Genprex

Uniphar introduces a new cell and gene therapy commercialization program. Positive preclinical data for Genprex's lung cancer gene therapy, Reqorsa®, is presented. BioCardia completes its Phase III trial for an ischemic heart failure therapy.

Genprex collaborates with University of Michigan Rogel Cancer Center and ALK Positive to study TUSC2 gene therapy combined with ALK-inhibitors for ALK-EML4 positive lung cancer, aiming to expand Reqorsa® Gene Therapy's potential patient population.

The Acclaim-3 trial's phase 1 dose-escalation of quaratusugene ozeplasmid (Reqorsa) and atezolizumab (Tecentriq) for extensive-stage small cell lung cancer (ES-SCLC) maintenance therapy completed the 0.09 mg/kg dose cohort with a favorable safety profile, leading to dose escalation to 0.12 mg/kg. No dose-limiting toxicities were observed, and one patient showed a partial response. The study aims to establish the maximum tolerated dose before proceeding to phase 2 expansion.

Genprex received SRC approval to proceed with the highest dose of 0.12mg/kg in the Phase I Acclaim-3 trial of Reqorsa Gene Therapy for ES-SCLC, following a favourable safety profile in the 0.09mg/kg dose group. The trial aims to evaluate REQORSA combined with Tecentriq as maintenance therapy, with Phase II expected to commence in H2 2024.

Genprex completes 0.09 mg/kg dose group in Phase 1 of Acclaim-3 trial for REQORSA Gene Therapy combined with Tecentriq for ES-SCLC, with SRC approval to escalate to 0.12 mg/kg. No dose-limiting toxicities observed, suggesting REQORSA's favorable safety profile.

Genprex forms Mesothelioma Clinical Advisory Board to advance Reqorsa, its immunogene therapy for mesothelioma, currently in phase 1/2 trials for NSCLC and ES-SCLC. The board includes 4 renowned researchers, and Reqorsa, expressing tumor suppressor gene TUSC2, aims to address unmet needs in difficult-to-treat cancers. Genprex halted enrollment in Acclaim-2 due to patient enrollment challenges, but all three combination therapy programs received FDA fast track designation.

Ractigen Therapeutics receives FDA orphan drug designation for RAG-18, a saRNA for DMD/Becker muscular dystrophy. Biogen's nusinersen shows higher dose efficacy in SMA. Cartesian Therapeutics initiates Descartes-15 CAR-T phase 1 trial for r/r multiple myeloma. Imugene's azer-cel CAR-T produces complete responses in r/r diffuse large B cell lymphoma. Novartis licenses Voyager Therapeutics' capsid for neurological target. BridgeBio Pharma's BBP-812 receives FDA RMAT designation for Canavan disease. Genprex plans to spin off its diabetes program into NewCo. NCI awards TransCode $2 million for TTX-MC138 RNA therapy in advanced solid tumors.