UB-VV111 / Umoja Biopharma, AbbVie - LARVOL DELTA

A phase I, multicenter, open-label study of UB-VV111 in combination with rapamycin in relapsed/refractory CD19+ B-cell malignancies. (ASCO 2025) - P1 | "Primary objectives include determining the safety profile, maximum tolerated/administered dose, and recommended Phase 2 dose of UB-VV111 +/- rapamycin. Secondary/exploratory objectives include measuring preliminary antitumor activity (magnitude and durability), as well as translational correlates of safety/efficacy."

Clinical • Combination therapy • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CD19 • CD58 • CD80

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

UB-VV111-01: A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies (clinicaltrials.gov) - P1 | N=106 | Recruiting | Sponsor: Umoja Biopharma | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase 1, Multicenter, Open-Label Study of UB-VV111 in Combination with Rapamycin in Relapsed/Refractory CD19+ B-Cell Malignancies (ASH 2024) - P1 | "Primary objectives include determining the safety profile, maximum tolerated/administered dose, and recommended Phase 2 dose of UB-VV111 +/- rapamycin. Secondary/exploratory objectives include measuring preliminary antitumor activity (magnitude and durability), as well as translational correlates of safety/efficacy."

Clinical • Combination therapy • P1 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CD19 • CD58 • CD80

Nonclinical Toxicology, Biodistribution, and Pharmacokinetics of UB-VV111, an In Vivo Anti-CD19 CAR T Cell Therapy (ASH 2024) - "Conclusion : UB-VV111 demonstrated a favorable safety and biodistribution profile, including a low risk of acute toxicity due to UB-VV111 and a low risk of toxicity from VivoVec mediated on-target (T cell) or off-target (non-T cell) transduction. Taken together, these nonclinical studies support the evaluation of UB-VV111 and rapamycin at the doses proposed in the planned Phase 1 clinical study."

CAR T-Cell Therapy • PK/PD data • Preclinical • Hematological Disorders • Hematological Malignancies • Oncology • CD34

Umoja Biopharma Announces Oral and Poster Presentations at the 66th American Society of Hematology Annual Meeting (GlobeNewswire) - "Umoja’s first oral presentation will demonstrate the performance of VivoVec particles following intralymphatic and intravenous delivery in two non-human primate species (Macaca fascicularis and Macaca nemestrina). The second oral presentation will focus on the high yield and scalability provided by Umoja’s Synthetic Receptor Enabled Differentiation (ShRED), a manufacturing process that produces unprecedented quantities of immune effector cells derived from induced pluripotent stem cells, via its Rapamycin Activated Cytokine Receptor (RACR) platform....Umoja’s poster presentation will provide a further update on UB-VV111’s favorable safety and biodistribution profile."

Preclinical • Hematological Malignancies • Oncology

Umoja Biopharma Announces FDA Clearance of IND Application for UB-VV111, a CD19 Directed in situ CAR T for Hematologic Malignancies (GlobeNewswire) - "Umoja Biopharma...announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for UB-VV111, a gene therapy that generates CD19 CAR T-cells in situ, intended to treat hematologic malignancies. Umoja expects to initiate a Phase 1 study and dose the first patient in the trial by the end of 2024....The Phase 1 study for UB-VV111 will be a dose escalation and confirmation study designed to evaluate the safety, tolerability, and clinical antitumor activity of UB-VV111. The study will enroll subjects in relapsed/refractory large-B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL) in both CAR T naïve and CAR T treated patients."

IND • New P1 trial • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies (clinicaltrials.gov) - P1 | N=106 | Not yet recruiting | Sponsor: Umoja Biopharma

Combination therapy • New P1 trial • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AbbVie and Umoja Biopharma Announce Strategic Collaboration to Develop Novel In-Situ CAR-T Cell Therapies (PRNewswire) - "AbbVie...and Umoja Biopharma (Umoja)...announced two exclusive option and license agreements to develop multiple in-situ generated CAR-T cell therapy candidates in oncology using Umoja's proprietary VivoVecTM platform. The first agreement provides AbbVie an exclusive option to license Umoja's CD19 directed in-situ generated CAR-T cell therapy candidates. This includes UB-VV111, Umoja's lead clinical program for hematologic malignancies currently at the IND-enabling phase. Under the terms of the second agreement, AbbVie and Umoja will develop up to four additional in-situ generated CAR-T cell therapy candidates for discovery targets selected by AbbVie....Under the terms of the two agreements, Umoja received upfront payments and an equity investment from AbbVie. Additionally, for the two agreements combined, Umoja may be eligible to receive up to $1.44B in aggregate for option exercise fees, development and regulatory milestones..."

Licensing / partnership • Hematological Malignancies

Umoja Biopharma Presents Preclinical Data at the 65th American Society of Hematology Annual Meeting Demonstrating In Vivo CAR T Cell Generation with Potent and Highly Durable Activity (GlobeNewswire) - "Durable B cell aplasia up to 76 days observed in non-human primates following a single dose of VivoVec™ particles without lymphodepletion, exceeding industry benchmarks for ex vivo CAR T cell therapies. Results support plans to initiate Phase 1 trial of lead candidate UB-VV111 in 2024....Resulting CAR T cells demonstrate tumor cell killing, cytokine secretion, and proliferation in response to serial antigen exposure....The VivoVec platform demonstrates potent and durable anti-tumor responses at low doses in a tumor xenograft model​, enabling low doses in the clinic relative to earlier generations."

New P1 trial • Preclinical • Hematological Malignancies • Oncology