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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

On January 21, 2026 Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, reported that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its investigational CAR-T cell therapy, Sofi-cel.

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Sofi-cel is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy currently under evaluation in a pivotal trial (T-RRex) for patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). Breakthrough Therapy Designation is intended to expedite the development and review of medicines for serious or life-threatening conditions with evidence of a substantial clinical improvement. Sofi-cel previously received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. FDA and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of R/R T-ALL/T-LBL.

Regulators granted Wugen this designation following their review of data that included results from the global Phase 1/2 clinical trial evaluating Sofi-cel in patients with R/R T-ALL/LBL.

The pivotal Phase 2 T-RRex study is a single-arm trial designed to evaluate the safety and efficacy of Sofi-cel in patients with R/R T-ALL/LBL.

"The FDA’s Breakthrough Therapy designation underscores the promising clinical data we have generated and the potential for Sofi-cel to make a meaningful difference for patients with Relapsed or Refractory T-ALL/LBL. This recognition enables close collaboration with the FDA to accelerate development and, ultimately, help bring this innovative therapy to patients as quickly as possible," said Cherry Thomas, M.D., Wugen Chief Medical Officer.

"Our goal is to bring this investigational off-the-shelf allogeneic CAR-T treatment to patients as soon as possible," said Kumar Srinivasan, Ph.D., M.B.A., Wugen President and Chief Executive Officer. "Receiving Breakthrough Therapy Designation from the FDA is a significant milestone for our company and a testament to the potential of our therapy to address a critical unmet medical need."

About Breakthrough Therapy Designation

Breakthrough Therapy Designation is intended to expedite the review of drugs for serious or life-threatening conditions. The criteria for designation require preliminary clinical evidence that demonstrates the drug may substantially improve on at least one clinically significant endpoint over available therapy.

A Breakthrough Therapy Designation conveys intensive FDA guidance on an efficient drug development, an organizational commitment involving senior FDA leadership, FDA collaboration to optimize clinical trial design, where scientifically appropriate, including minimizing patient exposure to potentially less effective therapies, and eligibility for rolling review of a marketing application, and eligibility for rolling review and priority review.

About Soficabtagene Geleucel (Sofi-cel)

Sofi-cel is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat T-cell cancers. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC) genes, thereby preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host disease (GvHD).

Sofi-cel is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-ALL/T-LBL. More information on the pivotal trial is available at ClinicalTrials.gov, identifier NCT06514794.

Sofi-cel has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. FDA and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed or refractory T-ALL/T-LBL. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.

(Press release, Wugen, JAN 21, 2026, View Source [SID1234662136])

Soley Therapeutics Announces Breakthrough Research Demonstrating How Cellular Stress Responses Reveal Drug Mechanisms, Enabling Entirely New and Accelerated Methods for Drug Discovery

On January 21, 2026 Soley Therapeutics reported the publication of a peer-reviewed study in Scientific Reports describing a new approach to understanding how living cells react to drug molecules, inverting traditional target-based drug discovery methods. The study shows that dynamic live-cell stress responses to drugs over time encode mechanistic information about a cell’s trajectory to survive, adapt, or die – information that is largely missed by traditional snapshot-based assays. This work establishes the scientific foundation for Soley’s platform, which enables a novel, proprietary live-cell approach to drug discovery based on how cells sense and respond to stress.

"This work reflects more than a decade of foundational research into how cells sense and respond to drugs and other external signals," said Yerem Yeghiazarians, M.D., Co-founder and CEO of Soley Therapeutics. "By focusing on the dynamic flow of information inside the cell, rather than static endpoints, we can delineate biology that conventional discovery methods often miss. Live Cell Dynamics is one piece of a much larger platform that Soley has created to translate whole-cell behavior into medicines. Our growing pipeline demonstrates the real-world impact of this pathbreaking science in moving drug hits to clinical candidates faster and at lower cost than traditional approaches."

Using live, label-free cell imaging, which follows living cells over time without dyes or reporter tags, the study establishes a novel approach to extract information that describes cellular stress responses by using proprietary self-supervised machine learning methods. The authors show that subtle information extracted from cells indicates dynamic responses to a drug, providing insight into a drug’s real mechanism across multiple dimensions, including toxicity and selectivity, even when compounds have similar targets and/or produce similar outcomes such as cell death. Incorporating temporal and dose-dependent information improves detection of a drug’s biological activity and mechanism-of-action, highlighting the limitations of binary readouts and morphology-only profiling approaches, particularly in complex cellular disease states.

"Through this research, our goal was to extract dynamic information from live cells for drug discovery and development purposes," said Kurosh Ameri, Ph.D., Co-founder and Chief Scientific Officer of Soley Therapeutics. "We have now shown that live cells sense drugs dynamically and convey different mechanistic information, which is dose- and time-dependent. Our proprietary machine learning methods can extract information about drugs directly from live, unstained images. This ability to measure and interpret detailed information directly from live cells in a scalable and reproducible way demonstrates a significant advance in drug discovery. This comprehensive approach provides a more accurate understanding of complex cellular responses and a drug’s true mechanism-of-action, moving beyond single endpoint and time point assays."

These experimental principles form the scientific underpinnings of Soley’s proprietary platform, which scales this biology-first approach using automation and AI to drive drug discovery across oncology and other complex diseases. The publication adds to Soley’s growing body of peer-reviewed research supporting its differentiated approach as the company advances multiple internally discovered programs toward the clinic.

(Press release, Soley Therapeutics, JAN 21, 2026, View Source [SID1234662135])

Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 2026 Tandem Meetings of ASTCT® and CIBMTR®

On January 21, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that new clinical data will be presented in two oral and seven poster sessions at the 2026 Tandem Meetings of ASTCT and CIBMTR from February 4-7 in Salt Lake City, UT.

The presentations will include data on the company’s pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematological malignancies, including Orca-T, Orca-Q and the Orca-T and allogeneic CAR-T combination therapy, OrCAR-T.

"Our presentations at this year’s Tandem Meetings reflect the growing body of evidence supporting the use of Orca-T as a precision-engineered cellular immunotherapy administered through an allogeneic stem cell transplant," said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. "From new data in myelodysplastic syndromes, to evaluations in reduced intensity conditioning, and a report on our ability to reliably distribute our products to patients nationwide, these findings represent our ongoing efforts to improve outcomes for the transplant community. We look forward to engaging with our peers and partners to discuss how these advancements can help redefine the treatment landscape for patients with blood cancer."

The Tandem abstracts are now available at www.tandemmeetings.com. Details of the Orca Bio presentations follow:

Oral Session: Session A – Clinical Progress in GVHD Prevention, Risk Stratification, and Treatment

Title: Interim Clinical Outcomes in Orca-T with Reduced Intensity Conditioning: An Observational Comparison to Registry-Based Post-Transplant Cyclophosphamide Patients

Presentation ID: 7

Date and Time: Wednesday, February 4, 3:15 PM – 3:30 PM MST

Location: Ballroom AB

Oral Session: Session E – Acute Lymphoid Leukemias: Advances in CAR T and Transplant Approaches

Title: Mature Outcomes from the Phase I Trial of Orca-T and Allogeneic CD19/CD22 CAR-T cells for Adults with High-Risk B-ALL

Presentation ID: 31

Date and Time: Thursday, February 5, 3:15 PM – 3:30 PM MST

Location: Ballroom AB

Poster Session: Myeloid Neoplasms Including Relapse – Clinical

Title: Clinical Outcomes in Myelodysplastic Syndrome Patients Treated with Orca-T or Post-Transplant Cyclophosphamide Patients: A Registry-Based Comparison

Presentation ID: 534