Clinical Trial News

A phase II study investigated the safety and efficacy of durvalumab in treating BCG-unresponsive non-muscle-invasive bladder cancer, showing a 12% complete response rate at month 6 with manageable side effects.

Evusheld, the only authorized COVID-19 preexposure prophylaxis, may not neutralize subvariant XBB.1.5, responsible for nearly 30% of cases, as per FDA. Efficacy against several dominant omicron subvariants remains undetermined. FDA advises healthcare providers to inform patients of increased risk with variants not neutralized by Evusheld.

A study involving over 2,400 patients with type 2 diabetes and overweight or obesity found that initiating a GLP-1 agonist without a structured behavioral intervention led to a 2% weight loss at 72 weeks. One-third of the patients achieved clinically significant weight loss, defined as at least 5% change from baseline. The study highlights the potential of GLP-1 agonists for weight loss in real-world settings, despite the absence of structured weight loss interventions.

Syros Pharmaceuticals reported a Q1 2023 EPS of $-0.85, beating expectations of $-1.09. The company highlighted progress in clinical trials for MDS, AML, and APL, including the SELECT-MDS-1 trial's amendment to include overall survival as a key secondary endpoint. Syros anticipates pivotal data from SELECT-MDS-1 in Q3 2024 and remains on track for milestones across its programs. Financials show a net loss of $23.8M, with $166M in cash, expected to fund operations into 2025.

Editas Medicine reported Q4 2022 earnings, highlighting clinical progress with EDIT-301 for sickle cell disease and beta thalassemia, strategic shifts towards in-vivo gene editing, and financial stability extending into 2025. The company aims to advance its gene editing technologies and clinical trials, focusing on delivering transformative medicines.

Aldeyra Therapeutics reported 2022 financial results, highlighting FDA acceptance of two new drug applications: Reproxalap for dry eye disease and ADX-2191 for primary vitreoretinal lymphoma. The company is advancing its RASP modulation platform, with ADX-629 in Phase 2 trials for various conditions. ADX-2191, targeting ocular lymphoma, has a PDUFA date of June 21, 2023. Aldeyra's cash position supports operations into late 2024, with a net loss of $62.0 million in 2022.

FDA withdrew AstraZeneca's Evusheld authorization in the U.S. due to its inefficacy against Omicron subvariants, responsible for over 90% of current infections. AstraZeneca's shares rose 11.3% this year. Evusheld remains authorized in Europe and Japan. AstraZeneca is developing a next-generation antibody for COVID-19, aiming for a 2023 launch.

Geron Corporation reported positive Phase 3 results for imetelstat in lower-risk MDS, planning NDA submission by mid-2023 and MAA by end of 2023. Anticipated U.S. and EU launches in 2024. Strong financial position with $445M cash, supporting operations through Q3 2025. Focused on commercial readiness and expanding imetelstat's applications in hematologic malignancies.

Penn Medicine researchers report promising early results for CAR T therapy in lupus patients, highlighting its potential beyond blood cancers. CAR T cells, engineered from a patient's own cells, target specific cell types, offering a personalized treatment approach. This development underscores the broader applicability of CAR T therapies in autoimmune diseases like lupus, driven by B cells.

The National Cancer Institute launched ComboMATCH, a precision medicine initiative testing drug combinations targeting specific tumor mutations. It aims to identify effective treatments for advanced clinical trials, involving both FDA-approved and investigational drugs. ComboMATCH includes phase 2 trials for adults and children, focusing on genomic abnormalities to improve treatment outcomes.