▎WuXiEdited by the Kant Content Team

Umoja Biopharma today announced that the U.S. FDA has approved the IND application for its investigational CD19-targeted in-situ generated CAR-T cell therapy UB-VV111 for the treatment of hematologic malignancies. Umoja expects to initiate a Phase 1 trial and dose the first patient by the end of 2024. According to the press release,UB-VV111 may be the first in situ generated CD19-targeting CAR-T cell therapy in hematology clinical trials.

Umoja’s VivoVec gene delivery platform combines third-generation lentiviral vector gene delivery technology with a novel T-cell targeting and activation surface complex, enabling the production of cancer-fighting CAR-T cells within the patient’s body and potentially eliminating some challenges associated with traditional CAR-T methods. These include reliance on collecting the patient’s own or donor cells, delays in associated cell production time, manufacturing challenges where ex vivo cells require external modification before being delivered back to the patient, and the need for patients to undergo lymphodepletion prior to treatment.Umoja Biopharma announced in September last year that the VivoVec platform effectively and durably generated CAR-T cells in a non-human primate (NHP) study, demonstrating good tolerability.Proof of Concept。

UB-VV111 is an in vivo product developed through the VivoVec platform.CAR-T Cell Therapy。UB-VV111 contains an engineered viral envelope and a transgene encoding a CD19-targeted CAR and rapamycin-activated cytokine receptor (RACRTM)., aimed at expanding UB-VV111 engineered CAR-T cells within the patient's body. This therapy is the first pipeline of the VivoVec gene delivery platform to enter clinical trials.

The Phase 1 study of UB-VV111 is a dose-escalation and validation study designed to evaluate the safety, tolerability, and clinical anti-tumor activity of UB-VV111.The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL)., including CAR-T naive patients and previously treated patients.

In January 2024, Umoja Biopharma and AbbVie reached twoTotal Potential Exceeding $1.4 BillionExclusive Option and LicenseAgreement，Utilizing Umoja's proprietary VivoVec platform in the field of oncology (and potentially in the field of immunology)Develop multiple in situ generated CAR-T cell therapy candidates.

Currently, many pharmaceutical companies are developing in vivo cell therapies, including Moderna, Capstan Therapeutics, Myeloid Therapeutics, and Interius BioTherapeutics. Among them, Interius has obtained approval to initiate human trials in Australia earlier this month.Approval。