinical study
(NCT03058289) in patients with various advanced solid tumors. In
preclinical studies, INT230-6 eradicated tumors by a combination of
direct tumor kill and recruitment of dendritic cells to the tumor
micro-environment that induced anti-cancer T-cell activation.
Treatment with INT230-6 in in vivo models of severe cancer resulted
in substantial improvement in overall survival compared to standard
therapies. Further, INT230-6 provided complete responder animals
with long-term, durable protection from multiple re-inoculations of
the initial cancer and resistance to other cancers. In mouse
models, INT230-6 has shown strong synergy with checkpoint blockage,
including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was
discovered from Intensity's DfuseRx(SM) platform.
About the Phase 1/2 Clinical Study
INT230-6 is being evaluated in a Phase 1/2 clinical study in
patients with different types of advanced solid tumor malignancies.
The study's primary objective is to assess the safety and
tolerability of multiple intratumoral doses of INT230-6. Secondary
assessments are the measurement of injected and bystander tumor
responses, and determination of the systemic pharmacokinetic
profile of multiple doses of INT230-6's drug substances after
single and then multiple intratumoral injections. Exploratory
analysis will characterize patient outcome, as well as evaluate
various tumor and anti-tumor immune response biomarkers that may
correlate with response. The study includes several adaptive
components that will allow for adjustments in patient groups,
dosing schedule and dose volumes administered. Data will be used to
assess the progression free and overall survival in patients
receiving INT230-6. For more information, please visit
www.clinicaltrials.gov (NCT03058289).
About Intensity Therapeutics
Intensity Therapeutics, Inc. is a clinical-stage biotechnology
company pioneering a new immune-based approach to treat solid tumor
cancers. Intensity leverages its DfuseRx(SM) technology platform to
create new drug formulations that, following direct injection,
rapidly disperse throughout a tumor and diffuse therapeutic agents
into cancer cells. Intensity's product candidates have the
potential to induce an adaptive immune response that not only
attacks the injected tumor, but also non-injected tumors and unseen
micro-metastases. INT230-6, Intensity's lead product candidate, is
being evaluated in a Phase 1/2 clinical study in patients with
various advanced solid tumors. For more information, please visit
www.intensitytherapeutics.com and follow us on Twitter
@IntensityInc.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
Forward Looking Statements
This press release contains forward-looking statements regarding
Intensity Therapeutics' plans, future operations and objectives.
Such statements involve known and unknown risks, uncertainties and
other factors that may cause actual performance or achievements to
be materially different from those currently anticipated. These
forward-looking statements include, among other things, statements
about the initiation and timing of future clinical trials.
Enquiries
SalvaRx Group plc
Ian B. Walters, MD (Chief Executive) Tel: +1 203 441 5451
Northland Capital Partners Limited Tel: +44 (0) 20 3861 6625
Nominated Adviser and Broker
Matthew Johnson / Edward Hutton (Corporate
Finance)
Vadim Alexandre (Corporate Broking)
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
UPDDMMZGRZKGRZG
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