Kiromic BioPharma Reports Favorable 10-Month Follow-Up Results for the First Patient Treated in its Deltacel-01 Clinical Trial
Kiromic BioPharma (OTCQB: KRBP) reports favorable 10-month follow-up results for the first patient in its Deltacel-01 Phase 1 clinical trial. The trial evaluates Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf, Gamma Delta T-cell therapy, in stage 4 metastatic non-small cell lung cancer patients who failed standard therapies. Key findings include:
- 27% tumor size reduction compared to pre-treatment
- No new disease sites identified
- 10-month progression-free survival (PFS)
- No reported adverse events
These results follow earlier observations of 20% tumor reduction at eight months and 13% at six months post-treatment. The patient is being treated at Beverly Hills Cancer Center. Kiromic's CEO and the trial's Principal Investigator expressed optimism about Deltacel's potential as a safe and effective treatment for late-stage cancers.
Kiromic BioPharma (OTCQB: KRBP) riporta risultati favorevoli a 10 mesi di follow-up per il primo paziente nel suo trial clinico di fase 1 Deltacel-01. Lo studio valuta Deltacel™ (KB-GDT-01), una terapia a base di cellule Gamma Delta T allogeniche e pronte all'uso, in pazienti con carcinoma polmonare non a piccole cellule metastatico di stadio 4 che non hanno risposto alle terapie standard. I principali risultati includono:
- Riduzione del 27% delle dimensioni del tumore rispetto al trattamento pregresso
- Non sono stati identificati nuovi siti di malattia
- Survival (PFS) di 10 mesi senza progressione
- Nessun evento avverso segnalato
Questi risultati seguono osservazioni precedenti di una riduzione del tumore del 20% a otto mesi e del 13% a sei mesi post-trattamento. Il paziente è in cura presso il Beverly Hills Cancer Center. Il CEO di Kiromic e il Principal Investigator del trial hanno espresso ottimismo riguardo al potenziale di Deltacel come trattamento sicuro ed efficace per i tumori in stadio avanzato.
Kiromic BioPharma (OTCQB: KRBP) informa sobre resultados favorables de seguimiento a 10 meses para el primer paciente en su ensayo clínico de fase 1 Deltacel-01. El ensayo evalúa Deltacel™ (KB-GDT-01), una terapia de células T Gamma Delta alogénica y lista para usar, en pacientes con cáncer de pulmón no microcítico metastásico en etapa 4 que no respondieron a las terapias estándar. Los hallazgos clave incluyen:
- Reducción del tamaño del tumor del 27% en comparación con el tratamiento previo
- No se identificaron nuevos sitios de enfermedad
- Supervivencia sin progresión (PFS) de 10 meses
- No se informaron eventos adversos
Estos resultados siguen a observaciones anteriores de una reducción del tumor del 20% a los ocho meses y del 13% a los seis meses después del tratamiento. El paciente está siendo tratado en el Beverly Hills Cancer Center. El CEO de Kiromic y el Investigador Principal del ensayo expresaron optimismo sobre el potencial de Deltacel como un tratamiento seguro y efectivo para los cánceres en etapa avanzada.
키로믹 바이오파마 (OTCQB: KRBP)는 Deltacel-01 1상 임상 시험에 참여한 첫 번째 환자의 10개월 추적 결과를 보고했습니다. 이 시험은 표준 치료에 실패한 4기 전이성 비소세포 폐암 환자에게 알로겐 대체 공여자 유래 감마 델타 T세포 치료인 Deltacel™ (KB-GDT-01)을 평가합니다. 주요 결과는 다음과 같습니다:
- 치료 전과 비교하여 27%의 종양 크기 감소
- 새로운 질병 부위 식별 없음
- 10개월 무진행 생존율(PFS)
- 보고된 부작용 없음
이 결과는 치료 후 6개월에 13% 및 8개월에 20%의 종양 감소라는 이전 관찰 결과를 따른 것입니다. 환자는 베벌리 힐스 암 센터에서 치료받고 있습니다. 키로믹의 CEO와 시험의 총괄 연구자는 Deltacel이 말기 암에 대한 안전하고 효과적인 치료법으로서의 잠재력에 대해 긍정적인 전망을 나타냈습니다.
Kiromic BioPharma (OTCQB: KRBP) rapporte des résultats favorables à 10 mois de suivi pour le premier patient de son essai clinique de phase 1 Deltacel-01. L'essai évalue Deltacel™ (KB-GDT-01), une thérapie à base de cellules T Gamma Delta allogéniques et prêtes à l'emploi, chez des patients atteints de cancer du poumon non à petites cellules métastatique de stade 4 n'ayant pas répondu aux thérapies standards. Les résultats clés incluent :
- Réduction de la taille de la tumeur de 27 % par rapport au traitement initial
- Aucun nouveau site de maladie identifié
- Survie sans progression (PFS) de 10 mois
- Aucun événement indésirable signalé
Ces résultats font suite à des observations antérieures d'une réduction de 20 % de la tumeur à huit mois et de 13 % à six mois après le traitement. Le patient est traité au Beverly Hills Cancer Center. Le PDG de Kiromic et le principal chercheur de l'essai ont exprimé leur optimisme quant au potentiel de Deltacel en tant que traitement sûr et efficace pour les cancers à un stade avancé.
Kiromic BioPharma (OTCQB: KRBP) berichtet über positive 10-Monats-Nachbeobachtungsergebnisse für den ersten Patienten in seiner Deltacel-01 Phase-1-Studie. Die Studie bewertet Deltacel™ (KB-GDT-01), eine allogene, sofort verfügbare Gamma-Delta-T-Zell-Therapie, bei Patienten mit metastasiertem nicht-kleinzelligem Lungenkrebs im Stadium 4, die auf Standardtherapien nicht angesprochen haben. Wichtige Ergebnisse umfassen:
- 27%ige Tumorgröße-Reduktion im Vergleich zur Vorbehandlung
- Keine neuen Krankheitsherde identifiziert
- 10 Monate progressionsfreies Überleben (PFS)
- Keine berichteten Nebenwirkungen
Diese Ergebnisse folgen früheren Beobachtungen einer Tumorreduktion von 20% nach acht Monaten und 13% nach sechs Monaten nach der Behandlung. Der Patient wird im Beverly Hills Cancer Center behandelt. Der CEO von Kiromic und der Hauptprüfer der Studie äußerten Optimismus über das Potenzial von Deltacel als sichere und effektive Behandlung für fortgeschrittene Krebsformen.
- 27% tumor size reduction in first patient after 10 months
- 10-month progression-free survival achieved
- No adverse events reported
- Consistent tumor reduction trend observed over time
- Potential breakthrough for late-stage cancer patients with options
- None.
In this patient, the tumor size was reduced by approximately
“As this patient is the most advanced in our ongoing Deltacel-01 clinical trial, we are particularly encouraged by these latest follow-up results that continue to validate the potential of Deltacel as a safe and effective treatment for patients with later-stage cancers,” said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. “We believe these findings underscore the promise of our allogeneic GDT therapy in providing durable clinical benefit.”
“The latest results from this patient are highly promising, particularly given the durable progression-free survival and tumor reduction we observed,” said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Deltacel-01 Principal Investigator at BHCC. “This patient’s response to Gama Delta T-Cell Treatment continues to provide optimism as we evaluate Deltacel’s therapeutic potential. Continued meaningful results could represent a significant breakthrough for these late-stage cancer patients with limited treatment options.”
Kiromic expects to report additional follow-up results from the fourth patient enrolled in this study in October.
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 the Beverly Hills Cancer Center
As a private, academic, community-based cancer center, the Beverly Hills Cancer Center not only provides the latest state-of-the-art cancer treatments all under one roof, but also provides leading clinical trials and research, attracting patients globally. By providing access to groundbreaking clinical trials, the Beverly Hills Cancer Center offers patients the opportunity to participate in the most advanced cancer treatments currently in development in the world. Beverly Hills Cancer Center is comprised of an internationally recognized multidisciplinary medical team consisting of medical oncologists, radiation oncologists, radiologists, hematologists and internists who provide exceptional patient care and support services including a robust and highly efficient team of clinical research professionals. More information is available at www.BHCancerCenter.com.
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
Beverly Hills Cancer Center
Sharon Neman, MBA
Chief Strategy Officer
SN@bhcancercenter.com
310-432-8925
Source: Kiromic BioPharma, Inc.
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