MEDICINE
Enhanced Health and Extended Lifespan through Exosome Diagnostics and Therapeutic Interventions
Examining circulating extracellular vesicles offers insight into cellular function, potentially enabling timelier and more precise diagnoses. Engineering exosomes to rectify aberrant cellular activities, preempting symptom onset, holds promise for restoring organ and tissue health, thereby addressing and averting the progression of diseases.
EV Diagnostics
Enhanced Sensitivity and Precision for Early Diagnosis
Advancements in molecular biology have deepened our scientific comprehension of circulating EV profiles, laying the groundwork for the development of more precise diagnostic tools. Ongoing research aims to uncover the distinct microRNA and protein compositions of EVs that are indicative of particular disease states and their severity. Leveraging the same EV purification and characterization technology employed by EV Biologics for quality control will facilitate the creation of earlier and more precise diagnostic tests.
The isolation and analysis of circulating EVs from easily accessible bodily fluids such as serum, plasma, CSF, urine, or saliva offer clinical researchers the opportunity to conduct liquid biopsies, bypassing the morbidity associated with surgical procedures. Future EV-based diagnostics hold the potential to enable the early detection and staging of diseases like pancreatic cancer, dementia, or diabetes, thereby potentially enhancing prognoses.
In line with their commitment to enhancing health and wellness, EV Biologics plans to establish repositories of EV profiles linked to various disease states utilizing their advanced EV isolation and characterization technology. These profiles will serve as the basis for developing targeted diagnostic assays for clinical applications.
JOURNEY TOWARDS EXOSOME CLINICAL DEVELOPMENT
1960'S
In the 1960s, the discovery of stem cells occurred and their distinctive behaviors were elucidated.
1983
In 1983, Stahl and Johnstone made independent discoveries regarding exosomes.
2002
In 2002, the role of microRNA in disease was documented.
2010
In 2010, it was demonstrated that exosomes serve as mediators of the biological effects of stem cells.
2016
In 2016, clinical research into extracellular vesicles for kidney disease in humans began.
2018
In 2018, scalable Good Manufacturing Practice (GMP) methods for exosome production were developed.
2020
In 2020, clinical trials involving exosomes for FDA approval commenced.
EXOSOME THERAPEUTICS
Development of Precision Biopharmaceuticals
As a novel category of biological therapeutics, EVs offer notable advantages over conventional small molecule drugs. A key distinction lies in their natural origin, which has demonstrated exceptional safety both in preclinical investigations and clinical practice. Moreover, EVs possess a diverse cargo, allowing them to target multiple receptors and signaling pathways within cells, thereby exerting various therapeutic effects. Stem cell EVs, in particular, harbor intrinsic properties that could prove beneficial across a wide spectrum of autoimmune, inflammatory, degenerative, metabolic, traumatic, and neoplastic disorders.
The next stride in biopharmaceutical advancement entails engineering tailored biological properties by optimizing the protein and RNA contents of exosomes for specific clinical contexts. Leveraging the expertise of molecular cell biologists, biological chemists, and regenerative medicine specialists, EV Biologics is spearheading the development of cutting-edge vaccines, therapeutics, and remedies built upon a multifaceted EV platform. Progressing towards clinical implementation necessitates GMP bioprocessing, rigorous quality assurance, and an impeccable safety track record, ensuring the delivery of innovative EV solutions to address critical clinical needs.
Cargo
Engineering cell lines and exosomes to achieve the optimal cargo composition of proteins, RNA, and small molecules.
Targeting
Modifying exosomes to improve their targeting to specific sites for desired therapeutic effects.
Purity
Advancements in EV design and bioprocessing techniques to produce purified exosomes.
Carrier
Enhanced delivery systems tailored for the precise administration of purified exosomes in targeted clinical scenarios.
Scale
A scalable bioprocess designed to produce clinically significant quantities of exosomes.
LONGEVITY
Early Diagnosis and Prevention
Detecting pathological conditions before the onset of symptoms and intervening therapeutically to prevent the progression of disease or injury into debilitation or mortality are essential for achieving longevity. Understanding the molecular underpinnings of disease allows for the development of extracellular vesicles (EVs) containing tailored biological cargo to prevent illness, potentially halting or reversing age-related manifestations. Leveraging the inherent biological properties of certain exosomes, particularly those derived from stem cells, offers a promising avenue to disrupt disease pathogenesis involving chronic inflammation, autoimmune responses, tissue degradation, aberrant metabolic pathways, and more.
Recognizing that molecular mechanisms like oxidative stress and inflammation drive age-related changes, and acknowledging the specific biological properties of EVs that can counteract these effects, raises the possibility of utilizing EVs to forestall cellular decline responsible for tissue degeneration, organ dysfunction, and ultimately mortality. By restoring cellular function through optimized EVs, it may be feasible to attenuate tissue degeneration, mitigate age-related manifestations, and promote a longer, healthier lifespan.
EV RESEARCH
FDA Clinical Trials
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