Kiromic BioPharma Reports Tumor Volume Decrease in Two Patients Enrolled in Deltacel-01
Kiromic BioPharma (OTCQB: KRBP) reports positive results from its Deltacel-01 Phase 1 clinical trial for advanced non-small cell lung cancer (NSCLC). The first patient showed a 33.33% tumor volume reduction at 12-month follow-up, achieving partial response. The seventh patient demonstrated a 9.5% tumor reduction at two-month follow-up.
Both responding patients are being treated at Beverly Hills Cancer Center. The eighth patient has completed treatment with results expected in February 2025, while the ninth patient has started treatment at Virginia Oncology Associates. The company expects to enroll the 10th and 11th patients by end of January.
Deltacel™ (KB-GDT-01) is an allogeneic, off-the-shelf, Gamma Delta T-cell therapy for patients with stage 4 metastatic or locally-advanced NSCLC who failed standard therapies. This marks the second partial response in the trial, following similar results in the fourth patient.
Kiromic BioPharma (OTCQB: KRBP) riporta risultati positivi dal suo studio clinico di fase 1 Deltacel-01 per il cancro ai polmoni notoriamente non a piccole cellule avanzato (NSCLC). Il primo paziente ha mostrato una riduzione del volume tumorale del 33,33% a 12 mesi di follow-up, raggiungendo una risposta parziale. Il settimo paziente ha dimostrato una riduzione tumorale del 9,5% a due mesi di follow-up.
Entrambi i pazienti in risposta sono in trattamento presso il Beverly Hills Cancer Center. L'ottavo paziente ha completato il trattamento con risultati attesi per febbraio 2025, mentre il nono paziente ha iniziato il trattamento presso la Virginia Oncology Associates. L'azienda prevede di arruolare i 10° e 11° pazienti entro la fine di gennaio.
Deltacel™ (KB-GDT-01) è una terapia con cellule T Gamma Delta allogeniche e pronte all’uso per pazienti con NSCLC metastatico di stadio 4 o localmente avanzato che hanno fallito le terapie standard. Questo segna la seconda risposta parziale nello studio, dopo risultati simili nel quarto paziente.
Kiromic BioPharma (OTCQB: KRBP) informa resultados positivos de su ensayo clínico de fase 1 Deltacel-01 para el cáncer de pulmón no microcítico avanzado (NSCLC). El primer paciente mostró una reducción del volumen tumoral del 33,33% a los 12 meses de seguimiento, logrando una respuesta parcial. El séptimo paciente demostró una reducción tumoral del 9,5% a los dos meses de seguimiento.
Ambos pacientes en respuesta están siendo tratados en el Beverly Hills Cancer Center. El octavo paciente ha completado el tratamiento y se esperan resultados en febrero de 2025, mientras que el noveno paciente ha comenzado el tratamiento en Virginia Oncology Associates. La compañía espera inscribir al 10° y 11° paciente antes de finales de enero.
Deltacel™ (KB-GDT-01) es una terapia con células T Gamma Delta alogénicas, lista para usar, para pacientes con NSCLC metastásico de estadio 4 o localmente avanzado que han fallado en las terapias estándar. Esto marca la segunda respuesta parcial en el ensayo, siguiendo resultados similares en el cuarto paciente.
키로믹 바이오파마(OTCQB: KRBP)는 진행성 비소세포 폐암(NSCLC)을 위한 Deltacel-01 1상 임상 시험에서 긍정적인 결과를 보고했습니다. 첫 번째 환자는 12개월 추적 조사에서 33.33% 종양 부피 감소를 보여주었으며, 부분 반응을 달성했습니다. 일곱 번째 환자는 두 달 추적 조사에서 9.5% 종양 감소를 입증했습니다.
응답 환자들은 모두 베벌리 힐스 암 센터에서 치료를 받고 있습니다. 여덟 번째 환자는 치료를 마쳤고 2025년 2월에 결과가 예상되며, 아홉 번째 환자는 버지니아 종양학 협회에서 치료를 시작했습니다. 기업은 1월 말까지 10번째와 11번째 환자를 등록할 계획입니다.
Deltacel™(KB-GDT-01)은 표준 치료에 실패한 4기 전이성 또는 국소 진행성 비소세포 폐암 환자를 위한 동종, 현탁형 감마 델타 T세포 요법입니다. 이로써 네 번째 환자와 비슷한 결과에 이어 이 시험에서 두 번째 부분 반응이 기록되었습니다.
Kiromic BioPharma (OTCQB: KRBP) annonce des résultats positifs de son essai clinique de phase 1 Deltacel-01 pour le cancer du poumon non à petites cellules avancé (NSCLC). Le premier patient a montré une réduction du volume tumoral de 33,33% lors du suivi de 12 mois, atteignant une réponse partielle. Le septième patient a démontré une réduction de 9,5% du volume tumoral après deux mois de suivi.
Les deux patients en réponse sont traités au Beverly Hills Cancer Center. Le huitième patient a terminé son traitement, avec des résultats attendus en février 2025, tandis que le neuvième patient a commencé son traitement chez Virginia Oncology Associates. L'entreprise prévoit de recruter le 10ème et le 11ème patient d'ici la fin du mois de janvier.
Deltacel™ (KB-GDT-01) est une thérapie cellulaire Gamma Delta T allogénique prête à l'emploi pour des patients atteints de NSCLC métastatique de stade 4 ou de NSCLC localement avancé ayant échoué aux thérapies standard. Cela marque la deuxième réponse partielle dans l'essai, après des résultats similaires chez le quatrième patient.
Kiromic BioPharma (OTCQB: KRBP) berichtet von positiven Ergebnissen seiner Deltacel-01 Phase 1-Studie für fortgeschrittenen nicht-kleinzelligen Lungenkrebs (NSCLC). Der erste Patient zeigte eine Reduktion des Tumorvolumens um 33,33% nach 12 Monaten Nachbeobachtung, was eine partielle Antwort bedeutet. Der siebte Patient demonstrierte eine Tumorreduzierung um 9,5% nach zwei Monaten Nachbeobachtung.
Beide Patienten, die gut auf die Therapie ansprechen, werden im Beverly Hills Cancer Center behandelt. Der achte Patient hat die Behandlung abgeschlossen, und die Ergebnisse werden im Februar 2025 erwartet, während der neunte Patient die Behandlung bei Virginia Oncology Associates begonnen hat. Das Unternehmen plant, bis Ende Januar den 10. und 11. Patienten zu rekrutieren.
Deltacel™ (KB-GDT-01) ist eine allogene, gebrauchsfertige Gamma-Delta-T-Zelltherapie für Patienten mit metastasiertem oder lokal fortgeschrittenem NSCLC im Stadium 4, die auf Standardtherapien nicht angesprochen haben. Dies markiert die zweite partielle Reaktion in der Studie, gefolgt von ähnlichen Ergebnissen beim vierten Patienten.
- Two patients achieved partial response with tumor volume reductions (33.33% and 9.5%)
- Successful completion of treatment in eighth patient
- Active enrollment continuing with 9th patient started and 10th-11th expected by January end
- Patients reporting improved energy and better quality of life
- None.
Provides Enrollment Update for Phase 1 Study in Late-Stage Non-small Cell Lung Cancer
At the 12-month post-treatment follow-up visit, the first patient in Deltacel-01 had a
“The sustained, positive results we are seeing with the Deltacel-01 clinical trial are highly encouraging. Having a second patient achieve partial response with the first patient’s remarkable
"The remarkable
The Eighth Patient Completes Treatment
The eighth patient successfully completed the Deltacel-01 treatment regimen and is tolerating therapy well. Initial efficacy results for this patient are expected in late February 2025. This patient was enrolled at the Clinical Research Advisors Koreatown, a satellite location of BHCC.
Kiromic also announces that the ninth patient in Deltacel-01 started treatment at Virginia Oncology Associates (
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 advanced NSCLC receive three intravenous infusions of Deltacel™ with six courses of low-dose, localized radiation over a 31-day period. The primary objective of Deltacel-01 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 Clinical Research Advisors LLC
Founded in 2022 by current researchers and technology entrepreneurs at Beverly Hills Cancer Center, Clinical Research Advisors is a first-of-its-kind clinical trial optimization company harnessing the power of AI and real-world data capitalizing on the decade success of the high-quality clinical trial program developed at its main site, Beverly Hills Cancer Center, established over 15 years ago. Having a central site makes us different than other site networks. We strive to accelerate the development of new treatments and cures by addressing major roadblocks in patient recruitment and site activation. By leveraging our central site, Beverly Hills Cancer Center, integrated network of growing satellite sites and advanced technologies, we aim to make clinical research participation more accessible and efficient. More information is available at www.ClinicalResearchAdvisors.com
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic is using its proprietary DIAMOND® artificial intelligence (AI) 2.0 platform to discover novel targets for immuno-oncology. The Company maintains offices in
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. 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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Alliance Advisors IR
Tirth T. Patel
tpatel@allianceadvisors.com
212-201-6614
Beverly Hills Cancer Center
Sharon Neman, MBA
Chief Strategy Officer
SN@bhcancercenter.com
310-432-8925
Clinical Research Advisors LLC
Ali Muhammad, MD, MBA
Co-Founder & Director of Clinical Research Operations
AMuhammad@BHCancerCenter.com
Ali@ClinicalResearchAdvisors.com
310-432-8934
Source: Kiromic BioPharma, Inc.
FAQ
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