Toralgen and Yale scientists demonstrate an oral drug delivery platform that will enable improved compliance and patient experience for biotherapeutics such as those used to treat diabetes.
INDIANAPOLIS, Indiana (October 6, 2021) – Toralgen, a biotechnology company focused on transforming the delivery of biologic drugs, and Yale University today announced the publication in Nature Biomedical Engineering of preclinical studies highlighting the effectiveness of Toralgen’s novel drug delivery platform in delivering active biologics via oral administration. Until now, this category of therapeutic drugs had to be administered via injection or intravenously.
The publication, Metabolic and immunomodulatory control of Type 1 diabetes via orally delivered bile-acid-polymer nanocarriers of insulin or rapamycin, is the result of more than a decade of research at Fahmy Labs (Yale University) by inventor and Toralgen cofounder, Tarek Fahmy, PhD. This work is the basis for Toralgen’s development of patented platform technology that facilitates the oral administration of active biologics used to treat diabetes and other conditions.
“To date there have been no therapies for diabetes that regulate glucose metabolism while simultaneously addressing the underlying cause of the disease. Our carrier works synergistically with the drug to regulate metabolic insulin levels while simultaneously restoring immune regulation and correcting for immune dysfunction. Those two activities make this a powerful short term therapeutic with potential to reverse disease in the long-term.” Dr. Fahmy said.
Toralgen’s poly-bile nanoparticle platform is unique in that it eliminates the challenges associated with the oral delivery of biologic drugs with a simple-to-fabricate pill. Our nanoparticles protect drug cargo as they pass through the gastrointestinal system and localize delivery of drug agents, potentially improving efficacy and safety of a wide range of therapies. Toralgen CEO Gerald Rea noted that this paper emphasizes the “potential of the platform to deliver, in a non-immunogenic and tolerogenic manner, novel oral therapies ranging from small molecules to insulin and large biologics.
“We are excited to share these data and the achievements of Dr. Fahmy and his lab as we mature the technology toward positively impacting patients’ lives,” Rea said.
About Toralgen, Inc.
Toralgen, Inc. is a preclinical stage biopharmaceutical company focused on the development and commercialization of human therapeutics. Its poly-bile nanoparticle platform eliminates many of the inherent challenges of biologics and has the potential to improve outcomes through optimized drug delivery. Toralgen is currently studying treatments for diabetes and autoimmune disorders. For information or to inquire about possible collaborations, visit our website.
Contact: Dave Moore, Toralgen, dnmoore@toralgen.com
INDIANAPOLIS, Indiana (April 28, 2021) – Toralgen, an Indiana-based biotechnology company focused on improving the delivery of biologics today announced the addition of Ed Bastyr III, MD to the newly created role of chief medical officer/clinical adviser. Dr. Bastyr will oversee Toralgen’s clinical drug development, bringing more than 25 years of clinical drug development experience “We are delighted to add Ed to our leadership team. His significant experience in clinical development is ideally suited to advance Toralgen into a clinical-stage company” said CEO, Gerald Rea.
Dr. Edward J Bastyr III work in science has taken him from basic bench research to clinical research in academic medicine and industry with the most recent 25 years dedicated to the pursuit of innovation in diabetes treatment, supporting both large pharma and smaller biotechnology companies. In various leadership roles at Lilly Research Laboratories (LRL), he was responsible for the development of several new molecular entities and was recognized by LRL with the President’s Recognition Award for Outstanding Scientific Achievement (Top 1% scientist Award) in 2002, 2009, and 2014. Subsequently he served as VP Medical at MB2, a small biotechnology company, where he developed unique peptides for the treatment of diabetes until the successful sale of the company and transfer of these peptides to Novo Nordisk. Dr. Bastyr is board certified by the American Board of Internal Medicine in Internal Medicine and Endocrinology Diabetes and Metabolism and is Associate Professor at Indiana University School of Medicine where his clinical responsibilities include the clinical training of the endocrinology fellows. Dr. Bastyr has published more than 150 abstracts and manuscripts in diabetes peer reviewed publications.
GlobalData Healthcare highlights Toralgen's drug deliver platform potential in diabetes: "Toralgen’s technology provides a significant promise to oral delivery of major diabetic therapies"
StartUs evaluated 266 emerging Biotech start-ups and highlighted Toralgen as one of 5 promising drug delivery startups.
INDIANAPOLIS, IN., December 14, 2020 – Toralgen, an Indiana-based biotechnology company has announced the successful completion of its second seed funding round, raising a total of $8.3 million. The preclinical stage company will use the funds to further development of their novel nanoparticle drug delivery platform and advance industry partnerships.
Participants in the round include Elevate Ventures, Solyco Advisors, and VisionTech Angels well as investors and strategic partners with deep domain expertise.
All of the company’s original investors participated in this second seed round. CEO Gerald Rea said, “This is a clear sign of confidence in our drug delivery platform technology and the commercial potential. Our strong preclinical data, growing world-class team, and industry interest give our company and investors great confidence going forward.”
Toralgen’s poly-bile nanoparticle platform is unique in that it eliminates the challenges of oral drug delivery in one, simple-to-fabricate nanopill. These nanopills also localize delivery of drug agents and potentially improve efficacy and safety of a wide range of therapies. Toralgen currently has two candidates in preclinical testing for the oral delivery of diabetes agents.
INDIANAPOLIS, IN., Nov 30, 2020 -- Toralgen, Inc., an Indiana-based biotechnology company is pleased to announce that it was accepted into the FDA's Emerging Technology Program. Toralgen is a preclinical stage company focused on developing a proprietary bile acid platform that has the potential to significantly improve drug delivery.
The Emerging Technology Program was created by FDA to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing. Through the program, industry representatives can meet with Emerging Technology Team (ETT) members to discuss, identify, and resolve potential technical and regulatory issues regarding the development and implementation of a novel technology prior to filing a regulatory submission. We view this as the beginning of a productive partnership with regulators to ensure safe development and implementation of this novel drug delivery technology.
"We are encouraged that our technology was well received by the Emerging Technology Team," said Gerald Rea, CEO "We appreciate the opportunity to gain valuable guidance as we develop a drug delivery platform that has so many potential applications across a wide variety of therapeutic areas.”
INDIANAPOLIS, IN., Oct. 28, 2020 – Toralgen, Inc., an Indiana-based biotechnology company focused on significantly improving drug delivery is pleased to announce that Gerald Rea, CEO, was selected to present at the CLINAM (The European Foundation for Clinical Nanomedicine) conference held October 26, 2020 through October 28, 2020. Mr. Rea co-presented with Dr. Caballido, Novartis Institute for Biomedical Research, on Orally Administered Polymetric Bile Acid Nanoparticles to Restore Glucose Control and Induce Immune Tolerance in Early and Advanced Diabetes.
INDIANAPOLIS, IN., March 1, 2020 – Toralgen, Inc., a preclinical stage company focused on improving drug delivery, today announced several additions to its’ leadership team. David Moore has joined the company as COO and Ron Bowsher and Andy Glasebrook have joined as company advisors.
“I am happy to formally welcome these gentlemen to the team. Between them, they bring over 100 years of excellence in pharmaceutical research, development, and commercialization to Toralgen.” CEO, Gerald Rea, continued, “We have an opportunity to drastically improve outcomes for patients suffering from autoimmune diseases and diabetes. Insights from Dave, Ron, and Andy will accelerate our path forward.”
Mr. Moore brings over 27 years of experience in drug development, business development, commercialization, and operations experience from his time at Eli Lilly & Co. He held a variety of leadership roles that resulted in several in-licensing deals and successful brand launches in diabetes and neurosciences. He brings extensive experience to the company in operational excellence as well as the ability to develop and launch of blockbuster brands. His final role at Lilly was as Sr Director of Global Market Research and Analytics. Mr. Moore received his bachelor’s degree from Purdue University and a Master of Business Administration from Kelly School of Management at Indiana University.
Dr. Glasebrook brings 32 years of research and drug development experience at Eli Lilly & Co. Andy is recognized for his leadership, organizational skills and technical expertise contributions to both small and large molecule drug discovery efforts in autoimmunity and osteoporosis that resulted in advancing numerous drug candidates from preclinical discovery to clinical evaluation and launch. Dr. Glasebrook established an immunology/autoimmunity research team of >20 scientists at the San Diego Lilly Biotechnology Center to identify and preclinically validate large molecule therapeutic opportunities in autoimmunity. He is a Past-President of the Inflammation Research Association, a named inventor on 9 issued US patents and co-author of 100 scientific publications. Dr. Glasebrook received a PhD in Immunology from the University of Chicago followed by postdoctoral training at the Swiss Institute for Experimental Cancer Research in Lausanne, Switzerland.
Dr. Bowsher brings to Toralgen 45 year of experience in the pharmaceutical/biotechnology and CRO industries. He is a recognized thought-leader in the areas of bioanalytical methods development for regulatory-compliant bioanalysis, ADME and immunogenicity assessments of biotherapeutics. He received his M.S. and Ph.D. degrees in Biochemistry & Molecular Biology at the Indiana University School of Medicine. He has published >200 research papers, monographs, and abstracts, has four patents, 75 invited lectures, been a consultant to >100 global companies and has served on several scientific advisory boards. He is a Past-Chair of the AAPS BIOTEC Section and AAPS Fellows Committee. Currently, he is Partner and CSO at B2S Life Sciences™, which provides analytical support to Toralgen.
INDIANAPOLIS, IN., September 10, 2019 – – Toralgen, Inc., an Indiana-based biotechnology company, announced the closure of its seed funding round, raising more than $1.9 million. Participants in the round include VisionTech Angels, Elevate Ventures, and Solyco Advisors as well as investors and strategic partners with deep domain expertise.
For people with Type 1 diabetes, a life free from injections and 24/7 monitoring of their blood glucose levels may seem only a fantasy, but an Indianapolis-based biotech company believes relief could come in pill form. Toralgen Inc. is developing a drug delivery technology it says can take existing drugs that have to be injected and transform them into oral medications.
Indianapolis-based Toralgen Inc. says it has raised nearly $2 million in seed funding for what the company calls its transformative drug delivery tool. The biotechnology firm is attempting to commercialize a nanopill system, a microscopic-sized dose of medication, for diabetes control and other diseases.