Umoja Biopharma’s VivoVec Platform Presents Encouraging Proof-of-Concept Data in Ongoing Non-Human Primate Study at the 8th CAR-TCR Summit

Preliminary data from ongoing preclinical study include rapid, durable chimeric antigen receptor (CAR) T cell generation in vivo after a single infusion of VivoVec particles

Additional data to be presented at future medical conferences

SEATTLE, September 1, 2023 – Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers, today announced new data from an ongoing non-human primate (NHP) study demonstrating effective, durable, and well tolerated in vivo chimeric antigen receptor (CAR) T cell generation using the Company’s VivoVec™ platform technology at the 8th CAR-TCR Summit taking place in Boston, MA, August 29 – September 1, 2023.

The data include results from the first four NHPs treated in an ongoing study and demonstrate rapid and efficient in vivo generation of anti-CD20-targeting CAR T cells following a single infusion of Umoja’s multidomain fusion (MDF) VivoVec particles without the administration of pre-conditioning lymphodepleting chemotherapy. Additionally, these data suggest that the CAR T cells generated in vivo demonstrated on-target activity and persistent T cell memory.

“In vivo CAR T technology has the potential to transform the cell therapy paradigm by providing an off-the-shelf, patient-specific solution for those with serious conditions, including cancers,” said Andy Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja. “These data highlight the incredible progress Umoja has made and the potential of our unique delivery platform to effectively generate CAR T cells in vivo. Beyond a single therapeutic, our platform could enable the delivery of virtually any CAR construct, creating the opportunity for Umoja to address a broad range of cancers and unlock the true potential of CAR T cell therapies.”

Executive Vice President of Discovery Research & Vector Biology, Byoung Ryu, Ph.D., added, “These results build on our previously presented preclinical data and highlight the ability of our VivoVec particles to efficiently generate CAR T cells in vivo. Beyond the generation of CAR T cells, we are observing on-target CAR activity and durable cell survival, which could potentially translate to significant clinical benefits for patients. We look forward to providing updates on this study at a future medical conference.”

Key results include:

  • Following a single VivoVec administration, anti-CD20 CAR T cells were generated in vivo with peak levels of CAR T expansion occurring between days 7-10
  • CD20 CAR T demonstrated on-target activity resulting in durable B-cell aplasia
  • In three animals treated at the planned clinical dose—and without preconditioning chemotherapy— peak CD20 CAR+ cells comprised ~40-60% of total circulating T-cell volume, including the demonstration of central memory T-cell responses
  • In the first animal, additional independent CAR T cell expansions were observed after day 30
  • No toxicity was associated with VivoVec administration

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 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