Tag Archives: GC027

Gracell’s GC012F IND Submission Plans; Ph2 Portion of GC007 Trial to Start in Q3 2022; Gracell’s Q2 2022 Earnings Call Summary

On Monday, August 15, Gracell held their Q2 2022 earnings call (press release / presentation) highlighting GC012F’s (autologous BCMAxCD19 FasTCAR-T) IND filing plans both in the US and China, while updating clinical milestones for both TruUCAR and SMART CAR-T platforms. Below, Celltelligence provides insights on regulatory updates for GC012F in r/r MM and the potential delay in the GC027 trial (allogeneic CD7 TruUCAR-T) for r/r T-ALL patients.

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Gracell’s GC012F US and Chinese IND in MM Planned for H1 2022: Could Gracell Leverage Data From Chinese Trials to Accelerate Their Clinical Programs in the US? Autolus’s Obe-cel Receives ILAP Designation in r/r Adult ALL

On Monday, June 14, Gracell held a clinical update conference call (webcast / presentation) discussing their regulatory strategy for GC012F (BCMA x CD19 CAR-T) and key company milestones. Additionally, on Tuesday, June 15, Autolus announced (press release) that the MHRA has granted obe-cel (AUTO1; CD19 CAR-T) an Innovation Passport and entry into the Innovative Licensing and Access Pathway (ILAP) in r/r adult ALL. Below, Celltelligence provides insights on how Gracell could strategically accelerate development of key assets in the US, while highlighting Gracell’s next TruUCAR candidates. Furthermore, Celltelligence will comment on Autolus’s ILAP designation for obe-cel in r/r adult ALL.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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