This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).

Start Date01 Nov 2024

Sponsor / Collaborator

Umoja Biopharma, Inc.Startup

NCT05312411 / RecruitingPhase 1IIT

A Phase I Feasibility And Safety Study of Fluorescein-Specific (FITC-Ew) CAR T Cells In Combination With Parenterally Administered Folate-Fluorescein (UB-TT170) For Osteogenic Sarcoma

The purpose of this study is to see if a new treatment could help patients who have osteosarcoma that does not go away with treatment (is refractory) or comes back after treatment (is recurrent).This study is testing a combination of study therapies, UB-TT170 and genetically modified chimeric antigen receptor T lymphocyte (CAR T) cells, which work together in a way that is different from chemotherapy.
In this study, researchers will take some of your blood and remove the T cells in a process called "apheresis". Then the T cells are taken to a lab and changed to CAR T cells that recognize the flags from UB-TT170. Once researchers think they have grown enough CAR T cells, called antiFL(FITC-E2) CAR T cells, to fight your cancer, you may get some chemotherapy to make room in your body for the new cells and then have those cells put back in your body.
A few days after the you get your CAR T cell infusion you will start to get infusions of UB-TT170, with the dose slowly increasing for the first few infusions until you have reached a maximum dose that you will get on a regular schedule. The UB-TT170 will attach to your tumor cells and flag them so that they attract the CAR T cells. When the CAR T cells see the labeled tumor cells they can kill the tumor cells.
The active part of the study lasts about 8 months, and if you get the CAR T cell infusion you will be in long-term follow-up for 15 years.

Start Date20 May 2022

Sponsor / Collaborator

Seattle Children's Hospital

[+1]

100 Clinical Results associated with Umoja Biopharma, Inc.

0 Patents (Medical) associated with Umoja Biopharma, Inc.

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01 Sep 2024·Journal of Pharmaceutical Sciences

Quality risk management and data integrity in R&D laboratories supporting CMC lifecycle of biological products

Article

Author: Vessely, Christina ; Maluf, Karl ; Roach, Shawn ; Hunt, Deanna ; Rogers, Richard S ; Cleveland, Chad ; Kendrick, Brent S ; Ritter, Nadine ; Christie, Merry ; Bowen, Steven ; Gabrielson, John P

The development of pharmaceutical products is the critical bridge that moves a potential new medicine from academic discovery to applied treatment of patients. It translates an idea for a new drug to bench-level research on how it can be manufactured, formulated, characterized and controlled for use in non-clinical and early clinical trials. From pre-clinical R&D discovery work through the commercial launch, substantial R&D CMC data is generated to develop and optimize cGMP manufacturing and testing operations, while also supporting product comparability, elucidating product / impurity structures, assessing critical quality attributes, developing the drug delivery mode, and developing the product formulation for long-term stability. Significant R&D CMC work continues post-approval to support continuous improvement and market expansion of the commercial product. These activities are crucial elements of Product Lifecycle Management, and taken together, they comprise Pharmaceutical Quality or Chemistry, Manufacturing and Controls (CMC). The objective of this paper is to mitigate the regulatory ambiguity of R&D quality systems with practical, risk-based examples and recommendations when conducting supportive CMC studies for biological products. Making sound strategic CMC decisions under any circumstances assumes data from R&D studies are reliable, traceable, and complete. While there are specific regulatory guidelines on phase-appropriate cGMP activities, none exist for quality practices in R&D CMC laboratories conducting non-cGMP studies. Hindsight is not the time to discover that R&D studies lack key elements that would otherwise have allowed the data to be directly presented to regulators, if needed. There is a strong prospective business interest in protecting considerable investments made for CMC R&D studies. Therefore, establishment of a robust and stage-appropriate R&D laboratory quality system is essential for companies seeking to capitalize on prior knowledge, protect investments, and be prepared for accelerated approval pathways.

01 Mar 2023·Journal for ImmunoTherapy of Cancer

Preclinical proof of concept for VivoVec, a lentiviral-based platform for in vivo CAR T-cell engineering

Article

Author: Gould, Sarah ; Freeman, Jessica ; Larson, Ryan P ; Nicolai, Christopher J ; Sheih, Alyssa ; Pankau, Mark D ; Irwin, Blythe ; Brandes, Alissa H ; Ryu, Byoung Y ; Hernandez, Susana A ; Shin, Seungjin ; Ting, Hung-An ; Gervascio, Timothy ; Michels, Kathryn R ; Scharenberg, Andrew M ; Sullivan, Alessandra M ; Green, Shon ; Parrilla, Don ; Muhonen, Mason ; Getto, Rich ; Perez, Anai M

BackgroundChimeric antigen receptor (CAR) T-cell therapies have demonstrated transformational outcomes in the treatment of B-cell malignancies, but their widespread use is hindered by technical and logistical challenges associated with ex vivo cell manufacturing. To overcome these challenges, we developed VivoVec, a lentiviral vector-based platform for in vivo engineering of T cells. UB-VV100, a VivoVec clinical candidate for the treatment of B-cell malignancies, displays an anti-CD3 single-chain variable fragment (scFv) on the surface and delivers a genetic payload that encodes a second-generation CD19-targeted CAR along with a rapamycin-activated cytokine receptor (RACR) system designed to overcome the need for lymphodepleting chemotherapy in supporting successful CAR T-cell expansion and persistence. In the presence of exogenous rapamycin, non-transduced immune cells are suppressed, while the RACR system in transduced cells converts rapamycin binding to an interleukin (IL)-2/IL-15 signal to promote proliferation.MethodsUB-VV100 was administered to peripheral blood mononuclear cells (PBMCs) from healthy donors and from patients with B-cell malignancy without additional stimulation. Cultures were assessed for CAR T-cell transduction and function. Biodistribution was evaluated in CD34-humanized mice and in canines. In vivo efficacy was evaluated against normal B cells in CD34-humanized mice and against systemic tumor xenografts in PBMC-humanized mice.ResultsIn vitro, administration of UB-VV100 resulted in dose-dependent and anti-CD3 scFv-dependent T-cell activation and CAR T-cell transduction. The resulting CAR T cells exhibited selective expansion in rapamycin and antigen-dependent activity against malignant B-cell targets. In humanized mouse and canine studies, UB-VV100 demonstrated a favorable biodistribution profile, with transduction events limited to the immune compartment after intranodal or intraperitoneal administration. Administration of UB-VV100 to humanized mice engrafted with B-cell tumors resulted in CAR T-cell transduction, expansion, and elimination of systemic malignancy.ConclusionsThese findings demonstrate that UB-VV100 generates functional CAR T cells in vivo, which could expand patient access to CAR T technology in both hematological and solid tumors without the need for ex vivo cell manufacturing.

01 Dec 2021·Regulatory Toxicology and PharmacologyQ4 · MEDICINE

Nonclinical safety assessment of engineered T cell therapies

Q4 · MEDICINE

Review

Author: Shenton, Jacintha ; Green, Shon ; Ponce, Rafael ; Maier, Curtis C ; Lebrec, Herve ; Maki, Kazushige

Over the last decade, immunotherapy has established itself as an important novel approach in the treatment of cancer, resulting in a growing importance in oncology. Engineered T cell therapies, namely chimeric antigen receptor (CAR) T cells and T cell receptor (TCR) T cell therapies, are platform technologies that have enabled the development of products with remarkable efficacy in several hematological malignancies and are thus the focus of intense research and development activity. While engineered T cell therapies offer promise in addressing currently intractable cancers, they also present unique challenges, including their nonclinical safety assessment. A workshop organized by HESI and the US Food and Drug Administration (FDA) was held to provide an interdisciplinary forum for representatives of industry, academia and regulatory authorities to share information and debate on current practices for the nonclinical safety evaluation of engineered T cell therapies. This manuscript leverages what was discussed at this workshop to provide an overview of the current important nonclinical safety assessment considerations for the development of these therapeutic modalities (cytokine release syndrome, neurotoxicity, on-target/off-tumor toxicities, off-target effects, gene editing or vector integration-associated genomic injury). The manuscript also discusses approaches used for hazard identification or risk assessment and provides a regulatory perspective on such aspects.

News (Medical) associated with Umoja Biopharma, Inc.

24 Oct 2024

·endpts.com

Bayer, Dewpoint to work on heart drug; Viking’s obesity manufacturing plans

Plus, news about Interius BioTherapeutics, Hope Medicine, PMV Pharmaceuticals, Epitopea, Alyssum Therapeutics and a new dementia trial accelerator in the UK: Bayer exercises option to develop heart drug with Dewpoint Therapeutics : The companies, which first teamed up in 2019, now plan to develop a therapy for dilated cardiomyopathy, a heart muscle disease. Bayer is paying $424 million in upfront and milestone payments. — Jaimy Lee Viking Therapeutics is already thinking about an obesity launch: The company plans to meet with the FDA before the end of the year to discuss Phase 3 plans for its subcutaneous GLP-1/GIP receptor agonist, VK2735, according to remarks made by CEO Brian Lian on Wednesday’s earnings call. Viking is already in conversation with manufacturers, and Lian said he’s confident the company will be able to supply “a blockbuster-sized product at the appropriate time.” Viking is also launching a Phase 2 trial this quarter for an oral version of VK2735. Lian described the experimental oral medicine as more of an “add-on” to the portfolio, while the subcutaneous version would be the “anchor piece.” — Nicole DeFeudis Interius BioTherapeutics doses first ever patient with in vivo CAR-T: The biotech gave an in vivo CAR-T therapy to a patient enrolled in a Phase 1 study of INT2104, which it’s developing for B cell cancers. The trial, which is being run in Australia, is the first test of its kind. Umoja Biopharma has said it plans to dose a patient in its US-based study of its own in vivo CAR-T therapy by the end of this year . — Lei Lei Wu Hope Medicine touts interim data for endometriosis treatment: The company’s monoclonal antibody, dubbed HMI-115 , demonstrated statistically significant improvement in endometriosis pain at 12 weeks. The Phase 2 trial enrolled 142 female patients in the US, Poland and China. The mean dysmenorrhea pain score was reduced by 42%, and non-menstrual pelvic pain score was reduced by 50%. Hope CEO Nathan Chen said the company plans to “move quickly” toward global Phase 3 trials. — Katherine Lewin PMV Pharmaceuticals discontinues early-stage cancer trial: Citing toxicities and limited clinical benefit, the company abandoned its Phase 1b study assessing rezatapopt and Merck’s Keytruda. It had been testing the combo in patients with advanced solid tumors harboring a TP53 Y220C mutation. PMV said enrollment for a Phase 2 trial evaluating rezatapopt as a monotherapy for patients with TP53 Y220C and KRAS wild-type advanced solid tumors is still on track. — Katherine Lewin Epitopea closes $31M pre-Series A: With today’s round, the cancer biotech has raised more than $45 million. The funds are set to go toward its preclinical discovery work in solid tumors and clinical development plans for its RNA-based immunotherapies. — Katherine Lewin Alyssum Therapeutics emerges from stealth with $26M Series A: The Cambridge, MA-based biotech’s lead asset is AT-1965, a clinical-stage small molecule CMTR2 inhibitor. This round was led by co-founder Patrick Soon-Shiong and Accel, Famy and Navam Capital. — Katherine Lewin UK government pours £20M into dementia trial accelerator: The new initiative aims to increase the number of participants in late-stage dementia studies to the tens of thousands and “address pharma-identified roadblocks” to running the trials. The Dementia Trials Accelerator’s objectives include creating a biomarker toolbox and extending trial enrollment to community settings. — Ayisha Sharma

Phase 2Clinical ResultImmunotherapyPhase 1Phase 3

04 Oct 2024

·www.globenewswire.com

Umoja Biopharma Announces Poster Presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer

SEATTLE, Oct. 04, 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 Umoja will present two poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held November 6-10, 2024, in Houston, Texas and virtually. Umoja’s poster presentations will focus on preclinical data of UB-VV400, an off-the-shelf, multidomain fusion (MDF) protein surface engineered lentiviral vector designed to generate CD22-directed CAR T cells in vivo without requiring lymphodepleting chemotherapy, as well as the company’s RACR-induced cytotoxic lymphocytes (iCIL) platform and its potential for increased production and persistence of CAR T cells. Details of the poster presentations can be found below: Presentation Title: Development of a Surface Engineered Lentiviral Vector for In Vivo Generation of CD22-Directed CAR T CellsPresenting Author: Jeffrey Teoh, Ph.D.Poster Number: 1145Presentation Date/Time: Friday, November 8, 2024; Poster Hall Hours: 9 am – 7 pm CT Presentation Title: Arming pluripotent stem cell-derived lymphocytes with a suite of synthetic receptors enables scalable manufacturing and enhanced persistence and potency for potential off-the-shelf immunotherapyPresenting Author: Dillon Jarrell, Ph.D.Poster Number: 272Presentation Date/Time: Saturday, November 9, 2024; Poster Hall Hours: 9 am – 8:30 pm CT In addition to Umoja’s poster presentations, Seattle Children’s Therapeutics, Umoja’s collaboration partner will be presenting early experience data from the ENLIGHTen-01 trial of UB-TT170. Details of the poster presentation can be found below: Presentation Title: Early Experience on ENLIGHTen-01: A Phase 1 Study of Bispecific Adapter Molecule-Controlled Folate Receptor CAR T-Cell Therapy for Relapsed/Refractory OsteosarcomaPresenting Author: Catherine Albert, M.D.Poster Number: 233Presentation Date/Time: Friday, November 8, 2024; Poster Hall Hours: 9 am – 7 pm CT About Umoja BiopharmaUmoja 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 empowers 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/. InvestorsStephen JasperGilmartin Group, LLCstephen@gilmartinir.com MediaMatt Wright Real Chemistrymwright@realchemistry.com

ImmunotherapyCell TherapyPhase 1

30 Sep 2024

·www.globenewswire.com

Umoja Biopharma Announces Oral Presentation at the American College of Rheumatology Convergence 2024

SEATTLE, Sept. 30, 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 Umoja will present an oral presentation on the company’s VivoVec™ in vivo gene delivery technology and the generation of B Cell depleting CAR T cell therapies for the treatment of autoimmune diseases in non-human primates (NHPs) at the American College of Rheumatology (ACR) Convergence 2024, being held November 14-19, 2024, in Washington, D.C. Details of the oral presentation can be found below: Presentation Title: In Vivo Generation of B Cell Depleting CAR T Cell Therapies for Treatment of Autoimmune DiseasesSession Title: Miscellaneous Rheumatic & Inflammatory Diseases IIAbstract Number: 2662Presentation Date/Time: Tuesday, November 19, 2024, 11:00 a.m. – 12:30 p.m. ETPresenting Speaker: Maura Parker, Ph.D., Principal Scientist of In Vivo Sciences, Umoja Biopharma About Umoja BiopharmaUmoja 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 empowers 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/. InvestorsStephen JasperGilmartin Group, LLCstephen@gilmartinir.com Media Matt Wright Real Chemistrymwright@realchemistry.com

ImmunotherapyCell Therapy

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Drug(Targets)	Indications	Global Highest Phase

Fluorescein-Specific CAR T Cells(Umoja Biopharma, Inc.)	Osteosarcoma More	Phase 1
UB-VV111 ( CD19 )	Chronic Lymphocytic Leukemia More	Phase 1
UB-TT500 ( FAP )	Neoplasms More	Preclinical
UB-iC300	Hematologic Neoplasms More	Preclinical
UB-TT440 ( PSMA )	Neoplasms More	Preclinical

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