Home » Drug & Device Pipeline News - April 15, 2024
Drug & Device Pipeline News - April 15, 2024
April 15, 2024
This week’s Pipeline features a phase 3 trial approval for retinitis pigmentosa, a phase 1 trial start for Parkinson’s disease with GBA1 mutations and an FDA drug expanded indication approval for HIV-1 infection.
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
BioCity Biopharma | BC2027 | GPC3-expressing cancers | IND for a phase 1 trial approved by the FDA |
IASO Biotechnology | Equecabtagene autoleucel | Generalized myasthenia gravis | IND for a phase 1 trial approved by the FDA |
Eilean Therapeutics | lomonitinib | Relapsed/refractory acute myeloid leukemia | IND for a phase 1 trial approved by Australia’s regulatory authority |
Delta-Fly Pharma | DFP-10917 plus venetoclax | Acute myeloid leukemia | IND for a phase 1/2 trial approved by the FDA |
ORYZON Genomics | Iadademstat plus immune checkpoint inhibitors | First-line extensive-stage small cell lung cancer | IND for a phase 1/2 trial approved by the FDA |
Ocugen | OCU400 gene therapy | Retinitis pigmentosa | IND for a phase 3 trial approved by the FDA |
Trials Initiated | |||
Corvus Pharmaceuticals | Soquelitinib | Moderate-to-severe atopic dermatitis | Initiation of a phase 1 trial |
CytomX Therapeutics | CX-2051 | Advanced solid tumors | Initiation of a phase 1 trial |
Vanqua Bio | VQ-101 | Parkinson’s disease with GBA1 mutations | Initiation of a phase 1 trial |
ViGeneron | VG901 gene therapy | Retinitis pigmentosa caused by mutations in the CNGA1 gene | Initiation of a phase 1b trial |
Biophytis | BIO101 plus GLP-1 receptor agonists | Muscle loss due to obesity treatment with GLP-1 receptor agonists | Initiation of a phase 2 trial |
IntelGenx | Montelukast VersaFilm | Parkinson’s disease | Initiation of a phase 2 trial |
Approvals | |||
2seventy bio Bristol Myers Squibb |
Abecma (idecabtagene vicleucel; ide-cel) | Relapsed/refractory multiple myeloma after two or more prior lines of therapy | Approved by the FDA for expanded indication |
Johnson & Johnson Legend Biotech |
Carvykti (ciltacabtagene autoleucel; cilta-cel) | Relapsed/refractory multiple myeloma after at least one prior line of therapy | Approved by the FDA for expanded indication |
ViiV Healthcare | Dovato (dolutegravir/lamivudine) | HIV-1 infection in adolescents age 12 years and older weighing at least 55 lbs with no antiretroviral treatment history | Approved by the FDA for expanded indication |
Upcoming Events
-
21Oct