INVINCIBLE-3 Study continues to recruit
patients with leiomyosarcoma, liposarcoma and undifferentiated
pleomorphic sarcoma; authorizations for the INVINCIBLE-3 Study have
been received in the U.S., Canada,
Europe and Australia
SHELTON,
Conn., Jan. 28, 2025 /PRNewswire/ -- Intensity
Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or "the Company") a
late-stage clinical biotechnology company focused on the discovery
and development of proprietary, novel immune-based intratumoral
cancer therapies designed to kill tumors and increase immune system
recognition of cancers, announces that following its most recent
periodic review meeting, the Data Monitoring Committee (DMC)
overseeing the Company's ongoing Phase 3 sarcoma study of INT230-6
(INVINCIBLE-3) (NCT06263231) has agreed that the study should
continue without modification. The DMC reviewed data covering
the six months from July to December
2024.
"The Data Monitoring Committee is designed to confidentially
review data to determine whether safety concerns with the data
collected to date exist. We are encouraged by the
continuation of the trial and continue to believe that INT230-6
represents important potential in a treatment area that has
significantly unmet medical need. We look forward to
continuing enrollment and to providing further updates as they
develop," commented Lewis H. Bender,
Intensity's President and Chief Executive
Officer.
INVINCIBLE-3 Study Overview
The INVINCIBLE-3 Study is a global open-label, randomized,
controlled study designed to evaluate INT230-6 administered
intratumorally by an interventional radiologist or an equivalently
trained physician using image guidance compared to systemically
dosed standard of care ("SOC") chemotherapy. The study endpoints
are overall survival and safety, along with an exploratory quality
of life (QoL) assessment using the EORTC-30 survey. The study
is testing the efficacy and safety of INT230-6 intratumoral (IT)
injection compared to any of three standard-of-care therapies
(pazopanib, trabectedin, or eribulin) in approximately 333 adult
participants with locally recurrent, inoperable, or metastatic soft
tissue sarcoma ("STS") patients who had disease progression prior
to study enrollment following standard therapies, which must have
included an anthracycline-based regimen unless contraindicated.
Participants may also have received a maximum of one additional
regimen. Randomization will occur after screening and eligibility
confirmation. As this is a survival study, there is no crossover
allowed between SOC and INT230-6. Disease progression will be
determined by the World Health Organization (WHO) criteria.
Participants will be prospectively stratified into 1 of 3
histologically defined STS strata:
- leiomyosarcoma
- liposarcoma (dedifferentiated, myxoid, round cell and
pleomorphic)
- undifferentiated pleomorphic sarcoma
The comparator agents used are all U.S., Europe, Canadian and Australian-approved
agents for sarcomas: pazopanib tablets, trabectedin, and eribulin
mesylate. Authorizations for the INVINCIBLE-3 Study have been
obtained from the U.S. FDA, Health Canada, the European Medicines
Agency, and Australia's
Therapeutic Goods Administration. Sites will be opened in 8
countries and the study is presently recruiting participants in the
U.S., Canada, and Europe.
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 DfuseRx℠ technology
platform. The drug is comprised of two proven, potent anti-cancer
agents, cisplatin and vinblastine sulfate, and a penetration
enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs
throughout tumors for diffusion into cancer cells. These agents
remain in the tumor, resulting in a favorable safety profile. In
addition to local disease control and direct tumor killing,
INT230-6 causes a release of a bolus of neoantigens specific to the
malignancy, leading to immune system engagement and systemic
anti-tumor effects. Importantly, these effects are mediated without
immunosuppression, which often occurs with systemic
chemotherapy.
About Intensity Therapeutics
Intensity is a late-stage clinical biotechnology company whose
novel engineered chemistry enables aqueous cytotoxic-containing
drug formulations to mix and saturate a tumor's dense, high-fat,
pressurized environment following direct intratumoral injection. As
a result of the saturation, Intensity's clinical trials have
demonstrated the ability of INT230-6 to kill tumors and elicit an
adaptive immune response within days of injection, representing a
new approach to cancer cell death that holds the potential to shift
the treatment paradigm and turn many deadly cancers into chronic
diseases even for malignancies that do not respond to conventional
immunotherapy. Intensity has completed two clinical studies and
enrolled over 200 patients using INT230-6: a Phase 1/2 dose
escalation study in metastatic cancers including sarcomas
(NCT03058289), and a Phase 2 randomized control clinical trial in
locally advanced breast cancer (the "INVINCIBLE-2 Study")
(NCT04781725) in women without undergoing chemotherapy prior to
their surgery. The Company initiated a Phase 3 trial in soft
tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing
INT230-6 as second or third-line monotherapy compared to the
standard of care ("SOC") with overall survival as an endpoint.
Intensity also initiated a Phase 2 study in collaboration with The
Swiss Group for Clinical Cancer Research, SAKK (the "INVINCIBLE-4
Study") (NCT06358573) as part of a Phase 2/3 program evaluating
INT230-6 followed by the SOC immunochemotherapy and the SOC alone
for patients with presurgical triple-negative breast cancer.
Pathological complete response ("pCR") is the endpoint. For more
information about Intensity, including publications, papers, and
posters about its novel approach to cancer therapeutics,
visit www.intensitytherapeutics.com.
Forward-Looking Statements
Certain statements in this press release may constitute
"forward-looking statements" within the meaning of the United
States Private Securities Litigation Reform Act of 1995, as amended
to date. These statements include, but are not limited to,
statements relating to the Company's expected future plans, cash
runway, development activities, projected milestones, business
activities or results. When or if used in this communication, the
words "may," "could," "should," "anticipate," "believe,"
"estimate," "expect," "intend," "plan," "predict" and similar
expressions and their variants, as they relate to the Company or
its management, may identify forward-looking statements. The
forward-looking statements contained in this press release are
based on management's current expectations and projections about
future events. Nevertheless, actual results or events could differ
materially from the plans, intentions, and expectations disclosed
in, or implied by, the forward-looking statements. These risks and
uncertainties, many of which are beyond our control, include: the
initiation, timing, progress and results of future preclinical
studies and clinical trials and research and development programs;
the need to raise additional funding before the Company can expect
to generate any revenues from product sales; plans to develop and
commercialize product candidates; the timing or likelihood of
regulatory filings and approvals; the ability of the Company's
research to generate and advance additional product candidates; the
implementation of the Company's business model, strategic plans for
the Company's business, product candidates and technology;
commercialization, marketing and manufacturing capabilities and
strategy; the rate and degree of market acceptance and clinical
utility of the Company's system; the Company's competitive
position; the Company's intellectual property position;
developments and projections relating to the Company's competitors
and its industry; the Company's ability to maintain and establish
collaborations or obtain additional funding; expectations related
to the use of cash and cash equivalents and investments; estimates
regarding expenses, future revenue, capital requirements and needs
for additional financing; and other risks described in the section
entitled "Risk Factors" in the Company's SEC filings, which can be
obtained on the SEC website at www.sec.gov. Readers are cautioned
not to place undue reliance on the forward-looking statements,
which speak only as of the date on which they are made and reflect
management's current estimates, projections, expectations and
beliefs. The Company does not plan to update any such
forward-looking statements and expressly disclaims any duty to
update the information contained in this press release except as
required by law.
Investor Relations Contact:
Justin Kulik
Justin@coreir.com
CORE IR
(516) 222-2560
Media Contact:
Jules
Abraham
CORE IR
pr@coreir.com
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SOURCE Intensity Therapeutics Inc.
