Smart Medicine™ for the Most Challenging Diseases
Black Bear Bio engineers T regulatory cells (Tregs) into cellular pharmacies living drug factories that travel to sites of disease and produce therapeutic proteins in situ.
Our platform creates potent, long-lived, multimodal therapies capable of addressing complex diseases starting in the central nervous system.
One platform. Any protein. Delivered where it matters most.
Smart Medicine™ for the Most Challenging Diseases
Black Bear Bio engineers T regulatory cells (Tregs) into cellular pharmacies living drug factories that travel to sites of disease and produce therapeutic proteins in situ.
Our platform creates potent, long-lived, multimodal therapies capable of addressing complex diseases starting in the central nervous system.
One platform. Any protein. Delivered where it matters most.
About
Transforming Tregs Into Smart Medicine™
Black Bear Bio is building a new class of cell therapies powered by engineered Tregs.
Tregs naturally regulate inflammation, enable tissue repair, and traffic broadly throughout the body — making them an ideal chassis for targeted biologic delivery. We enhance these innate strengths with precision engineering, allowing our Treg pharmacies to:
- Localize to sites of pathology using disease-specific CARs
- Persist long-term within target tissues
- Produce disease-modifying molecules (DMMs) in situ
- Act multimodally through simultaneous immunomodulation, neuroprotection, and molecular repair
- Address diverse diseases through programmable biologic output
Cellular Pharmacies: Targeted, Persistent, In Situ Biologic Production
01
Target
02
Treat
03
Persist
Our cells incorporate engineering elements that enable sustained residency and long-term activity within target tissues, including the CNS.
(Details available under NDA.)
Why Tregs Are the Right Cell for Smart Medicine™
Tregs are a uniquely powerful starting point for engineered cellular therapies:
- Innate anti-inflammatory activity directly counteracts disease-associated immune dysregulation.
- Tissue-trafficking behavior enables broad distribution across the body, including the CNS.
- Context-sensitive action allows Tregs to activate and function when and where inflammation occurs.
- Engineering flexibility allows controlled expression of virtually any protein, from cytokines and antibodies to enzymes and neurotrophic factors.
- Demonstrated relevance across neurodegeneration, autoimmunity, and metabolic disease.
BBB-SG01: A Multimodal Cellular Pharmacy for ALS
Black Bear Bio’s lead program, BBB-SG01, is a next-generation, rationally-designed therapeutic for patients with amyotrophic lateral sclerosis (ALS). BBB-SG01 combines:
- A CAR targeting misfolded SOD1 , found in the spinal cords of most ALS patients
- Endogenous Treg functions that modulate inflammatory microglia
- Engineered secretion of disease-modifying molecules, such as neurotrophic factors
- Engineering to enhance long-term persistence and CNS residency
BBB-SG01 is designed to address the complex, multifactorial biology of ALS by combining targeted localization, immunomodulation, and neuroprotection within a single, persistent therapy.
- CAR Tregs selectively bind misfolded SOD1 present in patient-derived tissues.
- Engineered Tregs localize to the spinal cord in vivo and reduce inflammatory signaling.
- BBB-SG01 demonstrates multimodal activity including cytokine production, neuroprotective factor release, and improved survival in the mSOD1-NSG ALS model (multiple experiments).
Pipeline
Program
Indication
Stage
BBB-SG01
ALS
Lead / Preclinical
BBB-SG02
ALS
Preclinical
BBB-SG03
Alzheimer’s disease
In vitro → In vivo PoC
BBB-SG04
Parkinson’s disease
In vitro → In vivo PoC
BBB-SG05
Metabolic disorder
Discovery
BBB-SG06
Metabolic disorder
Discovery
BBB-SG07
Metabolic disorder
Discovery
Additional programs
Metabolic disorder
Discovery
Science
Precision CAR Targeting
- Selectively exposed in diseased tissues
- Enriched at the site of pathology
- And often inaccessible to conventional antibodies or small molecules
This includes aggregated or misfolded proteins implicated in neurodegenerative disease.
Multimodal Payload Delivery
Each Treg pharmacy can be engineered to secrete combinations of:
- Anti-inflammatory cytokines
- Neurotrophic factors (e.g., BDNF)
- Anti-aggregate or anti-toxic proteins
- Enzymes
- Novel proteins encoded within the DMM (disease-modifying molecule) library
CNS Residency & Persistence
Origin
Black Bear Bio is a Celdara Medical® enterprise , founded to translate the next generation of Treg and CAR-Treg science into transformative therapies.
Our platform builds on pioneering work from Professor Charles Sentman, PhD, a leader in cellular immunotherapy whose research helped establish the principles underlying targeted Treg engineering.
Partner With Us
Black Bear Bio is actively seeking partnerships with organizations developing therapies for neurodegenerative disease, rare disease, inflammation-driven pathology, or complex, multifactorial conditions where multimodal, persistent biologic activity is required.
We offer:
- A programmable, modular Smart Medicine™ platform
- Proprietary CARs targeting CNS-localized pathological proteins
- A growing pipeline with lead programs in ALS
- A discovery engine for rapid generation of new engineered Treg therapies
- Access to Celdara Medical’s proven translational infrastructure
