Wugen Announces Positive Phase 2 Results for Off-the-Shelf CD7 CAR-T Therapy WU-CART-007 with 91% Overall Response Rate in R/R T-ALL/LBL

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On June 14, Wugen, a company dedicated to developing allogeneic, off-the-shelf cell therapies for the treatment of hematologic and solid tumor malignancies, a U.S.-based biotechnology company,Announced positive Phase 2 results for its investigational anti-CD7 CAR-T therapy, WU-CART-007 (W-T7), in patients with relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). The data showed that WU-CART-007 demonstrated clinically manageable safety and anti-leukemic activity in R/R T-ALL/LBL patients who had previously been treated with available therapies.

The press release noted that these positive results support the potential of this allogeneic CAR-T as a new therapy for treating patients with refractory disease who still face challenges after receiving the current best drugs for T-ALL/LBL.

Analysis shows that WU-CART-007 is more effective than the current standard therapies for R/R T-ALL/LBL, specifically including:

• Primary EndpointThe composite complete remission rate was 73% (8/11).The overall response rate was 91% (10/11; 2 cases of partial response (PR) in patients with extramedullary disease, R/R T-LBL).

• The median duration of response (mDOR) for patients was 6.2 months (95% CI: 1.8, NE); the median follow-up time was 8.5 months (95% CI: 2.7, NE).46% (5/11) of patients experienced sustained relief between 4.3 and 8.6 months.

• Pharmacokinetic analysis shows rapid expansion and persistence of this allogeneic cell therapy: WU-CART-007At the RP2D doseExpansion peaked on Day 10 and remained detectable on Day 90.

• No patients developed specific anti-HLA antibodies against the therapy. To date, no anti-drug antibodies have been detected in any patient.

WU-CART-007 is a CAR-T cell product targeting CD7, utilizing CRISPR/Cas9 technology to knock out CD7 and TRAC to prevent rejection and enable the use of allogeneic T-cells from healthy donors (Leedom et al. ASH 2021). This allogeneic CAR-T cell product is under development for the treatment of CD7+ malignancies. WU-CART-007 1001 (NCT04984356) is a global first-in-human phase 1/2 single-agent study designed to evaluate the safety and efficacy of WU-CART-007 in patients with relapsed/refractory T-ALL/LBL.

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Reference: Company Announcement