- First patient achieved a confirmed partial response with 51.2% tumor regression with TCR-T cell persistence ongoing at 3 months post infusion
- Sleeping Beauty TCR-T cell therapy had a manageable safety profile with no dose limiting toxicities observed
- Data to be presented on
Friday, September 30 at9:00am ET in a proffered presentation at theCRI-ENCI-AACR Sixth International Cancer Immunotherapy Conference
“The encouraging data from the first patient in our trial highlight the potential of our non-viral TCR-T cell therapies to treat solid tumors even at the lowest doses in the study design,” said
The TCR-T Library Phase 1/2 trial is an open label, dose escalation study being conducted at MD Anderson. The trial is enrolling patients with non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers that have a matching human leukocyte antigen (HLA) and hotspot mutation pairing in Alaunos’ TCR-T library.
Key highlights to be presented:
- First patient dosed was diagnosed with non-small cell lung cancer and had previously progressed on three prior lines of treatment. The patient was germline for HLA-A*11:01 with a KRAS G12D mutation, matching one of the ten TCRs within Alaunos’ TCR library.
- The patient received standard cy/flu lymphodepletion1 prior to an infusion of 9x109 TCR-T cells, which were produced using Sleepy Beauty at the Company’s in-house cGMP manufacturing facility.
- The patient was confirmed to have achieved a partial response with a regression of 46.3% in target lesions at six weeks, which subsequently deepened to 51.2% at week 12. T-cell persistence was ongoing as of week 12.
- The TCR-T cell therapy was well-tolerated and a manageable safety profile was observed in the first patient.
- The patient experienced grade 2 cytokine release syndrome (CRS) which resolved with nasal cannula oxygen supplementation and did not require anti-IL-6 treatment. Grade 4 thrombocytopenia and grade 3 anemia occurred and were both attributed to the lymphodepletion regimen.
Details of the presentation are as follows:
Title: Objective clinical response by KRAS mutation-specific TCR-T cell therapy in previously treated advanced non-small cell lung cancer
Presenter:
Date and Time:
Session Title: Session 6: Cellular Therapies: Engineering T cells
The full abstract may be accessed by visiting www.cancerimmunotherapyconference.org.
About
Alaunos is a clinical-stage oncology-focused cell therapy company, focused on developing T-cell receptor (TCR) therapies based on its proprietary, non-viral Sleeping Beauty gene transfer technology and its TCR library targeting shared tumor-specific hotspot mutations in key oncogenic genes including KRAS, TP53 and EGFR. The Company has a clinical and strategic collaboration with the
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Investor Relations Contact:
Stern Investor Relations
alex.lobo@sternir.com
1 Cyclophosphamide (60 mg/kg for 2 days) and Fludarabine (25 mg/m2 for 5 days)
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