Resource KSQ Achieves IND Clearance for Solid Tumor Treatment with MaxCyte Support

Case Study

KSQ Therapeutics Revolutionizes
Solid Tumor Treatment with MaxCyte Support

ksq-therapeutics-logo-casestudy

Introduction

Challenges & solutions

Impact

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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 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 programs. 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.

Preclinical challenges and solutions

Concept discovery

August 2019
ATxTM instrument used for R&D.

Challenge

KSQ faced editing efficiency, robustness, consistency and scalability issues when engineering TILs with their then existing transfection platform.

Solution

KSQ faced editing efficiency, robustness, consistency and scalability issues when engineering TILs with their then existing transfection platform.

Optimization – Early PD

December 2019
ExPERT GTx® added for GMP work.

Challenge

KSQ needed flexibility in the process to accommodate variations in donor TIL.

Solution

MaxCyte provided continuous support to demonstrate consistent CRISPR-Cas9 editing through scale up.

Verification – Late PD

May 2020
PD work complete and process transferred to CDMO.

Challenge

Process development faced challenges during the COVID pandemic.

Solution

MaxCyte provided continuous support to mitigate impact on PD and supported regulatory needs through the PD process.

Word clinical with a filled checkbox next to it

Clinical clearance

November 2023
Successful KSQ-001EX IND clearance announced.

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.