TenNor Therapeutics Ltd Zhenkun Ma, PhD ǀ Founder & CEO
TenNor Overview o Founded in 2013 as a Cayman corporation, TenNor is a clinical-stage new drug development company specialized in infectious diseases Product portfolio targeting major unmet needs – implant infections, peptic ulcer, o hepatic encephalopathy and bacterial vaginosis o Lead products with blockbuster market potential - completed Phase I and entering Phase II clinical trials in the US and China o Experienced management team with global new drug development expertise and track records Strong financial support from top tier VCs – 6 Dimensions Capital, Northern Light o Venture Capital, etc.
Core Technology Dual-acting drug conjugates – an unique solution to antibiotic resistance problem Multi-targeting molecules have demonstrated greater Patent-protected dual-acting synergy than simple drug combinations molecule series H. Pylori Isogenic Strains, MIC ( g/ml) • Novel linking site and linker Drug WT R to A R to B R to AB Synthesis chemistry Antibiotic A 0.5 >32 1 >32 Antibiotic B 4 4 64 64 A+B 1 8 1 >8 Expertise in design of dual- Conjugate A-B 0.02 0.25 0.04 0.25 acting molecules Novel dual-acting molecular • Mode of action evaluation platform • Structure-activity • Isolated target enzyme assays Evaluation Design relationships • Novel isogenic bacterial mutant • Target-inhibitor crystal panels structure • Specially designed animal models Clearly differentiated from traditional antibiotics • Multi-targeting – active against drug resistance and low propensity for development of drug resistance • Unique PK • Greater synergy than parent drug combination
Product Portfolio Drug Preclinical Clinical Dev Clinical Dev Clinical Dev Discovery Dev Phase I Phase II Phase III TNP-2092 IV Implant and other bacterial biofilm infections TNP-2092 PO (13/5 Grant)* Hepatic encephalopathy (HE) and other GI tract infections TNP-2198 (13/5 Grant)* Peptic ulcer, bacterial vaginosis and other anaerobic Infections MDR-TB (12/5 Grant)* Multidrug-resistant tuberculosis MDR-GN Multidrug-resistant Gram-negative bacterial infections * Supported by China major new drugs innovation and development grants
Global IP Protection U.S. Patent Title Filed Territories Issued 7,666,864 Bicyclic nitroimidazole-substituted phenyl 2009.03.25 US, China, JP, AU, NZ, Germany, France, Switzerland, oxazolidinones UK, Netherlands, Canada, Russia, India, SA, Brazil 7,884,099 Quinolone Carboxylic Acid-Substituted 2008.11.12 US Rifamycin Derivatives 7,678,791 Nitroheteroaryl-containing Rifamycin 2007.07.12 US derivatives 7,265,107 Rifamycin C-11 oxime cyclo derivatives 2005.03.09 US effective against drug-resistant microbes 7,256,187 Rifamycin C-11 Oxime Derivatives effective 2005.03.09 US against drug-resistant microbes 7,250,413 C-25 carbamate rifamycin derivatives w/ 2005.04.26 US activity against drug-resistant microbes 7,247,634 Rifamycin derivatives effective against drug- 2005.01.12 US, France, UK, Germany, Switzerland, Ireland, Japan resistant microbes 7,238,694 Rif imino derivatives effective against drug- 2005.01.12 US resistant microbes 7,202,246 Spiro-rifamycin derivatives targeting RNA 2005.06.08 US polymerase 7,229,996 Rifamycin derivatives 2005.07.21 US 7,226,931 (R/S) Rifamycin derivatives, their preparation 2005.07.21 US, China, Germany, France, UK, Canada, Japan, and pharmaceutical compositions Hong Kong, Australia, New Zealand ▪ Aggressive product lifecycle management strategy – filed 20 additional new patent applications in past 3 years to extend exclusivity to 3036 for key products
TNP-2092 IV for Implant Infections An intravenous formulation for the treatment of implant and other biofilm infections Unmet needs o Joint replacements: 1 million in 2010 increase to 4 million in 2030 (US) o 2% infection rate; biofilm formation o Lack of effective therapy: surgical implant removal required o High cost and patient suffering o Other biofilm infections – catheter infection, endocarditis, etc. TNP-2092 profile o Low potential for development of resistance (multi-targeting) o Advantage over current therapies in multiple biofilm animal models o Completed Phase I in the US o Held FDA formal meeting for clinical development plan o Plan to apply QIDP and Orphan Drug statues and initiate Phase II in 2018 Market Potential : peak annual sales >$1 billion
TNP-2092 Oral for GI Tract Infections An oral GI-specific formulation for the treatment of HE and other GI tract infections Unmet needs o Hepatic encephalopathy (HE): few treatment options o Irritable bowel syndrome-diarrhea (IBS-D): few treatment options o Peptic ulcer ( H. pylori infection): complicated quadruple therapy; drug resistance Xifaxan (rifaximin) o A GI specific antibiotic approved for HE and IBS-D; safety for long-term use o Current annual sale > $1 billion; $5 billion peak sale projected o Rapid development of drug resistance TNP-2092 Profile o GI specific with <1% systemic exposure o Lower potential for development of resistance o Completed Phase 1 – excellent safety/tolerability demonstrated o Plan to initiate Phase 2 for HE in 2018 ▪ Market potential : peak annual sales >$1 billion
TNP-2198 for Anaerobic Infections An oral formulation for the treatment of H. pylori (HP) and bacterial vaginosis (BV) Unmet Needs o Metronidazole a first-line therapy for HP and BV; high level of desistance − H. pylori : 70% resistance rate − G. vaginalis (BV): 40% resistance rate − C. difficile : 25-40% relapse rate TNP-2198 Profile o More potent than metronidazole (100-1000 folds) against key pathogens o Low potential for development of resistance o High distribution into infection tissues and excellent efficacy in animal models o Excellent safety/tolerability in GLP toxicology/safety pharmacology studies o Plan to file IND in 2018 Market Potential: Peak annual sales >$1 billion
Experienced Team China Team (15) o Zhenkun Ma, PhD (CEO): Abbott, Cumbre and TB Alliance o Ying Yuan, PhD (VP/Biology): NIH, Pathogenesis and Pfizer o Xiaomei Wang (VP/Clinical Operation): China CDC o Xiangyi Xu (Director/Regulatory): Suzhou FDA o Yu Liu, PhD (Project Management): WuXi AppTec o Huan Wang, PhD (Project Management): Notre Dame US/UK Team (10) o Martin Laurenzi, MD (Clinical Dev): Merck and TB Alliance o Mark Goldberger, MD (Regulatory): FDA and AbbVie o Aaron Dane (Statistician): AstraZeneca o Adam Belley, PhD (Clinical Microbiology): Medicine Co o Thomas Kovalcik, PhD (CMC): Eurofins o Paul B. Watkins, MD (Toxicology): U. of North Carolina
临床批件 TenNor Facilities Meeting Space Office Space Chemistry Lab Microbiology Lab Drug Stability Lab Sample Storage Document Room Analytical Lab
Valuation of Antibiotic Companies (Date: 2018/03/27) Lead Product Value Company Profile (Indication, Class) Stage (NASDAQ, USD) Arsanis (ASNS) VAP/HAP-MRSA, mAB (Novel) Phase 1 $314M Spero (SPRO) Potentiator, Polymyxin (Known) Phase 1 $206M Nabriva (NBRV) CAP, Pleuromutilin (Known) Phase 2 $193M Summit (SMMT) CDI, Ridinilazole (Novel) Phase 2 $201M Achaogen (AKAO) UTI/IAI, Aminoglycoside (Known) Phase 3 $593M Paratek (PRTK) CAP, Tetracycline (Known) Phase 3 $426M Insmed (INSM) CF/NTM, Amikacin Inhalation (Known) Phase 3 $ 1.74B
2018-2019 Strategy Portfolio o TNP-2092 IV: complete Phase 2 proof-of-concept study, initiate Phase 3 for implant infections o TNP-2092 PO: complete Phase 2 proof-of-concept study in HE o TNP-2198: complete Phase 1 for HP and BV Financial o Completed Series A in 2013 ($7M) o Completed Series B in 2016 ($25M) o Plan for a B+ round to support company until end 2019 Initiate IPO process in NASDAQ or HKEX in 2019-2020
TenNor Therapeutics Limited Contact : Zhenkun Ma zhenkun.ma@tennorx.com 186-2629-2110 www.tennorx.com
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