Author: Auston Sterling

CLAREMONT, Calif., October 15, 2024 – Synedgen Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced a partnership valued at up to $119 million over a six-year period with the Biomedical Advanced Research and Development Authority (BARDA), a center within the Administration for Strategic Preparedness and Response, part of the U.S. Department of Health and Human Services. This contract aims to develop Synedgen’s lead therapeutic, MIIST305, to address Gastrointestinal Acute Radiation Syndrome (GI-ARS) arising from acute exposure to ionizing radiation. The initial phase of the award provides up to $17 million for proof-of-concept studies in two animal models. If all options are exercised, this BARDA contract will advance MIIST305 development through U.S. Food and Drug Administration (FDA) approval and contribute to the field of medical countermeasures research by optimizing a new nonclinical GI-ARS model for FDA acceptance.

“We are delighted to be partnering with BARDA to develop MIIST305 as a therapeutic to address GIARS,” said Shenda Baker, Ph.D., President and CEO of Synedgen. “No currently available FDA-approved therapeutic exists to provide protection to major gastrointestinal organs against acute exposure to ionizing radiation. Importantly, this program leverages Synedgen’s MIIST305 program to address gastrointestinal inflammation and damage from radiation, chemical or physiological sources, thus potentially meeting this unmet need.”

Synedgen has developed a drug design platform called Multivalent Innate Immune Signaling Target (MIIST) to identify and synthesize an innovative class of glycomedicines. MIIST305, derived from this platform, is a non-systemic therapeutic that modulates innate immune receptor responses and targets the anionic glycocalyx at the gastrointestinal cell surface to repair and restore the gut mucosal barrier. By doing so, MIIST305 is designed to mitigate the systemic hyperinflammation and dysbiosis that are characteristic of the gastrointestinal injury caused by acute radiation exposure. MIIST305 is shelf-stable and orally administered, obviating the need for specialized administration in an emergent scenario. In a Phase 1-ready program established independently of the partnership
with BARDA, MIIST305 is also being developed as a therapy for ulcerative colitis (UC).

GI-ARS occurs when patients are exposed to a high level of radiation by sources which may be accidental or malicious in nature. ARS and UC are marked by similarities in disease pathophysiology, including mucosal barrier disruption, enterocyte death, activation of hyperinflammatory pathways, and dysbiosis. GI-ARS is a major radiation toxicity that can lead to sepsis and death. While there are four FDA approved products for hematopoietic acute radiation syndrome (H-ARS), there remains an unmet need for therapies that address GI-ARS. Together with BARDA, Synedgen is meeting this critical gap in national defense preparedness.

“Today’s announcement marks an important step in moving forward Synedgen’s innovative MIIST platform to produce therapies at the leading edge of medicine,” said LTC (retd.) Mark Bohannon, former Chief of the Medical Branch for the Joint Requirements Office for Chemical, Biological, Radiological, and Nuclear Defense (JRO-CBRND). “The development of MIIST305 as an FDA-approved GI-ARS therapeutic, in addition to its development as a UC drug, would be a major step forward in our efforts to improve not just civilian health but also provide a necessary option for furthering U.S. medical countermeasures against radiation threats.”

Disclaimer
The views and opinions presented herein are those of the contributing parties and do not necessarily represent the views of DoD or the Army. Appearance of, or reference to, any commercial products or services does not constitute DoD or Army endorsement of those products or services. The appearance of external hyperlinks does not constitute DoD or Army endorsement of the linked websites, or the information, products or services therein.

About Synedgen, Inc.
Synedgen, Inc. (Claremont, CA) is a biotechnology company developing Multivalent Innate Immune Signaling Target (MIIST) therapeutics that modulate and enhance the innate immune system. The company’s lead development candidate is MIIST305, an oral, glycocalyx-targeted therapy for ulcerative colitis (UC) and a medical countermeasure for gastrointestinal acute radiation syndrome (GI-ARS). MIIST technology has been validated with clinical trials in partnered programs and extensively peer-reviewed through National Institutes of Health grants and Department of Defense contracts. Synedgen’s GI-ARS program is funded in whole or in part with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority, under Contract No. 75A50124C00047. For more information, please visit www.synedgen.com.

Contact:
Laurence Watts
619-916-7620
laurence@newstreetir.com

Dr. Oien brings extensive entrepreneurial experience to Synedgen’s board

CLAREMONT, Calif., September 24, 2024 – Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced the appointment of Dr. Hal J. Oien to its board of directors.

“Dr. Oien’s appointment reflects the impactful contribution he has made as a key member of Synedgen’s Scientific Advisory Board. He maintains an expansive scientific vision while simultaneously focusing closely on product development and commercialization.” said Shenda Baker, PhD, President and CEO of Synedgen. “As a Director, his clinical and commercial expertise will be invaluable as Multivalent Innate Immune Signaling Target (MIIST) pipeline assets advance into the clinic.”

During his career, Dr. Oien has successfully leveraged his biomedical expertise as an entrepreneur for more than four decades. Dr. Oien is the President of Jordco Inc., where he oversees the Company’s product development, as well as sales and operations in the US, Europe, Middle East, Australia, Japan, and New Zealand. He recently co-founded H2O Molecular, Inc. (San Diego, CA), a biotechnology company focused on identifying microbial, oncologic, and pathogenic signatures from public water systems nationwide. Other successes include the development and launch of Interventional Hemostasis Products, Inc., a cardiac catheterization hemostasis device division that was sold to Advanced Vascular Dynamics (now Semler Technologies). He has served as the President of Interventional Hemostasis Products since 1992 and has been the Vice President of HemoBand Inc. for twenty years. In addition to his career achievements, Dr. Oien is a prolific scientific author and the inventor of record on 29 patents.

Notably, Dr. Oien has extensive regulatory experience that has led to FDA-cleared technologies that have been developed, patented and marketed worldwide. He is a trusted key opinion leader for civilian, academic, government and international partners. A noted philanthropist in his native state, Dr. Oien obtained a B.S. in Psychology from the University of California, Davis, a B.S. in General Science from the University of Oregon, and a D.M.D from the Oregon Health & Science University.

About Synedgen, Inc.

Synedgen, Inc. (Claremont, CA) is a biotechnology company developing Multivalent Innate Immune Signaling Target (MIIST) therapeutics that modulate and enhance the innate immune system. The company’s lead development candidate is MIIST305, an oral, glycocalyx targeted induction and maintenance therapy for ulcerative colitis (UC). With US Government support, MIIST305 is also being developed in parallel as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). MIIST technology has been validated with clinical trials in partnered programs and extensively peer-reviewed through twenty-two (22) National Institutes of Health grants and Department of Defense contracts. Synedgen has an in-house GMP manufacturing facility. For more information, please visit www.synedgen.com.

Contact:

Laurence Watts
619-916-7620
laurence@newstreetir.com

• Parallel programs will advance MIIST305 in ulcerative colitis (UC) and gastrointestinal acute radiation syndrome (GI-ARS)
• Phase 1 clinical studies expected to begin in 2025

CLAREMONT, Calif., April 25, 2024 – Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced it has completed IND-enabling studies for its lead candidate, MIIST305. MIIST305 is being developed for two parallel programs, an indication for ulcerative colitis (UC) and a medical countermeasure for gastrointestinal acute radiation syndrome (GI-ARS). Within a year, Synedgen plans to open an Investigational New Drug (IND) application for MIIST305 and initiate a Phase 1 clinical study to support both programs. Derived from Synedgen’s Multivalent Immune Signaling Target (MIIST) platform, MIIST305 is an orally delivered, gut-restricted, tissue regenerative drug candidate.

Synedgen was awarded a $4.4 million grant from the Congressionally Directed Medical Research Program (CDMRP) to fund some of MIIST305’s preclinical, IND-enabling studies. Previously, MIIST305 demonstrated evidence of restoring innate gut barrier function and early return to a healthy GI tract, both in murine models of radiation exposure and UC. MIIST305 has an excellent safety and toxicological profile. With CDMRP support, Synedgen has now completed dose administration testing, pharmacokinetic (PK) studies, IND-enabling Good Laboratory Practice (GLP) toxicology, a pre-IND meeting with the FDA and safety pharmacology studies as well as validated processes for chemistry, manufacturing, and controls (CMC).

“The completion of IND-enabling activities represents a significant milestone in our progress towards developing a treatment option for UC patients, the civilian application for MIIST305,” said Shenda Baker, PhD, President and CEO of Synedgen. “We are grateful for the CDMRP funding that has enabled us to complete preclinical studies of MIIST305, which could address an unmet medical need for a drug capable of rapid induction and sustained maintenance in ulcerative colitis. MIIST305 also holds great potential as a GI-ARS medical countermeasure, with the potential to reduce mortality after exposure to lethal ionizing radiation. To date, we have had constructive conversations with the FDA in pre-IND meetings for both MIIST305 programs, and we are enthusiastic about the potential to advance both our UC and GI-ARS programs into the clinic.”

In the U.S., UC is estimated to affect 214 per 100,000 people (or approximately 700,000). The UC drug market was worth approximately $7.5 billion worldwide in 2020, constituting 10% of the total immunology market. With limited treatment options, high rates of non-responsive or refractory patients, and frequent disease flares, there is a large unmet need for new therapies.

“There is an urgent need for innovative therapies that target the underlying disease, instead of just managing symptoms, considering that less than 30% of patients with UC achieve remission,” said Brian Feagan, MD, a gastroenterologist and Professor of Medicine at the Schulich School of Medicine & Dentistry in Ontario, Canada. “With its novel mechanism of action, excellent safety profile, and potential for combination therapy, MIIST305 could provide a much-needed therapy for the patients and physicians dealing with UC.”

About MIIST

Synedgen’s Multivalent Innate Immune Signaling Target (MIIST) platform targets the glycocalyx, a key to human innate immunity. Historically an underappreciated target in drug development, the glycocalyx is becoming more recognized as the key to intestinal homeostasis. Developed with extensive peer-review and funding from government partners, the MIIST platform is being used to advance a diverse array of therapeutics promoting mucosal barrier protection and regeneration. The Company is continuing to develop its GI-ARS program with support from key partnering agencies in the United States government.

About Synedgen

Synedgen, Inc. (Claremont, CA) is a biotechnology company developing Multivalent Innate Immune Signaling Target (MIIST) therapeutics that modulate and enhance the innate immune system. The company’s lead development candidate is MIIST305, an oral, glycocalyx targeted induction and maintenance therapy for ulcerative colitis (UC). With US Government support, MIIST305 is also being developed in parallel as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). MIIST technology has been validated with clinical trials in partnered programs and extensively peer-reviewed through twenty-two (22) National Institutes of Health grants and Department of Defense contracts. Synedgen has an in-house GMP manufacturing facility. For more information, please visit www.synedgen.com.

Contact:

Laurence Watts
619-916-7620
laurence@newstreetir.com