Cartesian Therapeutics, Inc. · NASDAQ:RNAC
Cartesian Therapeutics — Selecta Biosciences — Technical Presentation (September 2020)
13 slides from Cartesian Therapeutics's technical presentation, Sep 30, 2020
Slide 1: Phase 2 COMPARE Trial Topline Data Presentation
Phase 2 COMPARE Trial Topline Data Presentation September 30, 2020
Slide 2: Forward-looking statements
Any statements in this presentation about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the com pan y”), including without limitation, statements regarding the clinical development, regulatory, and commercialization activities related to SEL - 212 by either the company
Slide 3: Phase 2 COMPARE Study Design
3 SEL - 212 (n=83) pegloticase (n=87) Period 3 End of Study 0 1 2 3 4 5 6 Period 6 months Pegadricase 0.2 mg/kg ImmTOR ™ 0.15 mg/kg KRYSTEXXA® (pegloticase) 8 mg SEL - 212 Randomization Phase 2 COMPARE Study Design Patient Inclusion Criteria • Chronic refractory gout with serum uric acid (SUA) ≥7 mg
Slide 4: Phase 2 COMPARE Subject Disposition and Analysis Sets
4 Phase 2 COMPARE Subject Disposition and Analysis Sets 170 patients were randomized and dosed in the phase 2 COMPARE trial Randomized and Dosed (170) SEL - 212 (83) pegloticase (87) Intention to Treat (ITT) (83) Per Protocol (PP) (59) Intention to Treat (ITT) (87) Per Protocol (PP) (70) Per Protoco
Slide 5: Impact of COVID-19 Pandemic
5 Impact of COVID - 19 Pandemic Per FDA guidance, the statistical analysis plan was modified and submitted to FDA prior to database lock to address the potential impact of the COVID - 19 pandemic on the trial One patient in the pegloticase arm of the trial had a confirmed COVID - 19 infection, and t
Slide 6: Baseline Demographics and Characteristics
6 Parameter Stats Intention - to - Treat Per Protocol SEL - 212 (n=83) pegloticase (n=87) Total (n=170) SEL - 212 (n=59) pegloticase (n=70) Total (n=129) Age Mean (SD) 52.6 (11.47) 52.0 (10.43) 52.3 (10.92) 52.3 (11.86) 51.3 (10.89) 51.8 (11.31) Tophus Presence Yes n (%) 35 ( 42.2) 34 ( 39.1) 69 ( 4
Slide 7: Responder Rates: Reduction of SUA below 6 mg/dL
7 * Number of patients with Responder Assessment ** Absolute Treatment difference = SEL - 212 percent responders – pegloticase percent responders. Percent values are rounded to nearest integer *** Relative Treatment difference = (SEL - 212 percent responders – pegloticase percent responders) / peglo
Slide 8: Reduction in Mean Serum Uric Acid During Months 3 and 6 Combined
8 Treatment with SEL - 212 demonstrated a statistically significant greater reduction in mean SUA levels than pegloticase during months 3 plus 6 combined in both PP and ITT data sets Baseline SUA levels were not statistically different between SEL - 212 and pegloticase * Number of patients with SUA
Slide 9: Patients With Tophi at Baseline: SUA Responders
9 Patients With Tophi at Baseline Who Achieved and Maintained Reduction of Serum Uric Acid (SUA) < 6 mg/dL for at least 80% of the Time During the Evaluation Period A delta of 19 percentage points was observed on SEL - 212 versus pegloticase for patients with visible tophi at baseline Evaluation Per
Slide 10: Reduction in Mean SUA in Patients with Tophi at Baseline
10 * Number of patients with SUA assessments ** Reduction in SUA computed by subtracting baseline SUA from mean during treatment period as determined by the area under the S UA time curve divided by the corresponding time interval (mg/dL). Rounded to two decimal points. *** Computed by (pegloticase
Slide 11: Safety Summary
11 Topline data suggests that both SEL - 212 and pegloticase were generally well - tolerated There were no deaths during the study There were no differences in serious TEAEs, treatment - related serious TEAEs, or infusion reactions between the two groups Full analysis of safety signals, including go
Slide 12: Phase 3 DISSOLVE Program Design
2 double blinded placebo - controlled trials of SEL - 212 (0.1 mg/kg & 0.15 mg/kg ImmTOR ) Randomized 1:1:1 against Placebo with a total of 210 Treated Subjects First patient randomized and dosed in September 2020 Topline data from the DISSOLVE program is expected in 2H 2022 SEL - 212 Phase 3 DISSOL
Slide 13: Summary of Data From COMPARE Clinical Trial
13 SEL - 212 showed a numerical response rate on the primary endpoint during months 3 and 6 combined, but did not meet the primary endpoint of statistical superiority during months 3 and 6 combined Statistically significant higher response rate of SEL - 212 during month 3 Numerically higher response
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