cisplatin/vinblastine/SHAO-FA (INT230-6) / Intensity Therap - LARVOL DELTA

Intratumoral Injections of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy in Early-Stage Triple Negative Breast Cancer: Early observations from INVINCIBLE-4-SAKK 66/22 (NCT06358573), a Phase II Randomized Controlled Trial (SABCS 2025) - P2 | "By July 2025 15 of 54 patients could be enrolled, completion of accrual is expected in 2026. Preliminary safety data do not show unexpected or severe INT230-6 related adverse events. pCR results become available 6 months after the last patient starts the SOC and undergoes surgery."

Clinical • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Accelerating an Anthracycline-Free Future: A New Drug in Clinical Testing Offers Patients Hope for Safer, More Effective Breast Cancer Therapy Combinations (SABCS 2025) - P2 | "Title: Accelerating an Anthracycline-Free Future: A New Drug in Clinical Testing Offers Patients Hope for Safer, More Effective Breast Cancer Therapy Combinations Christine Handy1, Joshua Rodrigues2, Kim Guedes RN2, Ian B. Walters M.D.2, Lewis H. Bender21Hamza Mystique Films, Swampscott, MA 2Intensity Therapeutics, Inc., Shelton, CTNote: Christine Handy is a breast cancer survivor, ASCO-designated patient advocate, author, and executive producer of the award-winning film, Hello Beautiful.Background: Doxorubicin is used in several chemotherapy regimens for many breast cancer subtypes, including triple-negative breast cancer (TNBC) and HER2-positive breast cancer before surgery (neoadjuvant). pCR results could be available years before the SCARLET study data. However, EFS will be required for full approval of INT230-6 with an anthracycline-free regimen."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Intensity Therapeutics Announces Two Presentations at the Upcoming 2025 San Antonio Breast Cancer Symposium (PRNewswire)

Clinical data • Triple Negative Breast Cancer

Safety and efficacy of intratumourally administered INT230-6 in adult patients with advanced solid tumours: results from an open-label phase 1/2 dose escalation study. (PubMed, EBioMedicine) - P1/2 | "IT INT230-6 was well tolerated and manifested promising treatment benefits."

Journal • P1/2 data • Oncology • Solid Tumor

Intensity Therapeutics surges 395% on phase 1/2 data for solid tumors asset (MSN News)

P1/2 data • Stock price • Solid Tumor

Intensity Therapeutics, Inc. Announces Publication of Clinical Results of INT230-6 for the Treatment of Metastatic or Refractory Cancers in eBioMedicine, a Lancet Discovery Science Journal (PRNewswire) - "A disease control rate of 75% (48/64 patients) and median overall survival (mOS) of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months. In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months....Disease control rate was 83.3% (40/48) compared to 50% (8/16). Median overall survival was 18.7 months (95% CI: 11.5–23.5) compared to 3.1 months (95% CI: 1.6–5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081–0.342); P<0.0001..."

P1/2 data • Sarcoma • Solid Tumor

A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) (clinicaltrials.gov) - P3 | N=333 | Active, not recruiting | Sponsor: Intensity Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

INVINCIBLE-3 Study: - "This study has been authorized by the US FDA, Health Canada, the European Medicines Agency (for France, Germany, Italy, Poland, and Spain), and Australia's Therapeutic Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival. In March 2025, new patient enrollment and site activations were paused due to funding issues; however, patients who were already enrolled continue to be dosed, followed and monitored...Research and development expenses were $1.5 million for the three months ended June 30, 2025, compared to $3.6 million for the same period in 2024. Clinical trial expenses decreased $1.5 million primarily due to lower INVINCIBLE-3 Study costs."

Commercial • P2 data • Trial status • Soft Tissue Sarcoma

The INVINCIBLE-4 Study is currently recruiting patients in Switzerland and France. (Intensity Therap Press Release) - "The expected total is 54 patients. In June 2025 we showed images from the trial of a patient who received two doses of INT230-6. Prior to the injections, the tumor was active. In the post INT230-6 injection scans, the tumor became dark with only diminished live cancer observed at the interface of the healthy tissue and necrotic tumor."

Trial status • Triple Negative Breast Cancer

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

Preclinical • Oncology

Intensity Therapeutics, Inc. Announces Patients Receiving INT230-6 Prior to the Start of Standard-of-Care May Achieve High Levels of Tumor Necrosis in the Ongoing Randomized Controlled Phase 2 INVINCIBLE-4 Study (PRNewswire) - P2 | N=54 | INVINCIBLE-4 (NCT06358573) | "Intensity Therapeutics, Inc...announces first few patients receiving INT230-6 achieved high levels of necrosis after 8 days in the Phase 2, INVINCIBLE-4 study, before they initiated the standard-of-care regimen...The study is recruiting patients in Switzerland and France and is expected to enroll 54 patients....TNBC Patients who have no live cancer in their tumor or nodes at the time of surgery have a significantly improved event-free survival advantage compared to those who do not have a pathological complete response. TNBC patients risk their lives to achieve a pCR, and about forty percent fail to achieve the desired result. We look forward to seeing the pathological complete response data being generated by our partners at SAKK and Unicancer..."

P2 data • Trial status • Triple Negative Breast Cancer

A multicenter, randomized, global phase 3 study to assess the efficacy and safety of intratumoral (IT) INT230-6 (SHAO, vinblastine, cisplatin) as monotherapy compared with standard of care systemic chemotherapy in adults with locally recurrent, inoperable, or metastatic soft tissue sarcomas (STS; INVINCIBLE-3). (ASCO 2025) - P3 | " IT-03 is a 2:1 randomized trial comparing INT230-6 as monotherapy to an investigator's choice of pazopanib, trabectedin, or eribulin, per label. Bilirubin (BR) ≤ 1.5× ULN (except those with Gilbert's syndrome, who must have total BR ≤ 3.0 mg/dL [< 52 µmol/L]). CPK ≤ 2.5× ULN"

Clinical • Metastases • Monotherapy • P3 data • Fatigue • Hepatocellular Cancer • Hepatology • Oncology • Pain • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Intensity Therapeutics, Inc.'s Phase 3 INVINCIBLE-3 Sarcoma Study Selected for Presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting (PRNewswire) - "Intensity Therapeutics...announces that the Company will be presenting a Trials in Progress poster outlining its Phase 3 INVINCIBLE-3 clinical trial of INT230-6 for the treatment of metastatic soft tissue sarcomas....The poster, titled, 'A Multicenter, Randomized, Global Phase 3 Study to Assess the Efficacy and Safety of Intratumoral (IT) INT230-6 (SHAO, VINblastine, Cisplatin) as Monotherapy Compared with Standard of Care Systemic Chemotherapy in Adults with Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (STS) (INVINCIBLE-3),' will be presented by Sant P. Chawla M.D., Director, Sarcoma Oncology Center of Southern California, during the "Sarcoma" session to be held on Saturday May 31, 2025..."

Trial status • Soft Tissue Sarcoma

Intensity Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update (PRNewswire) - "INVINCIBLE-3 Study:...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....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."

Commercial • Trial status • Soft Tissue Sarcoma

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 Cancer in France (PRNewswire) - "Intensity Therapeutics, Inc...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 study is already recruiting patients in Switzerland and is expected to enroll 54 patients....'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.'"

Trial status • Triple Negative Breast Cancer

Intensity Therapeutics Reports 2024 Year End Financial Results and Provides Corporate Update (PRNewswire) - "In July 2024, the Company initiated and dosed its first patient in the INVINCIBLE-3 Study. The trial is actively enrolling patients across the US, Canada, Europe and Australia. Up to 60 sarcoma-focused institutions are expected to participate from these regions. The Company has contracted 32 sites with 25 patients screened to date. The Company expects to complete enrollment in the first half of 2026....In October 2024, in collaboration with The Swiss Group for Cancer Research SAKK ('SAKK'), the Company initiated and dosed its first patient in Switzerland in the INVINCIBLE-4 Study. To date, the Company has activated eight sites in Switzerland and treated several patients. The Company expects to activate additional sites in Switzerland and France in the first half of 2025 and complete enrollment by the end of the first quarter of 2026."

Trial status • Soft Tissue Sarcoma • Triple Negative Breast Cancer

Drug Monitoring Committee Authorizes Continuation of Intensity Therapeutics' Ongoing Global Randomized Phase 3 Sarcoma Trial ("INVINCIBLE-3 Study") Following Periodic Review (PRNewswire) - "Intensity Therapeutics...announces that following its most recent periodic review meeting, the Data Monitoring Committee (DMC) overseeing the Company's ongoing Phase 3 sarcoma study of INT230-6 (INVINCIBLE-3) (NCT06263231) has agreed that the study should continue without modification. The DMC reviewed data covering the six months from July to December 2024....The INVINCIBLE-3 Study is a global open-label, randomized, controlled study 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."

DSMB • Leiomyosarcoma • Liposarcoma • Undifferentiated Pleomorphic Sarcoma

Intensity Therapeutics Provides Business Update Highlighting Key Achievements with Lead Drug Candidate INT230-6 (PRNewswire) - "Twenty-three sites are currently contracted in the INVINCIBLE 3 study, and several sites have treated patients...Seven Swiss sites are activated in the Phase 2 (INVINCIBLE-4) study for early-stage, operable Triple Negative Breast Cancer ('TNBC'), and several patients have been treated...Phase 3 open-label, randomized study (the 'INVINCIBLE-3 Study') testing INT230-6 as a monotherapy compared to the standard of care ('SOC') drugs in second-and third-line treatment for certain soft tissue sarcoma subtypes....The trial is enrolling and being conducted in eight countries: the US, Australia, Canada, France, Germany, Italy, Poland, and Spain. Up to 62 sarcoma-focused hospitals and other centers are expected to participate from these countries."

Trial status • Leiomyosarcoma • Liposarcoma • Soft Tissue Sarcoma • Triple Negative Breast Cancer • Undifferentiated Pleomorphic Sarcoma

Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK Present…Overview of the Ongoing Randomized, Presurgical Triple Negative Breast Cancer Phase 2 Clinical Trial, INVINCIBLE-4 (SAKK 66/22), at the 2024 San Antonio Breast Cancer Symposium (SABCS) (Intensity Therap Press Release) - "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 recruiting and expected to enroll 54 patients....Enrollment is ongoing and seven sites in Switzerland have been activated."

Trial status • Triple Negative Breast Cancer

Evaluation of Pathological Complete Response & Immunomodulatory Effects Following Intratumoral Injection of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy in Early-Stage Triple Negative Breast Cancer: A Phase II Study INVINCIBLE-4-SAKK 66/22 (SABCS 2024) - P2 | "The accrual duration is expected to be 12 months, and the trial therapy per patient will be eight months. The duration of follow-up is 36 months."

Clinical • Immunomodulating • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

INVINCIBLE-3 Study Overview (PRNewswire) - "Intensity Therapeutics...presented...an overview of the Company's ongoing INVINCIBLE-3 Study design (NCT06263231)...during an oral podium presentation in a late-breaking session at the 2024 Connective Tissue Oncology Society....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."

Clinical protocol • Late-breaking abstract • Leiomyosarcoma • Liposarcoma • Soft Tissue Sarcoma • Undifferentiated Pleomorphic Sarcoma

A MULTICENTER, RANDOMIZED, PHASE 3 STUDY OF INTRATUMORAL INT230-6 (SHAO, VINBLASTINE, CISPLATIN) COMPARED TO STANDARD OF CARE THERAPY IN SELECTED METASTATIC SOFT TISSUE SARCOMAS: INVINCIBLE-3 TRIAL. (CTOS 2024) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Phase 1/2 Study (Sarcoma Subset Data: 15 Patients) (PRNewswire) - P1/2 | N=111 | NCT03058289 | Sponsor: Intensity Therapeutics, Inc. | "Intensity Therapeutics...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...during an oral podium presentation in a late-breaking session at the 2024 Connective Tissue Oncology Society....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."

Late-breaking abstract • P1/2 data • Chordoma • Kaposi Sarcoma • Leiomyosarcoma • Liposarcoma • Osteosarcoma • Undifferentiated Pleomorphic Sarcoma

Intensity Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update (PRNewswire) - "Corporate Update: (i) INVINCIBLE-3 Study:...July 2024: authorization received from Health Canada to initiate the INVINCIBLE-3 Study in Canada; September 2024: authorization received from The European Medicines Agency to initiate the INVINCIBLE-3 Study in Europe; October 2024: authorization received from Australia's Therapeutic Goods Administration to initiate INVINCIBLE-3 Study in Australia; (ii) INVINCIBLE-4 Study:...September 2024: authorization from the Swiss Medic and the Swiss Ethics Commission to initiate the INVINCIBLE-4 Study."

Trial status • Soft Tissue Sarcoma • Triple Negative Breast Cancer

Intensity Therapeutics Selected for Oral Podium Presentation in a Late-Breaking Session at the 2024 Annual Connective Tissue Oncology Society (Sarcomas) Meeting (PRNewswire) - "Intensity Therapeutics, Inc...today announced that its Phase 3 trial has been selected for an oral podium presentation at the 2024 Connective Tissue Oncology Society (CTOS) on November 16, 2024. Dr. Christian F. Meyer MD, Ph.D will be making the oral presentation highlighting completed Phase 2 results and the INVINCIBLE-3 (Phase 3) randomized soft tissue sarcoma trial design and important study criteria. The annual CTOS conference runs from November 13 to 16, 2024 in San Diego at the Grand Hyatt."

Clinical protocol • P2 data • Oncology • Soft Tissue Sarcoma