BI 3720931 News - LARVOL Sigma

|||||||||| BI 3720931 / Boehringer Ingelheim
P1 data, Journal, Gene therapy: Lentiviral Gene Therapy for Cystic Fibrosis: A Promising Approach and First-In-Human Trial. (Pubmed Central) - Dec 13, 2024
A third-generation lentiviral vector pseudotyped with Sendai virus F and HN envelope proteins (rSIV.F/HN) has been developed for the treatment of cystic fibrosis. Promising preclinical results support the progression of this vector carrying a full-length CFTR transgene (BI 3720931) into a first-in-human clinical trial expected to begin in 2024.

||||||||||  BI 3720931 / Boehringer Ingelheim
Enrollment open:  A Study to Test How Well BI 3720931 is Tolerated and Whether it Improves Lung Function in People With Cystic Fibrosis (Lenticlair (clinicaltrials.gov) -  Sep 20, 2024
P1/2, N=36, Recruiting,  Sponsor: Boehringer Ingelheim
Promising preclinical results support the progression of this vector carrying a full-length CFTR transgene (BI 3720931) into a first-in-human clinical trial expected to begin in 2024. Not yet recruiting --> Recruiting

|||||||||| BI 3720931 / Boehringer Ingelheim
Comprehensive methods to assess pharmacokinetics and monitor for viral shedding, replication competence, and immunogenicity of BI 3720931 in the first-in-human Lenticlair 1 Phase I/II trial () - Sep 4, 2024 - Abstract #NACFC2024NACFC_879;
This panel of novel assays complies with regulatory guidelines outlined for gene therapies and supports the monitoring of safety and tolerability of BI 3720931 in Lenticlair 1 and its extension trial, Lenticlair-ON, in PwCF. CRCs (mean (SD) out of 5).

||||||||||  BI 3720931 / Boehringer Ingelheim
Phase classification, Trial completion date, Trial initiation date, Trial primary completion date:  A Study to Test How Well BI 3720931 is Tolerated and Whether it Improves Lung Function in People With Cystic Fibrosis (Lenticlair (clinicaltrials.gov) -  Aug 27, 2024
P1/2, N=36, Not yet recruiting,  Sponsor: Boehringer Ingelheim
CRCs (mean (SD) out of 5). Phase classification: P --> P1/2

||||||||||  BI 3720931 / Boehringer Ingelheim
New P1/2 trial, New trial:  A Study to Test How Well BI 3720931 is Tolerated and Whether it Improves Lung Function in People With Cystic Fibrosis (Lenticlair (clinicaltrials.gov) -  Jul 23, 2024
P=N/A, N=0, Withheld,  Sponsor: [Redacted]

|||||||||| BI 3720931 / Boehringer Ingelheim
Lenticlair (Exhibition and Poster Area) - Mar 22, 2024 - Abstract #ECFS2024ECFS_134;
Phase classification: P --> P1/2 This trial will investigate long-term safety in pwCF treated with at least one BI 3720931 dose, assess efficacy duration after initial dosing and determine efficacy and safety after re-dosing, as applicable.

|||||||||| BI 3720931 / Boehringer Ingelheim
Lenticlair (Exhibition and Poster Area) - Mar 22, 2024 - Abstract #ECFS2024ECFS_133;
This trial will evaluate the safety and efficacy of BI 3720931 over 24 weeks in pwCF who are ineligible for CFTRmt. A separate trial will monitor long-term safety for 15 years.

|||||||||| BI 3720931 / Boehringer Ingelheim
F/HN pseudotyped lentiviral vector?mediated transduction of non?human primates () - Oct 15, 2023 - Abstract #ESGCT2023ESGCT_541;
Using a relatively low vector dose, NHPs demonstrated transduction efficiency in the range of values likely to relate to clinical benefit, without evidence of toxicity. Transduction efficiency and toxicology in animals treated with a higher dose is currently being analysed.

|||||||||| BI 3720931 / Boehringer Ingelheim
F/HN pseudotyped lentiviral vector-mediated transduction of non-human primates (Hall F2) - Feb 27, 2023 - Abstract #ECFS2023ECFS_359;
Using a relatively low vector dose, NHPs demonstrated transduction efficiency in the range of values likely to relate to clinical benefit, without evidence of toxicity. Transduction efficiency and toxicology in animals treated with a higher dose is currently being analysed.



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