Testing the efficacy and safety of our lead
product candidate, INT230-6, as Monotherapy Compared with Systemic
U.S. Standard-of-Care Chemotherapy
SHELTON,
Conn., July 9, 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 intratumorally injected cancer therapies
intended to kill tumors directly and increase immune system
recognition of cancers, announces that the first U.S. patient has
been dosed in the Company's Phase 3 study to treat metastatic
sarcoma (NCT06263231). The trial is a superiority study testing
INT230-6 as monotherapy compared to the investigator's choice of
three current standard-of-care systemic chemotherapy drugs in
second or third-line metastatic, recurrent, or inoperable soft
tissue sarcomas ("STS").
The global Phase 3 study is expected to enroll approximately 333
patients. The primary endpoint is overall survival. For every three
patients treated, two will receive INT230-6, and one will receive
the standard of care. STS subtypes being enrolled are
leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic
sarcoma. The Phase 3 initiation follows reported data from
the Company's Phase 1/2 trial, where INT230-6 showed tumor-killing
and immune-activating properties with increased survival in
metastatic disease.
"We have now dosed our first patient in the U.S. and have filed
regulatory documents to initiate this trial in Canada and Europe. Over the next several
months, we anticipate initiating sites in eight countries.
Sarcoma is a deadly cancer with a median overall survival following
second and third-line drug treatments of between 10 and 15 months,"
said Intensity Therapeutics' Founder, Chairman, and CEO,
Lewis H. Bender. "During our phase
1/2 metastatic dose escalation study, in a sarcoma population that
had progressed following a median of 3 lines of therapy, we
reported a median overall survival of 21.3 months with our drug
alone. Patients, their caregivers, and physicians worldwide
desperately need improved treatment options and we are excited to
have finally begun testing our new approach in Phase 3. I
want to take this opportunity to thank our dedicated team for
getting us to this tremendous milestone."
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 comprises 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 and direct killing of the tumor, INT230-6 releases
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 Sarcoma
Soft tissue sarcoma is a rare type of cancer that starts with
the growth of cells in the body's soft tissue, such as muscle, fat,
blood vessels, nerves, tendons, and linings of the joints. The
disease mostly occurs in the arms, legs and belly. There are
197,000 patients in the US living with sarcoma and more than 50
types of soft tissue sarcoma, the treatment of which first involves
surgery. Other treatments might include radiation therapy and then
chemotherapy. Using the U.S. SEER database, the Company
estimated that 14,337 patients have regional or distal (metastatic)
leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic
sarcoma.
About Intensity Therapeutics
Intensity Therapeutics is a late-stage clinical biotechnology
company that applies novel engineered chemistry 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 even for cancers that do not respond to
immunotherapy. INT230-6 has completed enrollment of over 200
patients in two studies; a Phase 1/2 dose escalation trial
(NCT03058289), and a Phase 2 randomized control clinical trial in
breast cancer (the INVINCIBLE 2 study) (NCT04781725). The
Company recently 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 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. Information on the Phase 2,
(INVINCIBLE-4-SAKK study is listed under (NCT06358573). 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 development of the Company's clinical
programs. 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-inc-announces-first-patient-dosed-in-its-global-randomized-phase-3-study-invincible-3-in-metastatic-soft-tissue-sarcoma-302190542.html
SOURCE Intensity Therapeutics Inc.