Agilent Technologies

Applied Therapeutics to Present Extended INSPIRE Trial Data for Govorestat in SORD Deficiency at PNS Annual Meeting

12 days ago

• Applied Therapeutics will present full 12-month results from the Phase 3 INSPIRE trial of govorestat for SORD Deficiency at the Peripheral Nerve Society 2025 Annual Meeting in Edinburgh, Scotland. • The presentation will include new topline 18-month and 24-month data from the double-blind, placebo-controlled registrational trial, extending beyond the previously reported 12-month results. • Govorestat, a CNS-penetrant Aldose Reductase Inhibitor, has received multiple regulatory designations including Orphan Drug status from both FDA and EMA for treating rare diseases including CMT-SORD.

Nadofaragene Firadenovec Shows 75% Complete Response Rate in Japanese Phase 3 Trial for BCG-Unresponsive Bladder Cancer

a month ago

• Nadofaragene firadenovec demonstrated a 75% complete response rate at 3 months in Japanese patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, according to new Phase 3 trial data. • The gene therapy showed a favorable safety profile with 84.2% of treatment-related adverse events being Grade 1 and 15.8% Grade 2, with no Grade 3 or higher events reported in the Japanese patient population. • These results appear higher than previously reported in US trials and align with recent Mayo Clinic real-world data showing a 79% complete response rate, potentially establishing nadofaragene as a new standard of care for patients who would otherwise face bladder removal.

Groundbreaking Study: Surgery May Be Unnecessary for Early-Stage Breast Cancer Patients

2 months ago

• MD Anderson Cancer Center researchers report that patients with early-stage breast cancer who achieved complete response to chemotherapy and radiation remained cancer-free after five years without surgery. • The phase II clinical trial tracked 31 women with triple-negative or HER2-positive breast cancer, demonstrating 100% overall survival and disease-free status at a median follow-up of 55.4 months. • Lead investigator Dr. Henry Kuerer suggests this surgery-free approach could become the new standard of care, potentially benefiting up to 60% of early-stage breast cancer patients while preserving their bodies.

Opthia Faces $1 Billion Investor Obligation Following Sozinibercept Trial Failure in WetAMD

2 months ago

• Opthia may owe up to $1 billion to investors following the failure of sozinibercept in clinical trials for wet age-related macular degeneration (WetAMD). • Regeneron Pharmaceuticals reports positive outcomes from the Phase III QUASAR trial of Eylea HD (aflibercept) 8mg injection, strengthening its position in the WetAMD market. • Ocugen advances its WetAMD pipeline as the Data and Safety Monitoring Board approves dosing of the second patient cohort in a Phase I trial of OCU200.

Allogene's CAR T-Cell Therapy Shows Promising Results in Large B-Cell Lymphoma Trials

3 months ago

• Phase 1 ALPHA and ALPHA2 trials demonstrate cemacabtagene ansegedleucel achieves 67% overall response rate and 58% complete response rate in relapsed/refractory LBCL patients using the selected Phase 2 regimen. • The therapy shows a manageable safety profile with no graft-versus-host disease or high-grade cytokine release syndrome, comparable to approved autologous CAR T-cell treatments. • Treatment initiation time of two days represents significant improvement over traditional autologous CAR T-cell therapies, which typically require over one month wait time.

Lonsurf Shows Promising Survival Benefits for Stage 4 Colorectal Cancer Patients with Molecular Residual Disease

3 months ago

• Phase 3 ALTAIR study reveals Lonsurf (trifluridine/tipiracil) significantly extended disease-free survival to 9.76 months versus 3.96 months with placebo in stage 4 colorectal cancer patients. • While the overall trial population showed no statistically significant improvement, patients with higher baseline tumor markers demonstrated stronger benefits from Lonsurf treatment. • The drug maintained a manageable safety profile with no new safety signals, though 73% of Lonsurf-treated patients experienced grade 3 or worse side effects.

Imugene Doses First Australian Patient in Phase 1b Trial of Azer-Cel for B-Cell Lymphoma

5 months ago

• Imugene has dosed the first Australian patient in a Phase 1b trial of azer-cel, an allogeneic CAR T-cell therapy, for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). • The trial aims to evaluate azer-cel's tolerability, safety, and clinical activity in DLBCL patients who have failed previous autologous CAR T-cell treatments. • Azer-cel offers an off-the-shelf solution, potentially reducing treatment times and increasing patient access compared to traditional autologous CAR T-cell therapies. • Promising outcomes from US trial sites showed complete responses in subjects who received lymphodepletion chemotherapy and interleukin-2 (IL-2) after failing prior treatments.

BioNTech's Bispecific Antibody BNT-327 Shows Promise in Triple-Negative Breast Cancer

5 months ago

• BioNTech's BNT-327, a bispecific antibody targeting PD-L1 and VEGF, has demonstrated positive early results in patients with triple-negative breast cancer. • The bispecific antibody builds on the success of checkpoint inhibitors like Keytruda, potentially representing the next generation of immunotherapy drugs. • Early trial data, presented at the San Antonio Breast Cancer Symposium, suggest BNT-327 could become a critical component in treating triple-negative breast cancer. • The development of BNT-327 aligns with a broader interest in PD1/PD-L1 and anti-VEGF bispecifics, following promising results from Summit Therapeutics in lung cancer.

Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial

6 months ago

• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial. • The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users. • Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy. • The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.

FDA to Review Belantamab Mafodotin and Linvoseltamab Combinations for Multiple Myeloma

6 months ago

• The FDA has accepted a BLA for belantamab mafodotin combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for multiple myeloma treatment. • Regeneron's linvoseltamab BLA resubmission has been accepted by the FDA, with a decision expected by July 10, 2025, for relapsed/refractory multiple myeloma. • Clinical trials DREAMM-7 and DREAMM-8 support the belantamab mafodotin BLA, while LINKER-MM1 supports the linvoseltamab BLA, showcasing improved progression-free survival. • Both belantamab mafodotin and linvoseltamab are under review by other regulatory authorities, potentially expanding treatment options for multiple myeloma patients.