Kinnear Pharmaceuticals

Pharmaceuticals Inspired by the Innate Immune System

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Overview


ADDRESSING IMPORTANT INFECTIOUS AND INFLAMMATORY CONDITIONS IN CYSTIC FIBROSIS

Kinnear Pharmaceuticals is a preclinical stage pharmaceutical company committed to the discovery, development and commercialization of ceragenin-based anti-infective and anti-inflammatory product candidates for diseases with large unmet clinical needs. Ceragenins are synthetic non-peptide small molecule mimetics of endogenous host defense or antimicrobial peptides. Ceragenins exhibit similar multi-faceted activities to naturally-occurring antimicrobial peptides. Unlike peptides, ceragenins are amenable to large scale manufacture and are not subject to proteolytic degradation. Ceragenins have the following favorable characteristics:

  • Unique mechanism of action
  • Potent antimicrobial activity, including against multidrug-resistant strains and biofilms
  • Unlikely to engender bacterial resistance
  • Attractive secondary attributes: anti-inflammatory activity, synergy with conventional antibiotics
  • Patent protection through the mid-2030s+

Leadership

Carl Genberg, B.Sc., JD

Chief Executive Officer

Mr. Genberg was previously Senior VP, R&D, Ceragenix Pharmaceuticals, where he successfully developed and licensed to Dr. Reddy’s Laboratories Ltd.  Epiceram®, a controlled-release skin-barrier-repair emulsion that offers unique, non-steroidal therapy for patients with eczema and atopic dermatitis. Mr. Genberg was also previously Co-Founder, Board Member and Regulatory counsel to medical device company where he helped design and implement a clinical trial leading to PMA approval of lead product in 14 months and key advisor to the CEO, leading to $100 million IPO led by Goldman Sachs. Successful track record leading commercialization of biotechnology products, including 510(k) and PMA, managing clinical studies, establishing research networks and obtaining non-dilutive financing; co-inventor on multiple patents. Prior experience in early career as an attorney  with extensive practice in intellectual property licensing transactions and issues and FDA regulatory matters.

Matt Reed, Ph.D.

Scientific Consultant

Dr. Reed is a pharmacologist, board certified toxicologist, ABT Board Member, and Fellow of the Academy of Toxicology Sciences (ATS). Dr. Reed is former VP, Applied Toxicology and Nonclinical Development at Lovelace Biomedical. Matt Reed is currently a principal at Coelus (www.coelusbio.com) where he facilitates early to late phase pharmaceutical program and IP development and provides consulting services in integrated drug development strategies, toxicology, pharmacology and hazard assessment. He was a strategic leader and member of Senior Management Teams from 2007-2017. From 2000-2009 he served as the line manager of the GLP Toxicology Pharma Division (building the division from inception) and served as study director for the largest ($20M+) inhaled source pollutant toxicology program ever performed. He has been a part of successful R&D programs that that have transitioned to IND, NDA and other regulatory registration milestones for small molecules, biologics, oligonucleotides, and alternative fuel additives. Dr. Reed has overseen and consulted on initiatives to include toxicant drug delivery, applied toxicology studies, formulation/device feasibility and development, pharmacokinetics, pharmacology, safety pharmacology pivotal IND and NDA GLP compliant studies. Dr. Reed has been an awardee, PI/Co-PI, or subcontract PI of over $51M in federal R&D grants and contracts for drugs and vaccines (delivery by multiple routes) working with government funded commercial firms, NIH, BARDA and DOD to develop pharmaceutics for clinical indications as well as combat, homeland and defense security threats.

Stephen Stick, Ph.D., MB, BChir, FRACP, FAAHMS

Scientific Consultant

Professor Stick is a career clinician and clinical researcher and holds a National Health and Medical Research (NHMRC) Practitioner Fellowship. Professor Stick is Director of the Telethon Kids Respiratory Research Centre and a Fellow of the Australian Academy of Health and Medical Science.  From 1998 to 2016 he was Head of the Department of Respiratory and Sleep Medicine at Princess Margaret Hospital for Children, Perth and in 2007 he was appointed Clinical Lead of the Health Department of Western Australia, Respiratory Health Network, responsible for the translation of evidenced-based models of care into state-wide health policy. Since 2005, he has been a Principal Investigator for the Australian Respiratory Early Surveillance Team for Cystic Fibrosis (AREST CF). AREST CF has developed a unique early surveillance program that has provided unique insight with regards to the early manifestations of CF lung disease contributing to paradigm shift from an approach based on amelioration of respiratory disease to one focused on prevention.

David S. Perlin, Ph.D.

Scientific Consultant

David Perlin, Ph.D. is the founding Chief Scientific Officer and Senior Vice President for the Hackensack Meridian Health Center for Discovery and Innovation. He is a highly accomplished senior administrator and biomedical researcher focused on combatting opportunistic infections in cancer, transplant and other high-risk patients. Dr. Perlin was most recently Executive Director and Professor at the Rutgers University, New Jersey Medical School where he led the 77-year old Public Health Research Institute (PHRI), a center for the study of infectious diseases. In the past 12 years, he helped PHRI attract more than $230 million in grant support and develop a robust portfolio of patents and licenses resulting in FDA-approved products. Dr. Perlin’s research emphasizes studies to diagnose and overcome drug-resistant fungal and bacterial infections in high-risk patients, and he is widely regarded as a global leader in antifungal drug resistance, molecular diagnostics and antifungal drug development. He has published more than 250 papers and book chapters, and has co-authored two books. His laboratory is supported by multiple grants from the NIH, CDC, Pharma and biopharma sectors.

Michael S. Niederman, Ph.D.

Scientific Advisor and Consultant

Dr. Niederman is Clinical Director and Associate Chief in the division of Pulmonary and Critical Care Medicine, at Weill Cornell Medical Center, and Professor of Clinical Medicine at Weill Cornell Medical College. Dr. Niederman previously was Professor of Medicine and Vice-Chairman of the Department of Medicine at the State University of New York at Stony Brook, Chairman of the Department of Medicine at Winthrop-University Hospital in Mineola, for 16 years. He erved for 6 years as a member of the Board of Regents of the American College of Chest Physicians and in 2013 was elected as a Master of the American College of Physicians. Dr. Niederman is Editor-in-Chief of Clinical Pulmonary Medicine and serves on the editorial boards of Critical Care Medicine, Intensive Care Medicine, Critical Care and Chest. Dr. Niederman holds expertise in respiratory tract infections, mechanisms of airway colonization, the management of community and hospital-acquired pneumonia, the role of guidelines for pneumonia, and the impact of antibiotic resistance on the management and outcomes of respiratory tract infections. Dr. Niederman has published over 400 peer-reviewed or review articles, and has lectured widely, both nationally and internationally. Dr. Niederman previously served as co-chairman of the committees that created the American Thoracic Society 1993 and 2001 guidelines for the treatment of community-acquired pneumonia and the 1996 and 2005 committees that wrote guidelines for the treatment of nosocomial pneumonia.

Harris Kaplan

Commercialization Consultant

Mr. Kaplan is currently Managing Partner of Red Team Associates and CEO of Healogix. Mr. Kaplan has founded and exited multiple healthcare industry research companies. Involved in the development and launch of over 100 new life science products across drug, device, and diagnostic markets; 30-year industry veteran; role in commercializing blockbusters such as Crestor, Rituxan, Nexium, Lipitor, Incivek, Eteplirsen (Sarepta), Austedo (Teva) and the cystic fibrosis  drug Kalydeco (Vertex).

Paul B. Savage, Ph.D.

Inventor, Consultant and Sponsored Research

Dr. Savage is the Reed M. Izatt Professor of Chemistry and Biochemistry at Brigham Young University and inventor of the ceragenin compounds. Research emphases include development of non-peptide mimics of antimicrobial peptides and optimization of glycolipid adjuvants, including a glycolipid vaccine adjuvant that entered human clinical trials. Author on over 190 papers, and inventor on over than 35 issued US patents. Technologies developed in Prof. Savage’s laboratory have been licensed to multiple companies and are in various stages of clinical development.

Technology

Ceragenins are synthetic, non-peptide small molecules inspired by naturally occurring endogenous host defense peptides Host defense peptides are critical components of the innate immune system. Like these  peptides, ceragenins function as innate immune modulators, expressing antimicrobial, anti-inflammatory,  osteo-induction and other pharmacological activities. Ceragenins have a unique mode of action and broad patent protection, and have been the subject of more than 75 peer-reviewed articles, numerous patents and millions of dollars of private and public investments. Ceragenins consist of a sterol backbone with amino acids and other chemical groups attached. Ceragenins have a net positive charge that is electrostatically attracted to the negatively-charged cell membranes of certain bacteria, fungi and viruses.

 

POTENT ANTIMICROBIALS

Ceragenins attack the membranes of microbes as opposed to their internal replication mechanisms. This results in broad-spectrum efficacy and improbability that resistance will develop, similar to naturally-occurring antimicrobial peptides. Ceragenins have demonstrated the ability to both prevent and eradicate bacterial and fungal biofilms, which are nearly impossible to eradicate with conventional antibiotics.  Lead ceragenin compounds KIN-213 and KIN-219 have exhibited potent antimicrobial properties and are rapidly bactericidal, fungicidal and virucidal against a wide array of pathogens, including multidrug resistant strains of Methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa (Pseudomonas).

 
STRONG ANTI-INFLAMMATORY AND IMMUNOMODULATORY ACTIVITIES

The anti-inflammatory and immunomodulatory properties of ceragenins are similar to naturally-occurring cathelicidin antimicrobial peptides and participate in various immunomodulatory pathways. Ceragenins are capable of modulating key inflammatory cytokines such as IL-6 and TNF alpha. Further, ceragenins can induce expression of chemokines, neutralize endotoxins, stimulate angiogenesis and apoptosis, suppress neutrophil apoptosis and accelerate wound healing and osteogenesis.

 

BACTERIAL RESISTANCE IS UNLIKELY

Ceragenins have minimal resistance potential due to their novel mechanism of action.  Serial passaging studies (30x) show no mutational resistance and recent proteomics data shows that KIN-213’s unique mechanism of action targets key components of conserved features of bacterial membranes.

 

ADDITIONAL, VALUE-ADDED ATTRIBUTES
  • Potent anti-biofilm activity capable of eradication at low concentration and prevention at very low concentration
  • Demonstrated synergy with traditional anti-infectives
  • Resists de-activation in cystic fibrosis mucus

Kinnear Pharmaceuticals is developing a portfolio of therapeutics for cystic fibrosis and inflammation-related gastrointestinal indications