Clinical Trial News

Immuron completes pre-IND meeting with FDA on IMM-529 for Clostridioides difficile infection (CDI), plans IND application for 1H 2025, and targets prevention, recurrence protection, and treatment of CDI with a 3-target approach.

In TROPHY-U-01 study, sacituzumab govitecan showed activity in cisplatin-ineligible patients with advanced urothelial cancer post-ICI therapy, with 32% objective response rate and manageable toxicity. Further evaluation is warranted.

The FDA approved FoundationOne®CDx and FoundationOne®Liquid CDx as companion diagnostics for olaparib plus abiraterone and prednisone in patients with BRCA-mutated metastatic CRPC, following the 2023 approval of this combination therapy based on the PROpel trial results.

FDA grants orphan drug designation to ABD-147, a next-gen radiopharmaceutical targeting DLL3-expressing neuroendocrine carcinomas. Developed using the ROVEr™ platform, ABD-147 aims to deliver Actinium-225 to tumors while sparing healthy cells. Plans include a phase 1 trial in SCLC and large cell neuroendocrine carcinoma patients.

FDA approved updated COVID-19 vaccines targeting Omicron variants JN.1 and KP.2 for ages 12+, with mRNA vaccines by Moderna and Pfizer for ages 6 months+. CDC recommends vaccination for everyone 6 months+, emphasizing importance for high-risk groups. Timing and doses depend on vaccination status. JN.1, KP.2, KP.3, and KP.3.1.1 are circulating variants. Pharmacies like CVS and Kroger offer the vaccines.

KalVista Pharmaceuticals provided an operational update and released financial results for the first fiscal quarter ended July 31, 2024. Highlights include the FDA's acceptance of the NDA for sebetralstat, an oral plasma kallikrein inhibitor for HAE, and the EMA's validation of the MAA. KalVista anticipates filing for approval in the UK, Japan, and other countries later in 2024, aiming for a June 2025 commercial launch. Financial results showed a net loss of $40.4 million, with R&D and G&A expenses increasing to $26.6 million and $17.6 million, respectively.

Biogen's nusinersen (Spinraza) showed efficacy at a higher dose than the FDA-approved regimen in the DEVOTE trial, with significant improvements on the CHOP-INTEND scale compared to a sham treatment. The higher dose was generally well-tolerated, though more serious adverse events were observed. Biogen plans to share detailed results with the SMA community and health authorities.

Palisade Bio announces successful refinement of patient selection strategies for Ulcerative Colitis (UC) based on PDE4B biomarkers, identifying 70% of adult and 90% of pediatric moderate to severe cases. The company is advancing PALI-2108, an orally administered, colon-specific PDE4 inhibitor, with a Phase 1 clinical trial for UC set to begin before year-end.

Poland emerges as a leading hub for clinical research, the FDA approves the first nasal spray for severe allergic reactions, lenacapavir offers 100% protection against HIV, Novartis' Leqvio significantly reduces LDL-C, alarming trends in men's cancer incidence are projected to 2050, Duality Biotherapeutics initiates Hong Kong IPO to fund cancer drug trials, Omny Health launches a GLP-1 data resource, an adaptive brain pacemaker improves Parkinson’s symptoms, Alzheimer’s drug Lecanemab slows cognitive decline, and AI tool AIM-MASH enhances liver disease trials.

Innovent Biologics' PD-1/IL-2a-bias Bispecific Antibody Fusion Protein (IBI363) received Fast Track Designation from the FDA for treating melanoma. Phase 1/2 trials in China, the US, and Australia show promising efficacy, with 29.7% ORR and 73.0% DCR in melanoma patients previously treated with immunotherapy. IBI363 aims to address unmet needs for immunotherapy-resistant melanoma.