About Enzychem Lifesciences
Enzychem Lifesciences (KOSDAQ:183490) is developing novel small molecule therapeutics to target fundamental pathways in inflammation, patients with significant unmet needs in oncology, inflammatory, and severe respiratory diseases. Based on more than two decades of research, we developed our leading candidate EC-18 (Mosedipimod), an oral small molecule derived from Sika deer antler, which has shown to be active across a number of different indications. The company is also developing EC-18 in fibrotic diseases such as nonalcoholic steatohepatitis (NASH), and in severe respiratory diseases as a potential therapy for COVID-19. EC-18, or PLAG, is a naturally synthesized substance, derived from an active ingredient in Sika deer antlers. Our pipeline candidates have the potential to be first-in-class therapies for use in combination or as monotherapy, in major areas of unmet medical need.
Our Vision
To Improve the Lives of Patients with
Cancer and Inflammatory Diseases
Executive Management
Ki Young Sohn
Ki Young Sohn, is a biopharmaceutical leader and executive with more than 30 years of experience in the life sciences and finance industry. He has successfully led teams in start-up, mid-size, and global, large pharmaceutical settings. He is the Chairman of Bridget Lifescience, a Korean biotech company focused on new drug development. He was also a Director at Samil PwC. He has published extensively on EC-18, and his research has been in peer-reviewed medical journals. He earned his BA and MBA in Business Administration from Korea University.
Hye Kyung Kim
Hye-Kyung Kim is the vice-chairman of Enzychem Lifesciences, where she oversees finance, business operations and strategy. She was one of the industry pioneers in market research surveys, starting her career at Nielsen Korea, where she created a TV rating survey that is the basis of today's advertising media industry. In 2003, she established Bridget Lifesecience, new drug development company which became a major shareholder of Enzychem Lifesciences. In 2010, she was selected as the Female Leader of the Year by Ewha Womans university, her alma mater.
Hong Gyun Lee, PhD
Hong Gyun Lee is the Vice President at Enzychem Lifesciences. He oversees global vaccine production of the company. With more than 20 years of industry experience at LG Chemical, he has profound experience in biopharmaceutical R&D, product licensing and commercialization. During his 10 years working at SK Bioscience, he was responsible for the engineering and construction of Andong Vaccine Plant (L House). After successfully building a vaccine facility, he severed as the plant manager and managed the company’s vaccine production and CDMO operation. With more than 32 years, he has abundant experience in vaccine and biopharmaceutical R&D, engineering, obtaining product license and commercial production
Changgi D. Hong, MD, PhD
Dr. Changgi D. Hong is an Emeritus Professor of Medicine at the Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. He earned a PhD in medical science from Seoul National University. He is a retired medical nephrologist. Dr. Hong was co-inventor of PLAG with his wife, Dr. Sang-Hee Kim, who was a medical oncologist at the Asan Medical Center, now retired. Dr. Hong served as the Dean of the College of Medicine, University of Ulsan, the President of Asan Medical Center, and the President of Asan Healthcare System, Korea. He was a leading reformer of medical education in Korea and an innovative hospital-based healthcare administrator in Korea.
Developing first-in-class small
molecules to target
fundamental
inflammation pathways
Scientific Advisory Board
Jeff Crawford, MD (Chairman of SAB)
Dr. Jeffrey Crawford is George Barth Geller Professor for Research in Cancer and Co-Leader of the Solid Tumor Therapeutics Program in the Duke Cancer Institute (DCI) in Durham, North Carolina. He earned his medical degree from Ohio State University and completed his internship, residency and hematology/oncology fellowship at Duke University Medical Center. Dr. Crawford served as Chief of the Division of Medical Oncology for 10 years prior to assuming his current leadership roles. He served as Chair of NCCN Myeloid Growth Factors Panel for 15 years. Dr. Crawford is Principal Investigator for the National Clinical Trials Network Lead Academic Site Grant at Duke. His research interests include new treatment approaches to lung cancer, supportive care therapies, including hematopoietic growth factors and biosimilars, and agents that impact muscle wasting. He has published more than 250 manuscripts, chapters and reviews.
Michael Charlton, M.B.B.S
Dr. Michael Charlton is currently a Professor of Medicine and Director, Center for Liver Diseases at University of Chicago School of Medicine. He is an internationally renowned specialist in liver diseases and transplant medicine. He has particular expertise in the diagnosis, treatment and management of nonalcoholic fatty liver disease (nonalcoholic steatohepatitis) and viral hepatitis. Additionally, Dr. Charlton served as a principal investigator on grants and as a study section member for the National Institutes of Health, including studies of the pathophysiology of nonalcoholic fatty liver disease and viral hepatitis. He has published more than 200 manuscripts and is a lead investigator for national and international clinical trials in viral hepatitis and nonalcoholic fatty liver disease. Dr. Charlton has served as a panel member and writer for the American Association for the Study of Liver Diseases (AASLD) for the management of hepatitis C and also for nonalcoholic steatohepatitis. He is the only physician to serve on both panels.
Larry Kwak, MD, PhD
Dr. Larry W. Kwak is a world-renowned physician and scientist who has pioneered breakthrough innovations in Immuno-oncology. He joined City of Hope in 2015, following a decade each of leadership in lymphoma and myeloma research and treatment at M.D. Anderson Cancer Center and the U.S. National Cancer Institute. Named one of TIME magazine's "100 Most Influential People" in 2010 and winner of the Ho-Am prize in Medicine in 2016, Dr. Kwak is the deputy director of City of Hope's cancer center, director of the Toni Stephenson Lymphoma Center, and is endowed with the title of the Dr. Michael Friedman Professor in Translational Medicine.
Stephen Sonis, DMD, DMSc
Dr. Stephen Sonis is Professor of Oral Medicine at Harvard, Senior Surgeon at Brigham and Women’s Hospital and a designated member of the Distinguished faculty of the Dana-Farber Cancer Institute. He is a world-renowned expert in epithelial injury associated with cancer therapy and the lead consultant for Enzychem’s Phase 2 CRIOM trial. Dr. Sonis’ development of predictive animal models has enabled the investigation of the biological basis of cancer regimen-related epithelial injury and has catalyzed the development of potential therapies. Dr. Sonis’ interest in the genomic basis for toxicity risk and its pathology has led to innovative genomics-based analytical approaches to clinically actionable outcomes to personalize disease therapy. Steve is the former President of Triad, an international not-for-profit company which focused on the adverse health and economic outcomes of cancer treatment toxicities and has served as a special government employee of the FDA. He has published extensively on the clinical, biological, and health economic aspects of cancer and complications associated with its treatment. Steve holds several patents and is the author of more than 300 original publications, reviews, and chapters and eleven books. After receiving his DMD from Tufts, Dr. Sonis completed a combined doctorate and residency program at Harvard. Subsequently, he was a Knox Fellow at Oxford (UK) where he studied tumor immunology.
David Grdina, PhD, MBA
Dr. David Grdina is a Professor Emeritus at the University of Chicago. His research is focused on the development of radio-protective drugs for use in the prevention of radiation-induced genomic instability and subsequent processes leading to cancer development. Specifically, studies are directed at very low dose radiation and select phosphorothioate drug exposures to induce adaptive responses affecting genomic instability development. He received his BA in Biology from St. Mary’s College, and his MS and PhD in Radiation Biophysics from the University of Kansas. He also has an MBA from the University of Houston. In 1988, he received a Japanese Government Research Award for Foreign Specialists, Chiba National Laboratory, Chiba Japan. He is also the recipient of the 1993 John Yuhas Award for Excellence in Research University of Pennsylvania.
Jae Wha Kim, PhD
Dr. Jae Wha Kim is a senior researcher at Korea Research Institute of Bioscience and Biotechnology and an expert in immune-oncology and innate and acquired immunity with inflammation. He has been a co-worker with Enzychem Lifesciences on a number of research projects on the evaluation of mechanism of action of PLAG and nonclinical efficacy in various acute and chronic inflammatory indications including cancer, chemotherapy-induced neutropenia, chemoradiation-induced oral mucositis, acute radiation syndrome, acute lung injury, hepatitis etc. He is a scientific board member of Enzychem Lifesciences Corporation. He has published extensively on the basic molecular biological mechanism of novel human genes related cancer progression and the development of immune modulators for the treatment of acute and chronic inflammatory diseases. He holds many patents and is the author of more than 120 original publications. He obtained PhD degree from KAIST and completed his post-doctoral education at University of Florida. He is a Professor, Department of Functional Genomics, University of Science and Technology (UST), South Korea.
Cameron Wolfe, MBBS
Dr. Cameron Wolfe is associate professor of medicine at Duke University School of Medicine. Dr. Wolfe has been leading Duke University Medical School’s Coronavirus Task Force, where he has been on the frontlines treating COVID-19 patients. He is a nationally recognized immunologist and infectious disease expert, specializing in HIV infection, transplant-related infectious diseases, general infectious diseases, biological and emergency preparedness for hospital systems, influenza and respiratory viral pathogens. He completed his fellowship in infectious diseases at Duke University School of Medicine, and his M.B.B.S from the University of Melbourne. He is currently an investigator on the Phase 3 study for Remdesivir (GS-5734) in severe COVID-19 participants, a Phase 3 study of Remdesivir in Moderate COVID-19 patients, the Adaptive COVID-19 Treatment Trial (ACTT), and the CARE Focus 1: Latency Biomarker Project.
Woo Joo Kim, MD, PhD
Dr. Woo Joo Kim is currently a Head of the Division of Infection Control at Korea University Guro Hospital in South Korea. He earned his medical degree and completed his internship, residency, and fellowship at Korea University College of Medicine. He is now the professor of Infectious Diseases at Korea University College of Medicine. Dr. Kim has over 33 years of experience and is well known as Korea's top infectious disease expert. Dr. Kim served as a Director of the Division of Respiratory Virus at Korea National Institutes of Health (NIH) and Korea Influenza Center. He also led the Korean government's epidemiological study of the MERS outbreak as the Head of the Korean Society of Infectious Disease.
Cecil Czerkinsky, DMD, PhD, DrMedSci
Dr. Cecil Czerkinsky, DMD, PhD, DrMedSci is a Research Director for the French National Institutes of Health and Medical Research (INSERM) at the Institut de Pharmacologie Moléculaire et Cellulaire (IPMC), a joint CNRS-INSERM-University of Nice research center located in the Sophia-Antipolis Science Park on the French Riviera. He previously served as Deputy Director General and Head of R&D at the International Vaccine Institute and as Professor at Göteborg University, Sweden. Dr. Cecil Czerkinsky is a Senior Scientific Advisor for Enzychem Lifesciences. He is also playing a role as Chief Scientific Advisor leading mRNA vaccine development. He has an extensive background in vaccine research and was the inventor of several proprietary technologies pertaining to mucosal vaccines, immunotherapy & immunodiagnostics which have been licensed to major pharma corporations. Dr. Czerkinsky is also an investor of the ELISSpot assay, a technique used worldwide for measuring human immune responses to anti-infectious and cancer vaccines. With more than 40 years of experience, he has published over 200 articles and 20 patents in the areas of immunology, with a main focus on vaccine science.
Corporate Advisory Committee
Frank Castellana, MD, Eng.Sc.D.
With more than 40 years of experience in healthcare industry, Dr. Frank Castellana has held Vice President positions at Bristol-Myers Squibb (BMS), for both the Pharmaceutical and Medical Device Divisions and assisted in the acquisitions of new drug candidates. Prior to joining BMS, he was associate professor of Chemical and Bioengineering at Columbia University. From 1977, he also served as a Medical Director, Senior Vice President for ConvaTec, Director of Medical and Regulatory Affairs at Squibb Diagnostics and many others. Dr. Castellana is a key authority in clinical development strategies such as market analysis, target product profile (TPP), and valuation. His areas of expertise include product development and commercialization strategy, product and licensing transaction valuation and portfolio strategy. Dr. Castellana received his medical degree from Albert Einstein College of Medicine of Yeshiva University and BS and Eng.Sc.D. from Columbia University in the City of New York.
Alexander Fleming, MD
Dr. Alexander “Zan” Fleming is co-founder, President and CEO of Kinexum, a life sciences strategic consulting organization that has helped over 400 companies. He has served on over a dozen corporate and advisory boards for major pharma and biotech companies. Previously, he was chief medical officer of Boston Medical Technologies and chief scientific officer of Ingenix Pharmaceutical Services – A UnitedHealth Group Company, and CEO of Tolerion. He also served as the Chief Technology Officer (CTO) for Enzychem Lifesciences. For 12 years, he served as reviewer and supervisory medical officer in FDA’s Center for Drug Evaluation and Research (CDER). He had regulatory responsibility in the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications. Dr. Fleming was responsible for multiple landmark approvals including the first statin, biotech products, and metformin. His regulatory and technical expertise has been requested in numerous international settings including the World Health Organization (WHO), where he was assigned during 1991-92. Dr. Fleming represented FDA on multiple expert working groups of the International Conference on Harmonisation (ICH). He was a major contributor to FDA’s Good Review Practice (GRP) initiative, and chair of the committee responsible for education and training at CDER.
History
2022
2021
NOVEMBER
pDNA Vaccine Partnership with Zydus Cadila
OCTOBER
CRIOM Phase 2 Study Successfully Completed
SEPTEMBER
CRIOM Phase 2 Stage 2 Database Lock Completed
JUNE
International Liver Congress 2021 (EASL) Presentation of First in-class, Orally Active TLR Signaling Inhibitor Mosedipimod Attenuates Molecular, Biochemical and Histologic Features of NASH in vitro and in vivo
MAY
2021 NASH-TAG Conference Presentation of TLR Signaling Inhibition with Mosedipimod
2021 Keystone Symposia Poster Presentation of DAMP/Toll-like Receptor Signaling Attenuation with Mosedipimod: Effect in vitro and in two animal models of NASH
APRIL
AACR Poster Presentation of Suppressive Effect of PLAG on Tumor Progression and its Synergistic Therapeutic Effect with ICI therapy through Adenosine Clearance
CRIOM Phase 2 Stage 2 Patient Enrollment Completed
MOU for Research Collaboration on Space Health Solution with Inha University
JANUARY
NASA Grant Funding Received to Evaluate EC-18 as a Protective Agent for Radiation and Pathogen-Induced Tissue Damage and Inflammation in Space
2020
OCTOBER
Two RRS Presentations of EC-18’s Efficacy as ARS Treatment
SEPTEMBER
ESMO Presentation of Synergistic PD-1 Antibody Anticancer Effect of EC-18 on Lung Cancer
AUGUST
COVID-19 Phase 2 IND US FDA Approval
JUNE
AACR Presentation of Synergistic PD-L1 Antibody Anticancer Effect of EC-18 on Bladder Cancer and EC-18’s Efficacy in CRIOM
MAY
COVID-19 Phase 2 IND Korea MFDS Approval
1st Evaluation of the Space Radiation Treatment Development Project Passed by NASA
JANUARY
Biotech Showcase Company Presentation
2019
DECEMBER
AFRRI and DoD Collaboration for EC-18 as Radiation Medical Countermeasure
NOVEMBER
AASLD Presentation for EC-18 Efficacy in NASH
OCTOBER
AACR-NCI-EORTC Conference Presentation of EC-18 in Anti-Cancer and Anti-Metastasis Effect and CIN Phase 2 Part 1 Study Results
MAY
ARS Phase 2 Multi-Animal Studies FDA Approval
CIN Phase 2 Stage 1 Study Completed
FEBRUARY
CRIOM Phase 2 Stage 1 Patient Enrollment Study Completed
EU GMP Approved
JANUARY
RNCP and CCRP’s support selected by NIH NIAID
2018
JUNE
Enzychem Lifesciences USA, Inc Established and Global Operation Launched
MARCH
Fast Track Designation by US FDA on CRIOM
FEBRUARY
Listed on the KOSDAQ Stock Market (KOSDAQ: 183490)
2017
DECEMBER
Orphan Drug Designation by US FDA on ARS
JULY
CRIOM Phase 2 IND US FDA Approval
MAY
AAI Presentation
2016
DECEMBER
CIN Phase 2 IND Korea MFDS Approval
NOVEMBER
3rd KDDF Government Grant for Global New Drug Development Awarded
JULY
CIN Phase 2 IND US FDA Approval
MAY
AAI Annual Meeting Presentation
2015
OCTOBER
2nd KDDF Government Grant for Global New Drug Development Awarded
MAY
CIN Phase 1 IND Approved by US FDA
MARCH
GMP Qualification Approved by Japan PMDA
FEBRUARY
1st KDDF Government Grant for Global New Drug Development Awarded
JANUARY
Pharm Navi Selected by Korea MFDS
New Technology Product Selected by the Korea MOTIE
2014
SEPTEMBER
CIN Investigators Initiated Study Completed at Asan Medical Center
JULY
EC-18 Approved IND by Korea MFDS
2013
SEPTEMBER
Listed on the KONEX Stock Market
JANUARY
Plant 2 Certified for GMP by Korea MFDS
1st Human Clinical Trial for EC-18 Conducted by Myung-Ji Hospital of Kwandong University
2011
JUNE
New Health Technology Certification Acquired from KHIDI
MARCH
Columbus Project Company through the Korea MOHW
FEBRUARY
Successful Commercial Production of EC-18
2009
APRIL
Plant Inspection Completed by Otto Brands GmbH, Hamburg, Germany for D – Cycloserine Production
2008
APRIL
Plant 1 Certified for GMP by Korea MFDS
2007
MARCH
INNOBIZ Certification Awarded by SMBA
2004
NOVEMBER
"Tower of Million-Dollar Export" Awarded by Korea MOTIE
2000
MARCH
Korea Good Technology Mark Acquired by Korea MEST
1999
JULY
Enzychem Lifesciences is Founded