Umoja Biopharma Announces Publication in Blood Highlighting Successful Generation of In Vivo CAR T-cells in Non-Human Primate Modeling

– First landmark, peer-reviewed publication of successful in vivo CAR T-cell data in an immune competent NHP model –
– Data validate the VivoVec™ platform in a translationally relevant model and support its transition into human clinical testing, offering a potential paradigm shift in the field of CAR T-cell therapies –

SEATTLE, June 13, 2024 (GLOBE NEWSWIRE) — Umoja Biopharma, Inc. (Umoja), a transformative immunotherapy company creating off-the-shelf treatments that aim to extend the reach and effectiveness of CAR T-cell therapies in oncology and autoimmunity, today announced that pre-clinical non-human primate (NHP) data on its VivoVec in vivo CAR T delivery system was published in Blood, the flagship journal of the American Society of Hematology. Results showed that in the absence of lymphodepleting chemotherapy, VivoVec lentiviral particles successfully generated CAR positive T (CAR+ T) cells targeting CD20 in vivo leading to the complete and durable depletion of B cells in excess of 10 weeks.

Key Study Findings

• VivoVec particles (VVPs) incorporating CD80 and CD58 costimulation proteins exhibit enhanced capacity for in vivo CAR T-cell generation and produce CAR T-cells with increased antitumor functionality compared to those produced from VVPs displaying anti-CD3 scFvs alone.
• Combining the anti-CD3 scFv together with the ligand binding domains of CD80 and CD58 into a single multi-domain fusion (MDF) protein markedly augments the particles’ ability to bind, activate, and transduce T-cells.
• VVPs incorporating MDF compatible with NHP T-cell activation and costimulation potently generate anti-CD20 CAR T-cells in vivo, comprising up to 65% of circulating T-cells, and results in complete B-cell depletion for up to 76 days.

“Currently approved ex vivo CAR T-cell therapies have significantly improved treatment outcomes in cancers like non-Hodgkin’s lymphoma and multiple myeloma. However, their adoption and patient access are limited by the need for extensive infrastructure such as apheresis facilities, and the lengthy process of manufacturing patient-by-patient lots of CAR T-cells,” said Byoung Ryu, Ph.D., Executive Vice President of Vector Biology and In Vivo Sciences at Umoja Biopharma added, “We are excited to move several VivoVec drug candidates into initial human trials later this year, aiming to address these challenges.”

“We are encouraged by these data that show continued validation of our VivoVec platform demonstrating the successful generation of CAR+ T-cells directly in vivo, eliminating the need for external cell collection, genetic modification, and extensive testing,” said Christopher Nicolai, Ph.D., lead author of the publication.

The VivoVec platform utilizes advanced lentiviral particles that are surface engineered with a multidomain fusion protein to drive particle binding to T-cells, and subsequent activation and transduction, resulting in CAR expression. The CAR transgene is delivered to reprogram the T-cells to target specific cancer cells.

The data published in Blood were collected in collaboration with the Washington National Primate Research Center. Umoja plans to initiate first-in-human trials of VivoVec-generated candidates in the second half of 2024.

About VivoVec

Umoja’s VivoVec gene delivery platform combines third generation lentiviral vector gene delivery with a novel T-cell targeting and activation surface complex. VivoVec is designed to enable T-cells in the body to manufacture their own cancer-fighting CAR T-cells in vivo. This has the potential to eliminate many challenges associated with traditional CAR T approaches, including reliance on gathering a patient’s own or donor cells which are modified externally before being delivered back to the patient, the associated time lag and manufacturing challenges of ex vivo cell modification, and the need for patient’s lymphodepletion.

About Umoja Biopharma

Umoja Biopharma, Inc. is a clinical-stage biotechnology company aiming to develop off-the-shelf therapeutics that improve the reach, effectiveness, and access of CAR T-cell therapies in both oncology and autoimmunity. Umoja’s VivoVec in vivo gene delivery technology is intended to empower a patient’s own immune system to fight disease. Enabling its core technology is the Company’s state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. Umoja believes its approach can provide broader access and improved effectiveness of the most advanced immunotherapies, enabling more patients to live better, fuller lives. To learn more, connect with Umoja on LinkedIn and visit http://umoja-biopharma.com/.

Umoja 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.

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