FastForward Innovations Limited Investee Company Update: Intensity Therapeutics (5590W)
18 April 2019 - 4:00PM
UK Regulatory
TIDMFFWD
RNS Number : 5590W
FastForward Innovations Limited
18 April 2019
18(th) April 2019
FastForward Innovations Limited
("FastForward" or the "Company")
Investee Company Update: Intensity Therapeutics Inc.
The Board of AIM-traded FastForward Innovations Limited, trading
under the symbol FFWD, ("FastForward", the "Company" or "FFWD"),
notes the following announcement released on 17 April 2019
concerning investee company Intensity Therapeutics Inc.
("Intensity"). FastForward has a current equity interest totalling
1.99% in the stock of Intensity.
The announcement is set out below without material changes or
adjustments.
Westport, Conn. - April 17, 2019 - Intensity Therapeutics, Inc.,
a clinical-stage biotechnology company pioneering a novel,
immune-based approach to treat solid tumor cancers through direct
injection of its proprietary therapeutic agents, today announced
that the U.S. Food and Drug Administration (FDA) has granted Fast
Track designation to the Company's development program evaluating
INT230-6 for the treatment of patients with relapsed or metastatic
triple negative breast cancer (TNBC) who have failed at least two
prior lines of therapy.
"We are extremely pleased to receive this Fast Track
designation, which validates the potential of INT230-6 to treat
patients with relapsed or metastatic triple negative breast cancer
as a single agent," said Lewis H. Bender, President and Chief
Executive Officer of Intensity Therapeutics. "Finding improved
therapies for this disease is a critical unmet medical need, and we
look forward to working closely with the FDA this year to initiate
a Phase 2 clinical study for this indication."
Approximately 15-20% of breast cancers test negative for
estrogen receptors, progesterone receptors, and excess HER2
protein, qualifying them as triple negative. TNBC is considered to
be more aggressive and have a poorer prognosis than other types of
breast cancer, mainly because there are fewer targeted medicines.
According to a study published in the Journal of Clinical Oncology,
patients who fail two lines of therapy for TNBC typically progress
within nine weeks. Those who have failed three lines progress
within four weeks.
"This important regulatory designation is based on the promising
data observed to date from use of INT230-6 in our breast cancer
research," said Ian B. Walters, M.D., Chief Medical Officer of
Intensity Therapeutics. "The Fast Track designation will allow us
to engage robustly with the Agency to most effectively and
efficiently develop our new cancer treatment approach, as well as
help us determine other potential indications to pursue for
INT230-6. To date, our ongoing Phase 1/2 trial has treated patients
with more than 14 different types of advanced solid tumors
including TNBC, and we look forward to evaluating use of INT230-6
in other areas for potential registration-enabling studies."
The FDA's Fast Track program facilitates development and
expedites the review of drugs to treat serious conditions and fill
an unmet medical need. The purpose is to get important new drugs to
the patient earlier. A fast track drug must show some advantage
over available therapy. Fast Track designation allows early and
frequent communication between the FDA and a drug company, often
leading to earlier drug approval and access by patients. In
addition, the Fast Track program allows for eligibility for
Accelerated Approval and Priority Review, if relevant criteria are
met.
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 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.
FastForward Innovations Limited
info@fstfwd.co
Guerhardt Lamprecht / Lance De Jersey / Ed McDermott
Beaumont Cornish Limited (Nomad) Tel: +44 (0) 207 628 3396
James Biddle / Roland Cornish
Optiva Securities Limited (Broker) Tel: +44 (0) 203 411
1881
Jeremy King/ Graeme Dickson
For further information please visit www.fstfwd.co or
contact:
CAUTIONARY STATEMENT
The AIM Market of London Stock Exchange plc does not accept
responsibility for the adequacy or accuracy of this release. No
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has approved or disapproved the information contained herein. All
statements, other than statements of historical fact, in this news
release are forward-looking statements that involve various risks
and uncertainties, including, without limitation, statements
regarding potential values, the future plans and objectives of Fast
Forward Innovations Ltd. There can be no assurance that such
statements will prove to be accurate, achievable or recognizable in
the near term.
Actual results and future events could differ materially from
those anticipated in such statements. These and all subsequent
written and oral forward-looking statements are based on the
estimates and opinions of management on the dates they are made and
are expressly qualified in their entirety by this notice. Fast
Forward Innovations assumes no obligation to update forward-looking
statements should circumstances or management's estimates or
opinions change.
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END
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