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
Intensity Therapeutics (NASDAQ: INTS) and The Swiss Group for Clinical Cancer Research (SAKK) have received EMA authorization to expand their INVINCIBLE-4 Phase 2 study for INT230-6 into France. The study evaluates INT230-6 in early-stage, operable triple-negative breast cancer (TNBC) patients.
The trial, currently active in Switzerland, will randomize 54 patients to receive either two doses of INT230-6 followed by standard of care (SOC) immunochemotherapy, or SOC alone. The primary endpoint is pathological complete response in the tumor and affected lymph nodes. Initial results show promising tumor necrosis and inflammation after INT230-6 treatment. The expansion into France through Unicancer is expected to accelerate enrollment starting Q2 2025.
Intensity Therapeutics (NASDAQ: INTS) e il Gruppo Svizzero per la Ricerca Clinica sul Cancro (SAKK) hanno ottenuto l'autorizzazione dall'EMA per estendere il loro studio di Fase 2 INVINCIBLE-4 su INT230-6 in Francia. Lo studio valuta INT230-6 in pazienti con carcinoma mammario triplo negativo (TNBC) in fase iniziale e operabile.
Il trial, attualmente attivo in Svizzera, prevede di randomizzare 54 pazienti per ricevere due dosi di INT230-6 seguite dalla terapia immunochimica standard (SOC) oppure solo la SOC. L'endpoint primario è la risposta patologica completa nel tumore e nei linfonodi coinvolti. I risultati iniziali mostrano una promettente necrosi tumorale e infiammazione dopo il trattamento con INT230-6. L'espansione in Francia tramite Unicancer dovrebbe accelerare il reclutamento a partire dal secondo trimestre 2025.
Intensity Therapeutics (NASDAQ: INTS) y el Grupo Suizo para la Investigación Clínica del Cáncer (SAKK) han recibido autorización de la EMA para ampliar su estudio de Fase 2 INVINCIBLE-4 con INT230-6 en Francia. El estudio evalúa INT230-6 en pacientes con cáncer de mama triple negativo (TNBC) en etapa temprana y operable.
El ensayo, actualmente activo en Suiza, aleatorizará a 54 pacientes para recibir dos dosis de INT230-6 seguidas del tratamiento inmunoquimioterapéutico estándar (SOC) o solo el SOC. El objetivo principal es la respuesta patológica completa en el tumor y los ganglios afectados. Los resultados iniciales muestran una prometedora necrosis tumoral e inflamación tras el tratamiento con INT230-6. La expansión a Francia a través de Unicancer se espera que acelere la inclusión de pacientes a partir del segundo trimestre de 2025.
Intensity Therapeutics (NASDAQ: INTS)와 스위스 임상 암 연구 그룹(SAKK)은 INT230-6에 대한 INVINCIBLE-4 2상 연구를 프랑스로 확대하기 위해 EMA 승인을 받았습니다. 이 연구는 초기 단계의 수술 가능한 삼중음성 유방암(TNBC) 환자에서 INT230-6을 평가합니다.
현재 스위스에서 진행 중인 임상시험은 54명의 환자를 무작위 배정하여 INT230-6 두 번 투여 후 표준 치료(SOC) 면역화학요법을 받거나 SOC만 받도록 합니다. 주요 평가변수는 종양과 영향을 받은 림프절에서의 병리학적 완전 반응입니다. 초기 결과는 INT230-6 치료 후 종양 괴사와 염증이 유망함을 보여줍니다. Unicancer를 통한 프랑스 확장은 2025년 2분기부터 등록 속도를 가속화할 것으로 예상됩니다.
Intensity Therapeutics (NASDAQ : INTS) et le Groupe Suisse pour la Recherche Clinique sur le Cancer (SAKK) ont obtenu l'autorisation de l'EMA pour étendre leur étude de Phase 2 INVINCIBLE-4 sur INT230-6 en France. L'étude évalue INT230-6 chez des patientes atteintes d'un cancer du sein triple négatif (TNBC) opérable à un stade précoce.
L'essai, actuellement en cours en Suisse, randomisera 54 patientes pour recevoir soit deux doses d'INT230-6 suivies d'une immunochimiothérapie standard (SOC), soit uniquement le SOC. Le critère principal est la réponse pathologique complète dans la tumeur et les ganglions affectés. Les résultats initiaux montrent une nécrose tumorale et une inflammation prometteuses après le traitement par INT230-6. L'extension en France via Unicancer devrait accélérer le recrutement à partir du deuxième trimestre 2025.
Intensity Therapeutics (NASDAQ: INTS) und die Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung (SAKK) haben von der EMA die Genehmigung erhalten, ihre INVINCIBLE-4 Phase-2-Studie mit INT230-6 auf Frankreich auszudehnen. Die Studie bewertet INT230-6 bei Patientinnen mit frühem, operablem triple-negativem Brustkrebs (TNBC).
Die derzeit in der Schweiz laufende Studie wird 54 Patienten randomisieren, die entweder zwei Dosen INT230-6 gefolgt von Standardtherapie (SOC) mit Immunchemotherapie oder nur SOC erhalten. Der primäre Endpunkt ist das pathologische komplette Ansprechen im Tumor und den betroffenen Lymphknoten. Erste Ergebnisse zeigen vielversprechende Tumornekrosen und Entzündungen nach INT230-6-Behandlung. Die Erweiterung nach Frankreich über Unicancer soll die Einschreibung ab dem zweiten Quartal 2025 beschleunigen.
- Early MRI scans show high levels of tumor necrosis and inflammation after INT230-6 treatment
- Trial expansion to France expected to double the number of patient screening sites
- Collaboration with prestigious institutions (SAKK and Unicancer) strengthens trial credibility
- None.
Insights
EMA authorization expands TNBC trial to France, potentially doubling enrollment sites with encouraging early tumor response signals observed.
The European Medicines Agency's authorization for Intensity Therapeutics' Phase 2 INVINCIBLE-4 study represents a significant expansion of their clinical program testing INT230-6 in triple-negative breast cancer (TNBC). This aggressive breast cancer subtype lacks traditional treatment targets, making new approaches particularly valuable.
The trial design is strategically sound - evaluating whether adding INT230-6 (an intratumoral therapy) to the established Keynote-522 regimen improves pathological complete response (pCR) rates in the neoadjuvant setting. This endpoint measures complete elimination of cancer cells in breast tissue and lymph nodes after pre-surgical treatment and correlates strongly with improved long-term outcomes.
Particularly noteworthy are Dr. Zürrer's observations of "high levels of tumor necrosis" and "evidence of tumor inflammation" on MRI scans after just two INT230-6 injections, prior to starting standard therapy. These findings align with INT230-6's proposed mechanism - directly killing tumor cells while enhancing immune recognition of cancer.
The expansion into France through Unicancer collaboration, combined with existing Swiss sites, should accelerate this 54-patient study. If INT230-6 meaningfully increases pCR rates beyond current standards without adding significant toxicity, it could represent an important advancement for TNBC treatment.
EMA authorization expands Intensity's TNBC trial to France, accelerating enrollment timeline and strengthening their clinical development strategy.
This EMA authorization for Intensity Therapeutics' INVINCIBLE-4 trial expansion represents a positive operational development that should accelerate their clinical program for INT230-6. The company explicitly states they expect to "almost double the number of sites actively screening patients" with enrollment acceleration beginning Q2 2025.
For clinical-stage biotechs like Intensity (NASDAQ: INTS), trial progress directly impacts development timelines and capital efficiency. The collaboration with Unicancer provides access to France's academic centers of excellence, complementing their existing partnership with SAKK across eight Swiss sites.
The INVINCIBLE-4 study design is noteworthy - testing whether adding INT230-6 (their lead asset) to the established Keynote-522 regimen improves pathological complete response in early-stage TNBC. This approach of enhancing rather than replacing standard therapy represents a pragmatic development strategy.
Early MRI observations of tumor necrosis and inflammation in initial patients provide encouraging signals, though these are preliminary findings rather than efficacy results. The 54-patient randomized study should generate meaningful data on whether INT230-6 can improve outcomes in this difficult-to-treat cancer.
This expansion demonstrates efficient execution of Intensity's clinical strategy, potentially accelerating their development timeline through access to additional high-quality clinical sites and investigator expertise.
INVINCIBLE-4 (SAKK/66/22) Study continues to recruit patients in eight sites in
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
"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,
"The acceptance of the INVINCIBLE-4 by the EMA and our expansion of the trial into
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
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
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.
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FAQ
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