Serina Therapeutics, Inc. · AMEX:SER
Serina Therapeutics — PODD 2016
16 slides from Serina Therapeutics's conference presentation, 2016
Slide 1: Poly(oxazoline) - POZ – The Next Generation Polymer for Drug Development
Poly(oxazoline) - POZTM – The Next Generation Polymer for Drug Development Company History Founded 2007 Raised $20 M Since Inception Ten employees Technology Pipeline Lead Clinical Candidate SER-214 Summary
Slide 2: Unparalleled Track Record of Excellence in Innovative Drug Delivery
Unparalleled Track Record of Excellence in Innovative Drug Delivery Serina Founders and Management Milton Harris and Michael Bentley developed first generation PEGs at Shearwater Polymers Acquired by Nektar Therapeutics* in 2001 Licensed for research and therapeutic applications (multiple prod
Slide 3: POZ vs PEG
POZ vs PEG Safe, inexpensive starting materials Explosive, toxic starting materials Does not form peroxides Forms peroxides (must add BHT) POZ – “one pot synthesis” Limited suppliers of quality PEG Stable at RT, refrigerator, - 20 C Stable only at < - 20 C Relatively low viscosity
Slide 4: Pipeline
Pipeline Drug Indication(s) Formulation Research Preclinical Phase I SER-214 Parkinson’s Disease and RLS SC SER-226 Schedule III POZ-analgesic, post-op pain SC SER-228 / SER-232 Schedule I POZ-cannabidiol Schedule I POZ-tetrahydrocannabinol SC POZ-polymer ADCs Undisclosed Partner (multi-target, mult
Slide 5: Polymer Synthesis
Polymer Synthesis How we make pendent POZ * Programmable loading of polymer determined by the ratio of pentynyl * : neutral monomers at initial synthesis (example above is a 20 kDa 10 pendent POZ) IEC for purification takes advantage of the –COOH on the terminus of the polymer (Typically > 70% y
Slide 6: Polymer Synthesis
Polymer Synthesis How we make pendent POZ-therapeutics * Programmable loading of polymer during initial synthesis – Controlled drug loading at the “click chemistry” step Single-step Cu(I)-catalyzed “click chemistry” at pendent alkyne (Scripps Research Institute Global Exclusive License to Serina
Slide 7: Parkinson's Disease Current Treatment
Parkinson’s Disease Current Treatment Patients take a variety of medications at multiple doses and frequencies to manage the disease Compliance, “wearing off” and dyskinesia are common Commonly used drugs MAO-B inhibitors/COMT inhibitors Levo-dopa : carbidopa Dopamine agonists (oral, transdermal) No
Slide 8: SER-214 Target Product Profile
SER-214 Target Product Profile (20 kDa POZ with 10 rotigotine molecules) Once weekly SC dosing that does not change week-to-week Week-to-week levels stay within the “therapeutic window” Provide prompt onset of dopaminergic “tone” PK profile provides continuous drug delivery with steady-state
Slide 9: Weekly SC Injection of SER-214 Provides Continuous Drug Delivery
Weekly SC Injection of SER-214 Provides Continuous Drug Delivery Plasma levels of Released Rotigotine following weekly SC injections of SER-214 to Normal Monkeys 7.0 mg/kg dose (male and fe male ; n=10, SD) 100 Plasma concentration (ng/mL) 10 1 week 1 week 5 0.1 week 9 week 12 0.01 0 1 2 3 4 5 6 7
Slide 10: ON-time without dyskinesia
“ON-time without dyskinesia” (Week two data from MPTP-monkey study) v e h ic le v e h ic le L -D O P A (1 5 m g /k g ) L -D O P A (1 5 m g /k g ) sev e re S E R -2 1 4 (1 m g /k g e q u iv .) 200 S E R -2 1 4 (1 m g /k g e q u iv .) * m a rk e d 150 O N -tim e (m in ) d y s k in e s ia m o d e ra te
Slide 11: ClinicalTrials.gov SER-214 Study Record
Example: “Heart aitack” AND "Los Angeles" ClinicalTrials.gov Search for studies: || Search Aservice of the U.S. National Institutes of Health Advanced Search | Help Studies by Topic Glossary Find Studies About Clinical Studies Submit Studies Resources About This Site Home > Find Studies > Study Reco
Slide 12: PK Data From Cohort
PK Data From Cohort 1 Cmax Day 3-4 Approximates 0.2-.3 ng/ml – 4 X = 1-1.2 ng/ml SER-214 Ia: Pharmacokinetic profile of rotigotine following a subcutaneous administration of SER-214 [Cohort 1: Dose 50mg (6 mg equiv); n=5, SD] 100 total drug released drug Plasma concentration (ng/mL) 10 1 0.1 0.05ng
Slide 13: Serina Oncology Platform
Serina Oncology Platform Antibody-targeted POZ-toxins Programmable loading of the polymer allows for very high drug antibody ratios (DAR) – multiple site attachment to resident – SH in the antibody May prove to be particularly important for low-density targets POZ polymers are stable – do not
Slide 14: POZ Polymer ADCs
POZ Polymer ADCs Increased DAR Employing POZ Improves Cell Kill of Low Density Antigen-expressing Tumor Cell Lines 100 80 Cell Viability (%) 60 40 20 0 0.1 1 10 100 1000 Concentration (nM ) CD79b-vc-PAB-MMAE (●) DAR=1, CD79b-POZ-(vc-PAB-MMAE)1 (♦) DAR=1 via POZ, and CD79b-POZ-(vc-PAB-MMAE)5 (■) DAR=
Slide 15: Summary
Summary POZ polymer technology represents a unique injectable platform technology with distinct advantages SER-214 for Parkinson’s Disease / RLS – SC Oncology – IV and IM {Extensive pre-clinical data, multiple oncolytics} Pain, epilepsy, CINV, inflammation, others – SC POZ polymer technolo
Slide 16: Thank You
Thank You PODD--s