Case Study
Revolutionizing Solid Tumor Treatment KSQ Therapeutics Case Study
Premier Therapeutic Developer Supported by MaxCyte
KSQ, a clinical-stage company, is revolutionizing the treatment of solid tumors with its proprietary CRISPRomics® and CRISPR2® platforms. Utilizing MaxCyte’s platforms and support, KSQ is engineering cells for its lead single-edit KSQ-001EX eTIL® program, which is currently in Phase 1 development. The two companies have been collaborating since 2019.
"Our partnership with Maxcyte has enabled KSQ to overcome key technical and operational challenges throughout development of our eTIL products. We are proud to continue our collaboration as we enter clinical manufacturing, delivering these important investigational therapies to patients."
– Thomas Leitch, Chief Technology Officer
KSQ Therapeutics, Inc.
Case Study
August 2019
ATxTM instrument used for R&D
November 2019
ExPERT GTx® added for GMP work
May 2020
PD work complete
Process transferred to CDMO
Pre-Clinical
Pre-Clinical
Pre-Clinical
Concept Discovery
Optimization – Early PD
Verification – Late PD
Challenge
Challenge
Challenge
KSQ faced editing efficiency, robustness, consistency, and scalability issues when engineering TILs with their then existing transfection platform
KSQ needed flexibility in the process to accommodate variations in donor TIL
Process development faced challenges during the COVID pandemic
Solution
Solution
Solution
Together MaxCyte & KSQ optimized and qualified a scalable, reproducible process using ExPERT ATx® platform
MaxCyte provided continuous support to demonstrate consistent CRISPR Cas9 editing through scale up
MaxCyte provided continuous support to mitigate impact on PD
MaxCyte supported regulatory needs through the PD process
November 2023
Successful KSQ-001EX IND clearance announced
Clinical
MaxCyte Impact
Developed and optimized scalable and reproducible process yielding superior gene editing outcomes (>90%)
Supported GMP compliant process which facilitated IND clearance
Provided continuous support throughout tech transfer to CDMO
Summary
- Collaboration: MaxCyte and KSQ Therapeutics have entered into a development and commercialization agreement.
- Technology: KSQ Therapeutics will leverage MaxCyte's Flow Electroporation® technology and ExPERT™ instruments.
- Application: This collaboration aims to advance KSQ's engineered tumor-infiltrating lymphocyte (eTIL™) programs.
- Technology Strength: MaxCyte's ExPERT instrument family represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cellular engineering.
