Umoja Biopharma Announces Publication in Blood Highlighting Successful Generation of In Vivo CAR T-cells in Non-Human Primate Modeling
Umoja Biopharma has announced a groundbreaking publication in the journal Blood, showcasing the first successful generation of in vivo CAR T-cells in a non-human primate (NHP) model. The data validate their VivoVec platform, demonstrating its potential to transform CAR T-cell therapies. Results indicated that VivoVec lentiviral particles could generate CAR+ T-cells targeting CD20 without lymphodepleting chemotherapy, leading to complete B-cell depletion for over 10 weeks. Key findings highlight the enhanced antitumor functionality of CAR T-cells generated via VivoVec particles, featuring a multidomain fusion protein. Umoja plans to initiate human trials in the latter half of 2024, aiming to improve treatment accessibility and effectiveness in oncology and autoimmunity.
- First successful in vivo CAR T-cell generation in an NHP model.
- Validation of VivoVec platform for transition into human trials.
- CAR+ T-cells targeting CD20 achieved complete B-cell depletion for over 10 weeks.
- Enhanced antitumor functionality of CAR T-cells produced by VivoVec.
- Human trials planned for the second half of 2024.
- No financial data provided, creating uncertainty about the company's financial health.
- Potential risks associated with first-in-human trials, including unforeseen side effects.
The publication of Umoja Biopharma's study in Blood signifies a pivotal moment for CAR T-cell therapies. Traditional CAR T-cell treatments require extensive infrastructure and a lengthy manufacturing process, limiting patient access. The successful in vivo generation of CAR T-cells using the VivoVec system could potentially revolutionize the field by eliminating the need for external cell collection and genetic modification.
This advancement is achieved through the incorporation of CD80 and CD58 costimulation proteins, which enhance the functionality and activation of CAR T-cells. The data shows complete B-cell depletion for up to 76 days, a significant milestone that supports the transition to human clinical trials. For investors, this highlights a strong potential for Umoja's technology to disrupt current CAR T-cell therapy paradigms, potentially positioning them as a leader in the market.
In simpler terms, this innovation could make CAR T-cell therapies more accessible and effective, which is promising for both patients and investors.
From a financial perspective, this development could significantly enhance Umoja Biopharma's market position. The ability to generate CAR T-cells in vivo may reduce the cost and time associated with current ex vivo processes. This could lead to broader adoption and potentially higher market share in the CAR T-cell therapy segment.
The announcement that human trials are set to begin later this year is a positive indicator for long-term growth. However, investors should be mindful of the inherent risks associated with clinical trials, including potential safety concerns and regulatory approvals. Short-term, the stock may see positive movement due to heightened investor interest and optimism, but long-term success will depend on the clinical trial outcomes and subsequent market adoption.
Overall, the financial implications are promising, but cautious optimism is warranted.
The VivoVec system's potential to generate CAR T-cells in vivo represents a significant leap forward for oncology treatments. Current approved therapies have shown success but are limited by logistical and manufacturing challenges. Umoja’s technology could simplify the treatment process, making these therapies more available and possibly more effective.
The successful use of multi-domain fusion proteins to enhance T-cell activation and transduction is a noteworthy innovation. If human trials replicate these preclinical results, it could change the landscape of CAR T-cell therapies, offering new hope for patients with difficult-to-treat cancers.
The key takeaway for investors is that this development not only holds potential clinical benefits but also positions Umoja Biopharma at the forefront of next-generation CAR T-cell therapies.
- 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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