Natural Beauty Bio-Technology Limited · HKEX:157
Natural Beauty Bio-Technology — TLC (Taiwan Liposome Company) — JPM Conference 2018
25 slides from Natural Beauty Bio-Technology's conference presentation, Jan 10, 2018
Slide 1: Innovative Solutions to Pain Management, Ophthalmology, and Oncology
Innovative Solutions to Pain Management, Ophthalmology, and Oncology January 10, 2018 George Yeh – President
Slide 2: Legal disclaimers
Legal disclaimers This presentation contains forward-looking statements. In some cases, you can identify forward-looking statements by the words “will,” “expect,” “intend,” “plan,” “objective,” “believe,” “estimate,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other com
Slide 3: TLC's focus and recent highlights
TLC’s focus and recent highlights Extensive experience in liposomal science Core technologies utilizing complex liposome technology (LipAD™) – BioSeizer™ for sustained release Complete pharmacokinetic (PK) control designed for immediate onset and extended duration – NanoX™ for targeted delivery
Slide 4: Experienced and dedicated management, board, and advisors with drug development know-how
Experienced and dedicated management, board, and advisors with drug development know-how Name and Title Experience Board Member Affiliation & Experience Keelung Hong, Ph.D. – Keelung Hong, Ph.D. Since 2002 CEO, TLC Chair Founder, Chairman, >20 years at UCSF Cancer CEO Research Institute Hong-Jen
Slide 5: The evolution of TLC's lipid-based products
The evolution of TLC’s lipid-based products – from oncology to pain management and more • Controlled density of 2011 Pain multi-layers for Pacira release BioSeizer Exparel TLC599 • Fast onset & Sustained Release sustained release Ophthalmology TLC590 designed for >6M(TLC399)/ >3M(TLC599) TLC399 • Ap
Slide 6: Pipeline
Pipeline Projected Program Preclinical Phase I Phase II Phase III Milestones Pain Management TLC599 Osteoarthritis Pain Ph II data 2H18 IND & Ph I/II TLC590 Post-op pain initiation 1H18 Ophthalmology Interim Ph II data TLC399 Macular edema 1H19 Oncology Advanced malignancies IND & Ph I/II TLC178 ini
Slide 7: Osteoarthritis (OA) pain program: TLC599 target product profile
Osteoarthritis (OA) pain program: TLC599 target product profile Current treatment landscape for knee OA pain Estimated 30.8 million OA patients in US1; estimated 20% of people >65 years will be at risk for knee OA by 20302 Immediate release corticosteroid injections: too short in duration3 Hya
Slide 8: TLC599: potential to become a best-in-class treatment for OA pain
TLC599: potential to become a best-in-class treatment for OA pain Desired Effect TLC599 Design Engineered % of free DSP on outer layers to provide Fast-acting immediate therapeutic effect Core lipid layers trap and maintain release of hydrophilic Sustained relief molecules for more than 3 months Dex
Slide 9: Preclinical studies: TLC599's API dexamethasone is least toxic and cartilage sparing
Preclinical studies: TLC599’s API dexamethasone is least toxic and cartilage sparing TLC599 TLC599 TA & ER TA Single Dose Repeated Doses Single Dose Canine: 12mg DSP Rabbit: 1.2mg DSP (eq. to 6mg TA) Canine: 18.75mg TA (eq. to 60mg TA) No proteoglycan No proteoglycan Decadron i.e. loss loss dexameth
Slide 10: Completed TLC599 Phase I/II clinical trial: design & objectives
Completed TLC599 Phase I/II clinical trial: design & objectives Screening period Treatment Follow-up Period period (3 month) (Day 0) TLC599 single dose Evaluation of Safety & Efficacy Randomization IA injection Screening (6 mg DSP) Day-14 to (n=20) Day 0 1W 4W 8W 12W Day-1 (n=40) TLC599 single dose
Slide 11: TLC599 Phase I/II results: rapid onset with sustained release
TLC599 Phase I/II clinical trial results: TLC599 demonstrated rapid onset with sustained release Phase I/II efficacy of TLC599 in knee OA — onset within 1W, persisted to 12W Strong immediate pain relief by first assessment Clear dose response over course of trial Continued downward trend after
Slide 12: TLC599 Phase I/II results: Improvements across WOMAC scales
TLC599 Phase I/II clinical trial results: Improvements across WOMAC scales Phase I/II efficacy of TLC599 in knee OA: demonstrated onset within 1W, persisted relief to 12W Confidential 12
Slide 13: Plasma cortisol levels in Phase I/II clinical trial remained in the normal range
Plasma cortisol levels in Phase I/II clinical trial remained in the normal range Cortisol is monitored due to its role in blood sugar metabolism and the body’s response to stress. 20 Mean Plasma Cortisol Level (μg/dL) 18 16 14 12 Normal Range 10 8 6 4 Group A (6 mg DSP, n=20) Group B (12mg DSP, n=20
Slide 14: Ongoing TLC599 Phase II clinical trial: evaluation at 24W
Ongoing TLC599 Phase II clinical trial: evaluation at 24W to confirm preliminary data Screening Treatment Period Follow-up Period Period (Day 0) (24 weeks) Placebo (normal saline) Randomization Screening (n=24) Day-14 to Evaluation of Safety & Efficacy TLC599 single dose IA Day-1 injection (n=72) (1
Slide 15: Post-surgical pain program: TLC590 target product profile
Post-surgical pain program: TLC590 target product profile Current treatment landscape for post-surgical pain 96 million surgical procedures are performed in the US in 20121 Local anesthetics play a major role in the management of post-surgical pain2 Long acting agents have modestly expanded du
Slide 16: TLC590 extends the effective half-life of ropivacaine by ~20 fold in rat models
TLC590 extends the effective half-life of ropivacaine by ~20 fold in rat models TLC590 PK Profile in Rats via Subcutaneous Injection Confidential 16
Slide 17: Ophthalmic disease program: TLC399 target product profile
Ophthalmic disease program: TLC399 target product profile Current treatment landscape for macular edema due to retinal vein occlusion (RVO) RVO affects >16 million adults worldwide1 Steroids still play a prominent role in the management of RVO even post the advent of anti-VEGF2 Current markete
Slide 18: Administration of TLC399 with smaller needle potentially means less risk of bleeding/infections
Administration of TLC399 with smaller needle potentially means less risk of bleeding/infections Approved brand TLC399 22G 30G 0.7176mm 0.3112mm Injections using 22G needle cause bleeding in 23% of patients1 TLC399 uses 30G needle and no implants ⇒ potentially less risk of bleeding and infections
Slide 19: TLC399 Phase I/II clinical trial: decrease in CST up to 12M after single injection
TLC399 Phase I/II clinical trial (0.6mg DSP): decrease in CST up to 12M after single injection Day 0 Day 90 Day 180 Day 360 CST 386 μm 253 μm 264 μm 206 μm CST (Central subfield thickness) Improved/stabilized vision for 6 to 12 months Improved OCT results for 6 to 12 months Confidential 19
Slide 20: TLC399 Phase II clinical trial design
TLC399 Phase II clinical trial design Treatment Screening Period Follow-up Period Period (Day 0) (12 months) TLC399 single dose injection (0.36mg DSP with 100mM PL (30µL)) (n=22) Randomization Screening Day-14 to TLC399 single dose Day-1 injection (n=66) (0.6mg DSP with Day 0 2W 1M 2M 3M 4.5M 6M 7.5
Slide 21: Soft tissue sarcoma (STS) program: TLC178 target product profile
Soft tissue sarcoma (STS) program: TLC178 target product profile Current treatment landscape for rhabdomyosarcoma (RMS), a type of STS Vinorelbine is listed by the National Comprehensive Cancer Network (NCCN) Guidelines as therapy agent with activity in RMS in combination with cyclophosphamide, or
Slide 22: TLC178 demonstrates more effective control of tumor growth than free vinorelbine
TLC178 demonstrates more effective control of tumor growth than free vinorelbine in CPA combo preclinical studies Antitumor efficacy of TLC178 + Cyclophosphamide(CPA) in a mouse xenograft model of human alveolar RMS Compared to free vinorelbine, TLC178 potentially has… Better pharmacokinetics Lo
Slide 23: TLC summary
TLC summary Focus LipAD™ – BioSeizer™ sustained release – NanoX™ targeted delivery Strategy Rapidly advance current product candidates Continue to leverage proprietary technology Take advantage of opportunities for streamlined regulatory approval Expand pipeline with one new IND every 18 m
Slide 24: Projected milestones: Four programs expected in pivotal stage by 2019
Projected milestones: Four programs expected in pivotal stage by 2019 TLC399 Pivotal trial initiation TLC590 TLC599 Pivotal trial Phase II topline data initiation TLC178 Pivotal trial initiation 1H 2018 2H 2018 1H 2019 2H 2019 TLC599 Phase II last patient enrollment TLC399 Phase II last patient enro
Slide 25: Thank you
Thank you