Allotera Therapeutics Closes $35 Million Financing, Bringing Total to $150 Million for Pivotal-Stage Off-the-Shelf CAR-T Therapy in T-Cell Cancers
核心洞察
Allotera Therapeutics (搜索) (formerly Wugen) closed a $35 million financing round including equity and venture debt, bringing total Series C capital raised to $150 million.
Proceeds will support the global pivotal T-RRex trial of Soficabtagene Geleucel (搜索) (Sofi-cel), an allogeneic CD7 (搜索)-targeted CAR-T therapy for relapsed/refractory T-ALL and T-LBL.
Sofi-cel uses CRISPR/Cas9 gene editing to delete CD7 (搜索) and TRAC genes, preventing CAR-T fratricide and reducing graft-versus-host disease risk.
Allotera Therapeutics (搜索), Inc., formerly known as Wugen, Inc., announced the successful closing of a $35 million financing round comprising equity and venture debt, bringing the company's total capital raised to $150 million. The funds will primarily support the ongoing global pivotal T-RRex clinical trial of Soficabtagene Geleucel (搜索) (Sofi-cel), an off-the-shelf, allogeneic CAR-T cell therapy targeting relapsed or refractory T-cell acute lymphoblastic leukemia (搜索) (T-ALL) and T-cell lymphoblastic lymphoma (搜索) (T-LBL).
The financing builds on Allotera's $115 million Series C announced in late 2025. The Series C was led by Fidelity Management & Research Company (搜索), with participation from all existing investors. The current extension includes additional participation from Lightchain Capital and BioGenerator, as well as new investors including Blood Cancer United (搜索)'s Therapy Acceleration Program (TAP) and others. Venture debt was provided by Banc of California (搜索).
"Allotera reflects who we are becoming as a company: a pivotal-stage cell therapy company focused on bringing off-the-shelf CAR-T therapies to patients with T-cell cancers," said Kumar Srinivasan, Ph.D., M.B.A., Chief Executive Officer of Allotera Therapeutics (搜索). "With Sofi-cel advancing in T-RRex, a global pivotal study, this financing strengthens our ability to execute across clinical development, manufacturing, and patient-community engagement as we work to address diseases where treatment options remain limited."
A New Identity for a Sharpened Focus
The company's rebranding from Wugen to Allotera Therapeutics (搜索) underscores its concentrated effort on advancing allogeneic cell therapies for aggressive blood cancers. The name change coincides with the company's transition to a pivotal-stage organization, reflecting both clinical progress and strategic maturation.
In connection with the financing, Allotera has entered into a strategic partnership with Blood Cancer United (搜索). Through TAP, the organization will provide ongoing access to scientific and drug development expertise, facilitate engagement with key opinion leaders, and connect Allotera to critical resources including clinical trial support, patient education, and community engagement capabilities.
"Our partnership with Blood Cancer United (搜索) reflects an important part of Allotera's next chapter," said Srinivasan. "As we advance Sofi-cel through pivotal development, we are committed not only to building the clinical and manufacturing capabilities needed to bring off-the-shelf cell therapies forward, but also to engaging with the communities most affected by these diseases."
Addressing a Challenging Therapeutic Setting
T-cell cancers represent one of the most difficult settings for CAR-T therapy development because many therapeutic targets are also present on the T cells used to manufacture the therapy. This biological overlap creates significant challenges for autologous approaches, where a patient's own T cells may be contaminated with malignant cells.
Sofi-cel is designed to overcome these barriers as an allogeneic, healthy donor-derived CAR-T cell therapy. The product targets CD7 (搜索), a protein expressed on T-cell malignancies. Allotera employs CRISPR/Cas9 gene editing to delete both CD7 and the T-cell receptor alpha constant (TRAC) genes. This dual-editing strategy is intended to prevent CAR-T cell fratricide—where CAR-T cells attack each other due to shared target expression—and mitigate the risk of graft-versus-host disease.
Sofi-cel is manufactured in the United States using healthy donor-derived T cells, an approach intended to avoid malignant cell contamination that can occur in the autologous CAR-T setting. The therapy is currently being evaluated in the global pivotal T-RRex clinical trial (ClinicalTrials.gov identifier NCT06514794).
Robust Regulatory Support
Sofi-cel has garnered significant regulatory attention, receiving multiple designations from the U.S. Food and Drug Administration: Breakthrough Therapy, Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations for the treatment of relapsed or refractory T-ALL/T-LBL. In the European Union, the therapy has received Priority Medicines (PRIME) designation. Both RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients with medical need.
Additionally, Sofi-cel was selected to participate in the FDA's Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program, further underscoring the agency's interest in facilitating the therapy's advancement toward potential approval.