GentiBio
GentiBio is a clinical-stage biopharmaceutical company developing engineered regulatory T cell therapies for autoimmune and inflammatory diseases, with lead candidate GNTI-122 in Phase 1 trials for recently diagnosed Type 1 Diabetes.
- Company typePrivate
- Founded2020
- HeadquartersSeattle, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What GentiBio does
GentiBio is a clinical-stage biopharmaceutical company developing engineered regulatory T cell (EngTreg) therapies to treat autoimmune and inflammatory diseases, with its lead candidate GNTI-122 currently in the Phase 1 POLARIS trial for recently diagnosed Type 1 Diabetes. The company's scientific foundation rests on a modular EngTreg platform that combines three technology pillars: targeting via CAR, TCR, or chemokine receptors for disease-site specificity; constitutive FOXP3 expression to lock in a durable Treg phenotype in inflammatory environments; and a proprietary Chimeric IL-2 Signaling Complex (CISC) that provides IL-2 survival support specifically to engineered cells. The platform extends to an off-the-shelf allogeneic format enabled by Immune Evasion Engineering (HLA knock-out combined with a proprietary NK inhibitor) and a scalable manufacturing system that delivers >10^9 autologous cells at >90% purity in two weeks or thousands of allogeneic doses per batch at low-thousands-of-dollars COGS. The pipeline includes GNTI-122 (autologous, T1D, Phase 1), GNTI-148 (allogeneic, T1D), GNTI-932 (allogeneic, IBD, under Bristol Myers Squibb collaboration), GNTI-350 (allogeneic CD19 CAR-Treg for B/T cell-mediated autoimmune disease), and GNTI-823 (allogeneic, acute inflammatory and ischemic disease).
GentiBio operates a pre-revenue, capital-intensive clinical development model. The company has raised approximately $177 million across a $20M seed round (August 2020) and a $157M Series A (August 2021), supplemented by non-dilutive grants from Breakthrough T1D and the Helmsley Charitable Trust. There are no commercialized products and no disclosed pricing. The current go-to-market motion is enterprise-oriented clinical execution: a Phase 1 trial enrolling across ten specialized U.S. clinical sites, GMP viral vector supply through Forge Biologics, and strategic collaboration with Bristol Myers Squibb for IBD development. End customers, post-approval, will be payers and patients in autoimmune and inflammatory disease populations. The company is headquartered in Cambridge, Massachusetts, with a Seattle, Washington office and 51-100 employees, and is led by CEO Andy Walker, PhD, with Mark Bach as CMO and Tom Wickham as CSO.
The business is anchored by a top-tier founding investor syndicate (OrbiMed, Novartis Venture Fund, RA Capital Management) with participation from Matrix Capital Management, Avidity Partners, and JDRF T1D Fund (now Breakthrough T1D). Scientific founders David Rawlings (Seattle Children's Research Institute) and Jane Buckner (Benaroya Research Institute) provide foundational IP and translational expertise. Key near-term value drivers are POLARIS Phase 1 data readouts scheduled for late 2026 and first half of 2027, which will determine whether the EngTreg platform achieves clinical proof-of-concept in Type 1 Diabetes and supports progression of the broader allogeneic pipeline.
GentiBio firmographics
Firmographics- Name
- GentiBio
- Legal name
- GentiBio, Inc.
- Website
- https://gentibio.com
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- GentiBio is a clinical-stage biopharmaceutical company developing engineered regulatory T cell therapies for autoimmune and inflammatory diseases, with lead candidate GNTI-122 in Phase 1 trials for recently diagnosed Type 1 Diabetes.
- Ownership category
- akta.pro rank
GentiBio industry classification
Industry- Product category
- Cell Therapy Biopharmaceuticals
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB)
- akta.pro secondary industries
- Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)
Keywords
Where GentiBio is headquartered
LocationHeadquarters
- HQ city
- Seattle
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
GentiBio business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales
Revenue model
- Biopharmaceutical / Cell Therapy Development: GentiBio is a clinical-stage biotechnology company developing engineered Treg therapies as investigational drugs. Revenue will be generated through product sales following regulatory approval. The company has no commercialized products yet and is pre-revenue.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
GentiBio product offering
Product offeringCore offering
GentiBio develops engineered regulatory T cell (EngTreg) therapies as investigational drugs targeting the root cause of autoimmune and inflammatory diseases. Its modular platform combines CAR/TCR targeting, constitutive FOXP3 expression, and proprietary CISC IL-2 signaling technology to create autologous and allogeneic Treg products. The lead candidate GNTI-122 is in the POLARIS Phase 1 clinical trial for recently diagnosed Type 1 Diabetes, with additional allogeneic programs in T1D (GNTI-148), IBD (GNTI-932), B/T cell-driven autoimmune disease (GNTI-350), and acute inflammatory/ischemic disease (GNTI-823).
Product overview
GentiBio is a clinical-stage biotechnology company developing engineered regulatory T cell (EngTreg) therapies to cure Type 1 diabetes and other autoimmune or acute inflammatory diseases. The company's integrated platform consists of three core technology pillars: (1) the EngTreg Platform for engineered Tregs with specificity, stability, and survival properties; (2) the Off-the-shelf Allogeneic Platform with immune evasive engineering for ready-to-use cell therapies; and (3) Scalable Manufacturing Platform supporting both autologous and allogeneic products. The product pipeline includes five distinct therapeutic candidates: GNTI-122 (autologous EngTreg for Type 1 Diabetes, in Phase 1 POLARIS trial), GNTI-148 (allogeneic version of GNTI-122 for T1D), GNTI-932 (allogeneic gut-targeted CAR EngTreg for Inflammatory Bowel Disease), GNTI-350 (allogeneic CD19 CAR EngTreg for B/T cell-mediated autoimmune diseases), and GNTI-823 (allogeneic tissue Treg for acute inflammatory and ischemic diseases).
Differentiator
Problem solved
Functional benefit
Products and services
- GNTI-122 An autologous engineered regulatory T cell (EngTreg) product designed to treat recently diagnosed Type 1 Diabetes by expressing a pancreatic islet-specific T cell receptor (TCR) to target the pancreas, with modifications to stabilize FOXP3 protein and a chimeric IL-2 signaling complex (CISC) for proliferative support. Currently in the Phase 1 POLARIS clinical trial; FDA Orphan Drug Designation granted July 2025 and FDA Fast Track Designation granted August 2025.
- GNTI-148
Quantifiable outcome
- Autologous manufacturing: >10^9 cells at >90% purity in two weeks, without cell sorting
- +2 more outcomes
Companies that use GentiBio
Customer profileSegments4 records
Ideal customer profiles4 records
GentiBio technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
GentiBio partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core scientific collaborator, strategic collaboration, cdmo partner and research collaborator.
- Benaroya Research Institute at Virginia Mason Franciscan Health (BRI)core scientific collaboratorBRI is a foundational scientific collaborator with GentiBio. Dr. Jane Buckner (President of BRI and Scientific Co-founder) contributed foundational discoveries on T cell receptors and patient-derived suppression assays. BRI provides ongoing expertise in human immunology and autoimmune disease biology supporting GNTI-122 development.
- Seattle Children's Research Institute (SCRI)core scientific collaboratorSCRI is a foundational scientific collaborator with GentiBio. Dr. David Rawlings (Director, Center for Immunity and Immunotherapies and Scientific Co-founder) developed methods to generate stable regulatory T cells by enforcing FOXP3 expression and the CISC technology. SCRI contributes ongoing expertise in immunology and immunotherapy translation.
- Bristol Myers Squibbstrategic collaborationGentiBio announced a collaboration with Bristol Myers Squibb to pioneer engineered Treg therapies for inflammatory bowel diseases (IBD), leveraging GentiBio's EngTreg platform for gut-specific therapeutic development.
- Forge Biologicscdmo partnerGentiBio entered into a partnership with Forge Biologics for viral vector contract development and GMP manufacturing. Forge Biologics serves as a contract development and manufacturing organization (CDMO) supporting GentiBio's cell therapy pipeline.
- MIGAL Galilee Research Instituteresearch collaboratorGentiBio expanded its leadership team and partnership with MIGAL (Galilee Research Institute) to help advance the development of engineered regulatory T cell therapies.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
GentiBio competitors and assessment
Company assessmentDirect peers
- Sonoma Biotherapeutics: Sonoma Biotherapeutics is a clinical-stage Treg cell therapy company developing engineered regulatory T cells for autoimmune and inflammatory diseases, including rheumatology and IBD indications. It is the closest direct competitor to GentiBio given shared Treg engineering modality, disease focus, and clinical-stage status.
- Kyverna Therapeutics: Kyverna Therapeutics develops CAR-Treg cell therapies for autoimmune diseases, with lead programs in lupus nephritis and other B-cell-mediated autoimmune indications. It competes directly with GentiBio's GNTI-350 in CD19-directed Treg approaches and shares the engineered-Treg modality.
- Quell Therapeutics: Quell Therapeutics is a clinical-stage cell therapy company developing engineered Treg therapies, with lead programs in liver transplant tolerance and autoimmune diseases. It shares GentiBio's Treg modality and autoimmune focus, making it a direct European-headquartered peer.
Emerging players
- Egle Therapeutics: Egle Therapeutics is an emerging Treg-focused biotech developing engineered regulatory T cells for autoimmune and inflammatory diseases, based on proprietary FOXP3 stabilization approaches. It overlaps with GentiBio's FOXP3 engineering pillar and indications in autoimmunity.
- Vertex Pharmaceuticals: Vertex has advanced a stem cell-derived islet cell therapy (VX-880/zimislecel) into clinical trials for Type 1 Diabetes, pursuing a beta-cell replacement rather than immune-modulation approach. It is a relevant T1D peer because it competes for the same patient population and KOL attention as GNTI-122.
- BlueRock Therapeutics: BlueRock Therapeutics (a Bayer company) develops iPSC-derived cell therapies, with a lead program in Parkinson's disease and ongoing immunology applications. It is a peer in engineered cell therapy manufacturing scale-up and has overlapping scientific approaches (iPSC-derived Tregs were previously explored at BlueRock).
- Sana Biotechnology: Sana Biotechnology is a clinical-stage cell therapy company developing hypoimmune allogeneic cell therapies and in vivo gene editing approaches, with applications in autoimmune and oncology indications. It is an emerging peer in engineered cell therapy with overlapping allogeneic hypoimmune engineering concepts.
- Allogene Therapeutics: Allogene Therapeutics is a clinical-stage allogeneic CAR-T company with leading manufacturing capabilities for off-the-shelf cell therapies. It is comparable as a peer in allogeneic cell therapy scale-up, manufacturing economics, and regulatory navigation, though focused on oncology indications.
Broad incumbents
- Bristol Myers Squibb: BMS is a global pharmaceutical company with established CAR-T franchises (Breyanzi, Abecma) and an active autoimmune pipeline, and is GentiBio's strategic collaborator on the IBD EngTreg program (GNTI-932). It is a broad incumbent in cell therapy and a potential acquirer/long-term partner for GentiBio's allogeneic platform.
Others
- Provention Bio (Sanofi): Provention Bio (acquired by Sanofi in 2023) developed teplizumab (Tzield), the first FDA-approved disease-modifying therapy for T1D, used to delay Stage 3 onset in at-risk patients. It is a relevant T1D adjacency because Tzield defines the existing standard of care that GNTI-122 would need to displace or complement.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights6 records
Customer concentration
GentiBio social profiles
Digital presenceGentiBio financial estimates
Financial estimateRevenue estimate
Valuation estimate
GentiBio leadership team
Management profileNumber of profiles
Profiles15 records
GentiBio funding detail
Funding detailFunding overview
Funding rounds2 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
GentiBio M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about GentiBio
What does GentiBio do?
GentiBio develops engineered regulatory T cell (EngTreg) therapies as investigational drugs targeting the root cause of autoimmune and inflammatory diseases. Its modular platform combines CAR/TCR targeting, constitutive FOXP3 expression, and proprietary CISC IL-2 signaling technology to create autologous and allogeneic Treg products. The lead candidate GNTI-122 is in the POLARIS Phase 1 clinical trial for recently diagnosed Type 1 Diabetes, with additional allogeneic programs in T1D (GNTI-148), IBD (GNTI-932), B/T cell-driven autoimmune disease (GNTI-350), and acute inflammatory/ischemic disease (GNTI-823).
Is GentiBio a public or private company?
GentiBio is a private company. It is classified as venture growth investor backed and is currently operating.
When was GentiBio founded?
GentiBio was founded in 2020. It employs 51 to 100 people.
Where is GentiBio based?
GentiBio is headquartered in Seattle, United States, in the North America region.
How does GentiBio make money?
One revenue line is on record: biopharmaceutical / Cell Therapy Development.
Who are GentiBio's main competitors?
Direct peers on record are Sonoma Biotherapeutics, Kyverna Therapeutics and Quell Therapeutics. Emerging players are Egle Therapeutics, Vertex Pharmaceuticals, BlueRock Therapeutics, Sana Biotechnology and Allogene Therapeutics. Bristol Myers Squibb is listed as a broad incumbent. Provention Bio (Sanofi) is listed as an others.
Does GentiBio have an API?
No public API is recorded for GentiBio.
What industry is GentiBio in?
GentiBio's product category is Cell Therapy Biopharmaceuticals. Its primary akta.pro industry code is HLAAABAB, Cell Therapy Developers (Allogeneic/Off-the-shelf), with a secondary code of HLAIAIAE, Rare Immunology, Autoimmune & Autoinflammatory Therapies. Its NAICS code is 325414 and its SIC code is 2836.