Press Releases Archives

Wugen Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of Soficabtagene Geleucel

FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program supports manufacturing readiness for therapies with expedited clinical development timelines WU-CART-007 (Soficabtagene Geleucel “Sofi-cel”) is selected for participation…

02 April

U.S. FDA Grants to Wugen’s WU-CART-007 Breakthrough Therapy Designation for Treatment of Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia / T Cell Lymphoblastic Lymphoma

-- Breakthrough Therapy Designation granted to WU-CART-007 (Soficabtagene Geleucel “Sofi-cel”), an allogeneic CAR-T therapy for the treatment of T cell malignancies -- Pivotal Study of Sofi-cel for Relapsed or Refractory…

21 January

Wugen to Present Correlative Data and Long-Term Follow-Up Updates for Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell therapy at the 2025 ASH Annual Meeting

Results from the Phase 1/2 Trial are a Foundation for the Ongoing Pivotal Study of Soficabtagene Geleucel for R/R T-Cell ALL/ LBL in Pediatric and Adult Patients ST. LOUIS, MO,…

05 December

Wugen Secures $115 Million to Advance Pivotal Study of First-in-Class Allogeneic CAR-T Therapy, WU-CART-007

— Financing led by Fidelity Management & Research Company with participation from RiverVest Venture Partners, Lightchain Capital, LYZZ Capital, Abingworth, Intermediate Capital Group (ICG), Tybourne Capital Management, Aisling Capital Management,…

27 August

Wugen Announces Dosing of First Patients in Pivotal Trial of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007

Previously reported Phase 1/2 data on WU-CART-007 demonstrated clinically manageable safety and evidence of anti-leukemic activity with an overall response rate of 91% and composite complete remission rate of 73%…

20 March

Wugen Announces Appointment of Jim Faulkner, Ph.D., as Chief Technology Officer

ST. LOUIS, MO and SAN DIEGO, CA, Feb. 26, 2025 – Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor…

26 February

Wugen to Present Clinical Data at the 2024 ASH Annual Meeting Ahead of Pivotal Trial Launch of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007

-- Data Support Start of First Pivotal Trial for an Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell Therapy in Pediatric and Adult Patients -- ST. LOUIS, MO and SAN DIEGO, CA, Dec.…

05 December

Wugen to Initiate a Pivotal Trial for Its Investigational, Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy, WU-CART-007, in Patients with Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia or T Cell Lymphoblastic Lymphoma

-- First Pivotal Trial for an Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell Therapy to Begin in First Quarter 2025 -- -- The Global Study Will Evaluate WU-CART-007 in Pediatric and Adult…

12 November

Cherry T. Thomas, M.D., Joins Wugen as Chief Medical Officer, Bringing Cell Therapy Expertise Across Clinical Development, Regulatory, and Medical Affairs as the Company Embarks on a Pivotal Trial for its Investigational, Allogeneic CD7-Targeted CAR-T Cell Therapy

ST. LOUIS, MO and SAN DIEGO, CA, Nov. 12, 2024 – Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor…

12 November

Phase 2 Findings Show Wugen’s Investigational Allogeneic CAR-T, WU-CART-007, Was Highly Effective and Surpassed Standard of Care in Treating Hard-to-Treat T-ALL/LBL; Data Presented Today at European Hematology Association (EHA) 2024 Hybrid Congress

-- Researchers Shared Findings Including a Clinically Manageable Safety Profile and Anti-leukemic Activity with WU-CART-007 in Patients with R/R T-ALL/LBL and Previously Treated with Existing Therapies -- -- U.S. Biotech…

14 June

ARCHIVE

Wugen Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of Soficabtagene Geleucel

U.S. FDA Grants to Wugen’s WU-CART-007 Breakthrough Therapy Designation for Treatment of Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia / T Cell Lymphoblastic Lymphoma

Wugen to Present Correlative Data and Long-Term Follow-Up Updates for Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell therapy at the 2025 ASH Annual Meeting

Wugen Secures $115 Million to Advance Pivotal Study of First-in-Class Allogeneic CAR-T Therapy, WU-CART-007

Wugen Announces Dosing of First Patients in Pivotal Trial of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007

Wugen Announces Appointment of Jim Faulkner, Ph.D., as Chief Technology Officer

Wugen to Present Clinical Data at the 2024 ASH Annual Meeting Ahead of Pivotal Trial Launch of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007

Wugen to Initiate a Pivotal Trial for Its Investigational, Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy, WU-CART-007, in Patients with Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia or T Cell Lymphoblastic Lymphoma

Cherry T. Thomas, M.D., Joins Wugen as Chief Medical Officer, Bringing Cell Therapy Expertise Across Clinical Development, Regulatory, and Medical Affairs as the Company Embarks on a Pivotal Trial for its Investigational, Allogeneic CD7-Targeted CAR-T Cell Therapy

Phase 2 Findings Show Wugen’s Investigational Allogeneic CAR-T, WU-CART-007, Was Highly Effective and Surpassed Standard of Care in Treating Hard-to-Treat T-ALL/LBL; Data Presented Today at European Hematology Association (EHA) 2024 Hybrid Congress

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