Selected News – 海角社区 Thu, 16 Jul 2026 12:04:05 +0000 en-US hourly 1 https://wordpress.org/?v=7.0.4 /wp-content/uploads/2022/08/cropped-umoja-site-icon-32x32.png Selected News – 海角社区 32 32 海角社区 Announces FDA Clearance of IND Application for UB-VV400, the Industry鈥檚 First Known CD22-Directed In Vivo CAR T Cell Therapy for Relapsed/Refractory B Cell Malignancies /news/umoja-biopharma-announces-fda-clearance-of-ind-application-for-ub-vv400-the-industrys-first-known-cd22-directed-in-vivo-car-t-cell-therapy-for-relapsed-refractory-b-cell-malignancies/ Thu, 16 Jul 2026 12:02:34 +0000 /?post_type=news&p=2413
  • The company鈥檚 lead internal program expands its聽in vivo聽CAR T clinical pipeline for patients with聽relapsed/refractory B cell malignancies
  • First patient expected to be dosed in Q3 2026
  • SEATTLE, WA, July 16, 2026 鈥斅海角社区, Inc., a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) recently cleared its Investigational New Drug (IND) application for UB-VV400, a CD22-directed聽in vivo聽CAR T cell therapy candidate for adults with relapsed/refractory B cell malignancies.

    鈥淯B-VV400 is our second VivoVec鈩 based in vivo CAR T cell program to advance to U.S. clinical trials,鈥 said Luke Walker, M.D., Chief Medical Officer of 海角社区. 鈥淕enerating CAR T cells within a patient鈥檚 body would have the potential to transform clinical practice. We designed this Phase 1/2 trial to address a critical, real-world unmet need for patients, including those who have progressed after prior CAR T cell treatment. We remain highly encouraged by the early clinical activity and safety profile seen in the patients treated in our investigator-initiated trial of UB-VV400, and we look forward to sharing initial clinical data.鈥

    The Phase 1/2 VIBRANT-1 study of UB-VV400 will open soon at U.S. clinical sites, with the first patient anticipated to be dosed in Q3 this year. The open-label, dose escalation and expansion trial is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, and preliminary antitumor activity of UB-VV400 with rapamycin in patients with relapsed/refractory B cell malignancies.

    Initial clinical data from the investigator-initiated trial of UB-VV400 in China is expected to be shared at a major medical meeting in the second half of 2026.

    About 海角社区 
    海角社区, Inc. is a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases. Umoja鈥檚 VivoVec鈩 in vivo gene delivery technology empowers a patient鈥檚 own immune system to fight disease. Enabling its core technology is the Company鈥檚 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  and visit umoja-biopharma.com.

    Contacts:

    Investors
    Nate Hardy
    Chief Financial Officer
    nate.hardy@umoja-biopharma.com

    Media
    Matt Wright
    Real Chemistry
    media@umoja-biopharma.com

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    海角社区 Announces Unveiling of UB-VV500 in Upcoming Poster Presentation at the American Society of Gene & Cell Therapy Annual Meeting /news/umoja-biopharma-announces-unveiling-of-ub-vv500-in-upcoming-poster-presentation-at-the-american-society-of-gene-cell-therapy-annual-meeting/ Mon, 27 Apr 2026 18:34:30 +0000 https://umojastg.wpengine.com/?post_type=news&p=2405 – Industry鈥檚 First Combination BCMA x GPRC5D In Vivo CAR T Cell Therapy for the Treatment of Multiple Myeloma –

    SEATTLE, WA, April 27, 2026 鈥 海角社区, Inc. (Umoja), a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases, today announced the acceptance of a poster presentation for UB-VV500, its dual-targeted BCMA x GPRC5D in vivo CAR T cell program for the treatment of multiple myeloma, at the upcoming American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. Preclinical data for UB-VV500 will be presented in a scientific poster at the conference.

    鈥淒evelopment in multiple myeloma is moving beyond single-targeted approaches toward dual-targeting and combination strategies, particularly as patients progress through existing BCMA-directed therapies,鈥 said Andrew Scharenberg, M.D., co-founder and Chief Executive Officer of 海角社区. 鈥淲e believe the future of multiple myeloma immunotherapy will be shaped by combination products that are designed from the ground-up to more effectively address antigen escape and disease heterogeneity while aiming to deliver greater and more durable efficacy. UB-VV500 is designed to realize that vision through our in vivo CAR T cell approach.鈥

    Umoja expects to advance UB-VV500 into a Phase 1 clinical trial by the end of 2026. Initial clinical data disclosures across the company鈥檚 other clinical programs are expected to be reported at major medical meetings in the second half of 2026.

    鈥淲e are encouraged by our safety and early clinical results in our three ongoing Phase 1 programs鈥擴B-VV111 for CD19 and UB-VV400/UB-VV410 for CD22鈥攚hich use the same VivoVecTM in vivo platform that UB-VV500 is built upon,鈥 Dr. Scharenberg added. 鈥淯B-VV500鈥檚 pre-clinical progress is exciting and we look forward to sharing more at ASGCT. Dual-targeting is the future of patient care for multiple myeloma, and we expect UB-VV500 to be at the forefront of that movement.鈥

    Details of the ASGCT poster presentation can be found below: 

    Poster Presentation Title: Preclinical development of UB-VV500, an in vivo potency-enhanced CAR T cell product targeting BCMA and GPRC5D for multiple myeloma
    Presentation Date/Time: Wednesday, May 13, 2026, 5:00 鈥 6:30 p.m. ET
    Presenting Speaker: Christopher Nicolai, Ph.D.
    Publication Number: 2046

    About 海角社区

    海角社区, Inc. is a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases. Umoja鈥檚 VivoVec鈩 in vivo gene delivery technology empowers a patient鈥檚 own immune system to fight disease. Enabling its core technology is the Company鈥檚 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 umoja-biopharma.com.

    Investors
    Nate Hardy
    Chief Financial Officer
    nate.hardy@umoja-biopharma.com

    Media
    Matt Wright
    Real Chemistry
    mwright@realchemistry.com

    ]]>
    海角社区 Appoints Dr. Marcela Maus and Dr. Athena Countouriotis to Board of Directors /news/umoja-biopharma-appoints-dr-marcela-maus-and-dr-athena-countouriotis-to-board-of-directors/ Mon, 23 Mar 2026 09:00:00 +0000 https://umojastg.wpengine.com/?post_type=news&p=2398 SEATTLE, WA, March 23, 2026 鈥 海角社区, Inc. (Umoja), a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases, today announced the appointment of Marcela Maus, M.D., Ph.D., and Athena Countouriotis, M.D., to its Board of Directors. Drs. Maus and Countouriotis bring deep expertise spanning cellular immunotherapy research, clinical development, and biotechnology company leadership.

    鈥淲e are thrilled to welcome Marcela and Athena to Umoja鈥檚 Board of Directors,鈥 said Andrew Scharenberg, M.D., co-founder and Chief Executive Officer of 海角社区. 鈥淭heir complementary perspectives on scientific innovation and clinical development leadership will be invaluable as we continue to advance our VivoVec鈩 platform and clinical programs with the goal of expanding access to transformative CAR T therapies for patients.鈥

    Marcela Maus, M.D., Ph.D., is a Professor of Medicine at Harvard Medical School, the Paula O鈥橩eeffe Chair in Oncology and Director of Cellular Immunotherapy at The Krantz Family Center for Cancer Research at Massachusetts General Hospital, and an Attending Physician in the Hematopoietic Cell Transplant and Cell Therapy division of Oncology at MGH. She is the Head of Cell Therapies and Associate Head of the Mass General Brigham Gene and Cell Therapy Institute and an Associate Member of the Broad Institute of Harvard and MIT. Dr. Maus is internationally recognized as a translational physician-scientist in immunology and T-cell鈥揵ased cancer therapies. She has authored more than 200 publications and holds multiple NIH R01 grants and several Investigational New Drug applications.

    鈥淯moja鈥檚 approach to generating CAR T cells directly in the body represents an exciting possibility for the field,鈥 said Dr. Maus. 鈥淚鈥檓 excited to support the Umoja team as they work to define how they may be applied across oncology and other serious diseases.鈥

    Athena Countouriotis, M.D., is the co-founder, President, and Chief Executive Officer of Avenzo Therapeutics. She previously led Turning Point Therapeutics as President and CEO from its IPO to eventual acquisition in 2022.  With over 20 years of industry experience, Dr. Countouriotis has also led multiple development programs to approval in the U.S. and Europe.  Dr. Countouriotis serves on the boards of Biomarin Inc., Iovance Biotherapeutics, Passage Bio, Recludix Pharma, and Leal Therapeutics, and previously was chairperson of Capstan Therapeutics.

    鈥淯moja鈥檚 platform has the potential to address some of the most significant barriers associated with traditional CAR T therapies, including complexity, timing and scalability,鈥 said Dr. Countouriotis. 鈥淭his opportunity to simplify delivery and expand access for patients is incredibly important, and I鈥檓 excited to support the team as it continues advancing its clinical programs.鈥

    About 海角社区 

    海角社区, Inc. is a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases. Umoja鈥檚 VivoVec鈩 in vivo gene delivery technology empowers a patient鈥檚 own immune system to fight disease. Enabling its core technology is the Company鈥檚 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  and visit umoja-biopharma.com.

    Contacts:

    Investors
    Nate Hardy
    Chief Financial Officer
    nate.hardy@umoja-biopharma.com

    Media
    Matt Wright
    Real Chemistry
    mwright@realchemistry.com

    ]]>
    海角社区 Announces that UB-VV111 Receives FDA Fast Track Designation for Relapsed/Refractory B-Cell Malignancies /news/umoja-biopharma-announces-that-ub-vv111-receives-fda-fast-track-designation-for-relapsed-refractory-b-cell-malignancies/ Tue, 30 Sep 2025 05:47:00 +0000 https://umojastg.wpengine.com/?post_type=news&p=2371 SEATTLE, WA, September 30, 2025 鈥 海角社区, the clinical-stage leader of in vivo cell therapies that aim to realize the full reach and promise of CAR T cells, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to UB-VV111 for the treatment of relapsed/refractory Large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia following two or more lines of prior therapy.

    UB-VV111 is an investigational, off-the-shelf drug product that generates CD19-directed CAR T cells in vivo, potentially addressing a range of shortcomings posed by traditional ex vivo autologous CAR T cell therapies which limit broad patient access, including high manufacturing costs, long wait times, burdensome treatment processes, and limited product availability.

    An ongoing Phase 1 clinical trial is evaluating the safety and antitumor activity of UB-VV111 in CD19+ B-cell malignancies (). In 2024, UB-VV111 became the first in vivo CAR T cell therapy to receive clearance of its Investigational New Drug application by the FDA. As previously announced, AbbVie retains an exclusive option to license Umoja鈥檚 CD19-directed in vivo CAR T cell therapy candidates, including UB-VV111.

    鈥淭his Fast Track Designation marks a key milestone in the advancement of in vivo CAR T cell therapies,鈥 said Luke Walker, M.D., Chief Medical Officer of 海角社区. 鈥淯B-VV111 continues to lead the in vivo CAR T cell field in the U.S., and today鈥檚 announcement further reinforces its potential to address unmet needs in the treatment of those living with relapsed/refractory B-cell malignancies. This achievement is a testament to the dedication of our clinical trial sites and to the patients who inspire our mission every day.鈥

    About 海角社区
    海角社区, Inc. is a clinical-stage biotechnology company aiming to develop in vivo cell therapies that improve the reach, effectiveness, and access of CAR T cell therapies in both oncology and autoimmunity. Umoja鈥檚 VivoVec鈩 in vivo gene delivery technology empowers a patient鈥檚 own immune system to fight disease. Enabling its core technology is the Company鈥檚 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 .

    Investors
    Tonya Swick
    Investor Relations Contact
    tonya.swick@umoja-biopharma.com

    Media
    Matt Wright
    Real Chemistry
    mwright@realchemistry.com

    ]]>
    海角社区 Named One of 2025鈥檚 Most Promising Biotech Companies by Endpoints News and Fierce Biotech /news/umoja-biopharma-named-one-of-2025s-most-promising-biotech-companies-by-endpoints-news-and-fierce-biotech/ Tue, 23 Sep 2025 11:46:12 +0000 https://umojastg.wpengine.com/?post_type=news&p=2369 SEATTLE, WA, September 23, 2025 鈥 海角社区, the clinical-stage leader of聽in vivo聽cell therapies that aim to realize the full reach and promise of CAR T cells, today announced its recognition by both Endpoints News and Fierce Biotech as one of the most promising biotechnology companies of the year. Umoja is honored to be named to the 2025 Endpoints 11 and the 2025 Fierce 15 lists鈥攑restigious annual awards that spotlight emerging companies driving innovation in science and medicine.

    鈥淭hese recognitions come at a pivotal moment for Umoja and the broader cell therapy field,鈥 said Andrew Scharenberg, M.D., co-founder and Chief Executive Officer of 海角社区. 鈥淥ur focus since day one has been about unity鈥攂ringing together the best science, manufacturing investments, people, and partners to advance our work into the clinic, all with the aspiration of helping future CAR T cell therapies reach their full potential.鈥

    鈥淥ne of the most significant challenges with current CAR T therapies is access. They’re challenging to deliver and often out of reach for many patients,鈥 added Luke Walker, M.D., Chief Medical Officer of 海角社区. 鈥淥ur in vivo approach hopes to change that by enabling treatment in a faster and more accessible way. Being recognized by both Endpoints News and Fierce Biotech affirms the meaningful progress we are making toward that goal.鈥

    For more than two decades, Endpoints News and Fierce Biotech have spotlighted companies that are making bold bets to redefine the boundaries of drug development. Umoja鈥檚 inclusion on both lists in 2025 reflects not only the potential of its in vivo CAR T therapies, but also the unwavering commitment of its team to deliver these medicines to patients.

    About 海角社区
    海角社区, Inc. is a clinical-stage biotechnology company aiming to develop in vivo cell therapies that improve the reach, effectiveness, and access of CAR T cell therapies in both oncology and autoimmunity. Umoja鈥檚 VivoVec鈩 in vivo gene delivery technology empowers a patient鈥檚 own immune system to fight disease. Enabling its core technology is the Company鈥檚 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 and visit umoja-biopharma.com.

    Contacts:

    Investors
    Tonya Swick
    Investor Relations Contact
    tonya.swick@umoja-biopharma.com

    Media
    Matt Wright
    Real Chemistry
    mwright@realchemistry.com

    ]]>