Kiromic BioPharma’s Deltacel Receives FDA Fast Track Designation
Kiromic BioPharma (OTCQB: KRBP) has received Fast Track designation from the FDA for Deltacel™ (KB-GDT-01), its allogeneic, off-the-shelf, Gamma Delta T-cell therapy. This designation is for Deltacel in combination with low-dose radiation therapy for treating metastatic non-small cell lung cancer (NSCLC) patients who have progressed on at least two lines of standard therapy.
The Fast Track status allows for more frequent FDA communication, potential priority review, and rolling submission of applications. Deltacel is currently in a Phase 1 study (Deltacel-01) for stage 4 NSCLC patients who failed standard therapies. Recent data from this trial has shown a favorable safety profile and preliminary clinical efficacy. Kiromic plans to activate a fifth clinical trial site on August 30th.
Kiromic BioPharma (OTCQB: KRBP) ha ricevuto la designazione Fast Track dalla FDA per Deltacel™ (KB-GDT-01), la sua terapia cellulare Gamma Delta T allogenica e pronta all'uso. Questa designazione è per Deltacel in combinazione con la terapia di radioterapia a basso dosaggio per il trattamento dei pazienti affetti da carcinoma polmonare non a piccole cellule metastatico (NSCLC) che hanno progredito dopo almeno due linee di terapia standard.
Lo stato di Fast Track consente comunicazioni più frequenti con la FDA, una possibile revisione prioritaria e la presentazione continua delle domande. Deltacel è attualmente in uno studio di Fase 1 (Deltacel-01) per pazienti con NSCLC in stadio 4 che hanno fallito le terapie standard. Dati recenti da questo studio hanno mostrato un profilo di sicurezza favorevole e una preliminare efficacia clinica. Kiromic prevede di attivare un quinto sito di sperimentazione clinica il 30 agosto.
Kiromic BioPharma (OTCQB: KRBP) ha recibido la designación Fast Track de la FDA para Deltacel™ (KB-GDT-01), su terapia con células T Gamma Delta alogénica y lista para usar. Esta designación es para Deltacel en combinación con terapia de radiación a baja dosis para tratar a pacientes con cáncer de pulmón no microcítico metastásico (NSCLC) que han progresado en al menos dos líneas de terapia estándar.
El estatus de Fast Track permite una comunicación más frecuente con la FDA, una posible revisión prioritaria y la presentación continua de solicitudes. Deltacel se encuentra actualmente en un estudio de Fase 1 (Deltacel-01) para pacientes con NSCLC en etapa 4 que fallaron en terapias estándar. Los datos recientes de este ensayo han mostrado un perfil de seguridad favorable y una eficacia clínica preliminar. Kiromic planea activar un quinto sitio de ensayo clínico el 30 de agosto.
키로믹 바이오파마(Kiromic BioPharma) (OTCQB: KRBP)는 FDA로부터 Deltacel™ (KB-GDT-01)에 대해 패스트 트랙 지정을 받았습니다. 이는 자가 면역 세포인 감마 델타 T 세포를 이용한 치료로, 즉시 사용할 수 있는 알로겐 치료법입니다. 이 지명은 두 가지 이상의 표준 치료에서 진행된 전이성 비소세포 폐암(NSCLC) 환자에 대한 Deltacel과 저용량 방사선 치료의 조합을 위한 것입니다.
패스트 트랙 상태는 FDA와의 더 빈번한 소통, 우선 심사 가능성 및 신청서의 단계적 제출을 허용합니다. Deltacel은 현재 4기 NSCLC 환자를 대상으로 하는 1상 연구 (Deltacel-01) 중에 있으며, 최근 이 시험의 데이터는 좋은 안전성 프로파일과 초기 임상 효능을 보여주었습니다. 키로믹은 8월 30일에 다섯 번째 임상 시험 사이트를 활성화할 계획입니다.
Kiromic BioPharma (OTCQB: KRBP) a reçu la dénomination Fast Track de la FDA pour Deltacel™ (KB-GDT-01), sa thérapie cellulaire Gamma Delta T allogénique et prête à l'emploi. Cette designation s'applique à Deltacel en combinaison avec une thérapie de radiothérapie à faible dose pour traiter les patients atteints de cancer du poumon non à petites cellules métastatique (NSCLC) qui ont progressé après au moins deux lignes de traitement standard.
Le statut Fast Track permet une communication plus fréquente avec la FDA, une révision prioritaire potentielle et une soumission progressive des demandes. Deltacel est actuellement dans une étude de Phase 1 (Deltacel-01) pour les patients atteints de NSCLC au stade 4 qui ont échoué aux thérapies standard. Les données récentes de cet essai ont montré un profil de sécurité favorable et une efficacité clinique préliminaire. Kiromic prévoit d'activer un cinquième site d'essai clinique le 30 août.
Kiromic BioPharma (OTCQB: KRBP) hat von der FDA die Fast Track-Status für Deltacel™ (KB-GDT-01), eine allogene, lagerfähige Gamma Delta T-Zelltherapie, erhalten. Diese Zulassung gilt für Deltacel in Kombination mit niedrig dosierter Strahlentherapie zur Behandlung von Patienten mit metastasiertem, nicht-kleinzelligem Lungenkrebs (NSCLC), die nach mindestens zwei Linien von Standardtherapien Fortschritte gezeigt haben.
Der Fast Track-Status ermöglicht häufigere Kommunikationen mit der FDA, eine potenzielle Prioritätsprüfung und eine schrittweise Einreichung von Anträgen. Deltacel befindet sich derzeit in einer Phase 1-Studie (Deltacel-01) für Patienten mit NSCLC im Stadium 4, die bei Standardtherapien versagt haben. Jüngste Daten aus dieser Studie haben ein günstiges Sicherheitsprofil und erste klinische Wirksamkeit gezeigt. Kiromic plant, am 30. August einen fünften klinischen Prüfstandort zu aktivieren.
- FDA granted Fast Track designation for Deltacel
- Deltacel shows favorable safety profile and preliminary efficacy in ongoing Phase 1 trial
- Fast Track status allows for more frequent FDA communication and potential priority review
- Company plans to activate a fifth clinical trial site on August 30th
- None.
Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. The designation allows for more frequent communication with the FDA, potential priority review, and a rolling submission of Biologics License Application or New Drug Application.
“Receipt of Fast Track designation is a significant milestone for Kiromic and underscores the potential of Deltacel to address the urgent needs of patients with advanced solid tumors,” said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. “We are encouraged by the FDA’s recognition of our innovative approach and are committed to the clinical development of Deltacel. Fast Track designation will enable us to work more closely with the FDA as we complete Deltacel-01 and advance this promising therapy into later stage studies.”
The Fast Track designation follows recent positive data from the ongoing Deltacel-01 clinical trial, in which Deltacel has demonstrated a favorable safety profile and preliminary clinical efficacy in NSCLC patients. Kiromic expects to activate a fifth clinical trial site on August 30th.
About Deltacel-01
In Kiromic’s open-label Phase 1 clinical trial, titled “Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer” (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel™ with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.
About Deltacel™
Deltacel™ (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel™ is the leading candidate in Kiromic’s GDT platform. Deltacel™ is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies focusing on immuno-oncology. Kiromic is developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic’s DIAMOND® AI is where data science meets target identification to dramatically compress the years and hundreds of millions of dollars required to develop a live drug. The Company maintains offices in
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LHA Investor Relations
Tirth T. Patel
tpatel@lhai.com
212-201-6614
Source: Kiromic BioPharma, Inc.
FAQ
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