On July 31, Umoja was given the green light by the US FDA to approve its IND application for CD19 to generate CAR T cell therapy UB-VV 111 for the treatment of hematological malignancies. Umoja is expected to start a phase I study and be medication for the first patient in the trial by the end of 2024.

UB-VV 111 is a lentiviral vector-based gene therapy derived from the VivoVec platform of Umoja, including the surface-engineered viral envelope. UB-VV 111 encodes a transgene against CD19 CAR and rapamycin-activated cytokine receptor (RACRTM), designed to enrich and amplify UB-VV 111 engineered CART cells in vivo.

UB-VV 111 is being investigated in a series of B-cell malignancies, including large B-cell lymphoma and chronic lymphocytic leukemia. UB-VV 111 is the first product of the VivoVecTM gene delivery platform into the clinic, and may be the first in situ CD19-targeted CAR T cell therapy in a hematology human trial.

 Company pipeline

The phase 1 study of UB-VV 111 is a dose escalation and validation study designed to evaluate the safety, tolerability, and clinical antitumor activity of UB-VV 111. The study will enroll patients with relapsed / refractory large B cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL), including CAR-T naive and treated patients.

The VivoVecTM gene delivery platform of Umoja combines gene delivery of third-generation lentiviral vector gene delivery with novel T cell targeting and activating surface complexes. This enables in vivo T cells to make their own anticancer CAR T cells in vivo. This has the potential to eliminate the range of challenges associated with conventional CAR-T approaches, including reliance on the collection of the patient's own cells or donor cells, associated time lags, manufacturing challenges of in vitro cell modification, and the need for patient lymphatic depletion.

On January 4,2024, Albervey and Umoja Biopharma announced two exclusive option and licensing agreements to use Umoja's proprietary VivoVecTM platform to develop CAR T cell therapy candidates for a variety of cancers in situ. Under the agreement, Umoja may be eligible for option exercise fees of up to $1.44 billion, development and regulatory milestones, and Umoja may also receive additional sales milestones and graded royalties on global net sales.(one billion, four hundred and forty million dollars! AbbVie has two agreements on CAR-T therapy)

The first protocol gave AbbVie an exclusive option to license Umoja's CAR-T candidate targeting CD19, UB-VV 111. Under the terms of the second agreement, the two companies will develop up to four in vivo CAR T candidates for their selected targets.

"UB-VV 111 IND approval is an important milestone in the development of off-the-shelf therapy for Umoja and overcoming the limitations of current in vitro cell immunotherapy," said Andrew Scharenberg, Umoja co-founder and CEO, MD. We are proud to be a leader in the in vivo field and our goal is to remove many of the obstacles and challenges of early in vitro CAR T cell therapy, from difficult, lengthy, expensive manufacturing processes to arduous medication experience. Doctors and patients have been waiting for better treatments, and we are excited to start the first clinical trial.”

sum up

Many pharmaceutical companies are developing in vivo cell therapies, including Moderna, Capstan Therapeutics, Myeloid Therapeutics, and Interius BioTherapeutics. On July 30, Myeloid Therapeutics revealed that it had advanced the second mRNA CAR MT-303 program targeting GPC 3 to clinical trials and completed the first patient dose in the phase 1 study of hepatocellular carcinoma (HCC). On July 9, Interius BioTherapeutics CAR-T therapy INT2104 was approved for a phase 1 clinical trial in Australia to treat B cell malignancies.

reference material:

https://www.umoja-biopharma.com/news/umoja-biopharma-announces-fda-clearance-of-ind-application-for-ub-vv111-a-cd19-directed-in-situ-car-t-for-hematologic-malignancies/

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