HER2/Neu GP2 vaccine (Greenwich LifeSciences Inc/NuGenerex Immuno-Oncology)

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.

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.

MAIA Biotechnology's THIO Shows Promise in Phase II Lung Cancer Trial; Institutional Investment Increases

4 months ago

• MAIA Biotechnology's lead candidate, THIO, is currently in Phase II clinical trials, evaluating its potential in treating patients with non-small cell lung cancer. • Recent SEC filings reveal that Geode Capital Management LLC increased its stake in MAIA Biotechnology by 22.9% during the third quarter, indicating growing investor confidence. • Greenwich LifeSciences' GP2 immunotherapy is in Phase III clinical trials, aimed at preventing breast cancer recurrences in patients post-surgery. • Institutional investors and hedge funds have shown increased interest in Greenwich LifeSciences, with Geode Capital Management LLC raising its position by 4.6%.

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.

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6 months ago

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Greenwich LifeSciences' Flamingo-01 Trial Expands into Europe and Broadens Patient Enrollment

a year ago

• Greenwich LifeSciences' Flamingo-01 Phase III trial, evaluating GLSI-100 for breast cancer recurrence prevention, has been approved for expansion into Europe, including Spain, France, Germany, Italy, and Poland. • The Flamingo-01 trial will activate 105 sites in Europe, with site initiation visits starting as early as March 4, 2024, aiming to enroll more patients and accelerate the study. • The trial's steering committee has agreed to expand the third arm of the study to enroll up to 250 patients with non-HLA-A*02 types, potentially broadening the patient population who could benefit from GLSI-100. • Greenwich LifeSciences is preparing for a BLA filing in the US, including commercial manufacturing data and study reports from prior clinical trials, marking progress toward potential commercialization of GLSI-100.