Lunai Bioworks achieves complete regression of both primary and metastatic pancreatic tumors in preclinical humanized models, marking a breakthrough in allogeneic cancer immunotherapy
Lunai Bioworks (NASDAQ: LNAI) announced that a second‑generation, clinical‑grade dendritic cell (DC) therapy produced complete regression of primary and metastatic pancreatic tumors in preclinical humanized mouse models.
The Brief Report was published in Vaccines on Nov 2, 2025 and describes an optimized, clinically compliant construct that preserves the original product's efficacy while improving promoter and manufacturing elements to support IND‑enabling studies.
The therapy triggered robust activation of cytotoxic T cells and NK cells, and the company says the data advance partnering conversations and the platform's translation toward clinical development.
Lunai Bioworks (NASDAQ: LNAI) ha annunciato che una terapia di seconda generazione, di livello clinico, a base di cellule dendritiche ha prodotto la regressione completa dei tumori pancreatici primari e metastatizzati nei modelli murini umanizzati preclinici.
Il Brief Report è stato pubblicato su Vaccines il 2 novembre 2025 e descrive un costrutto ottimizzato e clinicamente conforme che mantiene l'efficacia del prodotto originale migliorando elementi del promotore e della produzione per supportare studi abilitanti l'IND.
La terapia ha innescato una forte attivazione di cellule T citotossiche e cellule NK, e l'azienda afferma che i dati avanzano le discussioni di partnership e la traduzione della piattaforma verso lo sviluppo clinico.
Lunai Bioworks (NASDAQ: LNAI) anunció que una terapia de células dendríticas de segunda generación, grado clínico, produjo una regresión completa de los tumores pancreáticos primarios y metastásicos en modelos murinos humanizados preclínicos.
El Brief Report se publicó en Vaccines el 2 de noviembre de 2025 y describe un constructo optimizado y clínicamente compatible que conserva la eficacia del producto original mientras mejora elementos del promotor y de la fabricación para respaldar estudios habilitantes de IND.
La terapia desencadenó una fuerte activación de células T citotóxicas y células NK, y la compañía afirma que los datos avanzan las conversaciones de asociación y la traducción de la plataforma hacia el desarrollo clínico.
Lunai Bioworks (NASDAQ: LNAI)는 2세대 임상 등급 수지상세포(DC) 치료제가 전임상 인간화 마우스 모델에서 주요 종양 및 전이성 췌장 종양의 완전 관해를 유발했다고 발표했다.
Brief Report는 Vaccines 2025년 11월 2일에 게재되었으며 원 제품의 효능을 유지하면서 프로모터와 제조 요소를 개선해 IND를 가능하게 하는 연구를 지원하는 최적화된 임상 적합 구성을 설명한다.
이 치료법은 사이토톡식 T 세포와 NK 세포의 강력한 활성화를 유도했고, 회사는 데이터가 파트너십 협상과 플랫폼의 임상 개발로의 번역을 촉진한다고 밝혔다.
Lunai Bioworks (NASDAQ: LNAI) a annoncé qu'une thérapie à base de cellules dendritiques de deuxième génération, de grade clinique, a produit une régression complète des tumeurs pancréatiques primaires et métastatiques dans des modèles murins humanisés précliniques.
Le Brief Report a été publié dans Vaccines le 2 novembre 2025 et décrit une construction optimisée et conforme à l'usage clinique qui conserve l'efficacité du produit original tout en améliorant des éléments du promoteur et de la fabrication pour soutenir des études IND‑habilitantes.
La thérapie a déclenché une activation robuste des cellules T cytotoxiques et des cellules NK, et la société affirme que les données font progresser les discussions de partenariat et la traduction de la plateforme vers le développement clinique.
Lunai Bioworks (NASDAQ: LNAI) kündigte an, dass eine zweite Generation klinisch einsetzbare dendritische Zelltherapie eine vollständige Regression primärer und metastatischer Bauchspeicheldrüsen-Tumore in vorklinischen, humanisierten Mausmodellen erzielt hat.
Der Brief-Report wurde in Vaccines am 2. November 2025 veröffentlicht und beschreibt eine optimierte, klinisch konforme Konstruktion, die die ursprüngliche Wirksamkeit beibehält, während Promoter- und Herstellungsaspekte verbessert werden, um IND-freundliche Studien zu unterstützen.
Die Therapie löste eine robuste Aktivierung von zytotoxischen T-Zellen und NK-Zellen aus, und das Unternehmen sagt, dass die Daten Partnerschaftsgespräche vorantreiben und die Übersetzung der Plattform in die klinische Entwicklung unterstützen.
Lunai Bioworks (NASDAQ: LNAI) أعلنت أن علاجاً بالخلايا التائهة من الجيل الثاني وبدرجة إكلينيكية أُنتج انحداراً كاملاً للأورام البنكرياسية الأولية والمتكاثرة في نماذج فئران مُنمّاة بشرياً قبل السريرية.
تم نشر التقرير الموجز في Vaccines في 2 نوفمبر 2025 ويصف بنية مُحسّنة ومتوافقة مع العيادة تحافظ على فاعلية المنتج الأصلي مع تحسين عناصر المروّج والتصنيع لدعم دراسات IND التي تمكّن.
أثارت Therapy نشاطاً قوياً لخلايا T السامة للخلايا وخلايا NK، وتقول الشركة إن البيانات تدفع محادثات الشراكة وترجمة المنصة نحو التطوير السريري.
- Complete regression of primary and metastatic tumors in humanized mouse models
- Published in Vaccines on Nov 2, 2025
- Second‑generation construct preserved efficacy while improving clinical design
- Therapy triggered robust activation of cytotoxic T cells and NK cells
- Findings limited to preclinical humanized mouse models; no human data yet
- No IND filing or clinical trial readout reported in the announcement
Insights
Publication reports complete regression in humanized mouse models using a clinically optimized allogeneic dendritic cell platform.
In straightforward terms, Lunai Bioworks moved its research-grade dendritic cell (DC) therapy to a second-generation, clinically compliant construct while preserving the anti-tumor efficacy observed earlier. The construct uses engineered CD34+ HSC-derived DCs with enhanced genetic elements and a strong mammalian promoter to maintain expression of immune-stimulating molecules; in humanized mouse models this triggered cytotoxic T‑cell and NK activation and produced complete regression of primary and metastatic pancreatic tumors.
The practical pathway to value is clear: publication in Vaccines and an optimized, IND-capable construct support partnering and regulatory work. Key dependencies are explicit and limited to the content: confirmation that the clinical-grade design truly matches research-grade efficacy in GLP studies, successful IND-enabling safety and CMC data, and partner or sponsor interest. Risks in this stage are technical and regulatory; the release does not report human data, safety findings, or IND filings.
Watch for explicit, monitorable milestones: publication date
Lunai Bioworks Announces Publication of Second-Generation Allogeneic Dendritic Cell Therapy Platform in the journal "Vaccines".
The study was published in a new Brief Report in Vaccines on November 2, 2025. The peer-reviewed Brief Report details the development of a second-generation, clinical-grade DC construct that achieved complete regression of both primary and metastatic pancreatic tumors in preclinical humanized models. Pancreatic cancer is one of the deadliest cancers, often diagnosed late and resistant to conventional treatments. Lunai's therapy uses engineered dendritic cells — specialized immune cells created from stem cells — that are genetically enhanced to activate the body's immune system against cancer. This publication details a second-generation, clinical-compliant version of this platform, with the provided evidence critical in advancing ongoing partnering conversations for the therapy.
This new publication builds on Lunai's earlier study (Vaccines 2025 Jul 12;13(7):749; doi:10.3390/vaccines13070749), which first demonstrated potent anti-tumor activity of CD34+ hematopoietic stem cell (HSC)-derived DCs engineered to overexpress CD40L, CD93, and CXCL13 in humanized mouse models of pancreatic cancer. While the initial study utilized a research-grade lentiviral vector, the latest report describes an optimized, clinically compliant construct that preserves equivalent efficacy while improving design and manufacturing attributes to support future clinical translation.
The second-generation construct features a strong mammalian promoter and enhanced genetic elements to drive expression of key immune-modulating molecules. In preclinical humanized models, Lunai's next-generation DC therapy triggered robust activation of cytotoxic T cells and NK cells and led to complete regression of both primary and metastatic pancreatic tumors. These findings mirrored the outcomes achieved with the original research-grade product. While the allogeneic DC product has been evaluated in pancreatic cancer models, its therapeutic potential extends to a broad range of solid tumors.
"These findings demonstrate that our vector optimization strategy maintains therapeutic potency while bringing our allogeneic DC platform to the threshold of IND-enabling studies," said David Weinstein, CEO of Lunai Bioworks. "This represents an important inflection point as we move from research innovation to clinical translation—positioning Lunai at the forefront of next-generation cell-based immunotherapies."
The full article, titled "Modified Hematopoietic Stem Cell-Derived Dendritic Cell Therapy Retained Tumor-Inhibitory Function and Led to Regression of Primary and Metastatic Pancreatic Tumors in Humanized Mouse Models," is available in Vaccines (https://www.mdpi.com/2076-393X/13/11/1131).
About Lunai
Lunai Bioworks Inc. is an AI-powered drug discovery and biodefense company pioneering safe and responsible generative biology. With proprietary neurotoxicity datasets, advanced machine learning, and a focus on dual-use risk management, Lunai is redefining how artificial intelligence can accelerate therapeutic innovation while safeguarding society from emerging threats. For more visit www.lunaibioworks.com.
Forward-Looking Statements:
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future operations, plans, and market expectations. These statements are based on current assumptions and beliefs and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Words such as "may," "will," "expect," "believe," "anticipate," "intend," "plan," "estimate," and similar expressions are intended to identify forward-looking statements. Actual results may differ due to factors beyond the Company's control. You should not place undue reliance on these statements, which speak only as of the date of this release. For additional information about risks and uncertainties that could affect the Company, please refer to its filings with the Securities and Exchange Commission at www.sec.gov. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by law.
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FAQ
What did Lunai Bioworks (LNAI) announce on November 5, 2025 about its dendritic cell therapy?
Where and when was Lunai's preclinical study published for LNAI's DC therapy?
Does the Vaccines publication for LNAI mean human trials have started?
What mechanism did Lunai report for its LNAI dendritic cell therapy?
Will Lunai's LNAI therapy potentially apply beyond pancreatic cancer?
