INB-619 / IN8bio - LARVOL DELTA

IN8bio Announces Pricing of Private Placement of up to $40.2 Million to Advance Novel Gamma-Delta T Cell Engager (GlobeNewswire) - "IN8bio intends to use the net proceeds from the private placement to fund the IND enabling studies of INB-619, for use in oncology and autoimmune diseases. The Company expects to generate early animal model data for initial discussions with the U.S. Food and Drug Administration ('FDA') in 2026 with pivotal animal model data and potential IND submission in 2027. The Company also intends to use a portion of the net proceeds to fund the submission of data from the INB-200 and INB-400 Phase 1 and Phase 2 clinical programs in newly diagnosed glioblastoma to the FDA."

Financing • IND • Glioblastoma • Immunology

Novel γδ T cell engager platform for cancer immunotherapy promoted T cell expansion with a persistence-indicating phenotype (ASH 2025) - "Here, we present initial findings from a novel activating γδ T cellengager platform (γδ-TCE) targeting CD19+ B cell hematologic malignancies (INB-619). In vitro cytolytic function and EC50 were determined by addition of incremental concentrationsof INB-619 (0 to 10 nM) to co-cultures of equal numbers of the NALM-6 B-ALL cell line and γδ T cellsderived from peripheral blood mononuclear cells (PBMCs) in a 1:1 effector to target (E:T) ratio...Controlsincluded PBMC alone, PBMC + 10%NALM-6, and PBMC + 10% NALM-6 + Zoledronate as a control for γδ Tcell function... By combining meaningful effector cell expansion, strong anti-tumor activity, and a low CRS-associated cytokine profile, this innovative γδ TCE platform presents a promising new approach to cancerimmunotherapy. Additionally, its modular and flexible design suggests potential uses across a wide rangeof cancer targets by leveraging the innate recognition capabilities of γδ T cells with targeted engagementof specific..."

Hematological Malignancies • Leukemia • Oncology • CD27 • IFNG • TNFA

Additional preclinical data from INB-619 γδ T cell engager program in oncology will be presented at the American Society of Hematology (ASH) Annual Meeting, December 6-9, 2025 (GlobeNewswire)

Preclinical • Hematological Malignancies

INB-619 - A Novel Gamma-Delta (γδ) T cell Engager to Target B cells in Autoimmune Diseases (ACR Convergence 2025) - "INB-619 is a novel CD19-targeting γδ TCE that expands both major γδ T cell subtypes sufficiently to eliminate a large population of B cells in vitro. The combined expansion and activation of tissue-resident Vδ1 and circulating Vδ2 populations, with the favorable cytokine pattern evidenced here, suggests that INB-619 could provide deep B cell depletion with a clinically relevant improvement in safety over current methods."

IO biomarker • Immunology • Inflammation • Inflammatory Arthritis • CD20 • CD27 • CD69 • IL10 • IL4 • IL6 • LAMP1 • PD-1

IN8bio Presents T cell Engager Data Demonstrating Deep B Cell Depletion for Autoimmune Indications (The Manila Times) - "In preclinical SLE donor models, INB-619 achieved complete elimination of B cells with efficacy equivalent to approved CD19 and CD20 engagers, including the FDA-approved compounds blinatumomab and mosunetuzumab. The data demonstrated minimal secretion of adverse cytokines such as IL-6, a validated biomarker for cytokine release syndrome (CRS), at concentrations multiples lower than the currently marketed compounds tested."

Preclinical • Systemic Lupus Erythematosus

INB-600: A Novel T Cell Engager Platform Specific for gamma-delta (γδ) T cells (ASGCT 2025) - P1, P1/2 | "To determine B cell depletion, γδ T cell expansion, and optimal dosing, incremental concentrations of the INB-619, along with a no-treatment (NT) control and zoledronate treatment (Zol), were cultured with peripheral blood mononuclear cells (PBMC) for up to 10 days from two healthy donors... In addition to its specific target binding and robust cytotoxicity, this novel γδ TCE promotes the expansion of both Vδ1+ and Vδ2+ γδ T cells, thereby sustaining its killing effect over time. This approach harnesses the advantages of Vδ2-mediated antigen processing and the long-term durability of Vδ1+ T cells. Should this approach be confirmed in autoimmune disease models, INB-619 could represent a promising off-the-shelf therapy for autoimmune diseases, potentially with fewer side-effects, mobilizing both circulating and tissue-resident γδ T cells to eliminate autoreactive B cells and reset B cell hematop Disease Focus of Abstract:Autoimmune Disorders"

IO biomarker • Hematological Malignancies • Immunology • Infertility • Oncology • Sexual Disorders • IFNG • IL17A • IL4 • IL6 • TNFA

IN8bio Presents Preclinical Data Highlighting Potential of INB-619 T Cell Engager (TCE) for Autoimmune Disease at ASGCT 2025 (GlobeNewswire) - "Highlights from the Preclinical Data: INB-619 demonstrated complete, targeted depletion of B cells in lupus patient-derived samples; IN8bio’s γδ TCE successfully expands both Vδ1+ and Vδ2+ subtypes of γδ T cells, which are critical for targeting both circulating and tissue-resident B cells to potentially achieve deeper B cell depletion; Unlike conventional CD3-based TCEs, INB-619 did not trigger significant release of inflammatory cytokines such as IL-6, which are commonly associated with serious toxicities, including CRS."

Preclinical • Immunology • Lupus

IN8bio Unveils Promising New Data from Next Generation Gamma-Delta T Cell Engager (TCE) Platform at AACR 2025 (GlobeNewswire) - "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." "

Cytokine release syndrome • Preclinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia

IN8bio to Participate at the 11th Annual Immuno-Oncology 360° Conference 2025 (GlobeNewswire) - "During the afternoon session, at 4:35 PM EDT, Mr. Ho will present on the topic of 'Picking our Horse in the Race for Autoimmunity: The Gamma-Delta T cell Engager,' and provide a corporate overview of IN8bio’s recently announced INB-619, T cell engager program for oncology and autoimmune diseases."

Clinical • Immunology • Oncology

Upcoming Anticipated Pipeline Milestones and Important Events: INB-600 and INB-619 (GlobeNewswire) - "Present preclinical data evaluating potency, expansion potential, and safety profile at medical meetings in the second quarter of 2025; Plan to advance towards IND-enabling studies with additional funding to support future clinical development."

Preclinical • Oncology

IN8bio Announces Advanced Gamma-Delta (γδ) T cell Engager (TCE) Platform for Oncology and Autoimmune Diseases (GlobeNewswire) - "The platform’s first candidate, INB-619, targets CD19, a key marker broadly found on B cells, which play a central role in leukemias, lymphomas, and autoimmune diseases. In preclinical models, INB-619 demonstrated: Rapid and sustained B-cell depletion – target cells were eradicated as γδ T cells continued expanding up to 450-fold with continued proliferation until the target cells were undetectable; Simultaneous expansion and activation of both major γδ T cell subsets (Vδ1+ and Vδ2+) leverages both the rapid antigen presenting properties of Vδ2+ T cells and the longer-term resistance against exhaustion and tissue residence properties of Vδ1+ T cells, potentially resulting in deeper B cell depletion....IN8bio plans to evaluate INB-619 in preclinical studies and seek potential partners to support future IND-enabling trials."

Preclinical • Immunology • Leukemia • Lymphoma