Cartesian Therapeutics, Inc. · NASDAQ:RNAC
Cartesian Therapeutics — Selecta Biosciences — Technical Presentation (April 2018)
17 slides from Cartesian Therapeutics's technical presentation, Apr 10, 2018
Slide 1: New SEL-212 Phase 2 Data Presented at PANLAR
New SEL-212 Phase 2 Data Presented at PANLAR April 10, 2018
Slide 2: Safe Harbor / Disclaimer
Safe Harbor / Disclaimer 2 Any statements in this presentation about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, statements regarding the progress of the Phase 1/2 clinical program of SEL-212, the potential of SEL-212 to tr
Slide 3: SEL-212 Phase 2 Overview and Summary of New Data Presented at PANLAR
SEL-212 Phase 2 Overview and Summary of New Data Presented at PANLAR 3 Phase 2 Trial Overview for new data presented at PANLAR • Enrollment Criteria: Patients with symptomatic gout and serum uric acid (sUA) >6 mg/dl • Primary/Secondary Endpoints: • Safety, tolerability and pharmacokinetics of multip
Slide 4: SEL-212 Clinical Development Plan
SEL-212 Clinical Development Plan Primary Clinical Endpoint: Serum uric acid < 6 mg/dl measured at month 3 and 6 DETERMINATION OF DOSE REGIMEN TO TAKE INTO PHASE 3 PHASE 3 PROGRAM WITH DEFINED DOSE REGIMEN Phase 2 Dose Ranging Five monthly injections Matrix approach to find best doses of the two com
Slide 5: New Phase 2 Data at 3 Months Show 74% of Patients With Control of SUA <6 mg/dl
5 74%; (14/19) 0.2 or 0.4 mg/kg Pegsiticase Patients evaluable at 12 weeks who received a full first dose and completed treatment cycle 1 0.2 or 0.4 mg/kg 0.125 or 0.15 mg/kg SEL-212 Pegsiticase SVP-Rapamycin 0.2 or 0.4 mg/kg Pegsiticase 17% (1/6) Week % P ts. S U A <6 mg /d L Pegsiticase + SVP-Rapa
Slide 6: Patients Dosed With 0.125 mg/kg of SVP-Rapamycin + 0.4 mg/kg of Pegsiticase
Patients Dosed With 0.125 mg/kg of SVP-Rapamycin + 0.4 mg/kg of Pegsiticase 6 Unaudited data reported as of April 02, 2018 | Clinicaltrials.gov NCT02959918 Patient S e ru m U ric A cid ( m g /d L ) F E A D D Week G 106-0060 106-0061 111-0009 102-0019 107-0012 112-0002 112-0001 107-0014 111-0010 111-
Slide 7: Patients Dosed With 0.15 mg/kg of SVP-Rapamycin + 0.2 mg/kg of Pegsiticase
Patients Dosed With 0.15 mg/kg of SVP-Rapamycin + 0.2 mg/kg of Pegsiticase 7 Unaudited data reported as of April 02, 2018 | Clinicaltrials.gov NCT02959918 Patient S e ru m U ric A cid ( m g /d L ) Week A n ti-U ric a s e A n ti b o d y T it e r 0.15 mg/kg 0.2 mg/kg Withdrawn due to protocol deviatio
Slide 8: Patients Dosed With 0.15 mg/kg of SVP-Rapamycin + 0.4 mg/kg of Pegsiticase
Patients Dosed With 0.15 mg/kg of SVP-Rapamycin + 0.4 mg/kg of Pegsiticase 8 Unaudited data reported as of April 02, 2018 | Clinicaltrials.gov NCT02959918 S e ru m U ric A cid ( m g /d L ) Week A n ti-U ric a s e A n ti b o d y T it e r 0.15 mg/kg 0.4 mg/kg Stopping rules met A Withdrawal of consent
Slide 9: Percent patients with gout flare by treatment month
1 1 2 3 0 2 0 4 0 6 0 9 Percent patients with gout flare by treatment month % o f P a ti e n ts w /Fl a re SEL-212* 50% month Unaudited data reported as of April 02, 2018 | Clinicaltrials.gov NCT02959918 % o f P a ti e n ts w /Fl a re Pegsiticase Alone 37% 26% 5% Pegsiticase 0.2 or 0.4 mg/kg with SV
Slide 10: SEL-212 Continues to Show Low Overall Incidence of Gout Flares In Total Phase 2 Patient Population
SEL-212 Continues to Show Low Overall Incidence of Gout Flares In Total Phase 2 Patient Population 10 Percent patients with gout flare by treatment month 1 1 2 3 4 5 0 2 0 4 0 6 0 % o f P a ti e n ts w /Fl a re Pegsiticase Alone SEL-212 50% 26% 19% 4% 13% 4% month Unaudited data reported as of April
Slide 11: SEL-212 Safety For the Total Phase 2 Patient Population
SEL-212 Safety For the Total Phase 2 Patient Population 11 •SEL-212 has been generally well tolerated at clinically active doses following >300 administrations •Fifteen SAEs reported in the ongoing Phase 2 trial: • Seven were reported not to be or unlikely to be related to study drug • Eight infusio
Slide 12: SEL-212 PANLAR Data Compared to KRYSTEXXA Data
12 SEL-212 PANLAR Data Compared to KRYSTEXXA® Data+ SEL-212 (12 weeks) KRYSTEXXA® (16 weeks) 74%++ 44% 42% 52% 3 monthly injections 3 weekly followed by 7 bi-weekly injections +Krystexxa results from “Initial Clinical Study to determine whether a tolerizing regimen of pegloticase can increase freque
Slide 13: Phase 3 Initiation Expected in 2018
Phase 3 Initiation Expected in 2018 Primary Clinical Endpoint: Serum uric acid < 6 mg/dl measured at month 3 and 6 6 Monthly Combination Injections of SEL-212 SEL-212 PHASE 3 PROGRAM+ • Data expected in third quarter from patients receiving five combination doses of SEL-212 • Phase 3 trial expected
Slide 14: Preclinical Studies Demonstrate Induction of Antigen-Specific Immune Tolerance by SVP-Rapamycin
Preclinical Studies Demonstrate Induction of Antigen- Specific Immune Tolerance by SVP-Rapamycin Preclinical mechanism of action studies • Antigen-specific1, 2, 5 • Induction of tolerogenic DCs in vivo2 • Induction of antigen-specific Tregs in vivo1, 2, 4 • Biodistribution of SVP-Rapamycin to antige
Slide 15: Transfer of Tolerance from Treated Mice to Naïve Mice
15 0 5 , 0 0 0 1 0 , 0 0 0 S p l e n o c y t e s R e c e i v e d A n t i- L M B - 1 0 0 t it e r Cell number - 107 107 107 107 LMB-100 - - + - + SVP-Rapa - - - + + PBS - + Transfer of Tolerance from Treated Mice to Naïve Mice CONFIDENTIAL 4 5 TREATED DONOR +/-LMB-100 +/- SVP 1 3 Week Week NAÏVE RECI
Slide 16: Current Phase 2 Data Provides Evidence for Immune Tolerance Induction
16 Unaudited data reported as of April 02, 2018 | Clinicaltrials.gov NCT02959918 Current Phase 2 Data Provides Evidence for Immune Tolerance Induction 0 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 0 5 0 1 0 0 0.2 or 0.4 mg/kg 0.125 or 0.15 mg/kg SEL-212 Pegsiticase SVP-Rapamycin Patients evaluable at 16 weeks who
Slide 17: We thank all of the patients that participated in our clinical trials
We thank all of the patients that participated in our clinical trials. We are very grateful to the clinical trial site investigators and their staff.
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