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

GenVivo Reports Promising Phase 1 Data for GEN2 and Preclinical Results for GEN-1013 Cancer Immunotherapies at ASGCT 2025

7 days ago

• GenVivo's lead candidate GEN2, a non-replicating mRNA vector therapy, demonstrates favorable safety profile with minimal toxicity and encouraging pharmacodynamic activity in Phase 1 trials for solid tumors. • GEN-1013, the company's preclinical IL-12 encoding therapy, showed remarkable efficacy in murine cancer models with 89% of treated animals reaching study endpoints compared to just 11% in control groups. • Both therapies leverage GenVivo's innovative vector platform that activates patients' immune systems against their own tumor antigens, with GEN-1013 advancing toward IND filing by mid-2026.

Savara to Present Phase 3 IMPALA-2 Trial Data on Molgramostim for Rare Lung Disease at Multiple International Conferences

2 months ago

• Savara will showcase new data from its pivotal Phase 3 IMPALA-2 trial of molgramostim for autoimmune pulmonary alveolar proteinosis (aPAP) at the American Thoracic Society International Conference in May 2025. • Two poster presentations will highlight how molgramostim reduces surfactant burden, decreases whole lung lavage procedures, and improves respiratory health-related quality of life in aPAP patients. • The company will host an Industry Theater featuring world-renowned experts Dr. Bruce Trapnell and Dr. Cormac McCarthy to discuss advances in aPAP diagnosis and management.

Naxitamab Shows Promising Results in Phase 2 Trial for High-Risk Neuroblastoma

3 months ago

• Phase 2 trial of naxitamab with GM-CSF achieved 50% overall response rate in patients with relapsed/refractory high-risk neuroblastoma, meeting its primary endpoint. • The treatment demonstrated strong efficacy with 58% bone compartment response and 74% bone marrow compartment response, showing particular promise for patients with bone involvement. • Notable one-year survival outcomes include 93% overall survival rate, while some patients previously treated with anti-GD2 antibodies showed response to naxitamab therapy.

Naxitamab Shows Promising Results in Treating Relapsed/Refractory High-Risk Neuroblastoma

3 months ago

• Phase 2 trial demonstrates 50% overall response rate with naxitamab plus GM-CSF in patients with relapsed/refractory high-risk neuroblastoma limited to bone and bone marrow disease. • Complete response achieved in 38% of patients, with particularly high response rates in bone (58%) and bone marrow (74%) compartments, addressing a significant unmet need in this targeted population. • Treatment showed manageable safety profile with 92% of infusions administered in outpatient setting, though careful monitoring required for infusion-related reactions and pain management.

Greenwich LifeSciences Reports 46% HLA-A*02 Prevalence in FLAMINGO-01 Trial for Breast Cancer Vaccine

3 months ago

• Initial analysis of FLAMINGO-01 trial reveals 46% of screened patients carry at least one HLA-A*02 allele, a crucial factor for GLSI-100 breast cancer vaccine treatment. • The trial's open-label arm studying non-HLA-A*02 patients has been expanded from 100 to 250 participants following FDA and EMA approval. • The Phase III trial design includes approximately 500 HLA-A*02 positive patients in randomized arms, with an additional open-label arm to investigate vaccine efficacy in other HLA types.

FDA Grants RMAT Designation to Gradalis' Personalized Immunotherapy for Advanced Ovarian Cancer

4 months ago

• Gemogenovatucel-T (Vigil) received FDA RMAT designation for treating advanced ovarian cancer patients with specific genetic profiles, based on significant survival improvements in clinical trials. • The phase 2b VITAL trial demonstrated positive trends in recurrence-free survival and statistically significant improvements in overall survival for BRCAwt patients. • The personalized immunotherapy works by targeting clonal neoantigens and modulating immune response through bi-shRNA technology, showing promise as a safer and more precise treatment option.

Greenwich LifeSciences Expands Phase III Breast Cancer Trial Globally, Adds New Sites and Expertise

4 months ago

• Greenwich LifeSciences broadens its Phase III FLAMINGO-01 trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrence, by adding new clinical sites in the U.S. and Europe. • The trial expands into France through a partnership with Unicancer, activating 19 sites, and collaborates with GBG in Germany, adding approximately 38 sites to the study. • Harvard and Johns Hopkins join the trial in the U.S., with principal investigators Dr. Laura Spring and Dr. Cesar Santa-Maria joining the Steering Committee. • EMA approves the addition of 11 sites in Spain, Germany, and Poland, potentially activating 110-115 sites in Europe, with plans to expand to Ireland, Romania, and other countries.

Replimune's RP2 Advances in Clinical Trials for Melanoma and Liver Cancer

4 months ago

• Replimune has initiated two clinical trials for RP2, an oncolytic immunotherapy, targeting metastatic uveal melanoma and hepatocellular carcinoma. • The RP2-202 trial will evaluate RP2 in combination with nivolumab for patients with metastatic uveal melanoma, a cancer with limited treatment options. • The RP2-003 trial will assess RP2 combined with atezolizumab and bevacizumab for patients with advanced hepatocellular carcinoma (HCC). • RP2 is derived from Replimune's RP1, engineered from herpes simplex virus to enhance tumor cell death and stimulate systemic anti-tumor immune response.

Nivolumab/Relatlimab Combination Demonstrates Sustained Overall Survival Benefit in Advanced Melanoma

5 months ago

• Extended analysis of the RELATIVITY-047 trial shows nivolumab/relatlimab significantly improves overall survival compared to nivolumab alone in advanced melanoma patients. • Median overall survival reached 51.0 months with the combination therapy versus 34.1 months with nivolumab monotherapy, indicating a substantial survival advantage. • The study also reported improved progression-free survival and melanoma-specific survival with the nivolumab/relatlimab combination. • No new safety signals were identified, reinforcing the combination's manageable safety profile in previously untreated advanced melanoma.

Savara Initiates FDA Submission for MOLBREEVI in Rare Lung Disease

5 months ago

• Savara Inc. has begun a rolling submission of a Biologics License Application (BLA) to the FDA for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis (aPAP). • MOLBREEVI has received Fast Track, Breakthrough Therapy, and Orphan Drug Designations, potentially expediting its review and approval process. • The company anticipates completing the BLA submission by the end of Q1 2025 and will request a priority review for the treatment. • Phase 3 trial data supports MOLBREEVI's favorable benefit-risk profile, offering a potential first-in-class treatment for aPAP in the U.S. and Europe.

FDA Grants Priority Review to Replimune's RP1 Plus Nivolumab for Advanced Melanoma

5 months ago

• The FDA has granted priority review to Replimune's BLA for RP1 in combination with nivolumab for advanced melanoma, setting a PDUFA action date of July 22, 2025. • The BLA is supported by data from the IGNYTE trial, which evaluated RP1 plus nivolumab in patients with anti-PD-1 failed melanoma. • RP1 is a novel oncolytic immunotherapy based on a modified herpes simplex virus, designed to maximize tumor killing and stimulate an anti-tumor immune response. • The ongoing Phase 3 IGNYTE-3 trial is assessing the combination in patients who have progressed on or are ineligible for anti-CTLA-4 therapies.

SELLAS Life Sciences' GPS Shows Promise in Phase 3 AML Trial, IDMC Recommends Continuation

5 months ago

• The Independent Data Monitoring Committee (IDMC) recommended continuing SELLAS Life Sciences' Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). • Interim analysis showed GPS exceeded futility criteria with no safety concerns, indicating potential efficacy in AML patients achieving second complete remission. • Patients in the REGAL trial exhibited a median survival exceeding 13.5 months, compared to 6 months with conventional therapy in a similar Phase 2 study. • 80% of GPS-treated patients showed a specific T-cell immune response, surpassing previous Phase 2 study results, with final analysis planned upon reaching 80 events.

PIVOT-006 Trial Evaluates Cretostimogene vs. Surveillance in Intermediate-Risk Bladder Cancer

6 months ago

• The PIVOT-006 trial is a phase 3 study assessing cretostimogene, an oncolytic immunotherapy, against surveillance in intermediate-risk non-muscle invasive bladder cancer (NMIBC). • Cretostimogene, designed to selectively replicate in bladder cancer cells, has shown promising response rates and tolerability in BCG-unresponsive NMIBC. • The trial randomizes patients to intravesical cretostimogene or surveillance, with the option for crossover upon recurrence, aiming to improve recurrence-free survival. • Strong enrollment progress is noted, with support from organizations like SUO-CTC and BCAN, highlighting the importance of patient-centered research in this area.

Namilumab Fails to Meet Primary Endpoint in Phase 2 RESOLVE-Lung Study for Pulmonary Sarcoidosis

6 months ago

• Kinevant Sciences' Phase 2 RESOLVE-Lung study of namilumab in chronic active pulmonary sarcoidosis did not demonstrate a statistically significant treatment benefit. • The primary endpoint, proportion of subjects with a Rescue Event, was not met, and secondary endpoints showed no consistent treatment benefit. • Due to these results, Kinevant will discontinue further development of namilumab for the treatment of sarcoidosis. • The company plans to publish the RESOLVE-Lung study results to contribute to future research in sarcoidosis.

Greenwich LifeSciences Expands Breast Cancer Immunotherapy Trial to Italy

6 months ago

• Greenwich LifeSciences partners with Gruppo Italiano Mammella (GIM) to expand its Phase III FLAMINGO-01 trial in Italy. • Nine top Italian institutions will participate in evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrence. • In 2022, Italy reported 58,160 new breast cancer cases, highlighting the critical need for improved treatments and preventative strategies. • Patient enrollment has commenced at Italian sites, with Professor Grazia Arpino leading as the Italian National Principal Investigator.

Replimune's RP1 Receives FDA Breakthrough Therapy Designation and BLA Submission for Advanced Melanoma

6 months ago

• Replimune has submitted a Biologics License Application (BLA) to the FDA for RP1 in combination with nivolumab to treat advanced melanoma patients after anti-PD-1 therapy. • The FDA granted Breakthrough Therapy designation to RP1 plus nivolumab, expediting its development for patients with limited options after anti-PD-1 regimen failure. • RP1 (vusolimogene oderparepvec) is an oncolytic immunotherapy designed to maximize tumor killing, enhance immunogenicity, and activate a systemic anti-tumor immune response. • A Phase 3 trial is underway to confirm RP1's efficacy with nivolumab in advanced melanoma patients who have progressed on or are ineligible for anti-CTLA-4 therapy.

Savara's Molgramostim Shows Promise in Autoimmune Pulmonary Alveolar Proteinosis

6 months ago

• Savara Inc. presented results from the Phase 3 IMPALA-2 trial of molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (aPAP). • The presentation highlighted molgramostim's ability to improve pulmonary gas exchange and respiratory health-related quality of life in aPAP patients. • The data was presented at the British Thoracic Society Winter Meeting 2024, with slides available on Savara's website. • Molgramostim is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) delivered via eFlow Nebulizer System.

Savara Announces Presentation of Phase 3 IMPALA-2 Trial Results for Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis

6 months ago

• Savara Inc. will present results from the Phase 3 IMPALA-2 trial of inhaled molgramostim at the British Thoracic Society Winter Meeting. • The presentation will highlight molgramostim's impact on improving pulmonary gas exchange and respiratory health-related quality of life in aPAP patients. • The IMPALA-2 trial evaluated molgramostim, a recombinant human GM-CSF, delivered via eFlow Nebulizer, for treating autoimmune pulmonary alveolar proteinosis. • Following the presentation on November 29, the slides will be available on Savara's website for further review.

Replimune's RP1 Receives FDA Breakthrough Therapy Designation for Advanced Melanoma

6 months ago

• Replimune's RP1 (vusolimogene oderparepvec) has been granted Breakthrough Therapy designation by the FDA for advanced melanoma treatment. • The BLA for RP1 in combination with nivolumab has been submitted to the FDA under the Accelerated Approval pathway. • The designation is based on clinical activity observed in the IGNYTE clinical trial for patients who progressed on anti-PD1 regimens. • A confirmatory Phase 3 trial (IGNYTE-3) is currently enrolling patients with advanced melanoma who have progressed on prior therapies.

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6 months ago

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

Drug Development Updates