IDEA: A complex isolate with multiple indications (penicillin was a complex isolate with one indication - antibiotic)
STAGE: FDA in a pre-IND meeting approved the next step: Toxicology in rats to be done at Charles River Labs (This work is quoted). Then the following step is the IND is written so the Mayo Clinic can perform a proof of concept study in 300 humans.
STEP ONE: we will fund the first production runs of LGX 242 <$100k
STEP TWO: Then test in vitro at Microchem, Tx, LGX 242 on the top 10 multi-drug resistant bacteria. <$17K
Testing Includes:
• Microorganism(s):
◦ Target concentration: ≥1.5 x 108 CFU/mL
▪ Acinetobacter baumannii ATCC 19606
▪ Pseudomonas aeruginosa ATCC 15442
▪ Klebsiella pneumoniae ATCC 13883
▪ Enterococcus faecium ATCC 51559
▪ Staphylococcus aureus ATCC 33591
▪ Enterobacter cloacae ATCC 13047
▪ Mycobacterium terrae ATCC 15755
▪ Neisseria gonorrhoeae ATCC 19424
STEP THREE: Toxicology at Charles River Labs < $192K
STEP FOUR: blood, plasma and tissue toxicology analysis by ALS Group <$120K
STEP FIVE: Phase 1a clinical trial, the first indication is for allergy caused and non-allergy cause rhinitis: WHY rhinitis? Large Market, Large Need, and the quickest path to revenue.
STEP SIX: Subcutaneous ulcers that will not heal. Multi- drug-resistant bacterial infections, the third leading cause of death, globally. Large Market, Large Need, No current solutions.
STEP SEVEN: Breast Cancer: this is the long haul project; the largest market than steps 5-6 by a factor of three. UCLA is testing LGX 242 in mice.
Model: LogiX will always own the IP and manufacture LGX 242 in a patented process, proving the drug to large pharmaceutical companies under licensing agreements.
One of our team managed licensing agreements for Novartis.
Customers: Mom's are the healthcare CEO in the home - we bring them an anti-infective to prevent the petri dishes (the kids) from infecting the family.
TEAM
Management and Scientific Team
Founder& CEO – Gavin Gear Gavin is a results-proven innovator and transformational leader who has launched LogiX based on his previous commercial success in health and wellness products. He has successfully secured multiple partners since founding LogiX Biosciences. He is responsible for overseeing the company's non-drug products, the drug and medical device development pipeline, and patent design & development.
Co-Founder & Vice President of Product Development - Brett Edmonds. Brett is an Entrepreneur and Leader in Pharmacology since 1974.
Co-Founder & CFO Mark Morris. Mark is a financial executive with 40+ years of accounting and finance knowledge. He was the long-term owner and operator of Small Business Solutions, Inc., a financial software development company, and is a business strategist for multiple startup companies. He is also the long-term CFO of a non-profit focused on supporting impoverished populations in Peru.
Board Director - Amy Broidrick. Amy has over 25 years of pharmaceutical strategy and operations experience. She previously served as Director on the Board of Qualigen Therapeutics, a Nasdaq-listed clinical-stage company focused on developing rare cancer therapeutics. Her other roles included President, Qualigen Therapeutics, Sr. Vice President, Global Corporate Development at Viking Therapeutics, and management positions at Merck & Co., including Global Brand Leader with P&L accountability.
VP Medical Affairs - Michael Gentile. Michael is a clinical practitioner in Respiratory Care Services, Associate Director of Respiratory Care Services, and associate in research at Duke University Medical with extensive experience in the fields of pulmonary medicine. He is a Fellow of the AARC and SCCM and active in critical care and respiratory clinical research. He has 20 years of experience carrying out similar roles for other new and emerging therapeutics.
VP Regulatory Affairs - Robert (RL) Johnson, MSc, RAC. Robert (RL) is an experienced and creative regulatory affairs leader, drawing from progressive experience in regulatory strategy and compliance. RL has worked in regulatory affairs for 19 years, in the fields of pharmaceuticals, medical devices, and combination products. Using his CMG background in various therapeutic areas, including sterile injectable, medicinal gases, Class I-exempt through Class Ill medical devices, and biologic dosage forms, RL has established health agency negotiation and complete dossier response management. He has an extensive track record of complete and concise regulatory applications. RL received his MSc in Information Systems and Decisions Sciences from Louisiana State University
Company Advisors
Todd MacLaughlan (Scientific Advisor). Todd is an experienced Pharmaceutical entrepreneurial executive with a 30-year background in Sales, Marketing, Business Development and General management (Bayer, Novartis). His experience includes early-stage genomic activities to drug development and late-stage marketing of global brands, fund raising and start-up experience. His special expertise includes Marketing, Business Development, Licensing, General Management, Strategy, Operations, pharmaceuticals, biotech, product acquisition, Brand and Generic drugs.
Jonathan Meeks (Scientific Advisor). Jonathan holds a unique skillset gained over his 30-year career, leading strategic healthcare market development across over twenty countries in multiple segments including Pharma, Medical Devices, Diagnostics and Health IT sectors. His entrepreneurial and innovation expertise in technologic market development and precision medicine have spanned minimally invasive surgery, e-commerce, commercial start- ups, professional education, research and development, organization, and people leadership and most recently, leading the establishment of Novartis Oncology, Precision Medicine organization. Jonathan leads the Precision Healthcare Strategies group, in addition to multiple international board of directors advisory roles.
Chris McMahon, PhD (Scientific Advisor).
Chris has been a senior scientist for ManukaMed for over a decade. He completed a PhD at Agresearch, Invermay then completed two postdoctoral positions in the United States at Auburn University and Michigan state, respectively. He spent many years studying the role of growth hormone, IGF-1 and myostatin in regulating post-natal growth.
Dennis Watson (Scientific Advisor). Dennis was the cofounder of ManukaMed Ltd., New Zealand and ManukaMed USA, co-inventor of medical grade manuka honey; with IP, patents, and a state-of-the-art wound care dress manufacturing plant in New Zealand. He has spent 20 years developing Manuka honey products for medical indications.
Jonothan Scarlet (Scientific Advisor) Founder of First Honey LLC
Jono Scarlet is the Chief Operating Officer at First Honey, based in Nashville, United States. Prior to his current role, he was the Managing Partner at Mint Artist Management. Jono holds a Bachelor of Commerce degree from Victoria University of Wellington, and is responsible for overseeing the day-to-day operations and strategic direction of First Honey, a leading provider of high-quality honey products and ManukaMed USA.
Dr Sean Feast (Precision Chroma Drug technology) Founder and CEO.
Dr Sean Feast completed his PhD in 2021 at the University of Canterbury under Professor Conan Fee, the inventor of 3D printed chromatography. Dr Feast studied its use in the application of viral purification for gene therapies and scaling the technology from laboratory to commercial scale. He then Founded Precision Chroma in 2022 to commercialize PMA. Since then, Precision Chroma has been developing PMA for a range of biological purification applications as they scale the technology to full preparative column sizes.
Dr Brent Bauer (Clinical Advisor).
Brent A. Bauer, M.D., is board-certified in internal medicine, a Professor of Medicine, and the director of the Complementary and Integrative Medicine Program at Mayo Clinic, where he has been on staff for 24 years. Dr. Bauer's work is at the forefront of the emerging field of integrative medicine, which combines the best of conventional medicine with the best of evidence-based complementary therapies. Dr. Bauer has authored several book chapters and more than 100 papers on integrative therapies, and he is the medical editor of Mayo Clinic Book of Alternative Medicine. He is a member of numerous scientific review panels and is currently collaborating on more than twenty studies being conducted at Mayo Clinic.
Dr Rohit Divekar (Clinical Advisor).
Rohit Divekar, M.B.B.S., Ph.D., is a board-certified allergist and immunologist with specialized expertise in chronic rhinosinusitis with nasal polyposis, asthma, chronic urticaria. Dr. Divekar completed his medical degree at the University of Mumbai, KEM Hospital, GS Medical College and completed his residency at the University of Arkansas. His subspecialty training was completed in Allergy and Immunology at the University of Texas Medical Branch in Galveston. He also holds a Ph.D. in microbiology/immunology from the University of Missouri at Columbia. His clinical practice is dedicated to diagnosing and treating patients with chronic sinus disease and chronic hives. Dr. Divekar’s research is focused on understanding the immune mechanisms of those diseases. Moj Eram, PhD (Technical Advisor for Quality Management Systems).
Moj has over 20+ years of experience in the life sciences industry, with primary expertise in medical devices and diagnostic technology commercialization and development, regulatory affairs, quality and compliance, research, technical / medical writing, and project management. Her expertise includes regulatory and quality strategy planning, regulatory assessment and submission for medical devices and diagnostics products, combination products, and creation and implementation of Quality Management System (QMS).
Stacie Sundquist (Intellectual Property Law).
Stacie is a registered patent attorney whose practice focuses on intellectual property protection in the medical device, mechanical, micro-electro-mechanical systems (MEMS), surgical robotics, photovoltaic, semiconductor as well as life sciences technology areas. She provides services in all patent-related areas, including preparation and prosecution of US and international patent applications, freedom to operate and invalidity analyses, competitor activity, and strategies for portfolio management and development. Stacie is licensed to practice in California, Minnesota, and before the United States Patent and Trademark Office. She obtained a B.S. in Genetics and Cellular Biology from the University of Minnesota in 1999, and a J.D. from Chicago-Kent College of Law in 2003.