On April 23, 2024 Interius BioTherapeutics, a leading developer of in vivo cell-specific gene medicines, reported the presentation of preclinical data across six abstracts at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting to be held on May 7-11 in Baltimore, MD (Press release, Interius BioTherapeutics, APR 23, 2024, View Source [SID1234642254]).

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"Our lead candidate to treat B cell malignancies, INT2104, utilizes Interius’s proprietary lentiviral vector platform that incorporates CD7 targeting to specifically transduce T cells and NK cells upon intravenous (i.v.) administration – without preconditioning chemotherapy," said Phil Johnson, MD, President and CEO of Interius. "Data from humanized mice and cynomolgus macaques demonstrate that a single i.v. administration of INT2104 transduces both T and NK cells that are then reprogramed to become functional chimeric antigen receptor (CAR) cells." Biodistribution and immunohistochemical analyses confirmed vector targeting specificity. The in vivo generated autologous CAR cells targeted CD20 positive cells leading to B cell depletion in both animal models. One macaque had persistent B cell aplasia for one year, and at autopsy, had no detectable B cells in the peripheral circulation, spleen, bone marrow, or lymph nodes.

A formal GLP toxicology study established a substantial and impressive safety profile. In 20 vector-treated cynomolgus macaques, no clinical signs or symptoms of toxicity were observed, and no laboratory abnormalities were recorded over the 180-day study. These data, considered together with an extensive pre-clinical data package, support clinical entry of INT2104 this year for B cell malignancies and the rapid development of the company’s second program for autoimmune diseases.

Details of the presentations are as follows:

Abstract Number and Title: 2. In Vivo Generation of Both CAR T Cells and CAR NK Cells Using a CD7
Targeted Lentiviral Vector
Session: Presidential Symposium
Date and Time: Wednesday, May 8, 11:30-11:45 am
Location: Hall A-B

Abstract Number and Title: 201. Rational Design of a Detargeted Vesiculovirus Fusogen to Enable Targeted In Vivo Gene Delivery
Session: Emerging Viral Vectors
Date and Time: Thursday, May 9, 4:30-4:45 pm
Location: Ballroom 4

Abstract Number and Title: 235. Pharmacokinetics and Vector Shedding in NHPs Following a Single Intravenous Infusion of a CD20-Targeted Engineered Lentiviral Vector
Session: Pharmacology Toxicology Studies and Analytics Assay Development
Date and Time: Friday, May 10, 8:30-8:45 am
Location: Room 339-342

Abstract Number and Title: 1360. Automating a Lentivirus Infectious Titer Assay (ITA)
Poster Session: Vector Product Engineering, Development, and Manufacturing
Date and Time: Thursday, May 9, 12:00 pm – 7:00 pm
Location: Exhibit Hall

Abstract Number and Title: 1361. Evaluation of Residual Host Cell DNA Clearance and Sizing During Production of a Lentiviral Vector
Poster Session: Vector Product Engineering, Development, and Manufacturing,
Date and Time: Thursday, May 9, 12:00 pm – 7:00 pm
Location: Exhibit Hall

Abstract Number and Title: 1839. In Vivo Delivery of an Engineered Lentiviral CAR19 Vector for the Treatment of Autoimmune Diseases
Poster Session: In Vivo Therapy Approaches
Date and Time: Friday, May 10, 12:00 pm – 7:00 pm
Location: Exhibit Hall