Phase 1/2 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 Study is recruiting and expected
to enroll 333 patients with leiomyosarcoma, liposarcoma and
undeferential pleomorphic sarcoma; authorizations for the
INVINCIBLE-3 Study have been received in the U.S., Canada, Europe and Australia
SHELTON,
Conn., Nov. 18, 2024 /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, today announced that Christian F. Meyer M.D., Ph.D., Assistant
Professor of Oncology and lead medical oncologist for adult sarcoma
patients at Johns Hopkins University's
Sidney Kimmel Cancer Center, presented final safety and efficacy
data from the Company's Phase 1/2 clinical trial of
INT230-6 that was used as a monotherapy in patients with
relapsed, refractory, and metastatic sarcomas, along with an
overview of the Company's ongoing INVINCIBLE-3 Study design
(NCT06263231). Dr. Meyer shared the information during an oral
podium presentation in a late-breaking session at the 2024
Connective Tissue Oncology Society ("CTOS") on November 16, 2024, at 9 AM
PST. The abstract's lead author was Albiruni Razak, MB BCh,
BM BCh, Clinician Investigator, Princess Margaret Cancer Centre at
the University Hospital Network in Toronto, Ontario, Canada. Both Drs. Razak and
Meyer, enrolled patients in the Phase 1/2 clinical trial. This
year's annual CTOS conference was held in San Diego from November
13 to 16, 2024 at the Grand Hyatt.
"The data in the Phase 1/2 study has shown that INT230-6 causes
cell death leading to tumor necrosis, improved cancer recognition
by immune cells, and an ignition of a systemic anti-cancer immune
response that results in T-cells entering the tumor
microenvironment and has shown a favorable safety profile in soft
tissue sarcomas," said Dr. Razak. "Systemically delivered
chemotherapies have severe side effects, including cardiotoxicity,
and most sarcoma subtypes have only a minimal response to
immunotherapies. In addition, most sarcoma patients remain on
current therapies for only a few months prior to progression, death
or excessive toxicity. Demonstrating statistically significant
improvement in median overall survival for the INT230-6 treatment
arm compared to the standard of care arm in the INVINCIBLE-3 Study
would be a major step forward in treating patients with these
deadly soft tissue sarcomas."
Phase 1/2 Study (Sarcoma Subset Data: 15 Patients):
Demographics:
- Median (min, max) lines for prior drug therapies: 3 (1.00,
7.00)
- Mean (SD) age: 62.8 (8.1) years and ranged from 41.9 to 76.1
years
- ECOG performance status at screening was 0, 1 and 2 for 2
(13.3%), 12 (80.0%), and 1 (6.7%) subjects respectively
- The sarcoma diagnoses of the Phase 2 patients included
liposarcoma, pleomorphic sarcoma, leiomyosarcoma, chondrosarcoma,
osteosarcoma (chondroid syringoma), myofibroblastic, osteosarcoma,
Kaposi sarcoma and chordoma
Efficacy:
- The mOS in the mixed sarcoma population: 21.3 months for
INT230-6
- The mOS had not been reached with 21.4 months of median
follow-up for patients who received a cumulative INT230-6 dose
volume that was greater than 40% of their total tumor burden
- INT230-6 extended overall survival in refractory sarcoma
subjects by nearly 15 months as monotherapy when compared to a
synthetic control group based on the Royal Marsden Hospital scoring
method
- Sarcoma population's overall disease control rate (DCR): 93.3%
(95% CI: 68.1, 99.8) at 2 months
- Median duration of response (DOR): 4.0 months (95% CI: 1.7, NA)
and 11.3 months (95% CI: 2.8, NA) for subjects who received a
cumulative dose of ≥ 40% of the total incoming total tumor
burden
- INT230-6 demonstrated an increase in T-cells within the
tumors
- 27% of patients had uninjected tumors shrink (abscopal
effects), though tumors less than 1 cm were uninjected, untracked
and unreported by investigators, so the true abscopal percentage is
unknown; further radiomics work is on-going
Safety
- INT230-6 demonstrated a favorable safety profile and was
well-tolerated
- 3 subjects (20%) had one or more drug regimen-related Grade ≥ 3
Treatment Emergent Adverse Events (TEAE); all were grade 3 (there
were no grade 4 or 5 TEAEs)
INVINCIBLE-3 Study Overview
The INVINCIBLE-3 Study is
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. This is a global randomized
Phase 3 study comparing the efficacy and safety of INT230-6
intratumoral (IT) injection with 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.
"The safety and efficacy data of our lead drug candidate,
INT230-6, generated for sarcomas was quite encouraging. Many
insights were gained from the over 200 patients treated before
initiating the INVINCIBLE-3 study and applied to the ongoing study.
Our approach uses sophisticated interventional radiology
technologies to guide needles into tumors to inject our novel
cytotoxic drug, which is highly absorbed by tumors, and showed
a potential meaningful impact on lengthening metastatic sarcoma
patient lives, reducing toxicities and improving quality of life
compared to current treatments in our first clinical trial," said
Lewis H. Bender, Intensity's
President and Chief Executive Officer. "Our unique chemistry
enables water-based products to diffuse throughout tumors and into
cancer cells, causing immunologic cell death."
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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