Intensity Therapeutics, Inc. Announces that INT230-6 Achieved 100% Complete Response Rate in Preclinical Models of Malignant Peripheral Nerve Sheath Tumors (MPNST)

Rhea-AI Summary

Intensity Therapeutics (Nasdaq: INTS) has announced significant preclinical results for its drug candidate INT230-6 in treating Malignant Peripheral Nerve Sheath Tumors (MPNST). The study, conducted at Johns Hopkins University's Staedtke-Bai laboratory, demonstrated a 100% complete response rate in murine models after 21 days of treatment.

The research involved two groups of test subjects (n=5 each), with the INT230-6 treatment group achieving complete responses while the control group's tumors continued to grow. This marks the first time INT230-6 has been tested in neurological-specific tumors, with researchers noting that no other small molecule drug has achieved such results in their lab previously.

The company plans to conduct additional preclinical research with the Staedtke-Bai laboratory to explore INT230-6's potential in other neurological cancer models.

Positive

• Achieved 100% complete response rate in MPNST murine models
• First small molecule drug to achieve complete response in this specific lab testing
• Successfully demonstrated efficacy in first neurological-specific tumor application

Negative

• Results are only from preclinical animal studies, not human trials
• Limited sample size of only 5 subjects in each test group

Insights

Biotechnology Research Analyst

INT230-6 shows remarkable 100% complete response in MPNST preclinical models, adding a neurological indication to Intensity's pipeline.

Intensity Therapeutics' announcement of complete responses in all tested animals in a murine model of Malignant Peripheral Nerve Sheath Tumors (MPNST) represents a meaningful preclinical milestone. MPNST is a rare but aggressive cancer with limited treatment options, and achieving a 100% complete response rate in animal models is particularly noteworthy since, according to the researchers, no small molecule drug has previously accomplished this in their laboratory.

What makes this data significant is that it expands INT230-6's potential application into neurological tumors, a new territory for this asset. INT230-6 is Intensity's lead candidate - an intratumoral injection designed to directly kill tumor cells while enhancing immune system recognition of cancers. The therapy works through a dual mechanism: direct tumor cell killing and immune activation, potentially offering advantages over traditional systemic therapies.

This marks the first neurological-specific tumor for which INT230-6 has been tested, suggesting potential expansion of the drug's indications beyond its current development path. The consistency of results with previous in vivo models adds confidence in the drug's mechanism of action across different tumor types.

It's important to note that these are preclinical results in a small sample size (n=5 in treatment group), representing early-stage research. The path from successful animal models to approved human therapies is long and uncertain, requiring further studies, IND-enabling research, and multiple phases of clinical trials before potential commercialization.

SHELTON, Conn., June 30, 2025 /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, announces that INT230-6 achieved complete responses in a murine models of Malignant Peripheral Nerve Sheath Tumor ("MPNST"). In a study conducted in the Staedtke-Bai laboratory at Johns Hopkins University, at 21 days, animals tested with INT230-6 (n=5) all achieved a complete response, whereas all animals' tumors in the control group (N=5) continued to grow.

"We are excited to see complete responses in a murine model of malignant peripheral nerve sheath tumors, an effect that no small molecule drug before INT230-6 has achieved in our lab before," said Renyuan Bai, PhD, Kennedy Krieger Institute, Associate Professor, Department of Neurosurgery and Oncology Center, Johns Hopkins University School of Medicine, and the coordinating scientist for the study. "We are encouraged that these results can be achieved in this difficult-to-treat neurological model and look forward to continuing to work with Intensity on other preclinical models of neurological tumors."

"MPNST is the first neurological-specific tumor for which INT230-6 has been used. We are pleased to see that INT230-6 achieved meaningful results in MPMNST that are similar to the results we saw in other in vivo models where INT230-6 has been tested," said Lewis H. Bender, President and CEO of Intensity. "We look forward to conducting further preclinical research with the Staedtke-Bai laboratory in other neurological cancer models."

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 consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse 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 Malignant Peripheral Nerve Sheath Tumor
Malignant peripheral nerve sheath tumor (MPNST) is a rare and aggressive type of sarcoma that originates from the peripheral nerves or their surrounding sheath. Few therapies have been proven effective despite extensive efforts, and the five-year survival is 20 to 50%. Current treatment involves surgery, chemotherapy and radiation. The disease is characterized by its tendency to recur after treatment and metastasize to distant sites, making it a challenging cancer to manage. MPNSTs can arise spontaneously or are associated with neurofibromatosis type 1, referred to as NF1. They develop from the cells of the peripheral nerve sheath. One in 3,000 people can carry NF1 gene alternations and are predisposed to tumor formation, which can occur anywhere in the body. MPNSTs are most commonly found in the extremities and trunk. Common sites include the sciatic nerve, brachial plexus, and sacral plexus.

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.

About the Staedtke-Bai Laboratory
The Staedtke-Bai laboratory, also known as the Staedtke-Bai Living Therapeutics Laboratory, is a research group at Johns Hopkins that focuses on neurofibromatosis and related nervous system cancers. Led by Dr. Verena Staedtke, who passed away recently, and Dr. Renyuan Bai, the lab investigates mechanisms of immune-mediated toxicity and anti-tumor responses following immunotherapy, with a specific interest in brain cancer immunotherapy. 

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 risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; 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; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; 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 Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent 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.

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SOURCE Intensity Therapeutics Inc.

FAQ

What results did Intensity Therapeutics (INTS) achieve with INT230-6 in MPNST treatment?

INT230-6 achieved a 100% complete response rate in murine models of Malignant Peripheral Nerve Sheath Tumors after 21 days of treatment, while control group tumors continued to grow.

How many subjects were included in the INTS MPNST study?

The study included two groups of 5 subjects each - one treatment group receiving INT230-6 and one control group.

Where was the INT230-6 MPNST study conducted for Intensity Therapeutics?

The study was conducted in the Staedtke-Bai laboratory at Johns Hopkins University under the coordination of Dr. Renyuan Bai.

What is unique about INT230-6's results in MPNST treatment?

INT230-6 is the first small molecule drug to achieve complete responses in MPNST in the Staedtke-Bai laboratory, and it marks the drug's first application in neurological-specific tumors.

What are Intensity Therapeutics' (INTS) next steps for INT230-6?

The company plans to conduct further preclinical research with the Staedtke-Bai laboratory to test INT230-6 in other neurological cancer models.