Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK Announce the First Patient Dosed in the Randomized, Presurgical Triple Negative Breast Cancer Phase 2 Clinical Trial (INVINCIBLE-4 / SAKK 66/22)
Intensity Therapeutics (INTS) and The Swiss Group for Clinical Cancer Research SAKK announce the first patient dosed in their Phase 2 INVINCIBLE-4 clinical trial. The study evaluates INT230-6 combined with standard-of-care (SOC) versus SOC alone in treating triple-negative breast cancer (TNBC). The randomized trial will enroll approximately 54 patients in Switzerland and France, focusing on pathological complete response rates. Patients will receive either two doses of INT230-6 followed by SOC (pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel) or SOC alone. The initiation follows promising data from INVINCIBLE-2, where INT230-6 showed >95% tumor-killing properties with a single dose.
Intensity Therapeutics (INTS) e il Gruppo Svizzero per la Ricerca Clinica sul Cancro SAKK annunciano che il primo paziente è stato trattato nel loro studio clinico di Fase 2 INVINCIBLE-4. Lo studio valuta INT230-6 combinato con il trattamento standard (SOC) rispetto al SOC da solo nel trattamento del carcinoma mammario triplo negativo (TNBC). La sperimentazione randomizzata arruolerà circa 54 pazienti in Svizzera e Francia, concentrandosi sui tassi di risposta patologica completa. I pazienti riceveranno due dosi di INT230-6 seguite dal SOC (pembrolizumab, antracicline, carboplatino, ciclofosfamide e paclitaxel) oppure il solo SOC. L'inizio segue dati promettenti da INVINCIBLE-2, dove INT230-6 ha mostrato proprietà di uccisione tumorale superiori al 95% con una singola dose.
Intensity Therapeutics (INTS) y el Grupo Suizo para la Investigación Clínica del Cáncer SAKK anuncian que el primer paciente ha sido tratado en su ensayo clínico de Fase 2 INVINCIBLE-4. El estudio evalúa INT230-6 combinado con el tratamiento estándar (SOC) frente al SOC solo en el tratamiento del cáncer de mama triplemente negativo (TNBC). El ensayo aleatorizado inscribirá aproximadamente a 54 pacientes en Suiza y Francia, enfocándose en las tasas de respuesta patológica completa. Los pacientes recibirán dos dosis de INT230-6 seguidas de SOC (pembrolizumab, antraciclinas, carboplatino, ciclofosfamida y paclitaxel) o solo SOC. El inicio sigue a datos prometedores de INVINCIBLE-2, donde INT230-6 mostró propiedades de eliminación de tumores superiores al 95% con una sola dosis.
Intensity Therapeutics (INTS)와 스위스 임상 암 연구 그룹 SAKK는 그들의 2상 INVINCIBLE-4 임상 시험에서 첫 번째 환자가 투여되었음을 발표했습니다. 이 연구는 삼중 음성 유방암(TNBC) 치료에 있어 INT230-6과 표준 치료(SOC)의 병용 대 SOC 단독의 효과를 평가합니다. 무작위 시험에는 스위스와 프랑스에서 약 54명의 환자가 모집될 예정이며, 병리학적 완전 반응률에 초점을 맞춥니다. 환자들은 INT230-6 두 회차 투여 후 SOC(펨브롤리주맙, 안트라사이클린, 카보플라틴, 사이클로포스파미드 및 파클리탁셀)를 받거나 SOC만을 받을 것입니다. 이 연구는 단일 투여로 95% 이상의 종양 용해 특성을 보인 INVINCIBLE-2의 유망한 데이터에 이어 시작됩니다.
Intensity Therapeutics (INTS) et le Groupe Suisse pour la Recherche Clinique sur le Cancer SAKK annoncent que le premier patient a été traité dans leur essai clinique de Phase 2 INVINCIBLE-4. L'étude évalue INT230-6 en combinaison avec le traitement standard (SOC) par rapport au SOC seul dans le traitement du cancer du sein triple négatif (TNBC). L'essai randomisé inscrira environ 54 patients en Suisse et en France, en se concentrant sur les taux de réponse pathologique complète. Les patients recevront soit deux doses de INT230-6 suivies du SOC (pembrolizumab, anthracyclines, carboplatine, cyclophosphamide et paclitaxel), soit le SOC seul. Le début suit des données prometteuses de INVINCIBLE-2, où INT230-6 a montré des propriétés d'élimination tumorale supérieures à 95 % avec une dose unique.
Intensity Therapeutics (INTS) und die Schweizer Gruppe für klinische Krebsforschung SAKK geben bekannt, dass der erste Patient in ihrer Phase-2-Studie INVINCIBLE-4 behandelt wurde. Die Studie bewertet INT230-6 in Kombination mit der Standardbehandlung (SOC) im Vergleich zur alleinigen SOC-Behandlung bei der Behandlung von dreifach negativem Brustkrebs (TNBC). Die randomisierte Studie wird voraussichtlich etwa 54 Patienten in der Schweiz und Frankreich einschreiben und sich auf die raten der pathologischen vollständigen Reaktion konzentrieren. Die Patienten erhalten entweder zwei Dosen INT230-6 gefolgt von SOC (Pembrolizumab, Anthrazykline, Carboplatin, Cyclophosphamid und Paclitaxel) oder nur SOC. Der Beginn folgt vielversprechenden Daten aus INVINCIBLE-2, bei denen INT230-6 mit einer einzelnen Dosis Tumorabtötungs Eigenschaften von über 95% zeigte.
- INT230-6 demonstrated >95% tumor-killing efficacy in previous INVINCIBLE-2 study
- First European patient treated marks expansion into new markets
- Novel treatment approach showing tumor cell necrosis without systemic chemotoxicity
- Current SOC treatment can be fatal for some patients before surgery
- Trial results and potential market approval still uncertain
- patient enrollment (54) may affect statistical significance
Insights
This Phase 2 trial initiation for INT230-6 in triple-negative breast cancer (TNBC) represents a significant clinical development. The study's design comparing INT230-6 plus standard-of-care (SOC) versus SOC alone in presurgical TNBC patients is particularly noteworthy for several reasons:
- The trial targets an aggressive cancer type with poor prognosis and treatment options
- Previous data showed >
95% tumor killing with a single dose - The dual mechanism combining direct tumor killing with immune activation could potentially improve pathological complete response (pCR) rates
- The study expands INT230-6's testing into European markets
The trial's focus on pCR rates as the primary endpoint is clinically relevant, as higher pCR rates correlate with better survival outcomes in TNBC. With approximately 54 patients planned for enrollment, positive results could position INT230-6 as a valuable addition to current treatment protocols.
Testing the efficacy and safety of Intensity's lead drug candidate, INT230-6, when combined with Standard-of-Care versus Standard-of-Care alone
The endpoint is the change in pathological complete response rates
The Phase 2 study is expected to enroll approximately 54 patients in
"Many TNBC patients undergoing SOC treatment alone fail to achieve a pathological complete response at the time of surgery, especially in larger tumor sizes. INT230-6 has the potential to fill this unmet need for aggressive subtypes, such as TNBC, through its anti-cancer mechanisms of action that cause tumor cell necrosis and ignite an anti-cancer immune-based response," said Andreas Mueller, M.D. Past-President of the Breast Cancer Group at the National Swiss Association for Clinical Cancer Research in
"The majority of breast cancers are immune quiescent, resulting in minimal response to immunotherapies, and larger tumors are less responsive to therapy," said Ursina Zuerer-Haerdi, MD and Lead Physician for the Department of Medical Oncology and Hematology at the Cantonal Hospital in Winterthur,
"INT230-6 is an innovative investigational product that combines cisplatin and vinblastine with a penetration enhancer molecule (SHAO)," said Markus Joerger, Prof. MD-PhD and Coordinating Investigator on the study and principal investigator for the Department of Medical Oncology and Hematology at the Cantonal Hospital St. Gallen. INT230-6 results in local immunogenic cell death when injected into the breast tumor, without systemic chemotoxicity but a high potency to induce systemic immunostimulatory effects. INT230-6 tackles the innate immune pathway that is not addressed by immune checkpoint inhibitors, and it is suggested to complement the systemic neoadjuvant backbone in study patients with early-stage TNBC which consists of chemotherapy and the checkpoint inhibitor pembrolizumab. We believe that the SAKK 66/22 study will provide crucial data to inform a large randomized clinical trial in patients with early-stage TNBC, a disease that is still burdened by substantial rates of fatal relapses following potentially curative treatment."
"We are excited to have initiated our Phase 2 study in presurgical triple-negative breast cancer. This study marks the first European patient treated with our drug - a new milestone. Triple-negative is a deadly and aggressive form of breast cancer, and patients having local disease currently undergo a harsh four to six-month regimen whereby a small percentage can die from the SOC before their surgery. Those patients who achieve a pCR have a lower risk of disease recurrence," said Intensity Therapeutics' Founder, Chairman, and CEO, Lewis H. Bender. "We hope that by killing a substantial amount of the tumor upfront and increasing the immune response using INT230-6, we can increase the percentage of patients who achieve pCR and ultimately an improved event-free survival."
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 comprises 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 has been shown to release 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
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
About Intensity Therapeutics
Intensity Therapeutics is a late-stage clinical biotechnology company that applies novel engineered chemistry by enabling its aqueous cytotoxic-containing drug product, INT230-6, to mix and saturate the tumor's dense, high-fat pressurized environment. 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 novel approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for cancers that do not respond to immunotherapy. Intensity complete two large clinical studies using INT230-6 that enrolled over 200 patients: a Phase 1/2 dose escalation trial (NCT03058289) and a Phase 2 randomized control clinical trial in breast cancer (the INVINCIBLE-2 study) (NCT04781725). Intensity Therapeutics 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 with overall survival as an endpoint. The Company is also conducting a Phase 2 study in collaboration with SAKK as part of a Phase 2/3 program evaluating INT230-6 followed by SOC and SOC alone for patients with presurgical triple negative breast cancer. Information on the Phase 2 portion of the program (INVINCIBLE-4 Study) is listed under (NCT06358573). For more information about the Company, 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 tothe development of the Company's clinical programs. 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.
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