TIDMFFWD
FastForward Innovations Limited
12 November 2020
FastForward Innovations Ltd / AIM: FFWD / Sector: Closed End
Investments
12 November 2020
FastForward Innovations Ltd ("FastForward" or, "FFWD")
Investee Company Update: Portage Biotech Inc.
FastForward Innovations Ltd, the AIM quoted company focusing on
making investments in fast growing and industry leading businesses,
is pleased to note the update from Intensity Therapeutics, a
subsidiary of FastForward's investee company, Portage Biotech Inc.
('Portage'), in which it holds a 1.18% interest.
Intensity Therapeutics Reports Favorable Data of INT230-6 from
the Ongoing Phase 1/2 Study (IT-01/KEYNOTE A10) in Patients with
Advanced Solid Tumors at SITC 2020 (Abstract 411)
-- Kaplan Meier analysis shows a 79.1% survival probability
estimate at 1 year when dosing a volume of INT230-6 of >=50% of
the baseline tumor burden
-- Several subjects had regression in untreated tumors with INT230-6 monotherapy
-- Increased infiltration of activated CD4 and CD8 T-cells observed in tumors
-- Safety remains favorable, majority low grade adverse events
with no additional safety signals seen when dosing INT230-6 in
combination pembrolizumab
--
Westport, Conn. - November 11, 2020 - Intensity Therapeutics,
Inc., a clinical-stage biotechnology company developing proprietary
intratumoral immunotherapy products to kill tumors and increase
immune system recognition of cancers, today announced new efficacy
and safety data from the ongoing Phase 1/2 clinical study of
INT230-6, the Company's lead product candidate. These data will be
shared November 11th and 13th in a poster presentation at the
Society for Immunotherapy of Cancer's (SITC) 35th Annual
Meeting.
"The preliminary data generated supports the hypothesis that
dosing a substantial proportion of patient's tumor burden with
INT230-6 may cause enough tumor killing and immune activation to
provide the patient with extended survival," said poster presenter
and study investigator Anthony El-Khoueiry, MD, Associate Professor
of Clinical Medicine, Keck School of Medicine of the University of
Southern California and Director of the phase I program at the USC
Norris Comprehensive Cancer Center. "The emerging data shows that
the treatment is well tolerated with no patients having to
discontinue therapy due to treatment-related toxicities.
Observations of tumor shrinkage, tumor necrosis and the regression
of uninjected lesions in several patients provide early signs of
anti-cancer efficacy. We are looking forward to the emerging data
in combination with checkpoint inhibitors."
"We are excited to share this interim clinical data of
intratumoral INT230-6. There have been over 225 deep tumor
injections without complications to date including dosing directly
into the lung, liver, and pancreas. We and our investigators are
increasing our understanding of a suitable dosing regimen needed to
improve patient outcomes," said Ian B. Walters, MD, Chief Medical
Officer of Intensity Therapeutics. "Having the ability to safely
reduce tumor cell burden and prime an immune response is an
important advance in our ability to manage refractory cancers that
often are non-immunogenic. We look forward to evaluating the
combination of INT230-6 with Keytruda(R) as well as with Yervoy(R)
in our on-going phase 2 studies and to advancing INT230-6 into
registrational studies as soon as possible."
The presentation includes survival analysis on heavily
pretreated patients with 19 different types of advanced or
metastatic solid tumors. Enrolled patients progressed following a
median of three prior lines of therapy (range 0 to 10) including
all approved, appropriate therapies for a subject's particular
cancer. Patients enrolled into the study's cohorts with random
baseline tumor burden ranging from less than 2 cm3 to greater than
11,000 cm3. Four subjects who had total tumor burden below 2 cm3 or
above 1300 cm3 were censored from the survival analysis. Thirty
(30) patients received a cumulative dose volume of INT230-6 greater
than or equal to 50% of their total tumor burden (target dose).
Twenty-six (26) patients received a total dose of INT230-6 to less
than 50% of their total tumor burden. These two groups were
reasonably balanced with respect to age, gender, ethnicity, tumor
types and mean baseline tumor burden (243 cm3 vs. 270 cm3 (p
=0.7045)). Other prognostic factors have yet to be evaluated.
Median survival was 162 days for patients receiving cumulative
doses of INT230-6 less than 50% of their tumor burden. Whereas
median survival for subjects receiving cumulative doses of INT230-6
greater than or equal to 50% of their tumor burden has not yet been
reached after a median follow-up of over 385 days. Cox Model
analysis shows a hazard ratio of 0.272 (95% Confidence Interval;
0.152, 0.592).
A pharmacokinetic (PK) analysis revealed greater than 95% of the
active drugs (cisplatin (CIS) and vinblastine (VIN)) remain in the
tumor. There was no clinically meaningful difference in the rate or
severity of treatment emergent adverse events reported between the
monotherapy and pembrolizumab combination arms. Only 12.7% of
subjects in the monotherapy cohorts and 14.7% in the KEYNOTE A10
pembrolizumab cohort had treatment emergent grade 3 adverse events.
There have been no grade 4 or 5 treatment emergent adverse events
and no events that were dose limiting.
Local delivery of INT230-6 as monotherapy into tumors induced an
immune response with increases of activated CD4+ and CD8+ T-cells
in the tumor without any immune-related adverse events. These
clinical results are consistent with immune findings from in vivo
models.
Presentation Information
Title: Intratumoral INT230-6 increases tumor T cell infiltration
and results in durable benefit as monotherapy and in combination
with pembrolizumab in refractory patients.
Abstract Number: 411
Date/Time: Wednesday, November 11, 5:15-5:45 p.m. EST and
Friday, November 13 4:40-5:10 p.m. EST. Additionally, posters will
remain on display in the virtual poster hall from Monday, November
9 to Thursday, December 31.
Session: Clinical Trial In Progress
Presenter: Anthony El-Khoueiry, MD, Associate Professor of
Clinical Medicine, University of Southern California's Keck School
of Medicine
About INT230-6
INT230-6, Intensity's lead proprietary investigational product
candidate, is designed for direct intratumoral injection. INT230-6
was discovered using Intensity's proprietary DfuseRxSM technology
platform. The drug is comprised of two proven, potent anti-cancer
agents, cisplatin and vinblastine, and a penetration enhancer
molecule that helps disperse the drugs throughout tumors for
diffusion into cancer cells. In preclinical studies, INT230-6
eradicated tumors by a combination of direct tumor killing, release
of tumor antigens and recruitment of immune cells to the tumor.
Results generated by both the Company and the National Cancer
Institute (NCI) showed 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 responses in animals with long-term protection from
multiple re-challenges of the initial cancer and resistance to
other cancers. The Company's research published in the
International Journal of Molecular Sciences earlier this year and
joint research with the NCI published in July 2019 in the Journal
OncoImmunology as part of Intensity's awarded CRADA , also showed
strong synergy when INT230-6 was combined with anti-PD-1 and
anti-CTLA-4 antibodies.
Clinical Studies
INT230-6 is currently being evaluated in Phase 2 clinical
studies (NCT03058289) in patients with various advanced solid
tumors. Phase 1 dose escalation cohorts completed in 2020. There
have been no dose limiting adverse events observed in patients to
date, even when dosing into deep tumors in the lung, pancreas or
liver. In 2019, the Company executed a clinical collaboration
agreement with Merck Sharpe & Dohme (Merck) to evaluate the
combination of INT230-6, Intensity's lead product candidate, and
KEYTRUDA(R) (pembrolizumab), Merck's anti-PD-1 (programmed death
receptor-1) therapy, in patients with advanced solid malignancies.
In 2020, the Company executed a clinical collaboration agreement
with Bristol Myers Squibb (BMS) to evaluate the combination of the
Company's lead product, INT230-6, with BMS's anti-CTLA-4 antibody,
Yervoy(R) (ipilimumab), in patients with advanced solid
malignancies. Clinical data reported improved survival at higher
doses of INT230-6 per total tumor burden. Several patients
demonstrated tumor shrinkage, symptomatic improvement, and evidence
of cancer cell death and immune cell activation on tumor biopsy. In
the combination cohort with pembrolizumab the Company reported that
the safety of the combination was comparable to INT230-6
monotherapy.
About Intensity Therapeutics
Intensity Therapeutics, Inc. is a privately held, clinical-stage
biotechnology company pioneering a new immune-based approach to
treat solid tumor cancers. Intensity leverages its DfuseRxSM
technology platform to create new, proprietary 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. The Company executed a Cooperative Research
and Development Agreement (CRADA) with the National Cancer
Institute's (NCI) Vaccine Branch in 2014 and partnerships with
Merck and BMS. For more information, please visit
www.intensitytherapeutics.com and follow us on Twitter
@IntensityInc.
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.
ENDS
For further information on the Company please visit www.fstfwd.co or contact:
Ed McDermott / Lance FastForward Innovations Email: info@fstfwd.co
de Jersey Ltd
James Biddle / Roland Beaumont Cornish Tel: +44 (0) 207
Cornish Limited, 628 3396
Nomad
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Isabelle Pierre / Damon Shard Capital Tel: (0)207 186 9927
Heath Partners LLP
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Isabel De Salis / Beth St Brides Partners Tel: +44 (0)207 236
Melluish Ltd, 1177
Financial PR
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Notes
FastForward Innovations is an AIM quoted investment company
focused primarily on disruptive high growth life sciences and
technology businesses particularly within the medical cannabis
arena. The Company's strategy is to identify early stage
opportunities that have an upcoming investment catalyst and grow
its portfolio in terms of value whilst limiting the number of
investee companies to a level where relevant time can be devoted to
each.
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