Kiromic BioPharma Provides Update on Part 1 of the Deltacel-01 Trial
Kiromic BioPharma (OTCQB: KRBP) has reported interim results for Part 1 of its Deltacel-01 Phase 1 clinical trial, evaluating Deltacel™ (KB-GDT-01) in stage 4 metastatic non-small cell lung cancer (NSCLC) patients. Key findings include:
- Progression-Free Survival (PFS) ranging from 2 to 8 months, with an average of 4.8 months for five evaluated patients
- No dose limiting toxicities (DLTs) reported for patients completing full therapy
- One patient withdrawn due to unrelated adverse event
- Sixth and final patient in Part 1 started treatment on August 6th
The company is on track to initiate Part 2 of the Deltacel-01 trial in September, with early safety and tolerability outcomes expected in September and efficacy results in early October.
Kiromic BioPharma (OTCQB: KRBP) ha riportato i risultati intermedi per la Parte 1 del suo studio clinico Deltacel-01 di Fase 1, che valuta Deltacel™ (KB-GDT-01) in pazienti con carcinoma polmonare non a piccole cellule metastatico di stadio 4. Le principali scoperte includono:
- Sopravvivenza Libera da Progressione (PFS) compresa tra 2 e 8 mesi, con una media di 4,8 mesi per cinque pazienti valutati
- Nessuna tossicità limitante la dose (DLTs) riportata per i pazienti che hanno completato la terapia completa
- Un paziente si è ritirato a causa di un evento avverso non correlato
- Sesto e ultimo paziente della Parte 1 ha iniziato il trattamento il 6 agosto
L'azienda è in procinto di avviare la Parte 2 dello studio Deltacel-01 a settembre, con risultati iniziali di sicurezza e tollerabilità attesi a settembre e risultati di efficacia all'inizio di ottobre.
Kiromic BioPharma (OTCQB: KRBP) ha informado resultados intermedios para la Parte 1 de su ensayo clínico Deltacel-01 de Fase 1, que evalúa Deltacel™ (KB-GDT-01) en pacientes con cáncer de pulmón no microcítico metastásico en etapa 4. Los hallazgos clave incluyen:
- Supervivencia Libre de Progresión (PFS) que varía de 2 a 8 meses, con un promedio de 4.8 meses para cinco pacientes evaluados
- No se reportaron toxicidades limitantes de dosis (DLTs) para los pacientes que completaron la terapia completa
- Un paciente se retiró debido a un evento adverso no relacionado
- El sexto y último paciente en la Parte 1 comenzó el tratamiento el 6 de agosto
La compañía está en camino de iniciar la Parte 2 del ensayo Deltacel-01 en septiembre, con resultados iniciales de seguridad y tolerabilidad esperados en septiembre y resultados de eficacia a principios de octubre.
키로믹 바이오파마(Kiromic BioPharma) (OTCQB: KRBP)는 4기 전이성 비소세포 폐암(NSCLC) 환자에서 Deltacel™ (KB-GDT-01)의 Deltacel-01 1상 임상 시험 1부의 중간 결과를 보고했습니다. 주요 발견 사항은 다음과 같습니다:
- 진전 없는 생존 기간(PFS)은 2개월에서 8개월 사이이며, 평가받은 다섯 명의 환자 평균은 4.8개월입니다.
- 전체 치료를 완료한 환자에게 보고된 최대 용량 제한 독성(DLTs)은 없습니다.
- 관련 없는 부작용으로 인하여 한 명의 환자가 철회하였습니다.
- 1부의 여섯 번째이자 마지막 환자는 8월 6일에 치료를 시작했습니다.
회사는 9월에 Deltacel-01 시험의 2부를 시작할 계획이며, 초기 안전성과 내약성 결과는 9월에, 효능 결과는 10월 초에 예상됩니다.
Kiromic BioPharma (OTCQB: KRBP) a rapporté des résultats intermédiaires pour la Partie 1 de son essai clinique de Phase 1 Deltacel-01, évaluant Deltacel™ (KB-GDT-01) chez des patients atteints de cancer du poumon non à petites cellules métastatique stade 4. Les principales conclusions incluent :
- Survie sans progression (PFS) allant de 2 à 8 mois, avec une moyenne de 4,8 mois pour cinq patients évalués
- Aucune toxicité limitante de la dose (DLTs) reportée pour les patients ayant complété la thérapie complète
- Un patient s'est retiré en raison d'un événement indésirable non lié
- Le sixième et dernier patient de la Partie 1 a commencé le traitement le 6 août
L'entreprise est sur la bonne voie pour initier la Partie 2 de l'essai Deltacel-01 en septembre, avec des résultats préliminaires de sécurité et de tolérance attendus en septembre et des résultats d'efficacité début octobre.
Kiromic BioPharma (OTCQB: KRBP) hat Zwischenberichte zur ersten Phase seiner Deltacel-01-Studie veröffentlicht, die Deltacel™ (KB-GDT-01) bei Patienten mit metastasiertem nicht kleinzelligem Lungenkrebs (NSCLC) im Stadium 4 untersucht. Wichtige Erkenntnisse umfassen:
- Progressionsfreie Überlebenszeit (PFS) von 2 bis 8 Monaten, mit einem Durchschnitt von 4,8 Monaten für fünf bewertete Patienten
- Keine berichteten dosislimitierenden Toxizitäten (DLTs) für Patienten, die die vollständige Therapie abgeschlossen haben
- Ein Patient hat wegen eines nicht verwandten unerwünschten Ereignisses abgebrochen
- Der sechste und letzte Patient in Teil 1 begann die Behandlung am 6. August
Das Unternehmen ist auf dem richtigen Weg, Teil 2 der Deltacel-01-Studie im September zu starten, wobei erste Sicherheits- und Verträglichkeitsresultate im September und Wirksamkeitsresultate Anfang Oktober erwartet werden.
- Progression-Free Survival (PFS) ranging from 2 to 8 months, with an average of 4.8 months
- No dose limiting toxicities (DLTs) reported for patients completing full therapy
- On track to initiate Part 2 of Deltacel-01 trial in September
- One patient withdrawn due to adverse event related to pre-existing co-morbidity
On track to initiate Part 2 in September
Based on data from the five patients evaluated for Progression-Free Survival (PFS) in the long-term follow-up, Kiromic has registered a PFS ranging from 2 to 8 months, with an average of 4.8 months.
No dose limiting toxicities (DLTs) have been reported by the clinical site for patients that have completed the full course of therapy. One patient was withdrawn from the study before completing the full course of therapy due to an adverse event related to a pre-existing co-morbidity and unrelated to Deltacel. Consequently, this subject could not be evaluated for PFS.
Additionally, the sixth and last patient in Part 1 of the Deltacel-01 study started treatment on August 6th.
“We are pleased to have completed enrollment in Part 1 of our clinical trial. The favorable results of our GDT therapy, particularly with respect to PFS, in the first two cohorts that comprise Part 1 underscore the potential of Deltacel to treat solid tumors, and we look forward to launching Part 2 of this study,” said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.
Kiromic expects to obtain early safety and tolerability outcomes from the last enrolled patient in September and efficacy results in early October. Kiromic is on track to initiate Part 2 of Deltacel-01 in September.
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
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Kiromic makes such forward-looking statements pursuant to the safe harbor provisions of the United States Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as: “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding: Kiromic’s ability to achieve its objectives and Kiromic’s financing strategy and availability of funds. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in our Annual Report on Form 10-K for the year ended December 31, 2023, and as detailed from time to time in our other SEC filings. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Such forward-looking statements relate only to events as of the date of this press release. We undertake no obligation to update any forward-looking statements except to the extent required by law.
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LHA Investor Relations
Tirth T. Patel
tpatel@lhai.com
212-201-6614
Source: Kiromic BioPharma, Inc.
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