TSRL, Inc. Awarded $3 Million NIH Grant to Develop a First-in-Class Oral Antibiotic

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April 25, 2023, ANN ARBOR, MICHIGAN — TSRL, Inc., a privately held preclinical accelerator, announced today that the company was awarded a Phase IIB Small Business Technology Transfer (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institute of Health (NIH).

TSRL and its collaborators from the University of Washington were awarded $3 million over the next three years to conduct a successful development program that will be the foundation for an Investigational New Drug (IND) application for MRS-2541 (the lead candidate emerging from research conducted under our previous Phase II SBIR grant).

Acute bacterial skin and skin structure infections (ABSSSIs) pose a significant healthcare challenge in the United States, with over 14 million visits to ambulatory and hospital institutions each year. Considering this alarming statistic, our previous research has unveiled a novel antibiotic, MRS-2541, which exhibits a unique mechanism of action (MOA) and the potential for oral administration and would represent a major breakthrough in the treatment of Gram+ infections.

 

Traditionally, vancomycin has been the preferred treatment for hospitalized patients with ABSSSIs. However, rates of resistance or intermediate resistance to Staphylococcus aureus (SA) strains, which have now surpassed 5% and continue to climb, have now shed light on the urgent need for alternative therapeutic options.

 

Our extensive research has resulted in the revelation of MRS-2541, a novel small-molecule antibiotic. MRS-2541 exhibits a unique MOA by inhibiting the bacterial methionyl-tRNA synthetase enzyme (MRS), which is necessary for protein synthesis. Therefore, additional lead characterization studies will still be required to advance the lead candidate toward an IND application. This research holds the potential to revolutionize the treatment landscape for ABSSSIs, offering patients and healthcare professionals a much-needed alternative to addressing these complex infections.

 

About TSRL, Inc.:

TSRL, Inc. is a preclinical biotech accelerator. We collaborate with partners in academia and industry to develop early-stage therapeutics and drug delivery technologies. In these collaborations, we provide infrastructure, drug development expertise, and access to non-dilutive funding. Our portfolio holds promising lead-stage therapeutics. We are actively looking for new technologies and strategic partnerships. More information about TSRL, Inc. and portfolio technologies are available at http://www.tsrlinc.com or can be requested by contacting Elke Lipka, CEO, elipka@tsrlinc.com

TSRL, Inc. awarded NIH Grant to Discover Novel, Safe, Efficacious Heparin Reversal Therapy

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Ann Arbor, Michigan, December 8th, 2022 – TSRL, Inc., a privately-held preclinical accelerator, announced that in September the company was awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH).

TSRL and its collaborators from the University of Michigan and the University of British Columbia were awarded close to $400,000 to generate critical in vivo proof-of-concept data over the next year to de-risk their lead, second-generation, heparin-reversal therapeutic toward clinical development.

“We are excited to work with this world-class team on the development of a completely novel dendrimer-based therapy approach to rapidly restore blood clotting function when needed in a variety of conditions that require temporary or chronic heparin therapy.”
— TSRL’s CEO, Elke Lipka, PhD, MBA

Anticoagulants and their reversal agents are crucial for managing unwarranted blood clotting (i.e. thrombosis). Heparin is used for thrombosis prevention in multiple clinical indications, including procedures such as catheter ablation and cardiopulmonary bypass, after which heparin’s anticoagulant activity requires prompt neutralization.

Protamine sulfate, the only FDA-approved reversal agent for heparin, is a 60-year-old drug with a Black Box Warning. Its clinical use is constrained by two major limitations:

  1. Requirement of titration because of its very narrow therapeutic safety window.

  2. Potentially life-threatening hypersensitivity reactions or anaphylaxis manifesting as severe hypotension, cardiovascular collapse, pulmonary edema, pulmonary vasoconstriction, and pulmonary hypertension.

Thus, there is a large unmet medical need to discover and develop novel heparin reversal agents with a wider therapeutic window and better safety profile.

“Jay Kizhakkedathu, Ph.D. and colleagues at the University of British Columbia have developed a novel, safe drug platform that allows for safely blocking the action of all types of heparin – even low molecular weight heparins that currently lack an effective reversal agent. It is exciting to work with them and TSRL scientists to bring this promising drug candidate closer to the clinic.”
— James H. Morrisey, Ph.D. TSRL’s collaborator PI at the Univeristy of Michigan

About TSRL, Inc.:

TSRL, Inc. is a preclinical biotech accelerator. We collaborate with partners in academia and industry to develop early-stage therapeutics and drug delivery technologies. In these collaborations, we provide infrastructure, drug development expertise, and access to non-dilutive funding. Our portfolio holds promising lead-stage therapeutics. We are actively looking for new technologies and strategic partnerships. More information about TSRL, Inc. and portfolio technologies are available at http://www.tsrlinc.com or can be requested by contacting Elke Lipka, CEO, elipka@tsrlinc.com

TSRL, Inc.’s Microarray Patch (MAP) of Trospium Chloride for Overactive Bladder Disease Continues Development with Grant from the NIH

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TSRL, Inc.’s Microarray Patch (MAP) of Trospium Chloride for Overactive Bladder Disease Continues Development with Grant from the NIH

TSRL, Inc., a privately-held preclinical accelerator, has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institute of Health (NIH) for about $300,000 over 12 months.

TSRL, Inc. will continue to broaden its MAP portfolio with the development of a once-a-week patch of Trospium Chloride (TC) optimized for improved tolerance and patient outcomes in overactive bladder (OB) disease.

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TSRL, Inc. Awarded $1.7 NIH Grant to Develop Synthetic High-Density Lipoproteins (sHDL) for Treatment of Infection Complications such as Sepsis

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TSRL, Inc. Awarded $1.7 NIH Grant to Develop Synthetic High-Density Lipoproteins (sHDL) for Treatment of Infection Complications such as Sepsis

Ann Arbor, Michigan, September 5, 2021 – TSRL, Inc., announces its plans to develop a sHDL lead candidate for treatment of infection complications such as sepsis in collaboration with Anna Schwendeman, PhD, from University of Michigan. The company was awarded a Direct-to-Phase II Small Business Innovation Research (SBIR) grant from the National Institute of General Medical Sciences (NIGMS) of the National Institute of Health (NIH). TSRL and its collaborator, Dr. Anna Schwendeman, will receive an estimated $1.7M over the next two years to advance SPS-701 through preclinical development towards GLP toxicology testing.

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TSRL, Inc. CEO Speaks at in2being, LLC.'s Women Who Innovate Webinar

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TSRL, Inc. CEO, Elke Lipka, PhD, MBA, will be speaking at the in2being, LLC. MedTechCrossroads Women Who Innovate Series webinar subseries partnership with Michigan Economic Development Corporation.

The webinar will focus on how women are making a difference in the MedTech industry.

This is the final episode of our Women Who Innovate series. Don’t miss your last chance to hear from a panel of knowledgeable experts in MedTech.

– in2being, LLC.

The webinar will take place at 2:00 pm Eastern Time on Friday, August 26th, 2022

 

Registration is now closed.

About TSRL, Inc.:

TSRL, Inc. is a preclinical biotech accelerator. We collaborate with partners in academia and industry to develop early-stage therapeutics and drug delivery technologies. In these collaborations, we provide infrastructure, drug development expertise, and access to non-dilutive funding. Our portfolio holds promising lead-stage therapeutics. We are actively looking for new technologies and strategic partnerships. More information about TSRL, Inc. and portfolio technologies are available at http://www.tsrlinc.com or can be requested by contacting Elke Lipka, CEO, elipka@tsrlinc.com

TSRL, Inc. Awarded $3M NIH Grant to Continue Development of Microarray Patch (MAP) for Treatment of Influenza

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TSRL, Inc. Awarded $3M NIH Grant to Continue Development of Microarray Patch (MAP) for Treatment of Influenza

TSRL, Inc., announces the continued development of microarray patch (MAP) of Zanamivir (Relenza®), an inhalation drug product licensed for the treatment and prevention of influenza A and B. TSRL has exclusively licensed the MAP technology for its flu patch from Queen’s University Belfast, Northern Ireland, UK.

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PharmaTher and TSRL Enter into Co-Development Agreement For Microneedle Patch Delivery Technology for Psychedelics and Antivirals

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PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company and TSRL, Inc. (“TSRL”), a company focused on developing microneedle patches for the delivery of antivirals for the treatment of influenza, are pleased to announce that PharmaTher and TSRL (collectively the “Companies”) entered into a Co-Development Agreement to jointly develop a microneedle array patch with the aim to control the manufacturing and supply of microneedle patches for the Companies respective clinical and commercial drug programs.

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TSRL Announces the Appointments of Martha Farmer and Stephen Munk to Board of Directors, and Gregory Amidon as Chairman of the Board

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TSRL Announces the Appointments of Martha Farmer and Stephen Munk to Board of Directors, and Gregory Amidon as Chairman of the Board

TSRL, Inc., a preclinical accelerator, announces the appointments of Martha Farmer, PhD, and Stephen Munk, PhD to the Board of Directors, and Gregory Amidon, PhD, current board member, as Chairman. In addition, Dawn Reyna was appointed to Chief Operating Officer in January of 2019.

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TSRL, Inc. Awarded Two NIH Grants to Develop Therapeutics for Multi-Drug Resistant Infections

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TSRL, Inc. Awarded Two NIH Grants to Develop Therapeutics for Multi-Drug Resistant Infections

ANN ARBOR, MICHIGAN, August 10th, 2017—TSRL, Inc., a privately-held preclinical accelerator, announced today that the company was awarded a Phase I Small Business Technology Transfer (STTR) grant and a Direct-to-Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy & Infectious Diseases (NIAID) of the National Institute of Health (NIH).

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TSRL, Inc. Awarded NIH Grant to Develop Microneedle Patch for Treatment of Influenza

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TSRL, Inc. Awarded NIH Grant to Develop Microneedle Patch for Treatment of Influenza

ANN ARBOR, MICHIGAN, February 17, 2017—TSRL, Inc., announced today that the company was awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Institute of Allergy & Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). TSRL will receive approximately $600,000 over the next two years for the development of a transdermal delivery system of zanamivir (GSK, Relenza®), an inhalation drug product used in the treatment of influenza A & B.

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TSRL, Inc. Client Company Acquired by Allergan

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TSRL, Inc. Client Company Acquired by Allergan

Sept. 26th, 2016, Ann Arbor, Michigan: RetroSense Therapeutics, a privately-held biotechnology company developing novel gene therapies for vision restoration, announced that Allergan plc has acquired all assets related to its lead development program in an all-cash transaction. RetroSense’s RST-001 program employs a photosensitivity gene to restore vision in patients suffering from blindness due to retinitis pigmentosa (RP) and advanced dry age-related macular degeneration. Neither of these conditions have FDA-approved treatments to improve or restore vision.

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No Bugs, No Interest? How Public Search Queries for "ESKAPE" Pathogens Change Over Time

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No Bugs, No Interest? How Public Search Queries for "ESKAPE" Pathogens Change Over Time

Introduction

In July 2004, the Infectious Diseases Society of America (IDSA) released a report called "Bad Bugs, No Drugs." This report identified several species of antibiotic-resistant bacteria that were expected to play a lead role in the next global health crisis to come. The authors cited a high prevalence of drug-resistant infections--362,000 in the US in 2002--and lack of new antibiotics in development as warning signs. Twelve years have passed since the report published, and according to the CDC, >2 million people become infected and >23,000 die from drug-resistant infections every year. A 2009 paper by Boucher et al implicated six actors from their pathology, persistence, and presence in US hospitals: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter, Pseudomonas aeruginosa and Enterobacter. They termed them "ESKAPE" pathogens.

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TSRL, Inc. to Present at the 29th International Conference on Antiviral Research

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Ann Arbor, Michigan, March 3rd, 2016: TSRL Inc., a preclinical accelerator developing novel anti-infective therapeutics in areas of high unmet medical need, is presenting at the 29th International Conference on Antiviral Research (ICAR) April 17th - 21st at the Hilton La Jolla Torrey Pines hotel in La Jolla, CA.

Dr. Steven King will present on a "Genetically Optimized Banana Lectin for the Treatment of Influenza," and Dr. Eric Simon will present on an analytical method for characterization of BL-84, a genetically optimized therapeutic banana lectin. Furthermore, Dr. Shyamala Ganesan will present on the in vitro potency of nucleoside phosphonate analogues and Dr. Simon will present an LC-MS assay for measuring intracellular concentrations of USC-505, a nuceleoside phosphonate analogue.

Our collaborators Dr. William (Bill) Wold and Dr. Jennifer Moffat will present on the in vivo efficacy of nucleoside analogues in Syrian hamster and mice, respectively. Dr. Wold will present on the protection of immunocompromised Syrian hamsters against type 5 and 6 adenovirus and Dr. Moffat will present on the protection of mice against VZV, otherwise known as herpes zoster or shingles.

Abstracts are available here:

Genetically Optimized Banana Lectin for the Treatment of Influenza

Analytical Method Development for the Structural Characterization of BL-84, a Genetically Engineered, Recombinant Banana Lectin with Potent Antiviral Activity and Reduced Mitogenicity

Improved In Vitro Potency of Nucleoside Phosphonate Analogs against Different
Adenovirus Serotypes Using an Oral Prodrug Approach

Development of an LC-MS/MS Assay for Measurement of the Intracellular Concentrations of USC-505 (a Prodrug of Cidofovir) and its Metabolites

USC-087 and USC-505 Protect Immunosuppressed Syrian Hamsters against Lethal Intravenous Challenge with Human Type 5 and 6 Adenoviruses

Tyrosine Ester Prodrug of Cidofovir is Effective Against VZV in Mice

About TSRL, Inc:

TSRL, Inc. is a privately-held, anti-infectives pharmaceutical accelerator focused on the preclinical development of investigator-initiated drug therapy concepts. More information about TSRL, Inc. is available on the company website www.tsrlinc.com or can be requested by contacting Andrew Hertig, Business Development, 734-663-4233 x224, ahertig@tsrlinc.com.

 

TSRL, Inc. to Present at the 2015 AAPS Annual Meeting and Exposition

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Ann Arbor, Michigan, Sept 15th, 2015: TSRL Inc., a preclinical accelerator developing novel anti-infective therapeutics in areas of high unmet medical need, is presenting at the 2015 AAPS Annual Meeting and Exposition, October 25-29, at the Orange County Convention Center in Orlando Florida.

Dawn Reyna, Sr. Director of Laboratory Services, will be presenting on the "Pharmacokinetics of Potent HPMPA and HPMPC Tyrosinamide Prodrugs with Broad Spectrum Antiviral Activity" and Deanna Mudie, on behalf of the University of Michigan College of Pharmacy, will be presenting on the "Influence of Fluid Shear Rate on the Dissolution Rate of Poorly Soluble Drug Particles; Implications for In Vivo Predictive In Vitro Dissolution Methodologies and Mechanistic Computational Modeling".

Abstracts are available here:

Pharmacokinetics of Potent HPMPA and HPMPC Tyrosinamide Prodrugs with Broad Spectrum Antiviral Activity

Influence of Fluid Shear Rate on the Dissolution Rate of Poorly Soluble Drug Particles

About TSRL, Inc.

TSRL, Inc. is a privately-held anti-infectives drug development firm and accelerator focused on R&D efforts to optimize effectiveness and safety of investigational and marketed therapeutics. More information about TSRL, Inc. is available on the company website www.tsrlinc.com or can be requested by contacting Dr. Elke Lipka, President, 734-663-4233 x236, elipka@tsrlinc.com.

 

TSRL, Inc. Presents at the Cutting Edge/Drug Discovery & Development in Michigan Symposium

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Ann Arbor, Michigan, Sept 15th, 2015: TSRL Inc., a preclinical accelerator developing novel anti-infective therapeutics in areas of high unmet medical need, has presented on various topics at the Cutting Edge/Drug Discovery & Development in Michigan Symposium September 9th and 10th.

Eric Simon, PhD presented on the "Development of an LC-MS Assay for Measurement of of Intracellular Concentrations of Cidofovir Prodrug USC-505 and its Metabolites". Shyamala Ganesan, PhD presented on "Improved Intracellular Concentrations of Cidofovir Diphosphate Using an Oral Prodrug Approach". Andrew Hertig, MBA, presented on "The Preclinical Accelerator: A New Model for Drug Development".

Presentations are available for viewing here:

LC-MS Method for Measuring Cidofovir Prodrugs Poster

Intracellular Conversion of Cidofovir Prodrugs Poster

Preclinical Accelerator Model for Drug Development Poster

About TSRL, Inc.

TSRL, Inc. is a privately-held anti-infectives drug development firm and accelerator focused on R&D efforts to optimize effectiveness and safety of investigational and marketed therapeutics. More information about TSRL, Inc. is available on the company website www.tsrlinc.com or can be requested by contacting Dr. Elke Lipka, President, 734-663-4233 x236, elipka@tsrlinc.com.

Having Fun and Helping the Local Community

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Ann Arbor, Michigan, June 26th, 2015: Members of our team at TSRL, Inc. visited the Foundations Preschool of Washtenaw County (http://www.foundations-preschool.org/) last Friday for our annual Day of Caring. The weather couldn't have been better as we were put to work scrubbing floors, ripping out weeds, and staining decks. One of our team members even got a bee sting. They are okay--with the help of an onion to reduce the swelling--and the hard work was worth it for everybody. We were able to make our community preschool a cleaner, happier place for the at-risk children who need a place to learn and grow.

Looking forward to next time!

Learn more about United Way/Day of Caring: http://www.wuway.org/node/778

About Foundations Preschool:

Foundations Preschool prepares children from low income families for future academic and social success while providing their parents opportunities for professional, personal and parental growth.

We Accomplish This By Providing:

  • A focus on the needs of low-income families
  • Tuition subsidies based on household income
  • A researched-based curriculum and teaching methods
  • Professional and educated staff
  • Opportunities to strengthen parenting skills through monthly workshops and a true parent/school team approach
  • Speech/language/social work assessments and intervention services
  • On-site dental screenings and varnishes
  • Vision and auditory screenings
  • Free breakfast, lunch and afternoon snack