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Tsrl fact sheet potent dna therapeutics may 2016


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Description of preclinical potent DNA antivirals that are prodrugs of cidofovir for treatment of adenovirus & CMV in immunocompromised populations

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Tsrl fact sheet potent dna therapeutics may 2016

  1. 1. Spotlight: Market Potential Unmet Need Many antiviral drugs have poor cell penetration, which limits their ability to reach their target. These therapeutics cannot be given orally and must be delivered at high concentrations. This results in potential toxicity issues that limit their adoption. TSRL and the University of Southern California are developing orally available prodrugs of cidofovir with substantially increased cell-based potency against ganciclovir resistant human cytomegalovirus, adenovirus, herpes simplex viruses, polyoma viruses and smallpox. Solution • Higher potency than parent • Better safety profile than parent • Favorable tissue distribution • Efficacy against resistant strains Adenovirus, $423m CMV, $847m Shingles /PHN, $1379m • Total global market of ~$2.6b for shingles, CMV, and adenovirus • Orphan designation possible for CMV and adenovirus  734-663-4233 x224  ©TSRL 2016 Advantages • Two Phase II SBIRs • Three Phase I SBIRs • Private Investment Funding to Date Our lead series is covered by three jointly-owned patents and one patent-pending with IP coverage past 2030. Additional applications are being filed. Supported IP
  2. 2.  734-663-4233  Elke Lipka, PhD, MBA, President - 20 years of drug development experience and management of business operations and strategic partnerships. Gordon Amidon, PhD, Chairman & CSO - Internationally recognized expert in the field of solubility, transport phenomena, prodrugs, and drug absorption. Charles McKenna, PhD, Prof. of Chemistry, USC - NIH fellow and expert in the design and synthesis of potential agents to inhibit HIV, HPV & other viruses. About Us- TSRL, Inc. is a preclinical accelerator based in Ann Arbor, Michigan. Our mission to advance promising compounds for treating severe and multi-drug resistant infections. Lead 2016 2017 2018 IND 2019 API Synthesis API Scale-up to GMP & Phase I Clinical SuppliesCMC In Vitro Potency, ADME/PK & Formulation Preclinical Effacacy IND Toxicology Preclin. Studies Grant/NIAID TSRL, Inc. Fundraising Safety Timeline & Next Steps Spotlight: Compound HSV-2 hCMV VZV VACV CPXV AdV HPMPA 59.2 16.7 5.34 50.5 54.0 15.7 HPMPA-C16 0.46 0.008 0.005 0.068 0.05 0.024 HPMPC (Cidofovir) 31.6 0.60 0.52 22.5 23.9 2.98 HPMPC-C16 (USC-505) 0.2 0.001 0.004 0.153 0.257 0.03 EC50 Broad-Spectrum Activity (µM) About the Innovators Plates were seeded with primary HFF cells; in vivo safety & efficacy data available