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

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

SEATTLE, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Umoja Biopharma Inc., a transformative immunotherapy company creating off-the-shelf treatments for cancers and other indications of high unmet need, today announced proof-of-concept preclinical data evaluating the company’s VivoVec™ in vivo gene delivery technology to generate chimeric antigen receptor (CAR) T cells in vivo in an oral presentation at the 65^th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023, in San Diego, California.

These results show new findings in humanized mice and from an ongoing study in four non-human primates (NHPs) that build upon data presented in September at the 8^th CAR-TCR Summit. Data demonstrate that following a single injection of VivoVec particles, without the need for any form of lymphodepleting conditioning, CAR T cells are efficiently generated in vivo and expand in response to cognate antigen, eradicate target antigen-expressing cells, and form populations of memory CAR T cells.

“At Umoja, we are focused on developing off-the-shelf approaches that overcome the limitations of approved ex vivo CAR T cell therapies,” said Andy Scharenberg, M.D., Co-Founder and Chief Executive Officer of Umoja. “These results exemplify the progress we are making towards the clinic, and we remain on track to submit a request to the FDA in 2024 to bring our VivoVec technology into human studies.”

Executive Vice President of Discovery Research & Vector Biology, Byoung Ryu, Ph.D., added, “The data from these studies show efficient generation of CAR T cells in vivo at the planned clinical trial dose. CAR T cell expansion correlates with rapid and durable B cell aplasia in NHPs within our study which exceeds the current ex vivo CAR T cell benchmarks. Importantly, we continue to see no acute toxicity associated with VivoVec particle administration.”

Oral Presentation Title: VivoVec™ Surface-Engineered Lentiviral Particles Mediate In Vivo CAR T Generation with Potent and Highly Durable Activity in Non-Human Primates and Tumor-Bearing Humanized Mice

Key Highlights:

• In vitro studies:
  • VivoVec cultured with resting PBMCs selectively bind T cells in an MDF surface engineering-dependent manner, resulting in T cell activation, transduction, and CAR expression.
  • Resulting CAR T cells demonstrate tumor cell killing, cytokine secretion, and proliferation in response to serial antigen exposure.
• Humanized mice studies:
  • The VivoVec platform demonstrates dose-dependent T cell activation and CAR T cell expansion in NALM6 tumor xenograft model.
  • 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.
• Non-human primate studies:
  • At planned clinical trial dose, all four NHPs show CAR T cell generation in vivo, comprising up to 65% of T cells, and demonstrate a central memory T cell response.
  • Anti-CD20 CAR T cell expansion correlates with rapid and durable B cell aplasia up to 76 days after VivoVec administration.
  • VivoVec was well-tolerated with no acute toxicity associated with particle injection.

The abovementioned NHP studies are being conducted in collaboration with the Washington National Primate Research Center.

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 gene delivery technology and the RACR™/CAR in vivo cell expansion/control 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