tennor therapeutics ltd · tennor overview o founded in 2013 as a cayman corporation, tennor is a...
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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
o Product portfolio targeting major unmet needs – implant infections, peptic ulcer,
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
o Strong financial support from top tier VCs – 6 Dimensions Capital, Northern Light
Venture Capital, etc.
Core Technology
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
Synthesis
Design Evaluation
Expertise in design of dual-
acting molecules
• Mode of action
• Structure-activity
relationships
• Target-inhibitor crystal
structure
Novel dual-acting molecular
evaluation platform
• Isolated target enzyme assays
• Novel isogenic bacterial mutant
panels
• Specially designed animal models
Patent-protected dual-acting
molecule series
• Novel linking site and linker
chemistry
Dual-acting drug conjugates – an unique solution to
antibiotic resistance problem
DrugH. Pylori Isogenic Strains, MIC (g/ml)
WT R to A R to B R to AB
Antibiotic A 0.5 >32 1 >32
Antibiotic B 4 4 64 64
A+B 1 8 1 >8
Conjugate A-B 0.02 0.25 0.04 0.25
Multi-targeting molecules have demonstrated greater
synergy than simple drug combinations
Product Portfolio
Drug
Discovery
Preclinical
Dev
Clinical Dev
Phase I
Clinical Dev
Phase II
Clinical Dev
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
▪ Aggressive product lifecycle management strategy – filed 20 additional new patent
applications in past 3 years to extend exclusivity to 3036 for key products
U.S. Patent Title Filed Territories Issued
7,666,864 Bicyclic nitroimidazole-substituted phenyl
oxazolidinones
2009.03.25 US, China, JP, AU, NZ, Germany, France, Switzerland,
UK, Netherlands, Canada, Russia, India, SA, Brazil
7,884,099 Quinolone Carboxylic Acid-Substituted
Rifamycin Derivatives
2008.11.12 US
7,678,791 Nitroheteroaryl-containing Rifamycin
derivatives
2007.07.12 US
7,265,107 Rifamycin C-11 oxime cyclo derivatives
effective against drug-resistant microbes
2005.03.09 US
7,256,187 Rifamycin C-11 Oxime Derivatives effective
against drug-resistant microbes
2005.03.09 US
7,250,413 C-25 carbamate rifamycin derivatives w/
activity against drug-resistant microbes
2005.04.26 US
7,247,634 Rifamycin derivatives effective against drug-
resistant microbes
2005.01.12 US, France, UK, Germany, Switzerland, Ireland, Japan
7,238,694 Rif imino derivatives effective against drug-
resistant microbes
2005.01.12 US
7,202,246 Spiro-rifamycin derivatives targeting RNA
polymerase
2005.06.08 US
7,229,996 Rifamycin derivatives 2005.07.21 US
7,226,931 (R/S) Rifamycin derivatives, their preparation
and pharmaceutical compositions
2005.07.21 US, China, Germany, France, UK, Canada, Japan,
Hong Kong, Australia, New Zealand
TNP-2092 IV for Implant 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
An intravenous formulation for the treatment of implant and other biofilm infections
TNP-2092 Oral for 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
An oral GI-specific formulation for the treatment of HE and other GI tract infections
TNP-2198 for Anaerobic Infections
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
An oral formulation for the treatment of H. pylori (HP) and bacterial vaginosis (BV)
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
Analytical Lab Drug Stability Lab Sample Storage Document Room
Valuation of Antibiotic Companies
Company Profile (Indication, Class)Lead Product
Stage
Value
(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
(Date: 2018/03/27)
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
