Carolina BioOnocology Institute

What Carolina BioOnocology Institute does

Carolina BioOncology Institute (CBOI) is a private, community-based Phase I cancer clinical trial and translational research organization headquartered in Huntersville, North Carolina, operating as a subsidiary of BioCytics. Founded in 2005 by Dr. John Powderly, the institute enrolls metastatic and advanced solid tumor patients in early-phase immunotherapy clinical trials sponsored by biopharma companies, with a referral base extending across the Southeast United States. It functions as a regional Phase I hub and is described as the only independent Phase I cancer center with on-site cellular manufacturing capability on the East Coast.

CBOI's core technology stack centers on point-of-care autologous cell therapy manufacturing under cGMP/GLP/GDP, supported by three large and two medium ISO-7 cleanroom suites, Miltenyi CliniMACS Prodigy systems, a Terumo BCT Spectra Optia apheresis system, and an on-site CLIA-certified high-complexity diagnostic laboratory offering FDA-approved CELLSEARCH circulating tumor cell enumeration. The lead in-house pipeline asset is BioCytics Immune Fraction #1 (BCyIF-1), a non-genetically modified autologous immune cell fraction product for solid tumors, which received a productive FDA INTERACT meeting in November 2025 with first-in-human trials targeted for 2027. The Human Applications Lab (HAL) provides contract research services including biospecimen sourcing, process and assay development, translational analytics, and IND-enabling solutions for biopharma clients.

The business model combines three professional-services revenue streams: (1) per-trial compensation from conducting Phase I studies for 25+ biopharma sponsors including AbbVie, BioNTech, Exelixis, Incyte, and Revolution Medicines; (2) HAL contract research and cGMP manufacturing services; and (3) on-site clinical laboratory diagnostics. Patient acquisition is referral-led through community oncologists across the Southeast, with study drug provided by sponsors and travel reimbursement available for distant patients. The company is founder/family-owned, with no disclosed venture or institutional capital, no publicly reported revenue, and headcount of 11-50 employees.

Name

Carolina BioOnocology Institute

Legal name

Carolina BioOncology Institute

Website

https://carolinabiooncology.org

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

Carolina BioOncology Institute is a private, community-based Phase I cancer clinical trial site in Huntersville, NC, conducting immunotherapy trials for metastatic cancer patients on behalf of 25+ biopharma sponsors, with on-site point-of-care cell therapy manufacturing and a CLIA-certified diagnostic lab.

Ownership category

akta.pro rank

Product category

Phase I Oncology Clinical Research

NAICS

Medical and Diagnostic Laboratories (6215), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Offices & Clinics Of Doctors Of Medicine (8011), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Medical Oncology (HLAKAFAB)

akta.pro secondary industries

Clinical Research & Trial Central Laboratories (HLAFAMAL), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

Keywords

• Phase I clinical trials
• Immuno-oncology research
• Cell therapy manufacturing
• Contract research services
• Clinical laboratory diagnostics

Headquarters

HQ city

Huntersville

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Services

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Clinical Trial Conduct: Revenue generated from conducting Phase I clinical trials for biopharmaceutical sponsors. CBOI enrolls patients in immunotherapy trials and receives compensation for trial conduct, patient care, data collection, and regulatory compliance.
2. Contract Research Services (HAL): Human Applications Lab provides translational tumor immunology research, cell processing, biospecimen sourcing, technology transfer, process scale-up, and IND-enabling solutions for biopharma sponsors.
3. Clinical Laboratory Diagnostics: On-site CLIA-certified laboratory provides routine patient sample analyses including hematology, urinalysis, metabolic testing, and FDA-approved CTC enumeration services.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Carolina BioOncology Institute operates a community-based Phase I cancer research clinic in Huntersville, NC, providing patients access to investigational immunotherapy and cellular therapy clinical trials for advanced solid tumors. The institute runs an on-site CLIA-certified clinical laboratory offering routine and esoteric diagnostic testing, and a Human Applications Lab (HAL) that delivers contract research, biospecimen processing, and point-of-care cell therapy manufacturing services to biopharmaceutical sponsors.

Product overview

Carolina BioOncology Institute operates as a unified platform combining clinical care and research services. The core offering consists of Phase I Clinical Trials providing patients access to cutting-edge immunotherapy treatments in a community-based setting, complemented by an on-site CLIA-certified laboratory delivering same-day diagnostic results. The Human Applications Lab (HAL) serves as the translational research and manufacturing arm, offering biospecimen processing, cGMP manufacturing, and contract research services to biopharmaceutical sponsors. BioCytics, the biotech subsidiary, focuses on developing autologous cell therapies (AACT) including the BCyIF-1 pipeline product. Together, these integrated components enable bench-to-bedside medicine from early-phase trials through investigational cell therapy manufacturing.

Differentiator

Problem solved

Functional benefit

Products and services

• Phase I Immunotherapy Clinical Trials Early-phase clinical trial services providing patients with advanced or metastatic solid tumors access to investigational immunotherapy treatments, including TIL therapy, checkpoint inhibitors, and novel cell therapies, in a community-based setting.
• CLIA Laboratory Services High-complexity clinical diagnostic laboratory providing routine and esoteric patient sample analyses including hematology, urinalysis, comprehensive metabolic panels, immunology testing, CELLSEARCH CTC enumeration, and COVID-19 screening.
• Human Applications Lab (HAL) Contract Research Translational tumor immunology research services for biopharmaceutical sponsors including process and assay development, biospecimen sourcing and banking, translational analytics, cGMP manufacturing support, technology transfer, process scale-up, and IND-enabling solutions.
• Clinical Lab Analysis High-complexity clinical diagnostic testing services including Hematology (CBC, differential, reticulocyte count, peripheral smear), Urinalysis, General Immunology (CTC enumeration, SARS-CoV-2 testing), General Chemistry (comprehensive metabolic panel), and Esoteric Testing (clinical biomarkers, companion diagnostics).
• Process and Assay Development HAL staff assist in developing optimal protocols for enriching, culturing, and assessing preclinical cell therapy products, including IND-enabling processes and assays to optimize preclinical products for biopharmaceutical sponsors.
• Biospecimen Sourcing Internally sponsored observational clinical trial (BioCytics 0001) enabling collection of healthy donor and patient biospecimens for downstream laboratory Research Use Only (RUO), with manual and automated controlled-rate freezing processes.
• cGMP Manufacturing Point-of-care cell and gene therapy manufacturing capabilities including apheresis collection, cell processing, and patient infusion potential, with upscaling, technology transfer, and process optimization services under cGMP.

Quantifiable outcome

• Over 100 clinical trials conducted since founding in 2005
• +2 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Seven partnerships are on record, tiered minor and core.

• openEHR International and HL7minorStrategic or Co-development Partner · 12 May 2026Dr. John Powderly led a working group discussion at the Converge and Collaborate meeting on the convergence of Clinical Research and Informatics, representing CBOI in international healthcare data standards initiatives.
• AbbVie P1PER NetworkcoreStrategic or Co-development Partner · 29 May 2025Carolina BioOncology Institute was selected to participate in AbbVie's Phase I Partnerships for Excellence in Research (P1PER) network, a global network of leading clinical trial centers designed to accelerate early development of novel therapies across difficult-to-treat blood cancers and solid tumors.
• National Minority Quality Forum (NMQF)coreStrategic or Co-development Partner · 24 October 2024NMQF, Carolina BioOncology Institute, and BioCytics are collaborating to create a national registry and biorepository for CSSI (Cancer Stage-Shifting Initiative), collecting clinical, genetic, and demographic data from 20 communities to support cancer research and precision treatment development.
• BioCyticscoreStrategic or Co-development PartnerBioCytics is a privately-held biotechnology company co-located with CBOI in Huntersville, NC, researching autologous adaptive cell therapy (AACT) for solid tumors. BioCytics is clinically-incubated by CBOI and shares the same mission of developing personalized immune cells at the point of care. BioCytics is a parent company of CBOI.
• Duke UniversityminorOthersDr. Powderly serves as Adjunct Clinical Assistant Professor of Medicine at Duke University, hosting rotating medical students and collaborating on education.
• University of North Carolina at Chapel HillminorOthersDr. Powderly serves as Adjunct Clinical Assistant Professor of Medicine at UNC Chapel Hill, hosting rotating medical students and collaborating on education.
• Multiple Clinical Trial SponsorscoreStrategic or Co-development PartnerCBOI conducts Phase I clinical trials for over 25 biopharmaceutical sponsors including AbbVie, BioNTech, Exelixis, Incyte, Revolution Medicines, and others targeting advanced solid tumors. Services include patient enrollment, treatment administration, and data collection.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Florida Cancer Specialists & Research Institute: FCS operates community-based Phase I oncology trials across Florida with biopharma sponsors, including cell therapy and immunotherapy programs. Comparable to CBOI as a large community oncology practice with embedded Phase I research operations in the Southeastern US.
• START (South Texas Accelerated Research Therapeutics): START is a global network of early-phase oncology trial sites running Phase I programs in solid tumors with pharmaceutical sponsors — overlapping closely with CBOI's Phase I immunotherapy focus, sponsor relationships, and community-based delivery model.
• Tennessee Oncology / OneOncology: Tennessee Oncology is a large community-based oncology practice with an active Phase I clinical trials program serving biopharma sponsors in the Southeastern US. Highly comparable to CBOI in geographic reach, sponsor base, and community-based immunotherapy trial execution.
• NEXT Oncology: NEXT Oncology operates a network of community-based Phase I oncology clinical trial sites across the US conducting early-phase immunotherapy trials for biopharma — directly comparable to CBOI's Phase I immunotherapy focus and sponsor-driven business model.
• Sarah Cannon Research Institute (SCRI): SCRI is one of the largest community-based Phase I oncology clinical trial networks in the US, conducting early-phase trials across multiple sites with biopharma sponsors — directly comparable to CBOI in service mix, customer base (immunotherapy sponsors), and community-versus-academic positioning.
• Mary Crowley Cancer Research: Mary Crowley is a community-based Phase I oncology trials center running early-phase immunotherapy and cell therapy programs for biopharma sponsors — directly comparable in mission, scale, and patient population to CBOI.

Broad incumbents

• Iovance Biotherapeutics: Iovance is the leading commercial TIL therapy company with FDA-approved lifileucel for solid tumors. Comparable to BioCytics/CBOI's BCyIF-1 TIL program as a peer in autologous cell therapy for solid tumors, though Iovance is a commercial-stage biotech versus CBOI's pre-clinical position.
• MD Anderson Cancer Center: MD Anderson is a leading academic Phase I oncology center with deep biopharma trial relationships. Comparable to CBOI as a Phase I oncology trial site, but operating at much larger academic scale and competing with CBOI for the same sponsor pipeline.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/carolina-biooncology-institute/posts/?feedView=all
• Xx.com/CBiooncology

Compliance10 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Carolina BioOnocology Institute