Enrollment is ongoing and seven sites in
Switzerland have been
activated
SHELTON,
Conn. and BERN,
Switzerland, Dec. 12,
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, and The Swiss Group
for Clinical Cancer Research SAKK ("SAKK"),
a decentralized academic research institute
that has been conducting clinical trials of cancer treatments in
all major Swiss hospitals since 1965, announced that Andreas Mueller, M.D., Past-President of the
Project Group Breast Cancer of SAKK and Head of the Breast Center
at Kantonsspital Winterthur, Switzerland and a supporting coordinating
investigator for the study presented in an evening poster session
on December 11 the final data from
Intensity's INVINCIBLE-2 Study (NCT04781725), and an overview /
update of the INVINCIBLE-4 Study (NCT06358573) at the San Antonio
Breast Cancer Symposium being held December
10-13, at the Henry B. Gonzalez Convention Center in
San Antonio, Texas.
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 early-stage, operable Triple Negative
Breast Cancer ("TNBC") who undergo standard of care neoadjuvant
immunochemotherapy ("SOC") treatment and SOC alone. 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 either two doses of INT230-6 followed
by SOC, which consists of pembrolizumab, anthracyclines,
carboplatin, cyclophosphamide, and paclitaxel (i.e. the Keynote-522
regimen), or the SOC alone. The study is recruiting and expected to
enroll 54 patients.
"Women with aggressive forms of breast cancer, such as TNBC, are
often counseled to undergo pre-surgical (neoadjuvant) systemic
therapy in advance to reduce the risk of the disease returning.
Having a pathological complete response, meaning the absence of
live cancer at the time of surgery, has been shown to result in a
lower risk of recurrence. When the tumor diameters are bigger
than two centimeters, recurrence is more likely, so that
neoadjuvant treatment is warranted" said Dr. Mueller. "If the
immunological cancer cell death caused by INT230-6 and the ignition
of an anti-cancer immune response without increased toxicity shows
a meaningful increase in pCR, it would be a major advance for the
neoadjuvant treatment of breast cancer and potentially other
cancers. Further, if the results of this study are highly
favorable, perhaps the cardiotoxic anthracycline drugs could be
reduced or eliminated in future studies."
The Company's completed INVINCIBLE-2 Study, where INT230-6 was
given alone in multiple tumor types including TNBC, showed several
benefits:
- Tumor-killing properties at levels greater than 95% in some
patients on a single intratumoral dose with systemic immune
activation.
- Results in 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 significant differential gene expression
present and identified genes were associated with T cell
activation, lymphocyte activation and inflammatory response.
- 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.
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 primary endpoint. For more information about
Intensity, including publications, papers, and posters about its
novel approach to cancer therapeutics,
visit www.intensitytherapeutics.com.
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 generally 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 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.
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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