Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation
Greenwich LifeSciences (NASDAQ:GLSI) announced that the FDA has granted Fast Track designation for GLSI-100, its immunotherapy treatment for HLA-A*02 breast cancer patients. This designation may accelerate drug approval through enhanced FDA communication and rolling review process.
The company's Phase IIb clinical trial demonstrated impressive results with an 80% or greater reduction in cancer recurrences over 5 years in HER2/neu 3+ patients. The treatment showed no serious adverse events and was well-tolerated across 146 treated patients. GLSI-100 achieved peak immunity at 6 months, with booster injections providing extended protection.
The Fast Track status was granted based on GLSI-100's potential to improve invasive breast cancer-free survival in HER2-positive breast cancer patients with HLA-A*02 genotype who completed standard HER2/neu targeted therapy.Greenwich LifeSciences (NASDAQ:GLSI) ha comunicato che la FDA ha concesso la Fast Track designation a GLSI-100, il suo immunoterapico destinato a pazienti con carcinoma mammario HLA-A*02. Questa designazione può velocizzare il percorso di approvazione del farmaco grazie a comunicazioni più ravvicinate con la FDA e alla procedura di revisione rolling.
Lo studio clinico di fase IIb dell'azienda ha mostrato risultati notevoli, con una riduzione delle recidive tumorali pari o superiore all'80% in un arco di 5 anni nei pazienti HER2/neu 3+. Il trattamento non ha evidenziato eventi avversi gravi ed è stato ben tollerato nei 146 pazienti trattati. GLSI-100 ha raggiunto la risposta immunitaria massima a 6 mesi, mentre le dosi di richiamo hanno prolungato la protezione.
Lo status Fast Track è stato assegnato sulla base del potenziale di GLSI-100 di migliorare la sopravvivenza libera da tumore invasivo in pazienti con carcinoma mammario HER2-positivo e genotipo HLA-A*02 che hanno completato la terapia standard mirata contro HER2/neu.
Greenwich LifeSciences (NASDAQ:GLSI) anunció que la FDA otorgó la Fast Track designation a GLSI-100, su inmunoterapia para pacientes con cáncer de mama HLA-A*02. Esta designación podría acelerar la aprobación del fármaco mediante una mayor comunicación con la FDA y la revisión continua (rolling review).
El ensayo clínico de fase IIb de la compañía mostró resultados impresionantes, con una reducción de las recurrencias de cáncer del 80% o más a lo largo de 5 años en pacientes HER2/neu 3+. El tratamiento no presentó eventos adversos graves y fue bien tolerado entre los 146 pacientes tratados. GLSI-100 alcanzó la inmunidad máxima a los 6 meses, y las inyecciones de refuerzo prolongaron la protección.
El estatus Fast Track se concedió basándose en el potencial de GLSI-100 para mejorar la supervivencia libre de cáncer invasivo en pacientes con cáncer de mama HER2-positivo y genotipo HLA-A*02 que completaron la terapia estándar dirigida contra HER2/neu.
Greenwich LifeSciences (NASDAQ:GLSI)는 FDA가 HLA-A*02 유전형 유방암 환자를 위한 면역치료제 GLSI-100에 대해 Fast Track 지정을 부여했다고 발표했습니다. 이 지정은 FDA와의 강화된 소통 및 롤링 리뷰를 통해 약물 승인 절차를 앞당길 수 있습니다.
회사의 2상(IIb) 임상시험은 HER2/neu 3+ 환자에서 5년 동안 암 재발을 80% 이상 감소시키는 등 인상적인 결과를 보였습니다. 치료는 심각한 이상반응 없이 146명의 치료 환자에게서 잘 견뎌졌습니다. GLSI-100은 6개월에 면역 반응이 최고조에 달했으며, 추가 접종(부스터)으로 보호 효과가 연장되었습니다.
Fast Track 지위는 표준 HER2/neu 표적 치료를 마친 HLA-A*02 유전형의 HER2 양성 유방암 환자에서 GLSI-100이 침습성 유방암 무병 생존율을 개선할 가능성이 있다는 근거로 부여되었습니다.
Greenwich LifeSciences (NASDAQ:GLSI) a annoncé que la FDA a accordé la Fast Track designation à GLSI-100, son immunothérapie destinée aux patientes atteintes d'un cancer du sein HLA-A*02. Cette désignation peut accélérer l'approbation du médicament grâce à une communication renforcée avec la FDA et à une procédure d'examen continu (rolling review).
L'essai clinique de phase IIb de la société a montré des résultats impressionnants, avec une réduction des récidives de cancer de 80 % ou plus sur 5 ans chez les patientes HER2/neu 3+. Le traitement n'a pas entraîné d'événements indésirables graves et a été bien toléré chez les 146 patientes traitées. GLSI-100 a atteint une réponse immunitaire maximale à 6 mois, et des injections de rappel ont prolongé la protection.
Le statut Fast Track a été accordé en raison du potentiel de GLSI-100 à améliorer la survie sans cancer invasif chez les patientes atteintes d'un cancer du sein HER2-positif et porteuses du génotype HLA-A*02 ayant terminé la thérapie ciblée standard contre HER2/neu.
Greenwich LifeSciences (NASDAQ:GLSI) gab bekannt, dass die FDA der GLSI-100-Immuntherapie für HLA-A*02-Brustkrebspatientinnen die Fast Track designation erteilt hat. Diese Einstufung kann den Zulassungsprozess durch intensivere Kommunikation mit der FDA und ein Rolling-Review-Verfahren beschleunigen.
Die Phase-IIb-Studie des Unternehmens zeigte beeindruckende Ergebnisse mit einer Reduktion der Krebsrückfälle um 80% oder mehr über 5 Jahre bei HER2/neu 3+-Patientinnen. Die Behandlung brachte keine schwerwiegenden Nebenwirkungen mit sich und wurde bei 146 behandelten Patientinnen gut vertragen. GLSI-100 erreichte die höchste Immunantwort nach 6 Monaten; Auffrischungsimpfungen verlängerten den Schutz.
Der Fast-Track-Status wurde aufgrund des Potenzials von GLSI-100 vergeben, das krankheitsfreie Überleben bei invasivem Brustkrebs bei HER2-positiven Patientinnen mit dem HLA-A*02-Genotyp zu verbessern, nachdem sie die standardmäßige HER2/neu-zielgerichtete Therapie abgeschlossen hatten.
- None.
- Treatment limited to specific HLA-A*02 patient population
- Full treatment requires 6-month Primary Immunization Series plus ongoing boosters
Insights
FDA Fast Track designation for GLSI-100 could accelerate approval process, potentially transforming HER2+ breast cancer recurrence prevention.
Greenwich LifeSciences has secured a significant regulatory milestone with the FDA Fast Track designation for GLSI-100 in HLA-A*02 patients with HER2-positive breast cancer who have completed standard therapies. This designation recognizes the therapy's potential to address an unmet medical need in preventing breast cancer recurrences.
The Fast Track status offers substantial advantages in the regulatory pathway, including more frequent FDA communications, potential for rolling review of the Biologic License Application (BLA), and eligibility for Accelerated Approval. These benefits could significantly compress the timeline to market.
The designation is supported by compelling Phase IIb data showing an 80% or greater reduction in metastatic breast cancer recurrence over 5 years compared to the 20-50% reduction typically seen with other approved products. This remarkable efficacy profile, coupled with a clean safety record (no serious adverse events attributed to treatment), creates a potentially transformative clinical profile.
What's particularly noteworthy is the mechanism of action – GLSI-100 is an immunotherapy that achieves peak immune response at 6 months, with booster injections providing longer-term protection. This represents a novel approach to preventing breast cancer recurrence through immune system modulation rather than traditional cytotoxic therapies.
The Fast Track designation validates the company's development approach and suggests the FDA recognizes both the seriousness of metastatic breast cancer recurrence and the potential for GLSI-100 to meaningfully improve patient outcomes in this specific genetic population.
STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population.
The designation specifically states that "GLSI-100 for the treatment of patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival meets the criteria for Fast Track designation."
The Fast Track designation for GLSI-100 may lead to earlier drug approval as the Company and the FDA can communicate more frequently to expedite the Biologic License Application (BLA) filing of the clinical and manufacturing data from FLAMINGO-01. The Company may be able to utilize a rolling review process, where completed parts of the BLA can be submitted for review, even though other parts of the application are still being completed.
Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "Greenwich is pleased that the FDA sees the potential of GLSI-100 to change important clinical outcomes in this population of breast cancer patients. We continue to work earnestly to collect data to support a BLA filing demonstrating this benefit."
CEO Snehal Patel commented, "We are excited to have received Fast Track designation. The FDA review of our Fast Track application included a review of the potential of GLSI-100 as a new drug to treat serious conditions and to fill unmet medical need. By showing the potential of GLSI-100 to prevent metastatic breast cancer recurrence in the patient population that we are studying, we were able to estimate the potential lives that could be saved. The Company plans to continue discussions with the FDA, and potentially the European regulatory authorities, to explore additional ways to make GP2 and GLSI-100 available to larger populations."
A description of the Fast Track criteria and process is available on the FDA website:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
As described by the FDA website:
"Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions…Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy...Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients."
The FDA website further states:
"Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
- Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
- Avoiding serious side effects of an available therapy
- Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
- Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
- Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
- More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
- Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA"
Previously Published Phase IIb Data
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up compared to 20-50% reduction in recurrence rate by other approved products- Peak immune response at 6 months
- No reported serious adverse events attributable to treatment
- Well-tolerated safety profile
Full immunization was received in the Primary Immunization Series (PIS), which included the first 6 GLSI-100 injections over the first 6 months. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. Further, booster injections given every 6 months prolonged the immune response, thereby providing longer-term protection. In the Phase IIb and three Phase I clinical trials, where 146 patients were treated, the GP2 immunotherapy was well tolerated, and there were no reported serious adverse events related to GLSI-100.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides
For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in
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Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com
FAQ
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