SHELTON,
Conn., May 10, 2024 /PRNewswire/ -- Intensity
Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq:
INTS), 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 the Company
executed a collaboration agreement with The Swiss Group for
Clinical Cancer Research SAKK ("SAKK") to conduct a Phase 2
randomized, (one to one), controlled trial evaluating clinical and
biological effects of intratumoral INT230-6 followed by the
standard of care ("SOC") immuno/chemotherapy vs. SOC
immune/chemotherapy alone in early-stage triple-negative breast
cancer ("TNBC") in 54 patients in Switzerland and selected countries in
Europe (the "INVINCIBLE-4 Study").
The INVINCIBLE-4 Study is an open-label randomized two-cohort phase
2 clinical trial.
SAKK shall undertake the trial as the "Legal
Sponsor" of the study, with the regulatory agencies in Switzerland and the European Union as
described in the study protocol. SAKK will also ensure that all
investigators and personnel who participate in the study are
informed and trained. Intensity shall fund the study, provide the
investigational drug product, and other necessary information to
conduct the trial. The primary efficacy endpoint of the
INVINCIBLE-4 Study is pathological complete response (pCR) in the
primary tumor (ypT0/Tis) and affected lymph nodes (ypN0).
Additional key research questions include the immune landscape of
the tumor microenvironment and peripheral blood, magnetic resonance
imaging (MRI) changes predictive for pCR, and adverse events
according to National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) v5.0.
"We are excited to be working with SAKK on our
INVINCIBLE-4 Study in early-stage triple-negative breast cancer,"
said Lewis H. Bender, Founder,
President and CEO of Intensity Therapeutics, Inc. "TNBC poses
significant challenges due to its aggressiveness, high relapse
rates, and increased mortality especially in patients with large
tumors. Achieving pathological complete response (pCR) and clearing
positive lymph nodes are crucial prognostic factors for event-free
survival. Results from our first INVINCBLE-2 study showed that
INT230-6 could cause greater than 95% necrosis in large breast
cancer tumors following a single dose with the induction of an
immune response. By adding up to 2 doses of our unique drug before
the standard of care, we hope to increase the rate of patients'
pCR, which is an FDA-approved endpoint for accelerated approval.
The pCR data from this study, which we expect in the second
half of 2025, should provide the information needed to size our
Phase 3 trial in presurgical TNBC."
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 composed of
two proven, potent anti-cancer agents, cisplatin and vinblastine,
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, direct
killing of the tumor by INT230-6 releases a bolus of neoantigens
specific to the patient's malignancy, leading to engagement of the
immune system and systemic anti-tumor effects. Importantly, these
effects are mediated without immunosuppression that so often occurs
with systemic chemotherapy.
About Triple Negative Breast Cancer
Approximately 11-17% of breast cancers test
negative for estrogen receptors (ER), progesterone receptors (PR),
and excess human epidermal growth factor receptor 2 (HER2) protein,
qualifying them as triple negative. TNBC is considered to be more
aggressive and has a poorer prognosis than other types of breast
cancer, mainly because there are fewer available targeted
medicines. Most patients with local TNBC typically receive
immune/chemotherapy before surgery.
About SAKK
The Swiss Group for Clinical Cancer Research
(SAKK) is a decentralized academic research institute
that has been conducting clinical trials of cancer treatments in
all major Swiss hospitals since 1965. It federates a large network
of research groups with a Competence Center in Bern in charge of coordinating the clinical
operations. It also works with selected cooperative groups abroad,
particularly on rare forms of cancer. SAKK's aim is to advance
existing cancer treatments, investigate the efficacy and
tolerability of new treatments (radiotherapy, medicines and
surgery), and set new standards in treatment. 22 Swiss hospitals
are full members of SAKK. Research activity is funded by federal
subsidies provided by the State Secretariat for Education, Research
and Innovation (SERI) and financial support from other partner
organizations such as the Swiss Cancer League and the Swiss Cancer
Research Foundation. Further information can be found at
https://www.sakk.ch/en.
About Intensity Therapeutics
Intensity Therapeutics is a late-stage clinical
biotechnology company that applies novel engineered chemistry to
turn "cold" tumors "hot" by enabling its aqueous
cytotoxic-containing drug product, INT230-6, to mix and saturate
the dense, high-fat pressurized environment of the tumor. 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
novel approach to cancer cell death that holds the potential to
shift the treatment paradigm and turn many deadly cancers into
chronic diseases. INT230-6 has completed enrollment of over 200
patients in a Phase 1/2 dose escalation trial (NCT03058289) and
Phase 2 randomized control clinical trial in breast cancer (the
INVINCIBLE 2 study) (NCT04781725). The Company is initiating 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 with overall survival as an
endpoint. The Company is also planning a Phase 2/3 program in
presurgical triple-negative breast cancer testing INT230-6 in
combination with standard of care compared to standard of care
alone. For more information about the Company, 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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