Recombinant Human Granulocyte/Macrophage Colonystimulating Factor（rhGM-CSF）

Replimune Group submitted a BLA to the FDA for RP1 in combination with nivolumab for advanced melanoma, granted Breakthrough Therapy designation. Phase 3 IGNYTE-3 trial enrolling patients.

Greenwich LifeSciences updates on 2024 events, including conferences and sponsorships, and details its Phase III FLAMINGO-01 trial for GLSI-100, an immunotherapy targeting HER2+ breast cancer recurrence.

Savara reports Q3 2024 financials, plans BLA rolling submission for MOLBREEVI in aPAP by end of 2024, updates BLA completion to 1Q 2025, and expects MAA submission to EMA by end of 2025. The company has $219M in cash, sufficient through 2Q 2027.

Early serum IL-2 levels on days 1 and 3 post-CAR T-cell therapy infusion predict rapid and robust CAR T-cell expansion in leukemia/lymphoma patients, outperforming IFN-γ and GM-CSF. IL-2 remains strongly linked to expansion at day 7, suggesting its potential as an early biomarker for CAR T-cell activity.

Ultimovacs ASA's Phase II FOCUS trial results, published on medRxiv, showed no clinical benefits in PFS or OS when adding UV1 to pembrolizumab in late-stage HNSCC patients, missing primary and secondary endpoints. UV1 maintained a positive safety profile. The trial, led by Prof. Mascha Binder and sponsored by the University of Halle-Wittenberg, aimed to assess UV1's efficacy and tolerability as an add-on to pembrolizumab. Patients were randomized 2:1 to receive UV1+pembrolizumab or pembrolizumab alone, with primary endpoint PFS at 6 months. UV1, a universal cancer vaccine targeting telomerase, is administered via intradermal injections with GM-CSF over three months.

Transgene reports 2024 H1 results, highlighting clinical benefits of TG4050 in head and neck cancer, promising antitumor activity of BT-001 in solid tumors, and expected Phase II results for TG4001 in Q4 2024. Financial visibility confirmed until Q4 2025.

Dr. Colin Dinney presented BOND-003 trial results at the 2024 IBCN meeting, showing cretostimogene grenadenorepvec monotherapy achieved 75% complete response rates in BCG-unresponsive NMIBC. Urinary genomic disease burden analysis indicated a reduction in aneuploidy and key mutations, predicting 12-month recurrence-free survival with 80% for low risk and 33% for high risk patients.

RP1 (vusolimogene oderparepvec) combined with nivolumab (Opdivo) showed durable antitumor activity and a favorable safety profile in advanced melanoma patients who progressed on anti–PD-1 therapy, with a 33.6% overall response rate and a 15.0% complete response rate. The median duration of response was 21.6 months, and most treatment-related adverse events were grade 1 or 2. A phase 3 trial, IGNYTE-3, is underway to further evaluate this combination.

Ultimovacs ASA halts LUNGVAC trial recruitment due to slow enrollment, driven by new NSCLC treatments. 31 enrolled patients will continue treatment, with topline data expected in H1 2025. Ultimovacs also conducts Phase II DOVACC trial for ovarian cancer and pre-clinical research on a novel drug conjugation platform, with updates planned by end of 2024.

Ultimovacs ASA halts recruitment for LUNGVAC trial due to slow enrollment, driven by new NSCLC treatment options. All 31 enrolled patients will be treated, with topline data expected in H1 2025. Ultimovacs continues to investigate UV1 in ovarian cancer and pre-clinical research on a novel drug conjugation platform.