UB-VV400 / Umoja Biopharma, IASO BIO - LARVOL DELTA

Engineering T cells in vivo to express a synthetic cytokine receptor enables preferential expansion and enrichment of anti-CD22 CAR T cells. (PubMed, Mol Ther) - "UB-VV400 delivers a payload comprised of a fully human anti-CD22 CAR and the rapamycin-activated cytokine receptor (RACR), which enable preferential expansion and enrichment of CAR T cells in response to rapamycin. Here, we describe preclinical studies demonstrating that UB-VV400 generates anti-CD22 CAR T cells that kill CD22-expressing B cells and tumor cells in vitro and in vivo, and that engagement of RACR results in the selective expansion and enrichment of CAR T cells in vivo leading to complete tumor clearance and B cell depletion."

Journal • Preclinical • Immunology • Oncology

A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies (clinicaltrials.gov) - P1/2 | N=274 | Not yet recruiting | Sponsor: Umoja Biopharma

New P1/2 trial • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • Richter's Syndrome • CD22

Umoja Biopharma Announces FDA Clearance of IND Application for UB-VV400, the Industry’s First Known CD22-Directed In Vivo CAR T Cell Therapy for Relapsed/Refractory B Cell Malignancies (The Manila Times) - "The Phase 1/2 VIBRANT-1 study of UB-VV400 will open soon at U.S. clinical sites, with the first patient anticipated to be dosed in Q3 this year. The open-label, dose escalation and expansion trial is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, and preliminary antitumor activity of UB-VV400 in combination with rapamycin in patients with relapsed/refractory B cell malignancies....Initial clinical data from the investigator-initiated trial of UB-VV400 in China is expected to be shared at a major medical meeting in the second half of 2026."

IND • P1 data • Trial status • Follicular Lymphoma • High-grade B-cell lymphoma • Large B Cell Lymphoma • Primary Mediastinal Large B-Cell Lymphoma • Richter's Syndrome

A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF UB-VV400 IN COMBINATION WITH RAPAMYCIN IN RELAPSED OR REFRACTORY B-CELL MALIGNANCIES (EHA 2026) - "The primary objective in Phase 2 is to assess the antitumor activity (overall response rate); durability of response and pharmacokinetics (PK) will be assessed as a secondary objective. In both parts of the study, pharmacodynamics will be evaluated as exploratory objectives."

Clinical • Combination therapy • P1/2 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD22

UB-VV400 in Combination With Rapamycin in Relapsed or Refractory B-cell Malignancies (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Nanjing IASO Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2024 ➔ Apr 2025

Enrollment open • Trial initiation date • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Preclinical Development of UB-VV400, a Surface Engineered Lentiviral Vector for the In Vivo Generation of CD22-Directed CAR T Cells (ASGCT 2025) - "UB-VV400 demonstrated specific and efficient transduction of T cells, which corresponded with the generation of CD22-directed CAR T cells capable of killing both CD22hi and CD22lo tumor cells in vitro and in vivo. Moreover, the administration of rapamycin promoted RACR-mediated enrichment and expansion of CAR T cells in vivo resulting in complete tumor clearance and B-cell depletion. Overall, nonclinical studies of UB-VV400 ± rapamycin demonstrated a favorable safety profile, with no associated adverse events."

CAR T-Cell Therapy • Preclinical • Viral vector • Hematological Malignancies • Immunology • Oncology • CD22 • CD34 • IL15

Umoja Biopharma Announces Appointment of Dr. Luke Walker as Chief Medical Officer (GlobeNewswire) - "Umoja Biopharma, Inc...announced the appointment of Dr. Luke Walker as Chief Medical Officer...He will be responsible for the leadership of Umoja’s clinical, regulatory, and medical functions, including its two clinical stage in vivo CAR T cell programs UB-VV111 and UB-VV400 in B cell malignancies....'Two of Umoja’s VivoVec in vivo CAR T cell therapy programs are open to enrollment, both CD22-targeted UB-VV400 and CD19-targeted UB-VV111. We look forward to sharing initial clinical data in 2025...'"

P1 data • Hematological Malignancies

Umoja Biopharma Announces Oversubscribed $100 Million Series C Financing to Advance In Vivo CAR T Pipeline through Key Oncology Clinical Milestones (GlobeNewswire) - "Umoja Biopharma, Inc...announced the closing of a $100 million Series C financing....The proceeds from this financing will enable Umoja to advance its in vivo CAR T cell therapy pipeline, including its lead CD22 UB-VV400 program in multiple oncology and autoimmune clinical studies....'This Series C fundraise demonstrates both the progress and significant potential of Umoja’s in vivo oncology programs including UB-VV400 and UB-VV111'."

Financing • Oncology

Umoja Biopharma Announces Poster Presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (GlobeNewswire) - "Umoja Biopharma...announced that Umoja will present two poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)....Umoja’s poster presentations will focus on preclinical data of UB-VV400, an off-the-shelf, multidomain fusion (MDF) protein surface engineered lentiviral vector designed to generate CD22-directed CAR T cells in vivo without requiring lymphodepleting chemotherapy, as well as the company’s RACR-induced cytotoxic lymphocytes (iCIL) platform and its potential for increased production and persistence of CAR T cells....In addition to Umoja’s poster presentations, Seattle Children’s Therapeutics, Umoja’s collaboration partner will be presenting early experience data from the ENLIGHTen-01 trial of UB-TT170."

P1 data • Preclinical • Osteosarcoma