1-732-586-0439
From human GI biology to predictive translational models
Human GI epithelial and mucosal systems integrating multidimensional functional readouts of epithelial integrity, immune signaling, transport, injury, repair, and therapeutic response provide a foundation for disease biomarker and molecular target identification, therapeutic discovery and development, and predictive translational models of response, resistance, and tissue toxicity.
From Human GI Biology to Predictive Translational Models
Human GI epithelial and mucosal systems integrating multidimensional functional readouts of epithelial integrity, immune signaling, transport, injury, repair and therapeutic response provide a foundation for disease biomarker and molecular target identification, therapeutic development, and predictive translational models of response, resistance and tissue toxicity.
AlfaGene Bioscience is advancing a human tissue-derived approach designed to connect molecular observations with measurable epithelial function. The objective is to help research and development teams make better-informed decisions about disease biology, therapeutic activity, delivery, safety and patient-relevant response.
Core Differentiation
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Patient-derived, non-transformed human gastrointestinal stem, progenitor and differentiated epithelial cells
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Normal, inflammatory and malignant tissue systems, including matched colorectal tumor and normal tissues
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Segment-specific gastrointestinal biology spanning the stomach, small intestine, colon and rectum
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Planar and polarized systems providing experimental access to apical and basolateral epithelial functions
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Integration of functional, molecular, donor, disease and treatment-response data
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Mucosal immune-cell expertise supporting studies of immune-epithelial interactions
Program 1
GI inflammation and barrier biology
Program objective. Reproduce and validate disease-relevant human epithelial systems using normal, Crohn's disease and ulcerative colitis tissues. Establish quantitative measurements of barrier integrity, inflammatory and immune signaling, epithelial injury, repair and therapeutic response.
Application Highlights
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Comparative studies of healthy, Crohn's disease and ulcerative colitis epithelium
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Comparison of inflamed and non-inflamed intestinal regions, where available
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Functional assessment of epithelial barrier disruption and restoration
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Analysis of cytokines, receptors, innate immune pathways, apoptosis and epithelial signaling
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Studies of epithelial interactions with intraepithelial lymphocytes, lamina propria lymphocytes and circulating immune cells
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Identification and validation of disease-associated biomarkers and molecular targets
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Evaluation of anti-inflammatory, barrier-protective and repair-promoting candidates
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Characterization of response, non-response and resistance-associated phenotypes
R&D gap addressed: Many experimental systems do not adequately distinguish epithelial-specific mechanisms from signals generated by mixed tissues or circulating immune cells. AlfaGene's approach is designed to connect disease-associated molecular changes with functional human epithelial outcomes while preserving donor, disease and anatomic context.
Program 2
Transport Therapeutic Screening and Preclinical GI Safety
Translate validated planar, polarized systems into partner-defined studies of permeability, directional transport, epithelial integrity, toxicity, and formulation or candidate comparison. Generate quantitative functional data for candidate selection, safety assessment, and translational modeling.
Program 3
Colorectal oncology
Preserve matched tumor/normal and stem/differentiated systems as an option for disease-selective target discovery, biomarker validation, resistance, recurrence, and epithelial liability studies. Integrate functional and molecular measurements to identify response and resistance states, therapeutic vulnerabilities, and normal-tissue liabilities.
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Tumor-Normal Target Validation
Patient-matched tumor and adjacent-normal epithelial/stem cell systems enable direct comparison of tumor biology against matched normal epithelial counterparts.
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Reproducible Human Cell Resources
Cryopreserved, expandable, and regrowable epithelial/stem cell banks support repeat experiments and multi-assay workflows.
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Solid Tumor Focus
Current proof-of-concept is in colorectal cancer, with broader applicability to gastrointestinal and epithelial solid tumors.
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Partner-Ready Platform
AlfaGene is seeking strategic collaborations, pilot studies, and external innovation partnerships.
ABOUT ALFAGENE
ABOUT ALFAGENE:
AlfaGene is a human GI translational biology company dedicated to advancing the understanding and modeling of gastrointestinal mucosal biology to accelerate therapeutic discovery and development.
We specialize in GI mucosal immunology, epithelial barrier function, inflammatory bowel disease, colorectal cancer, biomarker and therapeutic target discovery, preclinical GI toxicology, and mechanism-of-action studies. Our human GI epithelial and mucosal model systems support disease-mechanism research, therapeutic evaluation, and translational assessment of efficacy, resistance, and normal-tissue liability.
Our goal is to connect human GI biology with therapeutic development through functional, biologically relevant translational models.
Physician-scientist backgrounds · expertise in human GI epithelial/stem cell systems · scientific publications and patents.
Mayur Doshi
Co-Founder, CEO
Asit Panja, MD, AGAF, ABAARM
Founder, CSO — Scientific Research Team
PLATFORM
Human Tumor-Normal Epithelial Target Engine
AlfaGene’s platform uses patient-matched tumor-derived and adjacent-normal epithelial/stem cell systems, together with broader normal epithelial panels, to evaluate whether tumor-associated biomarkers are sufficiently differentiated from normal tissues.
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03
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TUMOR-DERIVED
Patient-matched tumor
ADJACENT-NORMAL
epithelial/stem cells
Same patient, same anatomical
segment
Candidate antigenic biomarker profiling
Tumor versus matched-normal comparison
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Normal epithelial liability screening
Surface accessibility / expression validation
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Modality-fit recommendation
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Ranked target-validation package
OUTPUT EXAMPLES
Tumor-enrichment profile
Matched-normal liability assessment
Segment-resolved normal epithelial expression context
Target prioritization score
Modality-fit recommendation
Go / iterate / no-go decision support
TECHNOLOGY DIFFERENTIATORS
What the platform does that tumor-only systems cannot
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Patient-Matched Tumor-Normal Comparison
Direct comparison of tumor-derived and adjacent-normal epithelial/stem cells from the same patient and anatomical segment.
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Segment-Resolved Human GI Biology
Human epithelial/stem cell resources representing defined gastrointestinal segments.
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Cryopreserved, Expandable, Regrowable Cell Banks
Unlike one-time fresh tissue or short-lived explant systems, AlfaGene's resources are maintained as cryopreserved cell banks that can be thawed, expanded, and regrown for repeatable experiments.
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Controlled Pure Epithelial/Stem Cell Populations
The platform provides a controlled epithelial/stem cell system for standardized target-screening workflows.
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IP-Protected Antigenic Biomarker Candidates
AlfaGene has issued patent protection around antigenic biomarker discoveries relevant to GI disease and cancer.
ONCOLOGY APPLICATIONS
Applications in Solid Tumor Target Validation
Solid tumor therapies often fail because targets identified in tumor-biased systems are also expressed in normal tissues, narrowing the therapeutic window and increasing the risk of on-target/off-tumor toxicity.
Colorectal Cancer
Current proof-of-concept using paired tumor and adjacent-normal epithelial/stem cell resources.
Gastrointestinal Cancers
Potential application across GI epithelial malignancies where tumor-normal comparison is important.
Broader Epithelial Solid Tumors
The workflow may be extendable to other epithelial solid tumors, including lung cancer, through appropriate tumor/adjacent-normal sample partnerships.
THERAPEUTIC MODALITIES SUPPORTED
ADC target validation / Bispecific antibody target selection / Immune engager target de-risking / CAR-T & TCR-like target safety assessment / Companion diagnostic biomarker prioritization / Normal epithelial liability screening
Predictive translational modeling
Multidimensional functional and molecular data generated from human GI systems can be integrated with computational approaches, including AI/ML, to develop predictive models of therapeutic response, resistance, and tissue toxicity.
GI BIOLOGY & IBD PLATFORM HERITAGE
Human GI Epithelial Biology Foundation
AlfaGene's platform was originally built around human gastrointestinal epithelial/stem cell biology, including segment-resolved normal GI epithelial systems and disease-relevant epithelial models. This foundation supports applications in inflammatory bowel disease, colorectal cancer, epithelial barrier biology, and translational GI research.
GI epithelial biology / IBD disease modeling / Barrier biology / Colorectal cancer biology / Segment-specific epithelial response / Translational target validation
IP / PUBLICATIONS SNAPSHOT
Patents
AlfaGene has issued patent protection covering antigenic biomarker discoveries relevant to gastrointestinal disease and cancer.
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ISSUED U.S. PATENTS
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ISSUED EUROPEAN PATENT
Issued Patents
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Human Gastrointestinal Stem Cell-Derived Primary Intestinal Epithelial Cell System and Methods of Use Thereof:
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US Patent 8,367,316 B2
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US Patent 9,212,382 B2
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Biomarkers for Gastrointestinal Diseases
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US Patent 9,267,935 B2
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US Patent 10,087,488
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Drug Discovery Methods Involving a Preclinical Gastrointestinal Epithelial Stem Cell Platform:
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European Patent EP2279245B1
Selected Foundational Publications:
Novel Human Intestinal Epithelial Cell Platform
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Panja A. A novel method for the establishment of pure populations of non-transformed human intestinal primary epithelial cell (HIPEC) lines in long-term culture. Link: https://www.nature.com/articles/3780154
Mucosal Immunology & Inflammatory Disease:
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Panja A, Barone A, Mayer L. Stimulation of lamina propria lymphocytes by intestinal epithelial cells. Journal of Experimental Medicine. 1994; 179:943–950.
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Panja A et al. Regulation and functional consequences of pro-inflammatory cytokine binding on human intestinal epithelial cells. Journal of Immunology. 1998; 161:3675–3684.
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Panja A, E. Siden and L. Mayer. 1995. Synthesis and regulation of accessory/proinflammatory cytokines by intestinal epithelial cells. J. Clin. Exp. Immunol. 100:298-305.
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Panja A, S. Goldberg, L. Eckmann, P. Krishen and Lloyd Mayer. 1998. The regulation and the functionanl consequence of proinflammatory cytokine binding on human intestinal epithelial cells. Journal of Immunology 161: 3675-3684.
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C. A. Martin and A. Panja. 2002. Cytokine regulation of human intestinal primary epithelial cell susceptibility to Fas-mediated apoptosis. American J of Physiol Gastrointest Liver Physiol 282: G92-G104.
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Eckman L, H. C. Jung, C. Schurer-Maly, A. Panja, E. Morzycka-Wroblewska, and M. Kagnoff. 1993. Differential cytokine expression by human intestinal epithelial cells: regulated expression of interleukin-8. Gastroenterology. 105: 1689-1697.
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Jobin C, Panja A, et al. Inhibition of pro-inflammatory molecule production by NF-κB suppressor expression in human intestinal epithelial cells. Journal of Immunology. 1998; 160:410–418
PARTNERING
Partner With AlfaGene
AlfaGene is seeking strategic collaborations with oncology, immunology, drug discovery, and translational research teams interested in human tumor-normal target validation and epithelial disease modeling.
COLLABORATION MODELS
8–12 WEEKS
Feasibility Pilot
8–12 week study to evaluate selected antigenic biomarker candidates in tumor-normal epithelial systems.
4–6 MONTHS
Expanded Target Validation
4–6 month program to generate a ranked target-validation package with normal epithelial liability assessment.
ONGOING
Strategic Platform Collaboration
Broader collaboration to extend the tumor-normal epithelial workflow to additional solid tumor types or therapeutic modalities.
IDEAL PARTNERS
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Pharma oncology teams
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Biotech companies developing ADCs, bispecifics, immune engagers, or cell therapies
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Translational oncology groups
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External innovation teams
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Academic and clinical collaborators with access to tumor/adjacent-normal samples
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CRO/CDMO partners for assay scale-up and validation
CONTACT
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1-732-586-0439
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20 Corrielle Street
Fords, NJ 08863
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