- The US FDA, Health Canada, European Medicines Authority, and
the Australian Therapeutic Goods Administration authorized the
Company's global, randomized Phase 3 study (INVINCIBLE-3) in
Metastatic Soft Tissue Sarcoma
- Twenty-three sites are currently contracted in the
INVINCIBLE 3 study, and several sites have treated patients
- Seven Swiss sites are activated in the Phase 2
(INVINCIBLE-4) study for early-stage, operable Triple Negative
Breast Cancer ("TNBC"), and several patients have been
treated
SHELTON,
Conn., Jan. 10, 2025 /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, today announces a business
update highlighting key achievements with its lead drug candidate
INT230-6.
Business Development
Discussions with multiple companies regarding potential
strategic collaborations and licenses in various territories for
INT230-6 initiated in 2024. While term sheets may be negotiated,
there is no assurance that any ongoing discussions, negotiations,
or due diligence processes will result in definitive agreements,
partnerships, collaborations, or relationships.
Sarcoma INVINCIBLE-3
In July 2024, the Company
initiated and dosed its first patient in a Phase 3 open-label,
randomized study (the "INVINCIBLE-3 Study") testing INT230-6 as a
monotherapy compared to the standard of care ("SOC") drugs in
second-and third-line treatment for certain soft tissue sarcoma
subtypes. This study has been authorized by the US FDA,
Health Canada, the European Medicines Authority, and Australia's Therapeutics Goods Administration.
The trial is enrolling and being conducted in eight countries: the
US, Australia, Canada, France, Germany, Italy, Poland, and Spain. Up to 62 sarcoma-focused hospitals and
other centers are expected to participate from these countries.
In November 2024, the Company
presented INT230-6 Phase 1/2 data in a late-breaking session at the
2024 Annual Connective Tissue Oncology Society Meeting
(CTOS). These data showed a median overall survival ("mOS")
of 21.3 months versus a synthetic control of 6.7 months, an
increase in T-cell activation, and favorable safety profile for
patients receiving INT230-6 alone. INVINCIBLE-3 continues
recruiting with an expected enrollment of 333 patients with
leiomyosarcoma, liposarcoma and undeferential pleomorphic
sarcoma.
Breast Cancer INVINCIBLE-2 and INVINCIBLE-4
In October 2024, the Company, in
collaboration with the Swiss Group for Clinical Cancer Research
SAKK ("SAKK") in the INVINCIBLE-4 Study, a Phase 2 trial to treat
patients with localized triple-negative breast cancer ("TNBC"),
announced that the first patient has been dosed in the
study.
In December 2024, Phase 2 data in
presurgical breast cancer from the completed INVINCIBLE-2 study
along with an overview of the ongoing INVINCIBLE-4 (SAKK 66/22),
was presented at the 2024 San Antonio Breast Cancer Symposium
(SABCS).
The Company's completed INVINCIBLE-2 Study, where INT230-6 was
given alone in multiple tumor types including TNBC, showed the
following:
- Tumor-killing properties at levels greater than 95% in some
patients on a single intratumoral dose with systemic immune
activation.
- Tumors larger than 2 cm showed significant necrosis in 74% of
subjects at the time of surgery.
- Gene expression analysis showed a significant difference
between baseline biopsies and surgical specimens. Pathway analysis
identified genes associated with TCR signaling, B-cell and T-cell
activation, with increasing effects in post-treatment samples
(SABCS 2023 #PS16-03).
- The study demonstrated pathologic and immune priming effects of
intratumoral cytotoxicity in traditional immune quiescent breast
cancers, with a treatment that showed favorable safety and was well
tolerated.
- INT230-6 patients had increases in CD4 T cells and NK cells
within the tumor and associated changes in the diversity of T cell
repertoire.
The INVINCIBLE-4 Study is a randomized open-label, multicenter
study to determine the clinical activity, safety, and tolerability
of INT230-6 in patients with tumors greater than two centimeters
having early-stage, operable Triple Negative Breast Cancer
("TNBC"). These patients undergo standard-of-care neoadjuvant
immunochemotherapy ("SOC") treatment, which consists of
pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and
paclitaxel (i.e. the Keynote-522 regimen). The primary endpoint is
pathological complete response ("pCR") in the primary tumor and
affected lymph nodes. Patients will be randomized one to one to
receive a regimen of two doses of INT230-6 followed by SOC, or SOC
alone. The study is expected to enroll 54 patients in up to 16
centers in Switzerland and
France.
"The data from our prior studies and trial design has allowed
INT230-6 to be authorized by the leading regulatory agencies
globally to move into late-stage clinical trials. INT230-6 is being
tested in metastatic and pre-surgical cancers, which highlights the
broad potential for our new cancer treatment," said Lewis H. Bender, President and CEO of Intensity
Therapeutics, "There are many risks and hurdles in drug development
and advancing programs into phase 3 trials is an important
achievement and a testament that reflects the expertise and
dedication of our team. We are excited that contracts exist with
nearly two dozen top sarcoma-centric hospitals in our Phase 3 study
and nine sites in our Phase 2 presurgical breast cancer trial with
seven activated. Several sites are enrolling and continue to
recruit patients for both studies. Given the potential benefit of
our new drug, we are working to establish partnerships that
expedite product development and ultimate market access in the US
and abroad."
About Soft Tissue Sarcoma
Soft tissue sarcoma is a
broad term for cancers that start in soft tissues (muscle, tendons,
fat, lymph and blood vessels, and nerves). These cancers can
develop anywhere in the body but are found mainly in the arms,
legs, chest, and abdomen. There are many types of sarcomas;
however, the four most common are bone sarcoma (referred to as
osteosarcoma), leiomyosarcoma, undifferentiated pleomorphic sarcoma
(UPS), and liposarcoma. According to SEER estimates, approximately
14,500 patients have metastatic liposarcoma, leiomyosarcoma, and
undifferentiated pleomorphic disease at any one time in the US.
When sarcoma is metastatic, the prognosis is poor, even with
systemic chemotherapy.
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 Triple Negative Breast Cancer in the Presurgical
Setting
Approximately 11-17% of breast cancers test negative
for estrogen receptors (ER), progesterone receptors (PR), and
overexpression of 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, because there are fewer available targeted
medicines. Most patients with local TNBC typically receive
immune/chemotherapy before surgery. Since the publication of
Keynote-522, standard neoadjuvant treatment for TNBC includes
systemic chemotherapy (anthracyclines, cyclophosphamide,
paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody
pembrolizumab. pCR rates are 65%, with rates lower in the
larger-sized tumors. The toxicity of the Keynote-522 regimen is
high, with 80% of patients experiencing grade 3 or higher
treatment-related AEs, including treatment-related adverse events
that lead to death in 0.5% of patients.
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 primary 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.