On January 10, 2025 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, reported a business update highlighting key achievements with its lead drug candidate INT230-6 (Press release, Intensity Therapeutics, JAN 10, 2025, View Source [SID1234649604]).
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Business Development
Discussions with multiple companies regarding potential strategic collaborations and licenses in various territories for INT230-6 initiated in 2024. While term sheets may be negotiated, there is no assurance that any ongoing discussions, negotiations, or due diligence processes will result in definitive agreements, partnerships, collaborations, or relationships.
Sarcoma INVINCIBLE-3
In July 2024, the Company initiated and dosed its first patient in a 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. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority, and Australia’s Therapeutics Goods Administration. 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.
In November 2024, the Company presented INT230-6 Phase 1/2 data in a late-breaking session at the 2024 Annual Connective Tissue Oncology Society Meeting (CTOS). These data showed a median overall survival ("mOS") of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activation, and favorable safety profile for patients receiving INT230-6 alone. INVINCIBLE-3 continues recruiting with an expected enrollment of 333 patients with leiomyosarcoma, liposarcoma and undeferential pleomorphic sarcoma.
Breast Cancer INVINCIBLE-2 and INVINCIBLE-4
In October 2024, the Company, in collaboration with the Swiss Group for Clinical Cancer Research SAKK ("SAKK") in the INVINCIBLE-4 Study, a Phase 2 trial to treat patients with localized triple-negative breast cancer ("TNBC"), announced that the first patient has been dosed in the study.
In December 2024, Phase 2 data in presurgical breast cancer from the completed INVINCIBLE-2 study along with an overview of the ongoing INVINCIBLE-4 (SAKK 66/22), was presented at the 2024 San Antonio Breast Cancer Symposium (SABCS).
The Company’s completed INVINCIBLE-2 Study, where INT230-6 was given alone in multiple tumor types including TNBC, showed the following:
Tumor-killing properties at levels greater than 95% in some patients on a single intratumoral dose with systemic immune activation.
Tumors larger than 2 cm showed significant necrosis in 74% of subjects at the time of surgery.
Gene expression analysis showed a significant difference between baseline biopsies and surgical specimens. Pathway analysis identified genes associated with TCR signaling, B-cell and T-cell activation, with increasing effects in post-treatment samples (SABCS 2023 #PS16-03).
The study demonstrated pathologic and immune priming effects of intratumoral cytotoxicity in traditional immune quiescent breast cancers, with a treatment that showed favorable safety and was well tolerated.
INT230-6 patients had increases in CD4 T cells and NK cells within the tumor and associated changes in the diversity of T cell repertoire.
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 tumors greater than two centimeters having early-stage, operable Triple Negative Breast Cancer ("TNBC"). These patients undergo standard-of-care neoadjuvant immunochemotherapy ("SOC") treatment, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel (i.e. the Keynote-522 regimen). 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 two doses of INT230-6 followed by SOC, or SOC alone. The study is expected to enroll 54 patients in up to 16 centers in Switzerland and France.
"The data from our prior studies and trial design has allowed INT230-6 to be authorized by the leading regulatory agencies globally to move into late-stage clinical trials. INT230-6 is being tested in metastatic and pre-surgical cancers, which highlights the broad potential for our new cancer treatment," said Lewis H. Bender, President and CEO of Intensity Therapeutics, "There are many risks and hurdles in drug development and advancing programs into phase 3 trials is an important achievement and a testament that reflects the expertise and dedication of our team. We are excited that contracts exist with nearly two dozen top sarcoma-centric hospitals in our Phase 3 study and nine sites in our Phase 2 presurgical breast cancer trial with seven activated. Several sites are enrolling and continue to recruit patients for both studies. Given the potential benefit of our new drug, we are working to establish partnerships that expedite product development and ultimate market access in the US and abroad."
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 mainly in the arms, legs, chest, and abdomen. There are many types of sarcomas; however, the four most common are bone sarcoma (referred to as osteosarcoma), leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), and liposarcoma. According to SEER estimates, approximately 14,500 patients have metastatic liposarcoma, leiomyosarcoma, and undifferentiated pleomorphic disease at any one time in the US. When sarcoma is metastatic, the prognosis is poor, even with systemic chemotherapy.
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 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
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. 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, 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 lower in the larger-sized tumors. 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.