Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » Champions Oncology

Champions Oncology

Champions Oncology, Inc. (Nasdaq: CSBR) is an oncology-focused contract research organization headquartered in Hackensack, New Jersey, with laboratory operations in Rockville, Maryland.[S1] The company describes itself as "a leading provider of oncology CRO services, specializing in preclinical and clinical specialty testing,"[S2] and in its Form 10-K as "a technology-enabled research organization engaged in creating technology solutions to be utilized in drug discovery and development."[S1] Its work is built around a bank of patient-derived xenograft (PDX) models marketed as TumorGraft.[S4] This profile summarizes the services, models, stated compliance information, and company facts most relevant to US sponsors.

Nonclinical services relevant to US drug developers

Service lines

The services page groups the offering into in vivo models, ex vivo platforms, and clinical specialty testing. Named items include solid tumor PDX, pretreated PDX, mouse clinical trials, hematological malignancies, syngeneic, humanized, and cell line-derived xenograft (CDX) models; tissue microarrays; radiopharmaceutical testing; a KRAS preclinical platform; blood cancer and 3D solid tumor screens and co-culture assays; early drug discovery solutions; and clinical specialty testing covering flow cytometry, Luminex and ELISA, histology and immunohistochemistry, and next-generation sequencing.[S4] The two integrated early-discovery workflows named in the earlier Japanese version of this page, ChemiSelect and ADC-Flow, do not appear on the company's current pages and are not described here.

Mouse clinical trials

The company describes mouse clinical trials (MCT) as "preclinical studies designed to reflect the complexity of human clinical trials," using "patient-derived xenograft (PDX) models implanted in immunodeficient mice."[S5] It states that the design lets sponsors "assess efficacy across diverse tumor types, evaluate biomarkers and stratify responders vs. non-responders, investigate resistance mechanisms and optimize drug combinations."[S5] These are nonclinical studies in mice; despite the name, an MCT is not a clinical trial and its results do not establish efficacy in patients.

The company states that "our MCT designs are customizable to your study goals," with different designs depending on whether a sponsor is screening large model panels or validating a lead asset.[S5]

Humanized and syngeneic models for immuno-oncology

For immuno-oncology the company offers syngeneic mouse models with an intact mouse immune system and humanized models marketed as ImmunoGraft, described as "a diverse portfolio of Champions' ImmunoGraft® to assess the effect of therapeutics on functional components of the human immune system."[S4] The specific modalities that can be evaluated in a given model, and the limits of each model system, should be confirmed with the company at the study design stage.

Ex vivo platforms and the data platform

Alongside in vivo work the company lists ex vivo screening platforms, including a 3D solid tumor screen, a blood cancer screen, and co-culture assays.[S4] It also markets a bioinformatics product, Lumin, described as "an integrated software solution that harnesses the power of precisely curated oncology data, computational science and bioinformatics,"[S10] drawing on a dataset that the company says includes whole exome sequencing and RNA-seq, mass spectrometry proteomics and phosphoproteomics, cell surface proteomics, flow cytometry, immunohistochemistry, and Luminex data.[S9]

The TumorGraft PDX bank

The company's services page states "over 1,400 clinically relevant TumorGraft® models with correlation to clinical outcomes" — these are nonclinical mouse models, and the cited correlation claim does not establish efficacy or safety in patients, "."[S4] Model counts differ across the company's own pages: the in vivo models page says "over 1,500 clinically annotated, deeply characterized mouse models,"[S6] and the data ecosystem page refers to "over 2,000 low-passage, patient-derived tumor models."[S9] Sponsors should confirm the current count and the composition of the panel for their tumor type. Pretreated PDX models, established from patients who have already received therapy, are offered as a separate category alongside solid tumor PDX.[S4]

Quality, compliance, and animal welfare (as stated by the company)

GCLP, ISO 9001, and CLIA rather than GLP. The company states that it is "GCLP-compliant and ISO9001 certified for all of our specialty testing" and has "CLIA certification for assay-specific tests,"[S7] naming clinical flow cytometry, next-generation sequencing, immunohistochemistry, and plate-based platforms as the GCLP-compliant ones, and PD-L1 immunohistochemistry as an example of CLIA-certified testing.[S7] Good Clinical Laboratory Practice (GCLP) is a framework for laboratory analysis of clinical trial samples; the company itself describes it as integrating principles from GLP and Good Clinical Practice.[S7] It is not the same as compliance with the FDA GLP regulation for nonclinical laboratory studies, and no statement claiming GLP compliance or naming 21 CFR Part 58 was found on the pages reviewed. Sponsors who need a GLP nonclinical study should confirm with the company whether it can be run and under which regulation.[R2]

Animal welfare. The company states that it "maintains AAALAC accreditation, reflecting our commitment to the highest standards of animal care and ethical research practices within our in vivo programs," and describes "implementation of the 3Rs principles (Replacement, Reduction, and Refinement), continuous review of study design to optimize resource use."[S8] The accredited site or sites are not individually named, and no USDA registration, OLAW Animal Welfare Assurance, or IACUC statement was found on the pages reviewed. Its 10-K notes that the company is subject to "federal, state, local or foreign legislation applicable to the use of live animals in scientific testing, research and education."[S1] AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;[R4][R5] none of these establishes GLP compliance, which applies to individual studies.[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.[R6] This profile does not evaluate the company's animal care program; the statements above are the company's own.

Company facts

Legal nameChampions Oncology, Inc.; incorporated in Delaware on June 4, 1985[S1]
HeadquartersOne University Plaza, Suite 307, Hackensack, NJ 07601, United States[S1]
ListingNasdaq Stock Market, ticker CSBR[S1]
Fiscal year endApril 30[S1]
Employees214 full-time as of July 15, 2026, including 103 with doctoral or other advanced degrees; 149 in research, development and laboratory operations[S1]
SitesHackensack, NJ (headquarters); Rockville, MD (laboratory and office); Milan, Italy (lease terminated April 30, 2026). The company website also lists a bioinformatics office in Rehovot, Israel, which is not among the leased properties in the 10-K[S1][S2]
FY2026 revenue$59.4 million, up from $56.9 million in FY2025; net loss of approximately $1.2 million[S1]
Flagship model bankTumorGraft patient-derived xenografts; counts stated as over 1,400, over 1,500, or over 2,000 depending on the page[S4][S6][S9]
Other platformsImmunoGraft humanized models, syngeneic and CDX models, 3D solid tumor and blood cancer ex vivo screens, Lumin bioinformatics[S4][S10]
Quality statementsGCLP-compliant and ISO 9001 certified for specialty testing; CLIA certification for assay-specific tests; AAALAC accreditation for in vivo programs. No GLP statement found[S7][S8]
Phone+1 201-808-8400 (as published on the Japanese version of this page; not re-confirmed on the current site)
Websitewww.championsoncology.com

Matters disclosed in the company's SEC filings

In its FY2026 Form 10-K the company discloses a history of operating losses, stating that it "historically incurred losses from operating activities, may require significant capital and may never achieve sustained profitability," and reports a net loss of approximately $1.2 million for the year ended April 30, 2026.[S1] It also notes that all of its facilities are leased and that damage to a laboratory or a dispute with a landlord would negatively affect the business, and that a health crisis in its animal population, "such as a virus or other pathogen," would affect its business.[S1] These are the company's own disclosures as of the filing date; sponsors should check the most recent 10-K and 10-Q before contracting.

References

  1. Champions Oncology, Inc. — Form 10-K for the fiscal year ended April 30, 2026 (filed July 27, 2026), SEC EDGAR. https://www.sec.gov/Archives/edgar/data/771856/000162828026049834/csbr-20260430.htm (accessed 2026-09-03)
  2. Champions Oncology — Home. https://www.championsoncology.com/ (accessed 2026-09-03)
  3. Champions Oncology — Oncology CRO Services. https://www.championsoncology.com/oncology-cro-services/ (accessed 2026-09-03)
  4. Champions Oncology — Mouse Clinical Trials. https://www.championsoncology.com/mouse-clinical-trials/ (accessed 2026-09-03)
  5. Champions Oncology — In Vivo Preclinical Mouse Models. https://www.championsoncology.com/in-vivo-preclinical-mouse-models (accessed 2026-09-03)
  6. Champions Oncology — Quality Assurance. https://www.championsoncology.com/quality-assurance (accessed 2026-09-03)
  7. Champions Oncology — Quality (animal welfare). https://www.championsoncology.com/quality (accessed 2026-09-03)
  8. Champions Oncology — Data Ecosystem. https://www.championsoncology.com/data-ecosystem (accessed 2026-09-03)
  9. Lumin Bioinformatics (Champions Oncology). https://lumin.bio/ (accessed 2026-09-03)
  10. 21 CFR Part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies (§58.1 scope; §58.3 definitions; §58.35 quality assurance unit), eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58 (accessed 2026-09-03)
  11. AAALAC International — FAQs ("voluntary accreditation program"; re-evaluation every three years). https://www.aaalac.org/accreditation-program/faqs/ (accessed 2026-09-03)
  12. USDA APHIS — Animal Welfare Act: research facilities must obtain a registration; Animal Care inspections. https://www.aphis.usda.gov/awa/public-search (accessed 2026-09-03)
  13. Public Health Service Policy on Humane Care and Use of Laboratory Animals (Animal Welfare Assurance submitted to NIH OLAW). https://grants.nih.gov/policy-and-compliance/policy-topics/animal-welfare/laws-regulations/phs-policy (accessed 2026-09-03)
  14. FDA — "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)

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