PLPC-DB: Validated Structural Immunological Platform with “No Equivalent in Contemporary Oncology. ”
PLPC-DB™: A Validated Structural Immunological Platform with No Equivalent in Contemporary Oncology
PLPC-DB™ is a non-cellular, non-genomic, non-pharmacodynamic structural immunological platform. It is not a conventional drug or an exploratory therapy. The system is fully validated, technically closed, and designed for institutional transfer—requiring no hospitalization, no cold-chain logistics, and no systemic pharmacovigilance.
Regulatory Precedents Supporting RWE-Based Evaluation of PLPC-DB
Timeline of regulatory approvals from FDA, EMA, and COFEPRIS using real-world evidence as the primary or exclusive basis for evaluation. PLPC-DB follows a structurally aligned pathway, building on validated precedents such as sipuleucel-T and Onpattro, under a documentary, non-activated model.
PLPC-DB Strategic Immunotherapy Placement
Diagram illustrating the progressive evolution from receptor-dependent immunotherapies (ICIs, CAR-T) toward structurally activated, receptor-independent platforms. PLPC-DB engages HLA-DR⁺ dermal APCs without pharmacodynamic or genomic interaction.
It has been developed to meet the needs of populations excluded from conventional immunotherapy due to immunosuppression, comorbidities, or functional deterioration. Its mechanism of action bypasses classical receptor-dependence and acts via dermal APC phenotypic reprogramming (HLA-DR⁺), with no systemic absorption or off-target effects.
Comparative Functional Positioning Across Immunotherapy Modalities
While ICIs, CAR-T, and DC vaccines face complexity, toxicity, or personalization limits, PLPC-DB offers a scalable, robust, and phenotypically traceable alternative.
Technical Profile
All validated through STIP (Structural Traceability and Immunophenotypic Platform)—a published, patented framework with full auditability across over 24,000 applications.
- Dermal activation of APCs without receptor binding, plasma absorption, or systemic metabolism.
- Ambulatory administration: lyophilized formulation, shelf-stable, no hospitalization required.
- Zero incidence of severe adverse events across more than 24,000 documented applications.
- Cohort of 3,572 patients, with 154 PET–FDG documented cases and full STIP traceability.
- STIP (Structural Traceability and Immunophenotypic Platform): patented, published, and operational system linking batch, patient, biomarker, and outcome.
Documentation and Regulatory Status
- Full technical dossier in ICH eCTD format (Modules 1–5)
- CRF v13.1 with audited SAP and verified phenotypic and metabolic data
- Independent technical validation letter available under NDA
- List of peer-reviewed publications in Q1 journals (Cancers, Biomedicines, IJMS, MethodsX)
- Institutional coverage letter and editable Term Sheet available for legal teams
Strategic Entry Route
- Primary route: Direct acquisition of 80%–100% of the asset (preferred scenario)
- Alternative routes: Exclusive license, partial equity acquisition, or institutional mandate, subject to formal evaluation
📩 Institutional Contact
Department of Oncopathology – OGRD Alliance
✉️ plpc@ogrdalliance.org
Formal access requests to the technical dossier, scientific presentations, or confidential documentation will be responded to within 48 hours under a pre-approved NDA framework.
PLPC-DB™ designed
PLPC-DB™ is not designed to replace conventional therapies but to enable a functional option where they cannot be used—offering higher effectiveness and safety with fewer complications and lower associated costs. Its structural mode of action allows it to operate in the most challenging clinical margins, without toxicity or complex logistical requirements.
Contact
Information for corporate use in the Big Pharma and Biotechnology sectors
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