Exicure, Inc. (Nasdaq: XCUR) Announces Their Next Step in Planning for a New Clinical Trial in Acute Myeloid Leukemia (AML)
Exicure (XCUR) has announced plans for a new clinical trial of its lead asset GPC-100 (burixafor) in Acute Myeloid Leukemia (AML). The CXCR4 inhibitor has shown promise when combined with modern AML treatments. A previous Phase 1 study with 15 relapsed/refractory AML patients evaluated GPC-100's safety and preliminary efficacy in combination with fludarabine and cytarabine.
Recent preclinical data presented at the 2024 ASH Annual Meeting demonstrated improved chemotherapy response through dual inhibition of CXCR4 with GPC-100 and beta-2 adrenergic receptor blockade. The company has secured patents for this approach in multiple countries.
GPC-100 is currently in a Phase 2 trial for multiple myeloma patients undergoing autologous stem cell transplant, with results expected in Q4 2025. Exicure is also exploring potential expansions into sickle cell disease, pediatric oncology, and cell and gene therapy applications.
Exicure (XCUR) ha annunciato piani per un nuovo studio clinico del suo principale asset GPC-100 (burixafor) nella Leucemia Mieloide Acuta (AML). L'inibitore CXCR4 ha mostrato risultati promettenti quando combinato con i trattamenti moderni per l'AML. Un precedente studio di Fase 1 con 15 pazienti affetti da AML in recidiva/resistente ha valutato la sicurezza e l'efficacia preliminare di GPC-100 in combinazione con fludarabina e citarabina.
Dati preclinici recenti presentati al 2024 ASH Annual Meeting hanno dimostrato una risposta migliorata alla chemioterapia attraverso l'inibizione duale di CXCR4 con GPC-100 e il blocco del recettore adrenergico beta-2. L'azienda ha ottenuto brevetti per questo approccio in diversi paesi.
GPC-100 è attualmente in uno studio di Fase 2 per pazienti con mieloma multiplo sottoposti a trapianto di cellule staminali autologhe, con risultati attesi nel quarto trimestre del 2025. Exicure sta anche esplorando potenziali espansioni nella malattia delle cellule falciformi, in oncologia pediatrica e nelle applicazioni di terapia cellulare e genica.
Exicure (XCUR) ha anunciado planes para un nuevo ensayo clínico de su activo principal GPC-100 (burixafor) en Leucemia Mieloide Aguda (AML). El inhibidor de CXCR4 ha mostrado resultados prometedores cuando se combina con tratamientos modernos para la AML. Un estudio anterior de Fase 1 con 15 pacientes con AML en recaída/resistente evaluó la seguridad y la eficacia preliminar de GPC-100 en combinación con fludarabina y citarabina.
Datos preclínicos recientes presentados en la Reunión Anual ASH 2024 demostraron una respuesta mejorada a la quimioterapia a través de la inhibición dual de CXCR4 con GPC-100 y el bloqueo del receptor adrenérgico beta-2. La empresa ha asegurado patentes para este enfoque en varios países.
GPC-100 se encuentra actualmente en un ensayo de Fase 2 para pacientes con mieloma múltiple que se someten a un trasplante de células madre autólogas, con resultados esperados para el cuarto trimestre de 2025. Exicure también está explorando posibles expansiones en la enfermedad de células falciformes, oncología pediátrica y aplicaciones de terapia celular y génica.
Exicure (XCUR)는 급성 골수 백혈병 (AML)에 대한 주요 자산 GPC-100 (burixafor)의 새로운 임상 시험 계획을 발표했습니다. CXCR4 억제제는 현대 AML 치료와 결합했을 때 유망한 결과를 보여주었습니다. 이전의 1상 연구에서는 15명의 재발/내성 AML 환자를 대상으로 GPC-100의 안전성과 플루다라빈 및 사이타라빈과의 병용에서의 초기 효능을 평가했습니다.
2024 ASH 연례 회의에서 발표된 최근의 전임상 데이터는 GPC-100과 베타-2 아드레날린 수용체 차단제를 통한 CXCR4의 이중 억제를 통해 화학요법 반응이 개선되었음을 보여주었습니다. 이 회사는 여러 국가에서 이 접근 방식에 대한 특허를 확보했습니다.
GPC-100은 현재 자가 줄기 세포 이식 중인 다발성 골수종 환자를 위한 2상 시험 중이며, 결과는 2025년 4분기에 예상됩니다. Exicure는 또한 겸상적혈구병, 소아 종양학 및 세포 및 유전자 치료 응용 분야로의 잠재적 확장을 탐색하고 있습니다.
Exicure (XCUR) a annoncé des plans pour un nouvel essai clinique de son actif principal GPC-100 (burixafor) dans le cadre de la Leucémie Myéloïde Aiguë (AML). L'inhibiteur de CXCR4 a montré des résultats prometteurs lorsqu'il est combiné avec des traitements modernes de l'AML. Une étude précédente de Phase 1 avec 15 patients atteints d'AML en rechute/résistante a évalué la sécurité et l'efficacité préliminaire de GPC-100 en combinaison avec la fludarabine et la cytarabine.
Des données précliniques récentes présentées lors de la réunion annuelle ASH 2024 ont démontré une réponse améliorée à la chimiothérapie grâce à l'inhibition duale de CXCR4 avec GPC-100 et le blocage du récepteur bêta-2 adrénergique. L'entreprise a sécurisé des brevets pour cette approche dans plusieurs pays.
GPC-100 est actuellement en essai de Phase 2 pour des patients atteints de myélome multiple subissant une transplantation de cellules souches autologues, avec des résultats attendus au quatrième trimestre 2025. Exicure explore également des expansions potentielles dans la maladie des cellules falciformes, l'oncologie pédiatrique et les applications de thérapie cellulaire et génique.
Exicure (XCUR) hat Pläne für eine neue klinische Studie seines Hauptprodukts GPC-100 (burixafor) bei Akuter Myeloischer Leukämie (AML) angekündigt. Der CXCR4-Inhibitor hat sich in Kombination mit modernen AML-Behandlungen als vielversprechend erwiesen. Eine frühere Phase-1-Studie mit 15 Patienten mit rezidivierter/resistenter AML bewertete die Sicherheit und die vorläufige Wirksamkeit von GPC-100 in Kombination mit Fludarabin und Cytarabin.
Aktuelle präklinische Daten, die auf dem 2024 ASH Annual Meeting präsentiert wurden, zeigten eine verbesserte Chemotherapie-Ansprechrate durch die doppelte Hemmung von CXCR4 mit GPC-100 und der Blockade des Beta-2-Adrenozeptors. Das Unternehmen hat Patente für diesen Ansatz in mehreren Ländern gesichert.
GPC-100 befindet sich derzeit in einer Phase-2-Studie für Patienten mit multiplem Myelom, die sich einer autologen Stammzelltransplantation unterziehen, mit Ergebnissen, die im vierten Quartal 2025 erwartet werden. Exicure untersucht auch mögliche Erweiterungen in der Sichelzellenkrankheit, der pädiatrischen Onkologie und in Anwendungen der Zell- und Gentherapie.
- Phase 2 trial ongoing in multiple myeloma with results expected Q4 2025
- Preclinical data shows improved chemotherapy response through dual inhibition approach
- Patent protection secured in multiple major markets
- Potential expansion into multiple additional indications
- Phase 1 trial to only 15 patients
- Phase 2 results not available until late 2025
Exicure, Inc. (“Exicure”) is planning for a clinical trial in Acute Myeloid Leukemia (AML) with GPC-100. The company believes that GPC-100, when paired with modern AML treatment regimens, can further improve outcomes in this high unmet need clinical indication. A Phase 1 chemosensitization study involving 15 patients with relapsed or refractory AML was previously conducted by Taigen, the original developer of GPC-100. In that study, GPC-100 was combined with fludarabine and cytarabine to evaluate safety and preliminary efficacy. Preclinical data published by Dr. Pam Becker at City of Hope in collaboration with GPCR Therapeutics
In addition to AML, GPC-100 is currently being evaluated in an ongoing Phase 2 trial in patients with multiple myeloma (MM) undergoing autologous stem cell transplant (ASCT; NCT05561751). Clinical trial results for this study are expected in Q4 2025.
Current Evaluating Potential Indication Expansions – In addition to AML and MM, Exicure is evaluating a range of potential indications for GPC-100, including sickle cell disease, pediatric oncology, and cell and gene therapy settings.
About Exicure, Inc.
Exicure, Inc. has historically been an early-stage biotechnology company focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. Following its restructuring and suspension of clinical and development activities, the Company is exploring strategic alternatives to maximize stockholder value. For further information, see www.exicuretx.com.
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Media Contact:
Sarah Ellinwood, PhD
Kendall Investor Relations
sellinwood@kendallir.com
Source: Exicure, Inc.
FAQ
What are the key findings from GPC-100's Phase 1 trial in AML patients?
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