FDA provides "Study May Proceed" letter for
open-label, randomized phase 3 protocol in soft tissue sarcoma, and
plans to initiate phase 3 study in first half of 2024
SHELTON,
Conn., Jan. 3, 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, today announced a business update
reflecting progress in its phase 3 sarcoma clinical
program.
IND Submission for Phase 3
In the fourth quarter of 2023, the Company submitted a new
Investigational New Drug ("IND") to the Food and Drug
Administration ("FDA"). The submission included the phase 3
protocol for a superiority trial of the Company's lead product
INT230-6 used as monotherapy compared to the standard of care drugs
in 2nd and 3rd line treatment for certain
soft tissue sarcoma subtypes. The FDA provided the Company a "Study
May Proceed" letter for phase 3 within the 30 day period following
the IND submission. The study is an open-label, randomized phase 3
trial expected to enroll 333 patients. For every three patients
enrolled, two will receive INT230-6 and one will receive standard
of care drug(s) chosen by the investigators depending on the type
of sarcoma. The Company is working with its contracted vendors to
initiate the phase 3 trial in the first half of 2024.
Manufacturing
In the fourth quarter of 2023, the Company successfully developed
the phase 3 quality analytical methods for measurement of the key
INT230-6 components, validated those methods and manufactured a
clinical batch of the drug product that met specifications. During
the fourth quarter, the Company requested and was granted a meeting
that was held with the FDA to review the INT230-6 chemical
manufacturing and controls ("CMC") for INT230-6. The CMC discussion
focused on the tasks necessary to initiate the phase 3 study and
future product registration as part of a potential New Drug
Application (NDA). During the meeting, the Company and FDA agreed
upon a plan for the CMC set of activities for the active
pharmaceutical ingredients and the drug product (INT230-6)
necessary for the NDA.
"The FDA's 'Study May Proceed' letter is another important
milestone towards achieving our mission to develop a new, safer,
and more effective way to treat cancer patients especially in the
difficult to treat types such as sarcoma. A head-to-head comparison
of INT230-6 as monotherapy locally delivered in metastatic
sarcoma against the active, systemically-delivered standard-of-care
drugs may be a first-of-its kind clinical trial," said Lewis H. Bender, President and Chief Executive
Officer of Intensity. "Current standard-of-care drugs used for
sarcoma after progression of the first line therapies require
extensive safety monitoring. The standard of care drugs cause
severe toxicities and provide median overall survival of only
between 12 and 15 months depending on the drug and sarcoma subtype
used. New and more effective ways to treat these patients are
desperately needed."
In November of 2023 at the annual Connective Tissue Oncology
meeting held in Dublin,
Christian Frederick Meyer, M.D.,
Ph.D., M.S., an Assistant Professor of Oncology at the Sidney
Kimmel Cancer Center at Johns Hopkins
University and an investigator for Intensity's Phase 1/2
clinical trial of INT230-6, presented that when compared to a
synthetic control1, INT230-6 alone extended survival in
refractory soft tissue sarcoma subjects by approximately 14.9
months. Dosing higher amounts of INT230-6 relative to a patient's
presenting total tumor burden showed a potential further increase
in survival when compared to the synthetic control.
- Median survival of the synthetic control for subjects failing a
median of 3 lines of prior therapy was about 6.8 months.
- Median overall survival of INT230-6 monotherapy (n=15) was 21.5
months.
- The INT230-6 Disease Control Rate2 was 93% in
subjects who received at least one dose of INT230-6 as
monotherapy.
Data on INT230-6 generated in metastatic patients indicated that
INT230-6 has a favorable safety profile and is well tolerated with
the majority of treatment-emergent adverse events (TEAEs) being
grade 1 or 2 primarily localized pain, fatigue, and nausea.
In September of 2023 the Company announced that the US FDA's
Office of Orphan Products Development granted orphan-drug
designation for the treatment of soft tissue sarcoma (STS) to the
three active moieties comprising INT230-6, cisplatin, vinblastine
sulfate, and the diffusion enhancer SHAO-FA (8-((2-hydroxybenzoyl)
amino) octanoate).
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 mostly in the arms,
legs, chest, and abdomen. There are many types of sarcoma; however,
the four most common are bone sarcoma (referred to as
osteosarcoma), leiomyosarcoma, undifferentiated pleomorphic sarcoma
(UPS) and liposarcoma. When sarcoma is metastatic prognosis is
poor, even with chemotherapy. Each year, 12,000 people in the U.S.
and 1,150 in Canada are diagnosed
with soft tissue sarcomas. About 3,000 patients have bone
sarcomas.
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
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 i.e.
direct killing of the tumor by INT230-6, the dying tumor 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 systemically delivered chemotherapy.
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
truly novel approach to cancer cell death that holds the potential
to shift the treatment paradigm and turn many deadly cancers into
chronic diseases. For more information about the Company, including
publications, papers and posters about its novel approach to cancer
therapeutics, visit www.intensitytherapeutics.com. INT230-6 has
completed enrollment of over 200 patients in two phase 2 and phase
1 dose escalation clinical trials (NCT03058289 and NCT04781725)
with various advanced solid tumors; IT-01 in metastatic disease,
and IT-02 (the INVINCIBLE study) in presurgical breast cancer.
The Company partnered with Merck Sharpe & Dohme (Merck) to
evaluate the combination of INT230-6, Intensity's lead product
candidate, and KEYTRUDA® (pembrolizumab), Merck's
anti-PD-1 (programmed death receptor-1) therapy, in patients with
advanced malignancies. The Company also partnered with
Bristol-Myers Squibb to evaluate the combination of INT230-6 with
Bristol-Myers Squibb's anti-CTLA-4 antibody, ipilimumab, in
patients with advanced cancers. The Company also executed
agreements with the Ottawa Hospital Research Institute (OHRI) and
the Ontario Institute of Cancer Research (OICR) to study INT230-6
in the INVINCIBLE study, a randomized controlled neoadjuvant phase
2 study in women with early-stage breast cancer.
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 expected future
plans, development activities, projected milestones, business
activities or results. We have based these forward-looking
statements on our 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 we make. These
risks and uncertainties, many of which are beyond our control,
include: the risk that the anticipated milestones may be delayed or
not occur or be changed, as well as 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:
Argot Partners
Jonathan Nugent
Intensity@argotpartners.com
205-566-3026
Media Contact:
Argot Partners
David Rosen
david.rosen@argotpartners.com
212-600-1902
1 A synthetic control is a construction of a weighted
combination of reported data to which the treatment group is
compared. This comparison is used to estimate what would have
happened to the treatment group if it had not received the
treatment. The synthetic control developed to predict survival of
the enrolled IT-01 sarcoma population was based on the presenting
biomarker data and used the Royal Marsden Hospital Index method for
survival prediction.
2 The disease control rate measures the percentage of
patients with advanced or metastatic cancer who have achieved had
stable disease, partial response or complete response while on a
therapy.
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SOURCE Intensity Therapeutics Inc.