Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early Triple-negative Breast Cancer (TNBC). An Open-label Randomized Two-cohort Phase 2 Clinical Trial. INVINCIBLE-4-SAKK

About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66/22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined.

Start Date24 Oct 2024

Sponsor / Collaborator

Swiss Group for Clinical Cancer Research

NCT06263231

/ RecruitingPhase 3

A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

Start Date28 Jun 2024

Sponsor / Collaborator

Intensity Therapeutics, Inc.

[+1]

NCT04781725

/ Unknown statusPhase 2IIT

A Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological Effects of Intratumoral INT230-6 in Early Stage Breast Cancer: The INVINCIBLE Trial

This is a phase II, randomized, multi-center, parallel design, window of opportunity trial evaluating intratumoral INT230-6 in up to 90 patients with early stage breast cancer. In a 2:1 randomization, patients on the treatment arm will receive intratumoral INT230-6 injections prior to breast surgery.

Start Date25 Mar 2021

Sponsor / Collaborator

Ottawa Hospital Research Institute

[+2]

100 Clinical Results associated with Cisplatin/Vinblastine/SHAO

100 Translational Medicine associated with Cisplatin/Vinblastine/SHAO

100 Patents (Medical) associated with Cisplatin/Vinblastine/SHAO

Literatures (Medical) associated with Cisplatin/Vinblastine/SHAO

03 Oct 2019·OncoimmunologyQ2 · MEDICINE

Intratumorally delivered formulation, INT230-6, containing potent anticancer agents induces protective T cell immunity and memory

Q2 · MEDICINE

ArticleOA

Author: Bender, Lewis H. ; Jones, Jennifer C. ; Tiwary, Shweta ; Pasquet, Lise ; Xia, Zheng ; Berzofsky, Jay A. ; Bloom, Anja C. ; Terabe, Masaki ; Walters, Ian ; Morales-Kastresana, Aizea ; Clark, Katharine ; Jiang, Tianbo

The benefits of anti-cancer agents extend beyond direct tumor killing. One aspect of cell death is the potential to release antigens that initiate adaptive immune responses. Here, a diffusion enhanced formulation, INT230-6, containing potent anti-cancer cytotoxic agents, was administered intratumorally into large (approx. 300mm³) subcutaneous murine Colon26 tumors. Treatment resulted in regression from baseline in 100% of the tumors and complete response in up to 90%. CD8⁺ or CD8⁺/CD4⁺ T cell double-depletion at treatment onset prevented complete responses, indicating a critical role of T cells in promoting complete tumor regression. Mice with complete response were protected from subcutaneous and intravenous re-challenge of Colon26 cells in a CD4⁺/CD8⁺ dependent manner. Thus, immunological T cell memory was induced by INT230-6. Colon26 tumors express the endogenous retroviral protein gp70 containing the CD8⁺ T-cell AH-1 epitope. AH-1-specific CD8⁺ T cells were detected in peripheral blood of tumor-bearing mice and their frequency increased 14 days after treatment onset. AH-1-specific CD8⁺ T cells were also significantly enriched in tumors of untreated mice. These cells had an activated phenotype and highly expressed Programmed cell-death protein-1 (PD-1) but did not lead to tumor regression. CD8⁺ T cell tumor infiltrate also increased 11 days after treatment. INT230-6 synergized with checkpoint blockade, inducing a complete remission of the primary tumors and shrinking of untreated contralateral tumors, which demonstrates not only a local but also systemic immunological effect of the combined therapy. Similar T-cell dependent inhibition of tumor growth was also found in an orthotopic 4T1 breast cancer model.

01 Oct 2018·ANNALS OF ONCOLOGY

Phase I/II evaluation of intratumoral INT230-6 for the treatment of solid tumors

Article

Author: Bender, L ; Siu, L L ; Olszanski, A J ; Walters, I B ; Azad, N ; El-Khoeuiry, A ; Kamen, L

01 Sep 2017·Nature medicineQ1 · MEDICINE

Uncovering cancer: How enlisting T cells can boost the power of immunotherapy

Q1 · MEDICINE

Article

Author: Keener, Amanda B.

Many companies are now using immunogenic cell death as the basis for new approaches to increase the success of checkpoint inhibitors against tumors that tend to remain hidden from T cells.Intensity Therapeutics, a biotech company based in Westport, Connecticut, has developed a formulation called INT230-6, which pairs two common chemotherapies, vinblastine and cisplatin, with a mol. that enhances the drugs′ ability to penetrate cell membranes.Intensity has been working with vaccine immunologists at the US National Cancer Institute (NCI), and has tested the drug against mouse pancreatic, colon, and breast cancer tumors grown under the skin of mice.At the annual meeting of the American Association for Cancer Research (AACR) in Apr., NCI scientists reported that daily injections of INT230-6 into colon cancer tumors grown under the skin of mice for five days resulted in a surge of CD8 T cells into the tumors.When the NCI researchers combined INT230-6 with anti-PD-1 therapy, the tumors were untraceable in five of the nine treated animals."These mice have about two weeks left to live when we start the treatment, and 55% get cured and never get cancer again," says Lew Bender, Intensity′s CEO and founder.By contrast, there were no changes to the tumors of any of the mice, which were immunocompetent, when they were treated with checkpoint inhibitors alone.The company plans to test its drugs in combination with an anti-PD-1 antibody in its ongoing phase 1/2 trial, in which 60 patients with various forms of cancer will receive injections into their tumors once a month for five months.Anja Bloom, an immunologist at the NCI who headed up these experiments, says that she is now working to define the mechanisms that entice CD8 T cells into INT230-6-treated tumors.So far, she has found that the drug attracts to the tumors innate immune cells called dendritic cells, which digest and display pieces of dying cancer cells to train T cells to recognize cancer as something foreign.It′s not clear yet, however, whether the drug induces the release of DAMPs.Other groups in the field are also focused on understanding how cell death activates T cells and a broader immune response.In the late 2000s, a team headed by Guido Kroemer and Laurence Zitvogel at the Gustave Roussy Institute of Oncol. near Paris began to define what makes a dying tumor cell immunogenic.In 2007, they reported that a chemotherapy that caused dying cancer cells in culture to move a protein called calreticulin from the cytoplasm to the cell membrane allowed those cells to trigger an antitumor immune response once injected into mice.That immune response also protected the mice from developing tumors after researchers later injected live cancer cells.They went on to add high-mobility-group box 1 protein (HMGB1)-which normally acts in the nucleus to regulate gene transcription-and the energy-containing mol. ATP (ATP) to the list of DAMPs released by some dying cells.Chemotherapy is not the only way to induce immunogenic cell death.For example, Pittet is now working with the Norwegian company Lytix Biopharma to develop a peptide that breaks apart cancer cells and causes them to release DAMPs that attract T cells.Meanwhile, dozens of trials around the world are testing whether they can improve treatment by combining radiation with either ipilimumab or nivolumab.Laurent Levy, CEO and founder of the Paris-based company Nanobiotix, says that things really got exciting for his company about two years ago, when it started taking note of what its lead candidate, NBTXR3, does to tumor immunol.When cancer cells treated with NBTXR3 are hit with radiation, Levy says, the nanoparticles produce reactive atoms called free radicals.These mols. in turn amplify damage to the tumor cells, causing them to release more DAMPs and set off an antitumor immune response."Instead of using biol. or chem. to kill cancer, we use physics," Levy says.This year, at an immunotherapy workshop co-sponsored by the NCI, the Society for Immunotherapy of Cancer, and the American Society for Radiation Oncol., Levy and his colleagues reported preliminary results from a phase 2/3 trial to treat individuals with soft-tissue sarcoma.Their findings showed that combining NBTXR3 treatment with radiation increased the average number of CD8 T cells in eight patient tumors.Tumors from another set of six people who received only radiation, without NBTXR3, on the other hand, displayed no increase in CD8 T cells.The trial, which is still ongoing, was not designed to test the role of the immune response in overall survival, but Levy says that the company is taking advantage of biopsy samples from the trial to explore how the nanoparticles alter immune cells and gene expression in treated tumors.Nanobiotix is now planning a trial of its product in combination with checkpoint inhibitors."Potentially, we can apply this across oncol.," Levy says.Although researchers are relying on the presence of CD8 T cells in a tumor to determine whether the tumor may be more likely to respond to checkpoint-inhibitor therapy, Adi Diab, an oncologist at MD Anderson Cancer Center in Houston, cautions against using these T cells as tell-tale markers."In reality, we do not have absolute predictors for immunotherapy [response]," Diab says.

News (Medical) associated with Cisplatin/Vinblastine/SHAO

13 May 2025

·ir.intensitytherapeutics.com

Intensity Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update

Eight Swiss sites are activated in the INVINCIBLE-4 Study, and several patients have been treated European Medicines Agency Authorization to initiate INVINCIBLE-4-Study in France SHELTON, Conn., May 13, 2025 /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, announces first quarter 2025 financial results and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. The INVINCIBLE-4 Study is recruiting patients in Switzerland and is expected to enroll 54 patients across Switzerland and France. In April 2025, the Company and The Swiss Group for Clinical Cancer Research SAKK, a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals since 1965, announced that the European Medicines Agency has authorized the initiation of the INVINCIBLE-4 Study in France in collaboration with Unicancer. The Unicancer French breast intergroup (UCBG) is the French referent cooperative group in breast cancer. The French National Cancer Institute (INCa) accredited the group in 2013, thus acknowledging its academic excellence and operational capability. Since its creation, the group has conducted more than 40 national and international multicenter clinical trials, as well as various translational research projects. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority (for France, Germany, Italy, Poland and Spain), and Australia's Therapeutics Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival. In March 2025, the Company paused new site activations and patient enrollments due to funding constraints, and prioritized funding for the INVINCIBLE-4 Study. Prior to this pause, the trial had enrolled 23 patients. The Company will continue to treat all patients enrolled in this study in cooperation with its third-party contract research organizations to reduce ongoing costs during this pause. April 2025 Public Offering: In April 2025, the Company entered into a Securities Purchase Agreement with certain institutional investors participating in a public offering and raised an aggregate of $2.35 million, with net proceeds after deducting the fees and expenses of approximately $1.9 million. "The first quarter saw continued progress in our important programs despite high volatility in the markets and funding constraints," stated Lewis H. Bender, Intensity Founder, President, and CEO. "Several patients in our sarcoma study had their first follow-up scans, which showed high levels of necrosis in the injected tumors. Site contracting, site activation and patient enrollment were increasing nicely. However, due to cash needs, we made the necessary decision to pause the Phase 3 sarcoma enrollment and site activation until additional funding becomes available. We are working closely with our vendors and sites to treat those patients enrolled in INVINCIBLE-3, while maintaining the pharmacovigilance, site monitoring and the study database. Meanwhile, our partners SAKK and Unicancer will continue to work with the leading hospitals in Switzerland and France to seek patients for our breast cancer trial, INVINCIBLE-4. We believe in the potential for our drug to positively impact the lives of metastatic sarcoma and presurgical breast cancer patients worldwide. As cancer deaths increase, new and improved alternatives to current therapies are needed now more than ever." First Quarter 2025 Financial Results Research and development expenses were $2.2 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024. Clinical trial expenses increased marginally by $0.1 million due to the ongoing site initiations and patient enrollment of the INVINCIBLE-03 Study. Contract manufacturing costs declined by $0.2 million, as there were no manufacturing batches of INT230-6 in the first quarter of 2025. In addition, stock-based compensation was $0.4 million lower as no new equity grants were awarded in the first quarter of 2025. General and administrative expenses were $1.2 million for the three months ended March 31, 2025, compared to $1.9 million for the same period in 2024. Legal, audit and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas. In addition, stock-based compensation was $0.3 million lower as no new equity grants were awarded in the first quarter of 2025. Overall, net loss was $3.3 million for the three months ended March 31, 2025, compared to a net loss of $4.6 million for the three months ended March 31, 2024. As of March 31, 2025, cash and cash equivalents totaled $0.9 million. 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, 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 (558) 230-6401 Media Contact: Jules Abraham CORE IR julesa@coreir.com Intensity Therapeutics, Inc. Statements of Operations (in thousands, except share and per share amounts) (Unaudited) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $ 2,189 $ 2,815 General and administrative 1,205 1,928 Total operating expenses 3,394 4,743 Loss from operations (3,394) (4,743) Other income (expense): Interest income 15 140 Other income, net 32 — Net loss $ (3,347) $ (4,603) Loss per share, basic and diluted $ (0.22) $ (0.34) Weighted average number of shares of common stock, basic and diluted 15,173,196 13,709,487 Intensity Therapeutics, Inc. Balance Sheets (in thousands) March 31, 2025 December 31, 2024 (Unaudited) * Assets Current assets: Cash and cash equivalents $ 929 $ 2,590 Prepaid expenses and other current assets 722 773 Total current assets 1,651 3,363 Right-of-use asset, net 116 122 Other assets 1,298 1,298 Total assets $ 3,065 $ 4,783 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 1,586 $ 1,219 Accrued expenses 1,014 508 Lease liability, current portion 29 28 Total current liabilities 2,629 1,755 Lease liability, net of current portion 102 110 Total liabilities 2,731 1,865 Total stockholders' equity 334 2,918 Total liabilities and stockholders' equity $ 3,065 $ 4,783 *Derived from audited financial statements View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-reports-first-quarter-2025-financial-results-and-provides-corporate-update-302454456.html SOURCE Intensity Therapeutics Inc. Released May 13, 2025

Phase 3Phase 2Financial StatementImmunotherapy

06 May 2025

·ir.intensitytherapeutics.com

Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK Receive European Medicines Agency Authorization to Initiate Phase 2 INVINCIBLE-4 (SAKK/66/22) Study for INT230-6 in the Treatment of Presurgical Triple-Negative Breast

INVINCIBLE-4 (SAKK/66/22) Study continues to recruit patients in eight sites in Switzerland SHELTON, Conn. and BERN, Switzerland, May 6, 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, 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 the European Medicines Agency ("EMA") has authorized the initiation of the INVINCIBLE-4 (SAKK 66/22) ("INVINCIBLE-4 Study") (NCT06358573) in France in collaboration with Unicancer. 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 already recruiting patients in Switzerland and is expected to enroll 54 patients. "We are encouraged to see high levels of tumor necrosis from the MRI scans and evidence of tumor inflammation after two INT230-6 injections and prior to initiation of the SOC in our first patients," said Ursina Zürrer, M.D. Chief Physician for Genetic Counseling, Department of Medical Oncology and Hematology Cantonal Hospital Winterthur, Switzerland, and the Coordinating Investigator for the INVINCIBLE-4 Study. "If the immunological cancer cell death and the ignition of an anti-cancer immune response without increased toxicity in patients receiving INT230-6 shows a meaningful increase in pCR, it would be a major advance for the neoadjuvant treatment of breast cancer and potentially other cancers." "The acceptance of the INVINCIBLE-4 by the EMA and our expansion of the trial into France is expected to increase our enrollment rate starting in the second quarter of 2025. We should almost double the number of sites actively screening patients. We are excited to work with Unicancer, a group accredited by the French National Cancer Institute with centers of academic excellence and strong operational capability throughout France." Said Lewis H. Bender, President and CEO of Intensity Therapeutics." 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 diffusion and cell 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 Triple Negative Breast Cancer in the Presurgical Setting 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. 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. There are approximately 56,000 new cases of TNBC in the US and 420,000 Worldwide diagnosed each year, the majority of which are local to the breast. 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, the 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 or with lymph node metastasis. 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 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 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. About Unicancer The Unicancer French breast intergroup (UCBG) is the French referent cooperative group in Breast Cancer. The French National Cancer Institute (INCa) accredited the group in 2013, thus acknowledging its academic excellence and operational capability. Since its creation, the group has conducted more than 40 national and international multicenter clinical trials, as well as various translational research projects. 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 View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-inc-and-the-swiss-group-for-clinical-cancer-research-sakk-receive-european-medicines-agency-authorization-to-initiate-phase-2-invincible-4-sakk6622-study-for-int230-6-in-the-treatment-of-presurgical-tr-302444775.html SOURCE Intensity Therapeutics Inc.

Phase 2ImmunotherapyPhase 3

25 Apr 2025

·ir.intensitytherapeutics.com

Intensity Therapeutics, Inc. Announces $2.35 Million Public Offering

SHELTON, Conn., April 25, 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, today announced the pricing of its "reasonable best efforts" public offering with participation from certain new and existing institutional and accredited investors for the purchase and sale of 3,133,333 shares of its common stock (or common stock equivalents in lieu thereof) and accompanying Series B-1 common warrants to purchase up to 3,133,333 shares of common stock and Series B-2 common warrants to purchase up to 3,133,333 shares of common stock at a combined purchase price per share and accompanying common warrants of $0.75 (the "Offering"). The Series B-1 warrants will have an exercise price of $0.85 per share, will be immediately exercisable and will expire 5 years from issuance. The Series B-2 warrants will have an exercise price of $0.85 per share, will be immediately exercisable and will expire 18 months from issuance. The closing of the Offering is expected to occur on or about April 28, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $2.35 million, before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for the enrollment of patients in the INVINCIBLE-4 Study, for the treatment of existing patients enrolled in the INVINCIBLE-3 Study, and for working capital and general corporate purposes. A.G.P./Alliance Global Partners is acting as lead placement agent for the Offering and Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as a co-placement agent for the Offering. The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No.333-286683), previously filed with the Securities and Exchange Commission ("SEC"), which was declared effective on April 24, 2025. The Offering is being made only by means of a prospectus forming part of the effective registration statement. Copies of the preliminary prospectus and, when available, copies of the final prospectus, relating to the Offering may be obtained on the SEC's website located at http://www.sec.gov. Electronic copies of the final prospectus relating to the Offering may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. 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 expected closing date and anticipated use of proceeds. 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 risk that the Offerings may not close and other risks described in the section entitled "Risk Factors" described in the prospectus supplement and 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 View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-inc-announces-2-35-million-public-offering-302438075.html SOURCE Intensity Therapeutics Inc. Released April 25, 2025

Phase 2Immunotherapy

100 Deals associated with Cisplatin/Vinblastine/SHAO

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Soft Tissue Sarcoma	Phase 3	United States	Intensity Therapeutics, Inc.	28 Jun 2024
Metastatic Soft Tissue Sarcoma	Phase 3	Canada	Intensity Therapeutics, Inc.	28 Jun 2024
Metastatic Soft Tissue Sarcoma	Phase 3	France	Intensity Therapeutics, Inc.	28 Jun 2024
Metastatic Soft Tissue Sarcoma	Phase 3	Germany	Intensity Therapeutics, Inc.	28 Jun 2024
Metastatic Soft Tissue Sarcoma	Phase 3	Spain	Intensity Therapeutics, Inc.	28 Jun 2024
Soft Tissue Sarcoma	Phase 3	-	Portage Biotech, Inc.	15 Nov 2023
Triple Negative Breast Cancer	Phase 2	Switzerland	Swiss Group for Clinical Cancer Research	24 Oct 2024
Early Stage Breast Carcinoma	Phase 2	Canada	Intensity Therapeutics, Inc.	25 Mar 2021
Bile Duct Neoplasms	Phase 2	United States	Intensity Therapeutics, Inc.	09 Feb 2017
Bile Duct Neoplasms	Phase 2	Canada	Intensity Therapeutics, Inc.	09 Feb 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03058289 (Company_Website) Manual	Phase 3	Sarcoma	-	INT230-6	qlzeoqkqli(ieyddcemwj) = zroutoprvb ulqpojepih (eluuhgikyb ) View more	Positive	03 Jan 2025
				INT230-6 (failing a median of 3 lines of prior therapy)	qlzeoqkqli(ieyddcemwj) = drxcgkgcdm ulqpojepih (eluuhgikyb )
NCT03058289 (Corporate Publications) Manual	Phase 1/2	Sarcoma	29	INT230-6	mxhoatspxi(unlpstuugm) = mkmousgmif qllckpuvha (jhbwqwknpk ) View more	Positive	02 Nov 2023
				INT230-6+ipilimumab	mxhoatspxi(unlpstuugm) = edldxfkgxo qllckpuvha (jhbwqwknpk ) View more
NCT04781725 (INVINCIBLE, ASCO 12023 \| ASCO 22023) Manual	Phase 2	Estrogen receptor positive breast cancer ER Positive	12	INT230-6	hhnxazvmwq(pyuendeizq) = Significant tumor necrosis was observed in the majority of subjects injected with INT230-6. fmenlwvdks (etgfgpseik )	Positive	31 May 2023
NCT03058289 (CA184-592, ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Sarcoma	29	INT230-6	xmbybearrc(nicftixavy) = qwbdbesdtq pmocmqjnoe (brrgfzvuif ) View more	Positive	31 May 2023
				Ipilimumab+INT230-6	xmbybearrc(nicftixavy) = hscoolvluc pmocmqjnoe (brrgfzvuif ) View more
NCT04781725 (INVINCIBLE Trial, SABCS2023)	Phase 2	Early Stage Breast Carcinoma	90	INT230-6	vtlnckrqak(itmqfjjhuj) = injection site pain, injection site reaction, nausea/vomiting hacdkqkoyj (zbblreroxm )	Positive	01 Mar 2023
NCT03058289 (IT-01, Corporate Publications) Manual	Phase 1/2	Solid tumor	88	INT 230-6	pmsexqaosa(smwuqyltfl) = nezqjlrvlc bjauxvmjnv (ncsfxlkype ) View more	Positive	11 Nov 2022
				INT 230-6+Pembrolizumab	pmsexqaosa(smwuqyltfl) = tekevybcep bjauxvmjnv (ncsfxlkype ) View more
NCT04781725 (INVINCIBLE, SITC2022) Manual	Phase 2	Breast Cancer	87	INT 230-6	mqwmnfytqt(mgxylbomlt) = imsyrdnviy gdsogtszqf (gvvqepzgnm )	Positive	01 Nov 2022
NCT03058289 (IT-01, ASCO2022) Manual	Phase 1/2	Refractory Soft Tissue Sarcoma	22	INT230-6	cltzxxglpn(kpdqfpxpao) = fgpfqvwaka kacmfsgcoq (omuywgwerg ) View more	Positive	02 Jun 2022
				ipilimumab+INT230-6	cltzxxglpn(kpdqfpxpao) = miosrldrho kacmfsgcoq (omuywgwerg ) View more
NCT03058289 (Merck KEYNOTE-A10, ASCO2022) Manual	Phase 1/2	Solid tumor	83	INT230-6	tylznffzud(dccuwvcuvo) = none lrhtgyjkfk (uricxyqlrj ) View more	Positive	02 Jun 2022
				INT230-6+pembrolizumab
IT-01 study [KEYNOTE-A10] (SABCS2022)	Phase 1/2	Locally advanced breast cancer	7	INT230-6 monotherapy	yqqaprjteo(eeobhbfjot) = wdvptljmdt cijzcglago (udvjtnfveu ) View more	Positive	15 Feb 2022

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