Clinical Trial News

Lecanemab, a drug trialed at HMRI, effectively removes amyloid from the brain, potentially preventing Alzheimer's and dementia. The trial involved 400 participants nationwide, with 20 found to have amyloid. Lecanemab is expected to receive TGA approval by the end of 2024.

An open-label, non-randomized phase II clinical trial at Shanghai Public Health Clinical Center enrolled adult PLWH on ART with suppressed HIV viral load. Participants received ASC22 (1 mg/kg) and chidamide for 12 weeks, with 11 visits over 24 weeks. Primary outcomes measured changes in HIV DNA, secondary endpoints included CA HIV RNA and plasma HIV viral loads, and CD4/CD8 ratios. Adverse events were monitored, and statistical analysis used repeated measures ANOVA, paired t-tests, and correlation analyses.

MacroGenics to present Phase 2 data of vobramitamab duocarmazine in mCRPC at ESMO Congress on Sept. 15, 2024, with a conference call on Sept. 16, 2024.

The NeoCOAST-2 study showed durvalumab combined with Dato-DXd achieved the highest pathological complete response rates among tested regimens for resectable NSCLC, with Arm 4 yielding a 34.1% pCR rate and a favorable safety profile.

Cantargia reports strong antitumor effects and encouraging median survival times in 55 cancer patients treated with nadunolimab after pembrolizumab. Data suggest nadunolimab targets immunosuppressive cells in the tumor microenvironment, with significant benefits seen in second-line non-squamous patients and heavily pretreated patients. Results to be presented at ESMO Congress 2024.

Ultimovacs ASA presented updated data from the UV1 Phase II NIPU trial at the 2024 ESMO Congress, showing increased clinical benefit for the epithelioid subgroup, with a median PFS improvement of 5.5 months for UV1 combined with ipilimumab and nivolumab versus 2.9 months for immunotherapy alone. The trial did not meet the primary endpoint of improved PFS but demonstrated a doubling of ORR and a 27% reduction in death risk.

C4 Therapeutics announced an abstract with preliminary Phase 1 CFT1946 data for mutant BRAF V600 solid tumors, available on the ESMO Congress 2024 website. An oral presentation on September 13, 2024, will update data on 36 patients, including safety, pharmacokinetic, pharmacodynamic, and anti-tumor activity data. A webcast for analysts and investors will discuss these findings at 12:00 pm ET.

Summit Therapeutics' experimental drug ivonescimab reduced lung cancer progression risk by 49% compared to Merck's Keytruda in a Phase 3 trial, with a median progression-free survival of 11 months versus 6 months for Keytruda. Ivonescimab, discovered by Akeso, targets PD-1 and VEGF, showing potential to become a new standard treatment, though further global trials are needed to confirm its superiority over Keytruda plus chemotherapy.

Alexander Spira discusses MARIPOSA study findings showing amivantamab-vmjw plus lazertinib significantly improves progression-free survival vs osimertinib in EGFR-mutated NSCLC. FDA approved the combination in 2024. Longer-term data from 2024 IASLC World Conference on Lung Cancer indicates potential overall survival benefit with the doublet.

NeOnc Technologies, developing a brain cancer drug delivered intranasally to bypass the blood-brain barrier, is pursuing a direct listing after withdrawing from a traditional IPO due to lukewarm investor interest. The company's lead drug, NEO100, has shown safety in Phase 1 trials and is now in Phase 2a testing for glioblastoma patients with IDH1 mutations. NeOnc aims to raise $75 million initially and is focusing on glioblastoma treatment, with potential applications in other brain therapies.