Novel therapeutics and diagnostics targeting Porphyromonas gingivalis (Pg) — to shut down inflammation

Pioneering change to diagnose, treat, modify, and prevent inflammation-driven diseases including dementia, early Alzheimer's and cardio-metabolics

Keystone Bio brings Biotech, Medicine, and Dentistry together to shut down systemic inflammation.

Keystone Bio’s team has discovered a unique set of toxins released by Porphyromonas gingivalis (Pg) from the mouth into the bloodstream. Pg’s daily flow of toxins drive inflammation throughout the body. Pg’s toxins disrupts the innate immune system triggering the overexpression of the NLRP3 inflammasome and induce systemic and neuro-inflammation, tau phosphorylation and memory dysfuction.

This is currently untreatable, undiagnosable and has no cure.

Keystone Bio is advancing therapeutics and companion diagnostic targeting Porphyromonas gingivalis (Pg) to stop the flow of this toxin-driven inflammation.

Keystone Bio targets the root cause of inflammatory diseases by eliminating specific virulent strains of Porphyromonas gingivalis (Pg), a highly prevalent and oral pathogen that secrete toxins that travel through the bloodstream, triggering inflammatory pathways leading to disease.

About

Keystone Bio is advancing both novel therapeutics and companion diagnostics that together shuts down this primary driver of systemic inflammation, the root cause of many neurodegenerative and vascular diseases affecting hundreds of millions of people.

Our lead monoclonal antibody has been shown to eradicate Porphyromonas gingivalis (Pg) at its source stopping the daily flow of its highly virulent and disease-causing toxins throughout the body. Our team of entrepreneurs and scientists, including the world’s experts in Pg, Alzheimer’s, cardio-metabolic disease, and dentistry is working to stop disease at its source.​

Inflammatory diseases are the most significant cause of death in the world today, with more than 50% of all deaths attributable to inflammatory diseases. Inflammation is the root cause of many vascular, end organ and neurodegenerative diseases affecting hundreds of millions of people.

By diagnosing toxin producing strains then treating Pg in the mouth, we stop the flow of Pg toxins driving systemic inflammation driven diseases.

There’s robust scientific evidence linking Pg in the mouth to widespread, systemic acute/subacute and inflammation including several authored by KB’s team in peer-reviewed publications.  There’s also substantial evidence that early intervention can modify, prevent, and reverse the many vascular inflammation driven diseases, including dementia and early Alzheimer’s disease.

Pipeline

Our combination of monoclonal antibody therapeutics and companion diagnostics take aim at this highly validated daily driver of inflammation that has been shown to overexpress NLRP3 inflammasome/IL-1b/TNFa pathways and elevate systemic inflammatory biomarkers—Ox-LDL, hs-CRP, Hb-A1c, Lp-PLA2, MPO, Troponin, pro-BNP and adversely affect HDL.

Pipeline information

Clinical

KB-001

Topical, orally-placed monoclonal antibody that uniquely binds to Porphyromonas gingivalis toxin complex.

Preclinical

KBhu-001

Humanized chimeric monoclonal antibody candidates with similar binding to Porphyromonas gingivalis, ready for drug development.

KBd-001

CDx measuring serum antibodies to the toxic virulence factors.

CDx assay being further evaluated for a possible role in specific early diagnosis of various inflammatory based diseases.

KBvx-001

Vaccine development targeting same protein complex as KB-001 Mab.

Contact

Daniel Sindelar, DMD -- Chief Executive Officer
Daniel Sindelar, DMD
Chief Executive Officer

Dr. Sindelar is a pioneer in systemic oral health and a world’s leading expert on oral pathogens impact on neurodegenerative and inflammatory diseases. He is a co-founder and former President of the American Academy for Oral Systemic Health (AAOSH). He is the first dental professional to receive a Preceptorship for Heart Attack and Stroke Prevention. He has participated in several Harvard Executive Management Programs. Dr. Sindelar was previously President of Sindelar Dental for several decades providing Physician coordinated oral care.

Peter Nara, DVM, PhD, FAAAS -- Chief Scientific Officer
Peter Nara, DVM, PhD, FAAAS
Chief Scientific Officer

Dr. Nara is a serial biotechnology entrepreneur and a world’s leading expert in infectious diseases, biologics, and vaccinology. Prior to Keystone Bio, Dr. Nara was former Section Chief National Cancer Institute and co-founder and CEO of Biological Mimetics, a biotech firm developing new generation antigens, vaccines and antibodies. He also co-founded Lantern Pharma who develops precision cancer therapies leveraging AI and genomics.

Marc Penn, MD, PhD -- Chief Medical Officer
Marc Penn, MD, PhD
Chief Medical Officer

Dr. Penn is a world’s leading expert in cardiology, vascular inflammation, and inflammatory cardiovascular disease. He is the former Head of ICU cardiology at the Cleveland Clinic and founder and Chief Medical Officer of the Cleveland HeartLab, pioneering Inflammatory Testing. Former Director of the Bakken Heart Brain Institute. Dr Penn is Director of Research and Cardiovascular Medicine Fellowship at Summa Cardiovascular Institute. Dr Penn also serves as Senior Advisor and Medical Director, Cardio Metabolic Endocrine Franchise, Quest Diagnostics.

Michael Rafii, MD, PhD -- Senior Medical Advisor (Neuro)
Michael Rafii, MD, PhD
Senior Medical Advisor (Neuro)

Dr. Rafii is a physician-scientist with extensive research experience on Alzheimer’s disease and strong background in multi-center clinical trials on Alzheimer’s. He is a board-certified Neurologist, and also the Medical Director of the Alzheimer’s Therapeutic Research Institute (ATRI) and Associate Professor of Neurology at the Keck School of Medicine of the University of Southern California. He is the Principal Investigator of the international Alzheimer’s Clinical Trials Consortium - Down Syndrome (ACTC-DS).

Jim Klein, CPA -- Chief Financial Officer
Jim Klein, CPA
Chief Financial Officer

Jim Klein has extensive international experience working with both public and non-public companies in the life science sector with a background as CFO of several pharmaceutical and biotech companies.

He was previously CFO of Micell Technologies, Adherex Technologies and Triangle Pharmaceuticals, a $500m biotech firm where he led the IPO.

Garth Ehrlich, PhD, FAAAS
Garth Ehrlich, PhD, FAAAS

Executive Director of the Center for Genomic Sciences, Executive Director of the Center for Advanced Microbial Processing, and Executive Director of the Center for Surgical Infections and Biofilms within the Institute for Molecular Medicine and Infectious Disease at Drexel College of Medicine. In addition, Dr. Ehrlich serves as the Director of the Genomics Core Facility and the newly created Drexel Medicine Diagnostics Laboratory. To his role as Chair of the SAB, Dr. Ehrlich brings a lifetime of experience in molecular medicine, genomic science, and molecular diagnostics of infectious diseases.

Robert Rissman, PhD
Robert Rissman, PhD

Professor of Neuroscience and Director of Alzheimer's Disease Research Center (ADRC) neuropathology and biomarker cores at the University of California, San Diego. Dr. Rissman is the biomarker unit lead for NIA's Alzheimer's Clinical Trials Consortium (ACTC) through the Alzheimer's Therapeutic Research Institute (ATRI) of University of Southern California (USC). He contributes significant experience in diagnostics for neurodegenerative diseases including Alzheimer’s Disease. 

W. Sue T. Griffin, PhD
W. Sue T. Griffin, PhD

One of the world’s leading neuroscientists with a focus on the role of neuroinflammation in the pathogenesis of Alzheimer’s disease and other neurodegenerative conditions. In her role, Dr. Griffin provides deep expertise in neuroinflammation and its impact on Alzheimer’s Disease. Editor-in-Chief, Journal of Neuroinflammation. Professor & Vice Chairman, Donald W. Reynolds Dept. of Geriatrics, University of Arkansas for Medical Sciences. Director of Research, Geriatric Research, Education and Clinical Center, VAMC/CAVHS.

Rita Colwell, Ph. D.
Rita Colwell, PhD

Member of the National Academy of Sciences, Distinguished University Professor of the University of Maryland College Park and at Johns Hopkins University Bloomberg School of Public Health, Senior Advisor and Chairman Emeritus at Canon US Life Sciences, Inc., and President and Chairman of CosmosID, Inc. Dr. Colwell served as the eleventh director of the National Sciences Foundation and has received the 2006 National Medal of Science. She brings a wealth of experience in global infectious disease policy and research and deep scientific advisory acumen to her role.

Jan Potempa, PhD, DSc
Jan Potempa, PhD, DSc

One of the world’s leading researchers on Porphyromonas gingivalis. Research professor at Jagiellonian University and Professor and Academic Scholar at the University of Louisville School of Dentistry. Dr. Potempa brings expertise in Porphyromonas gingivalis (Pg) biology to his role.

Member of the Polish Biochemical Society, International Association of Dental Research, International Proteolysis Society and the American Microbiology Society. Laureate of the Prime Minister’s Award for exceptional scientific achievements (2001).

Shaun Lonergan, MS
Shaun Lonergan, MS

Chief Executive Officer at Precion LLC focusing on early detection chronic diseases. Lonergan shares his extensive knowledge on diagnostics for disease detection.

Edward J. Zuckerberg, DDS, FAGD
Edward J. Zuckerberg, DDS, FAGD

Chief Executive Officer and Founder of Painless Social Media, LLC, and Venture Partner at Revere Partners. Dr. Zuckerberg shares experience in dentistry, periodontal disease, and social media.