FastForward Innovations Limited Investee Company Update
May 30 2017 - 10:52AM
RNS Non-Regulatory
TIDMFFWD
FastForward Innovations Limited
30 May 2017
30 May 2017
FastForward Innovations Limited
("FastForward")
Investee Company Update: Intensity Therapeutics, Inc.
Successfully Administers INT230-6 to First Patient in a Phase 1/2
Trial
Study being conducted under both an accepted IND from the U.S.
Food and Drug Administration and a CTA from Health Canada
Intensity Therapeutics, Inc.(the "Company"), in which
FastForward has a holding of 2.118%, is a privately held
biotechnology company developing proprietary cancer immunotherapy
products, and has today announced that the first patient
successfully received treatment with the Company's lead product,
INT230-6 as part of a Phase 1/2 international clinical study.
Initiation of the study followed acceptance of an investigational
new drug (IND) submission by the U.S. Food and Drug
Administration's Division of Oncology Products 1 (DOP1) and receipt
from Health Canada of a No Objection Letter following submission of
a clinical trial application (CTA). The clinical trial, IT-01
(NCT#03058289), entitled A Phase 1/2 Safety Study of Intratumorally
Administered INT230-6 in Adult Subjects with Advanced Refractory
Cancers, aims to enroll approximately 60 patients with several
different types of advanced solid tumors.
"Bringing our novel product, INT230-6, into human testing is a
major milestone for Intensity Therapeutics," commented President
and CEO Lewis H. Bender. "Over the past few years our Company has
demonstrated impressive tumor shrinkage in several murine models of
cancers. INT230-6 eradicated large tumors, activated a systemic
immune response and improved survival. Animals having a complete
response acquired the capability to spontaneous clear re-challenges
of the same cancer throughout the remainder of their lives,
suggesting a protective effect similar to that of a vaccine. We are
therefore excited to have initiated human testing. Our staff,
investigators and clinical centers are enthusiastic about bringing
patients our potentially life-saving product."
This unique Phase 1/2 study will first assess the safety of
INT230-6 in tumors treated at the skin surface (e.g. breast,
melanoma, head-and-neck and lymphoma). Subsequent patients
receiving INT230-6 will include those with deep tumors (e.g. liver,
pancreatic, colon, lung and others). Investigators will utilize
image guidance to inject the tumors. Additionally, a cohort is
planned to explore INT230-6 in combination with anti-PD1 agents.
The study's primary goal is to demonstrate the safety of INT230-6.
Secondary analyses will examine the efficacy of INT230-6 treatment
via multiple parameters. The trial includes several adaptive
components that will allow for adjustments in patient groups,
dosing schedule and dose volumes administered.
"Our studies with INT230-6 have shown the ability to stimulate a
strong T-cell response as a monotherapy. There is considerably
enhanced activity using INT230-6 in combination with checkpoint
inhibitors such as anti-PD-1 antibodies, while maintaining a
favorable safety profile," said Chief Medical Officer Ian B.
Walters, MD. "We are optimistic that our novel trial design can
quickly detect evidence of direct tumor killing and immune system
activation. Physicians desperately need improved treatments for
patients with advanced cancers that are not responding to approved
immunotherapies. Intensity Therapeutics is grateful to the
volunteers participating in our study and looks forward to
collecting data on INT230-6 in different cancer types."
About INT230-6
INT230-6 is a novel, anti-cancer drug for direct intratumoral
injection. The product contains potent anti-cancer agents that
disperse throughout tumors and diffuse into cancer cells. INT230-6
was identified from Intensity's DfuseRx(SM) platform and is being
evaluated in a clinical trial; IT-01. In preclinical studies
INT230-6 administration eradicated tumors by a combination of
direct tumor kill coupled with recruitment of dendritic cells to
the tumor micro-environment that stimulated 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.
About Study IT-01
IT-01 is entitled A Phase 1/2 Safety Study of Intratumorally
Administered INT230-6 in Adult Subjects with Advanced Refractory
Cancers. The trial aims to enroll approximately 60 patients with
different types advanced solid tumor malignancies in a multicycle
dosing regimen. The study will be conducted in multiple countries
and includes a cohort combining INT230-6 with an anti-PD-1
antibody. Currently the study is recruiting in the U.S. at two
hospitals associated with the University of Southern California
(USC) and in Canada at the University Health Network (UHN) in
Toronto. The principal investigator at USC is Dr. Anthony
El-Khoueiry; the principal investigator at UHN is Dr. Lillian Siu.
The study's primary objective is to assess the safety and
tolerability of multiple intratumoral doses of INT230-6. Secondary
assessments are to understand preliminary efficacy of INT230-6 by
measuring the injected and bystander tumor responses. The study
will characterize 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. Data
will be used to assess the progression free and overall survival in
subjects receiving INT230-6. Further information can be found at
www.clinicaltrials.gov (NCT#03058289).
About Intensity Therapeutics, Inc.
Intensity Therapeutics, Inc. is a clinical-stage biotechnology
company whose mission is to greatly extend the lives of patients
with cancer. Intensity Therapeutics is pioneering a new
immune-based approach to treat cancer. The Company uses its
DfuseRx(SM) platform technology to create new drug formulations
that disperse throughout a tumor and diffuse into cancer cells.
Drug products created using the technology are capable of
attenuating (killing) a tumor in a manner that allows for the
adaptive immune system to recognize the cancer and attack distal
tumors and micrometastases. Further information can be found at
www.intensitytherapeutics.com.
For further information please visit www.fstfwd.co or
contact:
FastForward Innovations Limited info@fstfwd.co
Josh Epstein/ Ian Burns
------------------------------------------------------------
Beaumont Cornish Limited (Nomad) Tel: +44 (0) 207 628 3396
James Biddle / Michael Cornish
------------------------------------------------------------
Optiva Securities Limited (Broker) Tel: +44 (0) 203 411 1881
Ed McDermott
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CAUTIONARY STATEMENT
The AIM Market of London Stock Exchange plc does not accept
responsibility for the adequacy or accuracy of this release. No
stock exchange, securities commission or other regulatory authority
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
FastForward 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.
FastForward Innovations assumes no obligation to update
forward-looking statements should circumstances or management's
estimates or opinions change.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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