WESTPORT, Conn., Sept. 7,
2023 /PRNewswire/ -- Intensity Therapeutics, Inc.
("Intensity" or the "Company") (Nasdaq: INTS), a clinical-stage
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 the US Food and Drug Administration's
Office of Orphan Products Development has 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). INT230-6 is the Company's
lead product candidate.
"The designation of cisplatin, vinblastine and our diffusion
enhancer, SHAO for orphan status for STS is quite important," said
Lewis H. Bender President and CEO.
"The Orphan Drug Designation qualifies us for incentives including
tax credits for qualified clinical trials, exemption from user fees
and potentially seven years of marketing exclusivity for products
containing these three key components should the Company gain
approval of INT230-6 for treatment of STS."
An FDA condition to obtain orphan drug designation was for the
Company to provide a scientific rationale in its application with
sufficient data to establish a medically plausible basis for
expecting the drug to be effective in STS. The Company submitted
clinical data including immune activation results in sarcoma
patients.
At ASCO in June 2023 Assistant
Professor of Oncology at the Sidney Kimmel Cancer Center at
Johns Hopkins University Christian
Frederick Meyer, M.D., Ph.D., M.S., an investigator involved in
Intensity's Phase 1/2 clinical study, reported that compared to
synthetic controls, median overall survival using INT230-6 alone in
refractory soft tissue sarcoma subjects was prolonged by nearly 450
days with favorable safety over what would have been expected for
the patient population. Data also reported at ASCO showed that
INT230-6 when delivered locally led to a systemic immune response
in several sarcoma subtypes that are considered to be
non-immunogenic cancers. Intensity is planning a phase 3
registration study in STS.
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, half of people diagnosed with
metastatic disease die within 15 months. 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,
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, direct
killing of the tumor by INT230-6 releases a bolus of neoantigens
specific to the patient's malignancy, leading to engagement of the
immune system and systemic anti-tumor effects.
About Intensity Therapeutics
Intensity Therapeutics,
Inc. is a clinical-stage biotechnology company pioneering a new
immune-based approach to treat solid tumor cancers. Intensity
leverages its DfuseRx℠ technology platform to create proprietary
drug formulations that following direct injection rapidly disperse
throughout a tumor and diffuse therapeutic agents into cancer
cells. Intensity's product candidates have the potential to induce
an adaptive immune response that not only attacks the injected
tumor, but also non-injected tumors. The Company's lead product
candidate, INT230-6, is in development for the treatment of
patients with solid tumors, such as sarcoma and breast cancer.
Intensity has a clinical collaboration agreement with Merck Sharpe
& Dohme (Merck) to evaluate INT230-6 with pembrolizumab. In
addition, the Company has a clinical collaboration agreement with
Bristol-Myers Squibb to evaluate INT230-6 with Bristol-Myers
Squibb's anti-CTLA-4 antibody, ipilimumab. Intensity has also
executed agreements with the Ottawa Hospital Research Institute
(OHRI) and the Ontario Institute of Cancer Research (OICR) to study
INT230-6 in a randomized controlled neoadjuvant phase 2 study in
women with early stage breast cancer (the INVINCIBLE study)
(NCT04781725). Additionally, the Company executed a Cooperative
Research and Development Agreement (CRADA) with the National Cancer
Institute's (NCI) Vaccine Branch. For more information, please
visit www.intensitytherapeutics.com and follow the Company on
Twitter @IntensityInc.
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
Media Contact
Argot Partners
David Rosen
david.rosen@argotpartners.com
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SOURCE Intensity Therapeutics, Inc.