IN8bio Unveils Promising New Data from Next Generation Gamma-Delta T Cell Engager (TCE) Platform at AACR 2025
IN8bio (NASDAQ: INAB) has unveiled promising preclinical data from its gamma-delta (γδ) T cell engager (TCE) platform at AACR 2025. The company's novel platform demonstrates significant γδ T cell expansion and activation without serious side effects like cytokine release syndrome.
The platform's lead molecules, INB-619 (targeting CD19) and INB-633 (targeting CD33), showed potent anti-cancer activity in leukemia models at low picomolar concentrations. Unlike traditional TCEs that activate all T cells through CD3, IN8bio's platform specifically activates γδ T cells, potentially offering a safer alternative with minimal inflammatory cytokine release.
Key findings show both molecules successfully expanded Vδ1+ and Vδ2+ cell subsets and demonstrated strong cancer-killing capabilities without triggering dangerous cytokine responses. The platform's off-the-shelf nature, requiring no genetic engineering, suggests potential for scalable immunotherapy development for both cancer and autoimmune diseases.
IN8bio (NASDAQ: INAB) ha presentato dati preclinici promettenti della sua piattaforma per l'attivazione delle cellule T gamma-delta (γδ) (TCE) durante l'AACR 2025. La nuova piattaforma dell'azienda dimostra una significativa espansione e attivazione delle cellule T γδ senza effetti collaterali gravi come la sindrome da rilascio di citochine.
Le molecole principali della piattaforma, INB-619 (che mira a CD19) e INB-633 (che mira a CD33), hanno mostrato una potente attività antitumorale in modelli di leucemia a basse concentrazioni picomolari. A differenza dei TCE tradizionali che attivano tutte le cellule T tramite CD3, la piattaforma di IN8bio attiva specificamente le cellule T γδ, offrendo potenzialmente un'alternativa più sicura con un rilascio minimo di citochine infiammatorie.
I risultati chiave mostrano che entrambe le molecole hanno espanso con successo i sottogruppi cellulari Vδ1+ e Vδ2+ e hanno dimostrato forti capacità di eliminazione del cancro senza innescare risposte pericolose di citochine. La natura pronta all'uso della piattaforma, che non richiede ingegneria genetica, suggerisce un potenziale sviluppo scalabile di immunoterapie sia per il cancro che per le malattie autoimmuni.
IN8bio (NASDAQ: INAB) ha presentado datos preclínicos prometedores de su plataforma de activadores de células T gamma-delta (γδ) (TCE) en AACR 2025. La novedosa plataforma de la compañía demuestra una significativa expansión y activación de las células T γδ sin efectos secundarios graves como el síndrome de liberación de citocinas.
Las moléculas principales de la plataforma, INB-619 (que apunta a CD19) y INB-633 (que apunta a CD33), mostraron una potente actividad anticancerígena en modelos de leucemia a bajas concentraciones picomolares. A diferencia de los TCE tradicionales que activan todas las células T a través de CD3, la plataforma de IN8bio activa específicamente las células T γδ, ofreciendo potencialmente una alternativa más segura con una liberación mínima de citocinas inflamatorias.
Los hallazgos clave muestran que ambas moléculas expandieron con éxito los subconjuntos celulares Vδ1+ y Vδ2+ y demostraron fuertes capacidades para eliminar el cáncer sin desencadenar respuestas peligrosas de citocinas. La naturaleza lista para usar de la plataforma, que no requiere ingeniería genética, sugiere un desarrollo escalable de inmunoterapias tanto para el cáncer como para enfermedades autoinmunes.
IN8bio (NASDAQ: INAB)는 AACR 2025에서 감마-델타(γδ) T 세포 엔게이저(TCE) 플랫폼의 유망한 전임상 데이터를 공개했습니다. 회사의 혁신적인 플랫폼은 사이토카인 방출 증후군과 같은 심각한 부작용 없이 γδ T 세포의 유의미한 확장과 활성화를 보여줍니다.
플랫폼의 주요 분자인 INB-619 (CD19 표적)와 INB-633 (CD33 표적)은 낮은 피코몰 농도에서 백혈병 모델에 대해 강력한 항암 활성을 나타냈습니다. 기존의 모든 T 세포를 CD3를 통해 활성화하는 TCE와 달리, IN8bio의 플랫폼은 γδ T 세포만을 선택적으로 활성화하여 염증성 사이토카인 방출을 최소화한 보다 안전한 대안을 제공합니다.
주요 결과는 두 분자가 Vδ1+ 및 Vδ2+ 세포 아형을 성공적으로 확장하고 위험한 사이토카인 반응 없이 강력한 암세포 살상 능력을 입증했음을 보여줍니다. 유전자 조작이 필요 없는 즉시 사용 가능한 이 플랫폼은 암과 자가면역 질환 모두에 대한 확장 가능한 면역치료 개발 가능성을 시사합니다.
IN8bio (NASDAQ : INAB) a dévoilé des données précliniques prometteuses de sa plateforme d'engageurs de cellules T gamma-delta (γδ) (TCE) lors de l'AACR 2025. La nouvelle plateforme de l'entreprise démontre une expansion et une activation significatives des cellules T γδ sans effets secondaires graves tels que le syndrome de libération de cytokines.
Les molécules phares de la plateforme, INB-619 (ciblant CD19) et INB-633 (ciblant CD33), ont montré une puissante activité anticancéreuse dans des modèles de leucémie à de faibles concentrations picomolaires. Contrairement aux TCE traditionnels qui activent toutes les cellules T via CD3, la plateforme d'IN8bio active spécifiquement les cellules T γδ, offrant potentiellement une alternative plus sûre avec une libération minimale de cytokines inflammatoires.
Les résultats clés montrent que les deux molécules ont réussi à étendre les sous-ensembles cellulaires Vδ1+ et Vδ2+ et ont démontré de fortes capacités de destruction des cellules cancéreuses sans déclencher de réponses dangereuses de cytokines. La nature prête à l'emploi de la plateforme, ne nécessitant pas d'ingénierie génétique, suggère un potentiel de développement évolutif d'immunothérapies pour le cancer et les maladies auto-immunes.
IN8bio (NASDAQ: INAB) hat auf der AACR 2025 vielversprechende präklinische Daten seiner Gamma-Delta (γδ) T-Zell-Engager (TCE)-Plattform vorgestellt. Die neuartige Plattform des Unternehmens zeigt eine signifikante Expansion und Aktivierung von γδ T-Zellen ohne schwere Nebenwirkungen wie das Zytokinsturm-Syndrom.
Die führenden Moleküle der Plattform, INB-619 (gerichtet gegen CD19) und INB-633 (gerichtet gegen CD33), zeigten in Leukämiemodellen bei niedrigen Pikomol-Konzentrationen eine starke krebsbekämpfende Aktivität. Im Gegensatz zu herkömmlichen TCEs, die alle T-Zellen über CD3 aktivieren, aktiviert die Plattform von IN8bio gezielt γδ T-Zellen und bietet somit möglicherweise eine sicherere Alternative mit minimaler Freisetzung entzündlicher Zytokine.
Wesentliche Ergebnisse zeigen, dass beide Moleküle erfolgreich die Zelluntergruppen Vδ1+ und Vδ2+ expandierten und starke krebsabtötende Fähigkeiten zeigten, ohne gefährliche Zytokinreaktionen auszulösen. Die sofort einsatzbereite Natur der Plattform, die keine genetische Veränderung erfordert, deutet auf ein potenziell skalierbares Immuntherapie-Entwicklungsprogramm sowohl für Krebs als auch Autoimmunerkrankungen hin.
- Platform demonstrates potent anti-cancer activity without dangerous cytokine release
- Lead molecules show effective cancer cell killing at low picomolar concentrations
- Off-the-shelf platform requires no genetic engineering, enabling better scalability
- Potential expansion into autoimmune disease treatment market
- Results to preclinical stage only
- No human trial data available yet to confirm safety and efficacy
Insights
IN8bio's gamma-delta T cell platform shows promising cancer-killing activity with reduced toxicity risk compared to conventional immunotherapies.
IN8bio's preclinical data reveals a significant breakthrough in TCE (T cell engager) technology. Their gamma-delta T cell engager platform demonstrates a crucial advantage over conventional CD3-based approaches by specifically activating only gamma-delta T cells rather than all T cells in the body. This selective activation is critical because widespread T cell activation typically triggers the dangerous cytokine release syndrome affecting 60-75% of patients receiving conventional therapies.
The company's lead candidates—INB-619 (targeting CD19) and INB-633 (targeting CD33)—showed potent anti-cancer activity at picomolar concentrations while minimizing inflammatory cytokine release. Most importantly, their platform addresses a key limitation of previous gamma-delta therapies by successfully expanding both Vδ1+ and Vδ2+ T cell subsets, which are typically depleted in cancer patients.
The data demonstrates that these molecules induce effective cancer cell killing in leukemia models with a linear dose response. The platform's mechanism of precise immune activation without significant IL-6, IL-10, and IL-17a release suggests a substantially improved safety profile. As an off-the-shelf approach that doesn't require genetic engineering, this platform offers potential manufacturing and scalability advantages over current cell therapies.
While still preclinical, these results indicate a promising approach for addressing the severe toxicity limitations that have hampered broader adoption of T cell engager therapies in cancer treatment.
IN8bio's novel gamma-delta TCE platform shows potential differentiation in the competitive immuno-oncology landscape, advancing their pipeline value.
IN8bio's preclinical data announcement represents a potentially significant development for this micro-cap biotech (
Their platform's ability to specifically activate gamma-delta T cells rather than all T cells potentially addresses this safety limitation. The data showed potent cancer cell killing by both lead candidates in leukemia models with minimal release of dangerous cytokines—a key differentiator if replicated in clinical settings.
Strategically, this platform expands IN8bio's pipeline beyond their existing cellular therapies, creating a more diversified development portfolio. The company highlighted potential applications beyond oncology into autoimmune diseases, specifically mentioning B-cell driven conditions through their CD19-targeting candidate (INB-619).
For a company with IN8bio's market capitalization, this off-the-shelf platform that doesn't require genetic engineering could prove valuable for potential partnerships. The modular nature of the technology, allowing various disease targets, enhances its potential commercial application. However, investors should recognize that as preclinical data, these candidates face the typical long development timeline and risks associated with early-stage therapeutic programs.
- First gamma-delta (γδ) TCE to demonstrate significant γδ T cell expansion and activation, potentially offering an alternative to conventional CD3-based approaches without significant adverse events such as cytokine release syndrome (CRS)
- INB-600 TCE platform significantly expands both Vδ1+ and Vδ2+ subsets to address the reduced cell counts that have limited earlier γδ TCE therapies in cancer patients
- INB-619 (CD19) and INB-633 (CD33) consistently show potent and highly targeted anti-cancer activity with deep tumor cell depletion in preclinical studies without the increased secretion of dangerous cytokines such as IL-6
- Targeted B cell elimination (INB-619) highlights potential applications in B cell–driven autoimmune diseases as well as cancer
NEW YORK, April 28, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies for cancer and autoimmune diseases, today announced new preclinical data from its innovative γδ T cell engager (γδ-TCE) platform. The data will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting on April 30, 2025. The data showed that IN8bio’s new γδ-TCE platform demonstrated potent and consistent cancer-killing activity across targets in leukemia models, while avoiding the secretion of cytokines that drive the dangerous side effects seen with other TCE based immune therapies.
Unlike traditional TCEs that rely on CD3 to activate all T cells in the body – often triggering excessive inflammatory responses, potential T cell exhaustion and other serious side effects – IN8bio’s next-gen platform is designed to specifically activate only γδ T cells, a small but powerful subset of immune cells. These cells can naturally detect, phagocytose (eat) and kill tumors cells without needing to be "trained" to recognize specific targets. The platform’s lead molecules, INB-619 (targeting CD19) and INB-633 (targeting CD33), were able to eliminate cancer cells in preclinical studies with minimal release of inflammatory cytokines. This potentially offers a lower risk of cytokine release syndrome (CRS) or the neurotoxicity that can impact 60
William Ho, CEO and co-founder of IN8bio, commented, “Our INB-600 TCE platform combines the natural tumor-fighting abilities of γδ T cells with bispecific engagers to generate a more precise and powerful way to mobilize the immune system against cancer cells. These early results in leukemia models are exciting, and we believe this technology can eventually be applied to other hard-to-treat cancers, and even certain autoimmune diseases.”
Key highlights from the in vitro studies:
- INB-619 and INB-633 both triggered strong and specific, linear dose-related killing of leukemia cells (ALL and AML) at low picomolar concentrations.
- Both molecules activated and expanded two key γδ T cell subsets (Vδ1+ and Vδ2+), which is critical since most cancer patients have reduced numbers of these cells.
- Both molecules promoted activation and degranulation, with dose-related increases in the expression of cellular markers indicating a transition to a powerful cancer-cell killing phenotype.
- Importantly, they did so with minimal, if any, changes in dangerous cytokines, such as IL-6, IL-10, and IL-17a – markers that are often linked to cytokine release syndrome (CRS) and other treatment-related toxicities.
Because this new off-the-shelf platform can drive γδ T cell expansion without the need for genetic engineering, it has the potential to offer a more scalable and flexible approach to building next-generation immunotherapies.
IN8bio continues to expand its γδ T cell therapeutic pipeline beyond genetically engineered and drug-resistant cellular therapies and is exploring various disease indications and any opportunities for partnership with the INB-600 platform. This preclinical data reinforces the company’s differentiated strategy to build modular and scalable therapeutic approaches to leverage the power of γδ T cells to target malignancies with increased precision and reduced toxicity.
The AACR 2025 poster is available on the investor section of the company’s website at https://investors.in8bio.com.
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell-based immunotherapies for cancer and autoimmune diseases. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company's lead program, INB-100, is focused on acute myeloid leukemia evaluating haplo-matched allogeneic γδ T cells given to patients following a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI γδ T cells, in combination with standard of care, for glioblastoma, and advancing novel γδ T cell engagers for potential oncology and autoimmune indications. For more information about IN8bio, visit www.IN8bio.com.
Forward-Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the ability of the INB-600 platform to offer a scalable, flexible, more precise and more powerful alternative to conventional CD3-based approaches and have applications in autoimmune diseases as well as cancer; IN8bio’s plans to expand its pipeline beyond genetically engineered and drug-resistant cellular therapy and explore various disease indications and any opportunities for partnership with the INB-600 platform; and other statements that are not historical fact. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of its development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its γδ-TCE platform or DeltEx platform; the availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; the uncertainty of regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section entitled “Risk Factors” in IN8bio’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 13, 2025, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Contacts:
IN8bio, Inc.
Patrick McCall
646.933.5603
pfmccall@IN8bio.com
Media Contact:
Kimberly Ha
KKH Advisors
917.291.5744
kimberly.ha@kkhadvisors.com
FAQ
What are the key advantages of IN8bio's (INAB) new gamma-delta TCE platform over traditional TCEs?
How effective are INB-619 and INB-633 in treating leukemia based on INAB's preclinical studies?
What potential applications does IN8bio's (INAB) INB-619 have beyond cancer treatment?
How does IN8bio's (INAB) gamma-delta TCE platform address the limitations of earlier therapies?
