Delaware
|
|
001-37798
|
|
26-1622110
|
(State or other jurisdiction
of incorporation)
|
|
(Commission
File Number)
|
|
(IRS Employer
Identification No.)
|
☐
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
☐
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
☐
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
☐
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Securities registered pursuant to Section 12(b) of the Act:
|
||
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock (Par Value $0.0001)
|
RNAC
|
The Nasdaq Stock Market LLC
|
Exhibit
No.
|
|
Exhibit Description
|
|
|
|
|
Corporate slide presentation of Cartesian Therapeutics, Inc. dated January 2024
|
|
Press release announcing long-term follow-up data from Phase 2a study of Descartes-08 in myasthenia gravis issued on January 8, 2024
|
||
Press release announcing the Company’s 2024 strategic priorities issued on January 8, 2024
|
||
104
|
|
Cover Page Interactive Data File (embedded within the Inline XBRL document)
|
|
CARTESIAN THERAPEUTICS, INC.
|
|
|
|
|
|
|
|
Date: January 8, 2024
|
By:
|
/s/ Carsten Brunn, Ph.D.
|
|
|
Carsten Brunn, Ph.D.
|
|
|
President and Chief Executive Officer
|
•
|
Descartes-08 was infused in an outpatient setting without lymphodepleting chemotherapy. Throughout the study and long-term follow-up interval, Descartes-08 was well-tolerated, with no dose-limiting toxicities, cytokine release syndrome, or
neurotoxicity.
|
•
|
At Month 9 follow-up, all participants continued to experience marked and long-lasting clinical improvements across four validated MG disease scoring systems: MG Composite, MG Activities of Daily Living, Quantitative MG scores, and Quality
of Life 15-revised. These assessments occurred approximately 7 months after the last Descartes-08 infusion, and no participants received new or increased MG-directed drugs during the study period.
|
•
|
At Month 12, five of the seven participants maintained clinically meaningful improvement in the same four scoring systems. These assessments occurred approximately 10 months after the final Descartes-08 infusion.
|
•
|
Two participants experienced loss of clinical effect at Month 12 and were eligible for retreatment. One participant was retreated, and experienced rapid improvement in clinical scores, which was ongoing at Month 6 of follow-up with minimal
symptom expression.
|
•
|
All three participants with detectable anti-acetylcholine receptor (AChR) antibody levels at baseline experienced marked anti-AChR antibody reductions by Month 6, which deepened further by Month 9, and were maintained at Month 12.
|
•
|
Enrollment remains ongoing in the Company’s Phase 2b randomized, double-blind, placebo-controlled trial of Descartes-08 in patients with MG (NCT04146051), with topline results expected in mid-2024. In the open
label Phase 2a portion of the study, Descartes-08 was administered in an outpatient setting without preconditioning chemotherapy. The drug was observed to be safe, well tolerated, and appeared to lead to deep, durable clinical responses.
These results were published earlier this year in The Lancet Neurology.
|
•
|
In a separate press release issued today, the Company announced positive twelve-month follow-up data from the
Phase 2a portion of the Descartes-08 trial in patients with MG. In the study, five out of seven patients maintained clinically meaningful improvements across all four standard MG severity scores
approximately 10 months after the last infusion. In addition, all three participants with detectable anti-acetylcholine receptor antibody levels at baseline experienced durable depletion of autoantibodies through the one-year follow-up
period. Descartes-08 was observed to be well-tolerated, with no dose-limiting toxicities, cytokine release syndrome, or neurotoxicity.
|
•
|
The Company remains on track to initiate a Phase 2 study of Descartes-08 in patients with SLE (NCT06038474) in the first half of 2024. SLE is an incurable autoimmune disease marked by systemic inflammation that
affects multiple organ systems. It impacts approximately 1.5 million people in the United States. The Phase 2 study, for which the Company has received IND clearance, is designed to assess the safety and tolerability of outpatient
Descartes-08 administration without preconditioning chemotherapy.
|
•
|
Cartesian continues to anticipate the initiation of Phase 2 basket studies in additional autoimmune indications in the second half of 2024. The studies are designed to assess the safety and tolerability of
outpatient Descartes-08 administration without preconditioning chemotherapy.
|
•
|
The Company today announced that the U.S. FDA has cleared its IND application for Descartes-15. Planning for a first-in-human Phase 1 dose escalation study is underway. The study will be designed to assess the
safety and tolerability of outpatient Descartes-15 administration in patients with multiple myeloma. The Company expects to subsequently assess Descartes-15 in autoimmune indications.
|