Umoja Biopharma Presents New Preclinical Data at the American Society of Gene and Cell Therapy 26th Annual Meeting Demonstrating Potent In Vivo CAR T Cell Generation and Durable Anti-Tumor Activity

UB-VV200 preclinical data highlight successful generation of TagCAR T cells, which demonstrate dose-dependent anti-tumor activity when used in combination with TumorTag^™ technology in an in vivo model

Optimization of VivoVec particles increases anti-tumor activity and enables multiple routes of administration for VivoVec-mediated CAR delivery in in vivo models

SEATTLE, May 17, 2023 (GLOBE NEWSWIRE) — Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers, today announced the presentation of new preclinical data at the American Society of Gene and Cell Therapy (ASGCT) 26^th Annual Meeting demonstrating potent in vivo CAR T cell generation and robust anti-tumor activity using its VivoVec^™ platform.

“Our new preclinical data at ASGCT represent the significant progress we have made in our platform development and IND-enabling studies and bring VivoVec one step closer to delivering on the promise of off-the-shelf in vivo CAR T cell therapies,” said Andy Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja. “These data exemplify our continued efforts to push beyond the limitations of today’s CAR T cell therapies and showcase the advances we’ve made in our VivoVec platform together with promising results from our in vivo UB-VV200 solid tumor program. We look forward to bringing our product candidates to the clinic in the coming year.”

Umoja’s oral and poster presentations highlight preclinical data demonstrating efficient in vivo CAR T cell generation and anti-tumor activity using its off-the-shelf surface-engineered lentiviral VivoVec platform. Specifically, the preclinical data highlight advancements made in vector design by incorporating a multidomain fusion (MDF) protein that improves activity via multiple routes of administration. Additionally, preclinical data from the Company’s solid tumor program, UB-VV200, demonstrate efficient in vivo generation of TagCAR T cells, the ability to control their expansion using the RACR^™ system, and specific tumor targeting using TumorTag^™ technology. Cumulatively, these data represent significant progress toward an Investigational New Drug application (IND).

Presentation highlights:

Abstract #: 53
Title: UB-VV200 is a novel surface-engineered lentiviral product candidate for in vivo engineering of universal TagCAR T cells for the treatment of solid tumors
Presenter: Alyssa Sheih, Ph.D., Senior Scientist, Umoja Biopharma
Presentation Date, Time: Wednesday, May 17, 2023, 3:45 PM – 4:00 p.m. PT
Key Highlights:

• Oral presentation describes the development of UB-VV200 drug product with a payload encoding a universal CAR (TagCAR) and a synthetic cytokine receptor for the generation of TagCAR T cells in vivo and results from preclinical in vivo studies of UB-VV200 in combination with UB-TT170, a bispecific adaptor targeting folate receptors.
  • Surface engineered UB-VV200 selectively binds, activates, and efficiently transduces T cells in a dose-dependent manner
  • Resulting TagCAR T cells mediate antigen-specific cytolytic activity, cytokine release, and proliferation through engaging UB-TT170 bound tumor cells
  • The RACR system selectively enriches and expands TagCAR T cells through rapamycin administration
  • Engineered in vivo TagCAR T cells combined with UB-TT170 control aggressive FRα+ tumor cells in mice in a dose-dependent manner

Abstract #: 1441
Title: Potent in vivo CAR T cell generation and durable anti-tumor activity in preclinical models using VivoVec, a surface-engineered lentiviral vector drug platform   
Presenter: Christopher Nicolai, Ph.D., Principal Scientist, Umoja Biopharma
Presentation Date, Time: Friday, May 19, 2023, 12:00 p.m. PT
Key Highlights:

• Poster presentation details the optimization of VivoVec particles, Umoja’s novel surface-engineered lentiviral vectors for in vivo CAR T cell generation that promote high avidity T-cell binding and transduction.
  • Addition of costimulatory molecules to VivoVec particles increases T-cell binding, activation, and transduction of T-cells in vitro and dose-dependent T-cell transduction and anti-tumor immunity in vivo.
  • VivoVec particles that incorporate a multidomain fusion (MDF) molecule show enhanced T-cell binding and transduction in vitro, compared to particles containing separate costimulatory molecules.
  • MDF VivoVec particles demonstrate improved anti-tumor response in vivo and at a lower dose compared to particles containing separate costimulatory molecules.
  • MDF-engineered VivoVec particles delivered using Lupagen’s extracorporeal system generate functional CAR T cells in vivo that mediate durable anti-tumor responses in preclinical tumor xenograft models.

Presentations can be accessed from the ASGCT website at https://annualmeeting.asgct.org/.

About Umoja Biopharma
Umoja Biopharma, Inc. is an early clinical-stage company advancing an entirely new approach to immunotherapy. The Company is a transformative multi-platform immuno-oncology company founded with the goal of creating curative treatments for solid and hematological malignancies. Founded based on pioneering work performed at Seattle Children’s Research Institute and Purdue University, Umoja’s novel approach is powered by integrated cellular immunotherapy technologies including the VivoVec^™ off-the-shelf in vivo delivery platform, the RACR^™/CAR in vivo cell expansion/control platform, and the TumorTag^™ targeting platform. Designed from the ground up to work together, these platforms are being developed to create and harness a powerful immune response in the body to directly, safely, and controllably attack cancer. Umoja believes that its approach can provide broader access to the most advanced immunotherapies and enable more patients to live better, fuller lives. To learn more, visit http://umoja-biopharma.com/.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Umoja Biopharma, Inc. (the “Company,” “we,” “us,” or “our”). The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as any economic, market and social disruptions. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Umoja Media Contact:
Karissa Cross, Ph.D.
LifeSci Communications
kcross@lifescicomms.com