Author: Roselin Oonsiri

Synedgen Announces $2.2 Million JWMRP Award for MIIST305 For Use as a Prophylactic Radiation Medical Countermeasure

 – Work builds upon prior MIIST305 development in radiation mitigation and ulcerative colitis –

 CLAREMONT, Calif., October 31, 2024 – Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced that it has been awarded a $2.2 million contract from the Joint Warfighter Medical Research Program (JWMRP) for the development of its lead therapeutic, MIIST305, as a prophylactic radiation countermeasure.

MIIST305 is an orally delivered, shelf-stable, gut-restricted therapy that promotes gut barrier regeneration and mitigates gastrointestinal-driven systemic hyperinflammation.  MIIST305 is being developed by Synedgen as a treatment for Ulcerative Colitis (UC). With support from the Biomedical Advanced Research and Development Authority (BARDA), MIIST305 is additionally being developed as a medical countermeasure for acute radiation syndrome (ARS) when administered after acute exposure to ionizing radiation.

The JWMRP contract furthers the understanding of MIIST305’s efficacy in preventing damage from radiation by administration before radiation exposure. The award will fund drug substance and drug product manufacturing for animal studies in two species to assess dose administration timing for optimal efficacy.

“The risk of exposure to ionizing or nuclear radiation by military personnel, first responders and civilians is perhaps greater now than it has ever been. However, there is no available FDA approved therapeutic to provide protection from radiation injury to the gastrointestinal tract. We are developing MIIST305 to address this need and to provide prophylaxis for those who have anticipated radiation exposure,” said Shenda Baker, PhD, President and CEO of Synedgen. “In addition, we anticipate the results from this JWMRP funded program will also have important readthrough and benefits for our ulcerative colitis and post-exposure ARS programs.”

“The gastrointestinal tract is among the most vulnerable tissues to radiation injury. In addition to weaponized or accidental radiation exposure, this type of gastrointestinal injury is also commonly observed in cancer patients who receive certain types of radiation treatments,” said Constantinos Broustas, Associate Professor of Radiation Oncology at Columbia University Vagelos College of Physicians and Surgeons and principal investigator of a study of the drug’s efficacy as a treatment after radiation exposure. “As a prophylactic treatment, MIIST305 could have far-ranging implications not just as a radiomitigating countermeasure, but also as a protective measure for oncology patients.”

Although several FDA-approved drugs are available to counteract the later effects of hematopoietic acute radiation syndrome (H-ARS), no FDA-approved medical countermeasures have been approved to mitigate gastrointestinal radiation injury scenarios. In the case of gastrointestinal acute radiation syndrome (GI-ARS), radiation toxicity causes destruction of the intestinal epithelial barrier, allowing bacterial invasion into the mucus layer, causing inflammation, bacterial translocation, further damage to the GI tract, and death. MIIST305’s demonstrated activity the GI tract allows for development both as a potential prophylactic and post-exposure therapeutic for GI-ARS.

Disclaimer

This material is based upon work supported by the Defense Health Agency under Contract No. HT9425-24-C-0049. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Defense Health Agency.

About MIIST

Synedgen’s Multivalent Innate Immune Signaling Target (MIIST) platform targets receptors in 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. 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

ALPHARETTA, GA, October 19, 2021 – Scapa Healthcare, an SWM International (NYSE: SWM) business and the trusted strategic partner for the world’s leading companies in advanced wound care, consumer wellness, and medical device and fixation, and Synedgen Inc., a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, announced today that they have signed an exclusive worldwide licensing agreement for two novel innovative wound care treatments developed using Synedgen’s proprietary glycochemistry technology platform. The agreement also gives Scapa Healthcare the right to use Synedgen’s glycopolymer technology in conjunction with other wound care technologies.

Under the terms of the agreement, Scapa Healthcare has exclusive rights over Synedgen’s glycopolymer technology in the field of dermal wounds and surgical care applications both over the counter and in the professional setting.

The advanced glycopolymer-based wound cleanser and wound hydrogel formulae are proven to control infection and promote wound healing by limiting bacterial infection, disrupting mature biofilm, and reducing inflammation and scarring of acute and chronic wounds and surgical incisions. Developed with support from the Defense Health Agency (DHA) and the Defense Advanced Research Projects Agency (DARPA), these wound care products are FDA 510(k) cleared and offer substantial advances over existing wound cleansers and wound hydrogels products in the market.

In addition to the two market-ready products, this technology offers a wide range of possibilities for customized wound management solutions in combination with other advanced wound care technologies including hydrocolloids, hydrogels, collagen and medical foam materials.

“We are delighted to be entering into this agreement with Synedgen, a company that shares our commitment to deliver innovative medical solutions that truly enhance people’s lives” said John Petreanu, president of the Scapa Healthcare business. “This novel glycopolymer technology strengthens our portfolio of advanced wound care products and enables us to bring cutting-edge wound management solutions to our customers in a variety of formats leveraging our skin contact adhesive and topical technologies.”

“This agreement with Scapa Healthcare will expand Synedgen’s effective approach to treating challenging wounds for patients worldwide,” said Shenda Baker, PhD, President and CEO of Synedgen. “With a rich Defense heritage, we have been able to create a new class of wound care products for warfighter and civilian use. We are honored to partner with such a well-known, world industry leader that adds to the level of consumer trust and experience to expand the application and distribution of this technology.”

With development and manufacturing facilities throughout North America and Europe, Scapa Healthcare offers single-source, dual supply to its partners. Scapa Healthcare’s facilities are ISO-certified and FDA-registered with cleanrooms and environmentally controlled rooms for full-scale production of finished goods. In April 2021, Schweitzer-Mauduit International, Inc., known as SWM International, acquired Scapa Group PLC, including the Scapa Healthcare business.

About SWM International:

Schweitzer-Mauduit International, Inc., operating as SWM International, is a leading global performance materials company, focused on bringing best-in-class innovation, design, and manufacturing solutions to our customers. Our highly engineered films, adhesive tapes, foams, nets, nonwovens, and papers are designed and manufactured using resins, polymers, and natural fibers for a variety of industries and specialty applications. SWM and its subsidiaries manufacture on four continents, conduct business in over 90 countries and employ approximately 5,000 people worldwide. For further information, please visit SWM’s website at www.swmintl.com.

SWM’s Scapa Healthcare business is the trusted strategic partner of choice for the world’s leading companies in advanced wound care, consumer wellness and medical device & fixation. Our strategy is to collaborate with industry leaders to develop and manufacture innovative skin friendly medical device fixation and topical solutions. Through pursuing these collaborations, Scapa now provides integrated services to the top global MedTech companies. Our state-of-the-art facilities enable Scapa Healthcare to offer customers the whole spectrum of production services from inception through to market delivery. For more information visit: scapahealthcare.com or email healthcare@scapa.com

About Synedgen:

Synedgen is a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system. The company’s lead development candidate is SYGN305 for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycochemistry platform has already generated five FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 program, to Synspira, for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information, please visit www.synedgen.com.

 

SWM | Scapa Healthcare Media Contact
Hillary Lima
SVM Public Relations and Marketing Communications
hillary.lima@svmpr.com
(401) 490-9700

Synedgen, Inc. Media Contact
Laurence Watts
Gilmartin Group, LLC.
laurence@gilmartinir.com
(619) 916-7620

 

– Trial funded by Defense Health Agency (DHA) through US Army Medical Research and Development Command’s (USAMRDC) Small Business Innovation Research (SBIR) program –

– SynePure and Catasyn are FDA 510(k) cleared wound care medical devices –

 

CLAREMONT, Calif., August 5, 2021 – Synedgen, a biotechnology company using glycopolymer chemistry to develop therapeutics that enhance and control signaling in the innate immune system, today announced the initiation of a randomized controlled trial (RCT) to test the safety and effectiveness of SynePure™ Wound Cleanser (SynePure) in combination with Catasyn™ Advanced Technology Hydrogel (Catasyn) for the treatment of superficial partial-thickness burn wounds.

This study is an investigator-initiated randomized trial comparing SynePure and Catasyn (intervention group) to the current gold standard treatment, Silvadene (control group). Both groups will receive the same care other than cleansing treatment. Subjects will be recruited from the University of Pittsburgh Medical Center (UPMC) Mercy Burn Center adult patient population who have sustained superficial partial- thickness burn wounds. Dr. J. Peter Rubin, MD, the Chair of Plastic Surgery at UPMC, is the principal investigator for this study. The trial is being funded by the Defense Health Agency (DHA) through the US Army Medical Research and Development Command’s (USAMRDC) Small Business Innovation Research (SBIR) program to improve the current treatment of burn wounds, particularly to meet a gap in the early acute phase of treatment and will potentially increase the technological readiness level of these products.

“We’re excited to announce that the first patient has received treatment in the burn study,” said Shenda Baker, Ph.D., President and Chief Executive Officer of Synedgen. “We believe the combination of our two wound care products is not only safe but improves time-to-heal and infection rates in superficial partial-thickness burn wounds versus the current standard of care treatment. We are thankful to our partners at the DHA and USAMRDC for funding this important study, which we hope will introduce an improved standard of care for partial thickness burns.”

“Burn wounds are associated with significant morbidity and mortality as well as quality of life impairments for the patient. Burn wounds are particularly problematic, as they can compromise skin integrity, which can lead to infection,” said J. Peter Rubin, MD, UPMC Endowed Professor and Chair of Plastic Surgery and principal investigator for the study. “Moreover, thermal destruction of the skin provides an ideal environment for microbial colonization where, if left untreated, infection can spread to a systemic level. I am pleased to be leading this study and very much look forward to its findings.”

SynePure and Catasyn are Food and Drug Administration (FDA) 510(k) cleared wound care medical devices, formulated with a novel glycopolymer designed to be biocompatible and protective of dermal surfaces. SynePure is optimized for the cleansing and debridement of wounds and thermal injuries, while Catasyn is a protective gel dressing that provides an environment that supports wound healing. SynePure and Catasyn are biocompatible, shelf-stable up to two years, non-staining, and may be used in any care setting from the battlefield to a tertiary hospital.

Current Defense standard-of-care offers an array of antimicrobial, silver-based, stem cell, or autologous graft therapies which are normally deployed in the day(s) or week(s) following initial trauma. SynePure and Catasyn are first-in-class products can be used to treat initial trauma within the acute care gap of the minutes or hours immediately following traumatic injury. Immediate use following injury reduces time to healing, provides a protective barrier against infiltration by damage-causing microbes, and in some cases, reduces scar formation. Results from this RCT are expected not only to enhance choice of care available to warfighters, but also permit a significant enhancement in civilian care by bringing cutting-edge technologies to the patient bedside.

SynePure and Catasyn were developed with grants from the Army and DARPA (W81XWH-13-C-0053 and N66001-12-C-4053), with the RCT funded through SBIR contract W81XWH-16-C-0023 with the USAMRDC SBIR office.

About Synedgen

Synedgen is a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system. The company’s lead development candidate is SYGN305 for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycochemistry platform has already generated five FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 program, to Synspira, for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information, please visit www.synedgen.com.

 

Contact:

Laurence Watts

Gilmartin Group, LLC.

619 916 7620

laurence@gilmartinir.com

– Synvaza is an oral treatment that manages pain and promotes healing for many types of oral wounds, injuries, and ulcers –

– Premium addition to Prisyna, Synedgen’s oral health portfolio, which includes Moisyn® and Moisyn® Mist for dry mouth –

CLAREMONT, Calif. June 4, 2020 – Synedgen, a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Synvaza Mouth Sore and Wound Rinse over-the-counter (OTC). Synvaza is the most recent addition to Synedgen’s oral health care business unit, Prisyna, which already includes Moisyn and Moisyn Mist for dry mouth, as well as Synedent® and Synedent® FLX oral rinses.

“The Agency’s clearance of Synvaza provides a new and effective treatment option that helps manage pain while promoting healing for patients who suffer from painful ulcers and mouth sores of the oral mucosa. Synvaza also provides an innovative solution for patients with many types of oral wounds, including traumatic ulcers and surgical injuries,” said Shenda Baker, Ph.D., President and Chief Executive Officer of Synedgen. “With Prisyna’s multiple offerings, Synedgen is uniquely positioned to improve oral health across multiple patient segments.”

Prisyna’s oral care portfolio contains cutting-edge ChitoTek® technology, which has been developed using Synedgen’s proprietary glycochemistry platform. Synvaza is an oral wound rinse formulated with ChitoTek, mucoadhesive, hygroscopic biopolymers that form a protective barrier around oral wounds to prevent irritation and help manage pain. This formulation provides a moist wound environment, which is optimal for wound healing.

In a clinical study, Synvaza was shown to decrease pain associated with ulcerative oral lesions. Patients reported decreases in oral soreness related to drinking, swallowing, eating, talking, and sleeping. Pain relief was reported by patients including those with aphthous stomatitis, oral lichen planus, and chronic graft versus host disease. Studied lesions were associated with medications, cancer treatment, acid reflux, and other underlying conditions.

Synedgen’s glycochemistry platform is also being used to develop therapeutics for pulmonary and gastrointestinal diseases, as well as for ocular and dermal injuries. Synedgen has developed its technology with support from the Defense Advanced Research Projects Agency (DARPA), Defense Health Agency (DHA), Medical Research and Materiel Command (MRMC), and six institutes of the National Institutes of Health. We formally thank the National Institute for Dental and Craniofacial Research (R44DE019740) for supporting Synvaza’s development.

 

About Award

The project described was supported by Award Number R44DE019740 from the National Institute Of Dental & Craniofacial Research. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Dental & Craniofacial Research of the National Institutes of Health.

About Synedgen

Synedgen is a biotechnology company using glycochemistry to develop therapeutics that mimic and enhance the innate immune system. The company’s lead development candidate is SYGN305 for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycochemistry platform has already generated seven FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 drug program, to Synspira (Framingham, MA), for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information, please visit www.synedgen.com.

 

Contact:

Laurence Watts

Gilmartin Group, LLC.

619 916 7620

laurence@gilmartinir.com