Kiromic BioPharma Advances Deltacel-01 Into Expansion Phase Following Safety Monitoring Committee’s Unanimous Recommendation
Kiromic BioPharma (OTCQB: KRBP) has received unanimous approval from the Safety Monitoring Committee (SMC) to advance its Deltacel-01 clinical trial into the expansion phase. The trial is evaluating Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf, Gamma Delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed standard therapies.
The SMC's recommendation follows a favorable review of safety data from the first two cohorts, including the 40-day follow-up of the sixth patient, which showed a positive safety and tolerability profile with no dose-limiting toxicities. The expansion phase will enroll approximately nine patients, with screening expected to begin later this month. This phase aims to further assess Deltacel's effectiveness in treating solid tumors.
Kiromic BioPharma (OTCQB: KRBP) ha ricevuto l'approvazione unanime dal Comitato di Monitoraggio della Sicurezza (SMC) per avanzare la sua trial clinica Deltacel-01 nella fase di espansione. Lo studio sta valutando Deltacel™ (KB-GDT-01), una terapia cellulare T gamma delta allogenica, pronta all'uso, in pazienti con carcinoma polmonare non a piccole cellule (NSCLC) in stadio 4 metastatici che non hanno risposto alle terapie standard.
La raccomandazione del SMC segue una revisione favorevole dei dati di sicurezza provenienti dai primi due gruppi, incluso il follow-up di 40 giorni del sesto paziente, che ha mostrato un profilo di sicurezza e tollerabilità positivo senza tossicità limitanti alla dose. La fase di espansione prevederà l'arruolamento di circa nove pazienti, con screening previsto per iniziare entro la fine di questo mese. Questa fase mira a valutare ulteriormente l'efficacia di Deltacel nel trattamento dei tumori solidi.
Kiromic BioPharma (OTCQB: KRBP) ha recibido aprobación unánime del Comité de Monitoreo de Seguridad (SMC) para avanzar su ensayo clínico Deltacel-01 a la fase de expansión. El ensayo está evaluando Deltacel™ (KB-GDT-01), una terapia de células T gamma delta alogénica y lista para usar, en pacientes con cáncer de pulmón no microcítico (NSCLC) en estadio 4 metastásico que no han respondido a terapias estándar.
La recomendación del SMC sigue a una revisión favorable de los datos de seguridad de los primeros dos grupos, incluido el seguimiento de 40 días del sexto paciente, que mostró un perfil de seguridad y tolerabilidad positivo sin toxicidades limitantes de dosis. La fase de expansión inscribirá aproximadamente a nueve pacientes, y se espera que el cribado comience a finales de este mes. Esta fase tiene como objetivo evaluar más a fondo la efectividad de Deltacel en el tratamiento de tumores sólidos.
키로믹 바이오파마 (OTCQB: KRBP)는 안전 모니터링 위원회(SMC)로부터 Deltacel-01 임상 시험을 확장 단계로 진행할 수 있는 만장일치 승인을 받았습니다. 이 시험은 표준 치료에 실패한 4기 전이성 비소세포 폐암 (NSCLC) 환자들에게 Deltacel™ (KB-GDT-01)이라는 알로_GENIC의 오프더셸 감마 델타 T세포 요법을 평가하고 있습니다.
SMC의 권고는 첫 두 그룹에서의 안전성 데이터에 대한 긍정적인 검토에 따른 것으로, 여섯 번째 환자의 40일 후속 검토에서 긍정적인 안전성과 내약성 프로필이 나타났으며, 용량 제한 독성이 없음을 보여주었습니다. 확장 단계에서는 약 9명의 환자를 등록할 예정이며, 이달 말에 선별이 시작될 것으로 예상됩니다. 이 단계의 목표는 Deltacel이 고형 종양 치료에 얼마나 효과적인지를 추가로 평가하는 것입니다.
Kiromic BioPharma (OTCQB: KRBP) a reçu l'approbation unanime du Comité de Surveillance de la Sécurité (SMC) pour avancer son essai clinique Deltacel-01 dans la phase d'expansion. L'essai évalue Deltacel™ (KB-GDT-01), une thérapie par cellules T gamma delta allogènes et prête à l'emploi, chez des patients atteints de cancer du poumon non à petites cellules (NSCLC) de stade 4 métastatique ayant échoué aux thérapies standards.
La recommandation du SMC fait suite à un examen favorable des données de sécurité des deux premiers cohortes, y compris le suivi de 40 jours du sixième patient, qui a montré un profil de sécurité et de tolérance positif sans toxicités limitantes de dose. La phase d'expansion inscrira environ neuf patients, avec un dépistage prévu pour commencer plus tard ce mois-ci. Cette phase vise à évaluer davantage l'efficacité de Deltacel dans le traitement des tumeurs solides.
Kiromic BioPharma (OTCQB: KRBP) hat einstimmige Genehmigung vom Sicherheitsüberwachungsausschuss (SMC) erhalten, um die Deltacel-01 klinische Studie in die Expansionsphase zu überführen. Die Studie bewertet Deltacel™ (KB-GDT-01), eine allogene, gebrauchsfertige Gamma-Delta-T-Zelltherapie, bei Patienten mit stadium 4 metastasierendem nicht-kleinzelligem Lungenkrebs (NSCLC), die auf Standardtherapien nicht angesprochen haben.
Die Empfehlung des SMC folgt einer positiven Bewertung der Sicherheitsdaten aus den ersten beiden Kohorten, einschließlich der 40-tägigen Nachuntersuchung des sechsten Patienten, die ein positives Sicherheits- und Verträglichkeitsprofil ohne dosislimitierende Toxizität zeigte. In der Expansionsphase sollen etwa neun Patienten rekrutiert werden, wobei das Screening voraussichtlich noch in diesem Monat beginnen wird. Diese Phase zielt darauf ab, die Wirksamkeit von Deltacel bei der Behandlung solider Tumoren weiter zu bewerten.
- Unanimous SMC approval to proceed with expansion phase of Deltacel-01 trial
- Positive safety and tolerability profile observed in initial cohorts
- No dose-limiting toxicities reported in the trial so far
- Expansion phase to enroll approximately nine additional patients
- Potential to address unmet needs in solid tumor treatment
- None.
This recommendation by the SMC follows a favorable review of safety data from the first two cohorts, including recent results from the 40-day follow-up visit of the sixth patient in Deltacel-01, which demonstrated a positive safety and tolerability profile with no dose-limiting toxicities (DLTs) observed.
As part of the expansion phase of Deltacel-01, Kiromic will enroll approximately nine patients. Screening for new participants is expected to commence later this month. The expansion phase, or Part 2 of Deltacel-01, will further assess the effectiveness of Deltacel treatment.
“We are delighted to receive unanimous SMC approval to move forward with the expansion phase of the Deltacel-01 trial,” said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. “As we enter this next phase with more activated clinical sites, we expect a solid cadence of patient enrollment. We are optimistic about the potential to further evaluate Deltacel’s impact on patient outcomes and address critical unmet needs in solid tumors.”
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
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212-201-6614
Source: Kiromic BioPharma, Inc.
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