BioOra
BioOra is a New Zealand clinical-stage biotechnology company developing Atla-cel, a third-generation anti-CD19 CAR T-cell therapy manufactured on the Cocoon automated platform, targeting relapsed/refractory B-cell lymphoma and leukemia patients via hospital-based delivery.
- Company typePrivate
- Founded2021
- HeadquartersWellington, New Zealand
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What BioOra does
BioOra Limited is a New Zealand-incorporated biotechnology company headquartered in Wellington that develops and manufactures third-generation CAR T-cell immunotherapies for B-cell hematologic malignancies. Founded in 2021 as a joint venture between the Malaghan Institute of Medical Research and Bridgewest Ventures NZ LP, the company's lead clinical asset is Atla-cel (also designated WZTL-002), an autologous anti-CD19 CAR T-cell therapy incorporating CD28 co-stimulatory, TLR2 signaling, and CD3-zeta activation domains — a construct licensed inbound from Wellington Zhaotai Therapies Limited. The TLR2 domain is positioned as the differentiating structural feature relative to earlier-generation approved CAR-T products, with ENABLE-1 Phase 1 data showing a 52% complete response rate alongside zero severe cytokine release syndrome and zero neurotoxicity. BioOra manufactures Atla-cel on the Cocoon closed, automated cell-therapy platform from Octane Medical Group, enabling GMP-grade production without large-scale cleanroom infrastructure.
The company is pre-revenue and currently operates exclusively through investigator-initiated clinical trials: ENABLE-1 (completed in 30 patients with relapsed/refractory B-cell non-Hodgkin lymphoma) and ENABLE-2 (an ongoing Phase 1/II registration trial targeting 60 patients across three New Zealand hospital sites). BioOra has secured a GMP manufacturing license from Medsafe and is building out decentralized manufacturing capacity through a planned Christchurch facility and a Queensland government-backed Brisbane site at ENTRI, with an announced 72 specialist positions targeted by 2029. The business model is autologous, per-patient cell therapy manufacturing and hospital-based delivery, with future commercial revenue anticipated upon regulatory approval. In May 2026, BioOra signed binding Heads of Terms with WZTL granting exclusive global commercialization rights outside China and India, including USA, Europe, and UK, establishing a path from an ANZ-anchored regional biotech to a potential global commercial entity.
BioOra firmographics
Firmographics- Name
- BioOra
- Legal name
- BioOra Limited
- Website
- https://bioora.com
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- BioOra is a New Zealand clinical-stage biotechnology company developing Atla-cel, a third-generation anti-CD19 CAR T-cell therapy manufactured on the Cocoon automated platform, targeting relapsed/refractory B-cell lymphoma and leukemia patients via hospital-based delivery.
- Ownership category
- akta.pro rank
BioOra industry classification
Industry- Product category
- Cell Therapy / CAR T-cell Biopharmaceuticals
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- CAR-T & TCR-T Therapies (HLAAABAC)
- akta.pro secondary industries
- Cell Therapy CDMO (Autologous/Allogeneic Manufacturing) (HLAGAGAA), Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC)
Keywords
Where BioOra is headquartered
LocationHeadquarters
- HQ city
- Wellington
- HQ country
- New Zealand
- HQ region
- Oceania
Offices3 records
Markets served
BioOra business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Infrastructure, Supply Chain
Revenue model
- CAR T-cell Therapy Commercialization: BioOra is currently pre-revenue, operating exclusively through clinical trials (ENABLE-1 and ENABLE-2). Future revenue is anticipated upon regulatory approval and commercial launch of CAR T-cell therapies through hospital-based clinical delivery. Personalized, autologous cell therapy revenue model based on per-patient manufacturing and delivery rather than traditional product licensing.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Therapy not yet commercially available; pricing TBD at launch |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
BioOra product offering
Product offeringCore offering
BioOra develops and manufactures Atla-cel (WZTL-002), a third-generation anti-CD19 CAR T-cell therapy for relapsed or refractory B-cell non-Hodgkin lymphoma and B-cell acute lymphoblastic leukaemia. The therapy is produced using the Cocoon automated closed-system manufacturing platform under GMP conditions and is currently delivered to patients through hospital-based investigator-initiated clinical trials (ENABLE-1 and ENABLE-2) in New Zealand.
Product overview
BioOra's product portfolio centres on Atla-cel (also designated WZTL-002), a third-generation anti-CD19 CAR T-cell therapy for B-cell malignancies. This core therapeutic product is manufactured using the Cocoon® automated platform, which enables scalable, closed-system production of personalised CAR-T therapies. Together, the therapy asset and manufacturing platform form an integrated offering designed to improve patient access through reduced costs, faster turnaround times, and decentralised delivery.
Differentiator
Problem solved
Functional benefit
Products and services
- Atla-cel (WZTL-002) Third-generation anti-CD19 CAR T-cell therapy for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma and B-cell acute lymphoblastic leukaemia. Incorporates CD28, Toll-like receptor 2, and CD3-zeta co-stimulatory domains designed to deliver robust efficacy with reduced neurotoxicity and cytokine release syndrome compared to earlier-generation CAR-T therapies. Currently delivered through investigator-initiated clinical trials at New Zealand hospital sites under Medsafe oversight.
- Cocoon® Manufacturing Platform Deployment
Quantifiable outcome
- ENABLE-1 trial completed with 30 patients; favorable safety profile with reduced neurotoxicity and CRS observed
- +1 more outcomes
Companies that use BioOra
Customer profileNamed customers1 record
Segments2 records
Ideal customer profiles2 records
BioOra technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
BioOra partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core, secondary and minor.
- Malaghan Institute of Medical ResearchcoreMalaghan Institute is BioOra's foundational joint venture partner and the sponsoring institution for the ENABLE-1 and ENABLE-2 clinical trials. As New Zealand's independent medical research institute with a focus on immunology and cancer, Malaghan provides clinical trial infrastructure, scientific expertise, and regulatory oversight. The partnership is the operational backbone of BioOra's clinical development program.
- Octane Medical Group (Octane Biotech Inc.)coreOctane Medical Group provides BioOra access to its Cocoon automated cell therapy manufacturing platform — a closed, automated system for GMP-grade CAR T-cell production. This platform is central to BioOra's manufacturing strategy, enabling regional production without the capital intensity of traditional cleanroom infrastructure. Octane's Kingston, Canada facility supports technology validation and process development.
- Wellington Zhaotai Therapies Limited (WZTL)coreWZTL is the intellectual property licensor of the proprietary third-generation WZTL-002 anti-CD19 CAR T-cell construct to BioOra. WZTL holds the rights to the CAR construct design (incorporating CD28, TLR2, and CD3-zeta domains) that underlies BioOra's lead therapy candidate. The licensing agreement grants BioOra clinical and commercial development rights in specified territories.
- Cincinnati Children's Hospital Medical CentersecondaryCincinnati Children's Hospital Medical Center serves as a clinical partnership site for pediatric CAR-T development, contributing clinical expertise and patient population access for CAR-T therapy research. This partnership provides pediatric-specific clinical capability that complements BioOra's adult-focused ENABLE trial program.
- ENTRI (Brisbane, Australia)secondaryENTRI in Brisbane, Australia is a manufacturing facility partnership for BioOra's planned Queensland operations. ENTRI provides facility infrastructure and operational capability to support BioOra's regional manufacturing footprint expansion into Australia, complementing the $7.7M Queensland government grant-funded facility development.
- Callaghan InnovationminorCallaghan Innovation is New Zealand's government-funded research and development agency that supports advanced technology companies. BioOra's partnership with Callaghan Innovation likely provides access to R&D funding, technical expertise, and innovation ecosystem resources supporting BioOra's manufacturing technology development in New Zealand.
Scale indicators6 records
Recent moves9 records
Expansion highlights5 records
BioOra competitors and assessment
Company assessmentBroad incumbents
- Novartis: Maker of Kymriah, the first FDA-approved CD19 CAR-T therapy, and BioOra's most direct large-pharma competitor in B-cell NHL/ALL. Novartis has established global manufacturing, regulatory approval, and commercial infrastructure that BioOra is attempting to compete against with a differentiated safety profile.
- Gilead Sciences (Kite Pharma): Commercializes Yescarta and Tecartus — leading approved CD19 CAR-T products for B-cell NHL/ALL. Operates large-scale GMP manufacturing facilities and global commercial infrastructure, directly competing with BioOra's target indications.
- Bristol-Myers Squibb (Celgene/Juno): Markets Breyanzi (lisocabtagene maraleucel) and Abecma, both autologous CAR-T cell therapies for hematologic malignancies. BMS's commercial scale, payer access, and established CAR-T center network make it a primary competitive threat to BioOra's planned launch.
Direct peers
- Allogene Therapeutics: Clinical-stage allogeneic ("off-the-shelf") CAR-T developer targeting CD19 and BCMA in B-cell malignancies. Direct product overlap with BioOra's autologous approach but competing modality that could erode BioOra's cost/logistics advantages if approved.
- Caribou Biosciences: Clinical-stage allogeneic CAR-T developer (CB-010, CB-012) targeting B-cell malignancies with CRISPR-edited cell therapies. Competes in the same indications as BioOra and represents the off-the-shelf alternative to BioOra's autologous manufacturing model.
- CRISPR Therapeutics: Develops CRISPR/Cas9-edited allogeneic CAR-T therapies (e.g., CTX112 for CD19+ B-cell malignancies) in direct competition with BioOra for the same B-cell hematologic cancer patient population. Both companies pair novel cell engineering with novel manufacturing approaches.
- Cellectis: Clinical-stage gene-edited allogeneic CAR-T developer (UCART19) targeting CD19+ B-cell malignancies. Directly competes with BioOra in B-ALL/NHL with an off-the-shelf modality that aims to address autologous CAR-T's logistical and cost limitations.
- Fate Therapeutics: Develops off-the-shelf iPSC-derived CAR-T and NK cell therapies for hematologic malignancies, including B-cell lymphoma programs. Competes with BioOra's autologous approach by targeting the same unmet need with a more scalable manufacturing model.
Emerging players
- Tessa Therapeutics: Clinical-stage cell therapy company developing autologous CD30 CAR-T (TT11) for hematologic malignancies with a regional Asia-Pacific clinical footprint similar in spirit to BioOra's hub-and-spoke approach. Comparable in stage and regional commercialization focus.
- Legend Biotech: Developer of Carvykti (ciltacabtagene autoleucel), a BCMA-directed CAR-T for multiple myeloma partnered with Janssen. While targeting a different antigen (BCMA vs. CD19), Legend is a useful comparable for autologous CAR-T manufacturing scale-up and global commercialization economics that BioOra will eventually need to navigate.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key highlights7 records
Customer concentration
BioOra social profiles
Digital presenceBioOra compliance and trust
Trust signalCompliance1 record
BioOra financial estimates
Financial estimateRevenue estimate
Valuation estimate
BioOra leadership team
Management profileNumber of profiles
Profiles7 records
BioOra subsidiaries and ownership
Company hierarchySubsidiaries1 record
BioOra funding detail
Funding detailFunding overview
Funding rounds2 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
BioOra 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 BioOra
What does BioOra do?
BioOra develops and manufactures Atla-cel (WZTL-002), a third-generation anti-CD19 CAR T-cell therapy for relapsed or refractory B-cell non-Hodgkin lymphoma and B-cell acute lymphoblastic leukaemia. The therapy is produced using the Cocoon automated closed-system manufacturing platform under GMP conditions and is currently delivered to patients through hospital-based investigator-initiated clinical trials (ENABLE-1 and ENABLE-2) in New Zealand.
Is BioOra a public or private company?
BioOra is a private company. It is classified as venture growth investor backed and is currently operating.
When was BioOra founded?
BioOra was founded in 2021. It employs 11 to 50 people.
Where is BioOra based?
BioOra is headquartered in Wellington, New Zealand, in the Oceania region.
How does BioOra make money?
One revenue line is on record: CAR T-cell Therapy Commercialization.
Who are BioOra's main competitors?
Broad incumbents on record are Novartis, Gilead Sciences (Kite Pharma) and Bristol-Myers Squibb (Celgene/Juno). Direct peers are Allogene Therapeutics, Caribou Biosciences, CRISPR Therapeutics, Cellectis and Fate Therapeutics. Emerging players are Tessa Therapeutics and Legend Biotech.
Does BioOra have an API?
No public API is recorded for BioOra.
What industry is BioOra in?
BioOra's product category is Cell Therapy / CAR T-cell Biopharmaceuticals. Its primary akta.pro industry code is HLAAABAC, CAR-T & TCR-T Therapies, with a secondary code of HLAGAGAA, Cell Therapy CDMO (Autologous/Allogeneic Manufacturing). Its NAICS code is 325414 and its SIC code is 2836.