Advancing Regenerative Immunology Through Strategic Collaboration
Breathe Biologics is focused on advancing JadiCell™, an investigational allogeneic mesenchymal cell platform, through rigorous clinical development and strategic collaboration in severe pulmonary disease.
Building Strategic Relationships Around Pulmonary Innovation
Breathe Biologics is interested in relationships that can accelerate the scientific, clinical, regulatory, manufacturing, and commercial development of the JadiCell™ platform.
JadiCell™ is derived from the subepithelial layer of umbilical cord tissue and is being investigated for its potential to modulate inflammatory signaling and support restoration of the injured pulmonary microenvironment. Breathe Biologics is evaluating strategic opportunities where complementary capabilities may advance development of the platform.
Differentiated Biology
A proprietary neonatal-tissue-derived mesenchymal cell platform with biological characteristics being investigated across inflammatory and regenerative pathways.
Human Clinical Evidence
Published randomized clinical research in COVID-19-associated ARDS provides human safety, biomarker, and exploratory clinical observations supporting continued investigation.
Allogeneic Scalability
A donor-derived manufacturing model designed around standardized cell banking, controlled expansion, release testing, cryopreservation, and clinical distribution.
A Regenerative Immunology Platform for Severe Pulmonary Disease
The scientific rationale for JadiCell™ extends beyond a single molecular target. The platform is being investigated across interconnected biological processes involved in inflammatory lung injury and repair.
Immune Modulation
Investigation of cellular signaling associated with dysregulated innate and adaptive immune responses.
Endothelial Biology
Potential relevance to pulmonary vascular integrity, permeability, and the alveolar-capillary barrier.
Epithelial Repair
Investigation of paracrine signaling potentially relevant to alveolar epithelial recovery and tissue homeostasis.
Tissue Remodeling
Research into pathways associated with fibrosis, extracellular matrix regulation, and maladaptive pulmonary repair.
Scientific Qualification: These biological activities represent areas of mechanistic and translational investigation. Proposed mechanisms should not be interpreted as established clinical effects.
Opportunities Across the Pulmonary Development Continuum
Strategic collaboration may provide complementary expertise and resources across clinical development, translational medicine, regulatory strategy, manufacturing, and future pulmonary evaluation.
Acute Respiratory Distress Syndrome
ARDS is the lead late-stage program for JadiCell™, building from published randomized clinical experience and a registered Phase 3 development program.
COPD
Chronic Obstructive Pulmonary Disease represents an additional pulmonary development pathway for the JadiCell™ platform.
Pulmonary Fibrosis / ILD
A pulmonary disease area that may be considered for future evaluation based on biological rationale, regulatory strategy, clinical feasibility, and available development resources.
Bronchiectasis
A pulmonary disease area that may be considered for future evaluation based on biological rationale, regulatory strategy, clinical feasibility, and available development resources.
Pulmonary Vascular Disease
A pulmonary disease area that may be considered for future evaluation based on biological rationale, regulatory strategy, clinical feasibility, and available development resources.
Development Qualification: Pulmonary Fibrosis / ILD, Bronchiectasis, and Pulmonary Vascular Disease are identified only as potential future indications. Their inclusion does not establish an active clinical program, IND authorization, regulatory approval, clinical efficacy, or a commitment to initiate development in these disease areas.
Potential Areas for Strategic Collaboration
Breathe Biologics is open to evaluating structures that align complementary capabilities with the long-term development of JadiCell™ and its pulmonary applications.
Clinical Development
Trial strategy, site networks, operational capabilities, clinical execution, and late-stage pulmonary development.
Translational Medicine
Biomarker strategy, pharmacodynamic research, patient stratification, responder biology, and translational analytics.
Regulatory Development
Regulatory strategy and development planning for advanced cellular therapies in pulmonary indications.
CMC & Manufacturing
Process development, scale-up, analytical characterization, potency, comparability, quality systems, and supply strategy.
Medical Affairs
Scientific exchange, evidence generation, pulmonary thought-leader engagement, publications, and medical education.
Strategic Transactions
Potential licensing, co-development, regional development, commercialization, investment, and other strategic structures.
Scalability Is Central to Cell-Therapy Development
For an allogeneic cell therapy, successful development requires more than biological activity. Manufacturing reproducibility, potency, quality, comparability, cryopreservation, and dose economics are fundamental to clinical and commercial translation.
Building a Reproducible Allogeneic Manufacturing Platform
JadiCell™ development incorporates a donor-derived manufacturing model intended to support standardized clinical product while maintaining critical quality attributes throughout expansion, formulation, storage, and distribution.
Who We Seek to Engage
Breathe Biologics welcomes scientific and strategic dialogue with organizations possessing complementary pulmonary, cell-therapy, clinical-development, manufacturing, or investment capabilities.
Pharmaceutical & Biotechnology Companies
Organizations with pulmonary franchises, advanced-therapy capabilities, clinical-development infrastructure, or strategic interest in regenerative immunology.
Healthcare Investors
Life-science private equity, venture, strategic investment, and other capital partners evaluating differentiated pulmonary biotechnology opportunities.
Research & Clinical Institutions
Pulmonary research hospitals, academic investigators, clinical trial networks, and translational research organizations.
From Initial Dialogue to Scientific Diligence
Partnering discussions can progress through a structured process appropriate to the opportunity and level of scientific diligence required.
Initial Discussion
Strategic objectives, areas of interest, and potential alignment.
Scientific Exchange
Platform biology, clinical evidence, development strategy, and CMC.
Confidential Diligence
Appropriate non-public materials may be reviewed under confidentiality.
Strategic Structure
Evaluation of collaboration, development, investment, licensing, or transaction structures.
Start a Strategic Conversation
Breathe Biologics welcomes inquiries from pharmaceutical and biotechnology companies, healthcare investors, research institutions, and other organizations interested in exploring the JadiCell™ platform and pulmonary development opportunities.