Greenwich LifeSciences Provides Update on Open Label HLA Data from FLAMINGO-01
Greenwich LifeSciences (NASDAQ: GLSI) has provided an update on the open label HLA data from its Phase III FLAMINGO-01 trial, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention. The analysis reveals that 46% of screened patients have at least one HLA-A*02 allele, meeting the expected 40-50% prevalence rate and supporting sample size estimates for the trial.
The study includes three arms: two blinded arms for HLA-A*02 patients (treatment vs. placebo) and an expanded open-label arm for non-HLA-A*02 patients, recently increased from 100 to 250 participants. Notably, 8% of patients have received HLA-A*02 alleles from both parents, which could potentially lead to greater immune response and efficacy. The trial's design allows for analysis of various HLA combinations and their prevalence across different racial and ethnic groups, which may inform future commercial development strategies.
Greenwich LifeSciences (NASDAQ: GLSI) ha fornito un aggiornamento sui dati HLA a etichetta aperta del suo studio di Fase III FLAMINGO-01, che valuta l'immunoterapia GLSI-100 per la prevenzione della ricorrenza del cancro al seno. L'analisi rivela che il 46% dei pazienti sottoposti a screening ha almeno un allele HLA-A*02, soddisfacendo il previsto tasso di prevalenza del 40-50% e supportando le stime della dimensione del campione per lo studio.
Lo studio include tre bracci: due bracci ciechi per pazienti HLA-A*02 (trattamento vs. placebo) e un braccio a etichetta aperta espanso per pazienti non HLA-A*02, recentemente aumentato da 100 a 250 partecipanti. È notevole che l'8% dei pazienti ha ricevuto alleli HLA-A*02 da entrambi i genitori, il che potrebbe portare a una maggiore risposta immunitaria e efficacia. Il design dello studio consente di analizzare varie combinazioni di HLA e la loro prevalenza tra diversi gruppi razziali ed etnici, il che potrebbe informare le future strategie di sviluppo commerciale.
Greenwich LifeSciences (NASDAQ: GLSI) ha proporcionado una actualización sobre los datos HLA de etiqueta abierta de su ensayo de Fase III FLAMINGO-01, que evalúa la inmunoterapia GLSI-100 para la prevención de la recurrencia del cáncer de mama. El análisis revela que el 46% de los pacientes examinados tienen al menos un alelo HLA-A*02, cumpliendo con la tasa de prevalencia esperada del 40-50% y apoyando las estimaciones del tamaño de la muestra para el ensayo.
El estudio incluye tres brazos: dos brazos ciegos para pacientes HLA-A*02 (tratamiento vs. placebo) y un brazo de etiqueta abierta ampliado para pacientes no HLA-A*02, que recientemente se aumentó de 100 a 250 participantes. Es notable que el 8% de los pacientes ha recibido alelos HLA-A*02 de ambos padres, lo que podría llevar a una mayor respuesta inmune y eficacia. El diseño del ensayo permite el análisis de varias combinaciones de HLA y su prevalencia entre diferentes grupos raciales y étnicos, lo que puede informar las futuras estrategias de desarrollo comercial.
그리너치 생명과학(Greenwich LifeSciences) (NASDAQ: GLSI)는 유방암 재발 방지를 위한 GLSI-100 면역요법을 평가하는 III상 FLAMINGO-01 시험의 오픈 레이블 HLA 데이터에 대한 업데이트를 제공했습니다. 분석 결과 선별된 환자의 46%가 최소 하나의 HLA-A*02 대립유전자를 가지고 있다는 것이 밝혀졌으며, 이는 예상되는 40-50%의 유병률을 충족하고 시험의 샘플 크기 추정치를 지원합니다.
이 연구는 HLA-A*02 환자를 위한 두 개의 블라인드 팔(치료 vs. 위약)과 HLA-A*02가 아닌 환자를 위한 확대 오픈 레이블 팔을 포함하며, 최근 100명에서 250명으로 증가했습니다. 특히 환자의 8%가 두 부모 모두에게서 HLA-A*02 대립유전자를 받은 것으로 나타났으며, 이는 더 큰 면역 반응과 효능으로 이어질 수 있습니다. 시험 설계는 다양한 HLA 조합과 그 유병률이 다양한 인종 및 민족 집단 간에 얼마나 되는지를 분석할 수 있도록 하여, 향후 상업적 개발 전략에 도움이 될 수 있습니다.
Greenwich LifeSciences (NASDAQ: GLSI) a fourni une mise à jour sur les données HLA à étiquette ouverte de son essai de Phase III FLAMINGO-01, qui évalue l'immunothérapie GLSI-100 pour la prévention de la récurrence du cancer du sein. L'analyse révèle que 46 % des patients examinés ont au moins un allèle HLA-A*02, ce qui répond au taux de prévalence attendu de 40-50 % et soutient les estimations de taille d'échantillon pour l'essai.
L'étude comprend trois bras : deux bras aveugles pour les patients HLA-A*02 (traitement contre placebo) et un bras élargi à étiquette ouverte pour les patients non-HLA-A*02, récemment augmenté de 100 à 250 participants. Notamment, 8 % des patients ont reçu des allèles HLA-A*02 de leurs deux parents, ce qui pourrait potentiellement entraîner une meilleure réponse immunitaire et efficacité. La conception de l'essai permet l'analyse de diverses combinaisons HLA et de leur prévalence parmi différents groupes raciaux et ethniques, ce qui pourrait éclairer les futures stratégies de développement commercial.
Greenwich LifeSciences (NASDAQ: GLSI) hat ein Update zu den offenen HLA-Daten seiner Phase-III-Studie FLAMINGO-01 bereitgestellt, die die GLSI-100-Immuntherapie zur Prävention von Brustkrebsrezidiven bewertet. Die Analyse zeigt, dass 46% der gescreenten Patienten mindestens ein HLA-A*02-Allel haben, was der erwarteten Prävalenzrate von 40-50% entspricht und die Schätzungen zur Stichprobengröße für die Studie unterstützt.
Die Studie umfasst drei Arme: zwei verblindete Arme für HLA-A*02-Patienten (Behandlung vs. Placebo) und einen erweiterten offenen Arm für Nicht-HLA-A*02-Patienten, der kürzlich von 100 auf 250 Teilnehmer erhöht wurde. Bemerkenswert ist, dass 8% der Patienten HLA-A*02-Allele von beiden Elternteilen erhalten haben, was potenziell zu einer stärkeren Immunantwort und Wirksamkeit führen könnte. Das Design der Studie ermöglicht die Analyse verschiedener HLA-Kombinationen und ihrer Prävalenz in verschiedenen Rassen- und Ethniengruppen, die zukünftige kommerzielle Entwicklungsstrategien informieren könnte.
- Trial enrollment meets target HLA-A*02 prevalence of 40-50%, validating sample size estimates
- FDA and EMA approved expansion of open label arm from 100 to 250 patients
- Potential for enhanced efficacy in 8% of patients with double HLA-A*02 alleles
- Ability to analyze multiple HLA combinations and subgroups for efficacy assessment
- None.
Insights
The latest FLAMINGO-01 trial data reveals important insights for GLSI's breast cancer immunotherapy program. The 46% HLA-A*02 prevalence among screened patients validates the trial's fundamental design assumptions and strengthens confidence in reaching the required sample size for meaningful statistical analysis.
A particularly significant finding is the 8% double HLA-A*02 prevalence, which could represent a highly responsive patient subgroup. These patients may experience enhanced therapeutic effects due to potentially doubled presentation of the GP2 peptide to immune cells, possibly leading to stronger anti-tumor responses. This discovery could inform future patient stratification strategies and potentially create a precision medicine approach for optimal responders.
The expansion of the non-HLA-A*02 open-label arm from 100 to 250 patients, approved by both FDA and EMA, represents a strategic enhancement to the trial design. This larger cohort will provide:
- Robust safety data across diverse HLA types
- Potential identification of additional responsive HLA subgroups
- Stronger statistical power for secondary endpoint analyses
The racial/ethnic HLA distribution data has significant commercial implications:
- Strong HLA-A*02 prevalence in White (50%) and Hispanic (50%) populations suggests primary market opportunities in North America and Europe
- Lower prevalence in Asian populations (17%) indicates potential need for alternative strategies in Asian markets
- The identification of other prevalent HLA types could inform future product development and market expansion strategies
This data strengthens GLSI's position by providing clear direction for both clinical development and future commercialization strategies, while potentially expanding the addressable patient population beyond the initial HLA-A*02 focus.
STAFFORD, Texas, Feb. 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 the following update on FLAMINGO-01 open label HLA data.
Analysis of the open label data from FLAMINGO-01 has commenced and has been conducted in a manner that maintains the study blind. A preliminary review of FLAMINGO-01 HLA data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types, shows that approximately
The main purpose of the open label arm is to investigate the safety and efficacy of GLSI-100 vaccination in patients who do not have an HLA-A*02 allele. It is possible that the open label arm may be large enough to draw immune response and efficacy conclusions. As discussed below, the HLA type can be analyzed by race and ethnicity in those patients who self-reported such information.
CEO Snehal Patel commented, "The review of open label data and the ability to look at multiple patient populations in the Phase III trial will be much greater than was possible in the Phase IIb trial. The HLA-A*02 prevalence of
Mr. Patel further added, "There may be other subgroups of HLA types that can be analyzed in addition to the main arms. Approximately
Background on FLAMINGO-01 Trial Design and HLA Testing
The design of the Phase III trial can be seen here. The trial is a prospective, randomized, double-blinded, multi-center study. The patient population is defined by major screening criteria and is stratified to balance the patient population between the treated and placebo arms of the trial.
As currently designed, approximately 500 patients with the HLA-A*02 allele will be randomized to receive GLSI-100 (GP2 and GM-CSF) or placebo control in the first two pivotal arms of the trial with a planned interim analysis.
In addition, patients without the HLA-A*02 allele will be enrolled in the third open label arm where all patients will receive GLSI-100 and where all endpoints will be open label. This non-HLA-A*02 arm was recently expanded from 100 to 250 patients based on recommendation of the steering committee and review/approval by the FDA and EMA.
- HLA-A*02 blinded arms: A patient has 2 HLA-A genes, one from each parent, thus a single HLA-A*02 patient has received the HLA-A*02 allele from one parent. A double HLA-A*02 patient has received the HLA-A*02 allele from both parents. Both single and double HLA-A*02 patients are enrolled in the HLA-A*02 treated and placebo arms, which are blinded. Those patients who have a single HLA-A*02 allele will also have a second HLA-A gene of any other type.
- Double HLA-A*02 Potential Mechanism of Action: Theoretically, a double HLA-A*02 patient may have double the amount of HLA-A*02-GP2 complex presented to the immune system to create cancer killing T-cells during the GLSI-100 vaccinations, and as a cancer cell recurs, the HER2 positive recurring cancer cells may have double the amounts HLA-A*02-GP2 complex for the trained T-cells to target and kill. It may be interesting to investigate immune or clinical response differences between single and double HLA-A*02 patients.
- Open Label non-HLA-A*02 Third Arm: If a patient has no HLA-A*02 alleles, they will have 2 different or identical non-HLA-A*02 alleles. These non-HLA-A*02 patients are enrolled in the open label arm, where the immune or clinical response can be assessed as a group or by each HLA-A type, including double HLA-A types, providing the number of patients is sufficiently high to draw conclusions or trends.
- Additional Information: A central laboratory in the US is sequencing the DNA of patients to determine both HLA-A allele types. The technology is available to sequence the HLA-B and HLA-C alleles, in addition to the HLA-A allele, to further assess other HLA types that may associate with GP2 to create a positive therapeutic effect. GP2 prediction binding algorithms may suggest that some HLA-B or HLA-C alleles may associate similarly to or stronger than HLA-A*02.
Phase IIb Clinical Trial Results
A variety of HLA types are predicted to associate with GP2 based on binding algorithms, and such binding can be tested in preclinical experiments. However, HLA-A*02 is the most common HLA type, thus it was studied first, and all patients in the Phase IIb trial had at least one HLA-A*02 allele. The HLA data collected did not identify if a patient was double HLA-A*02, nor were any other non-HLA-A*02 alleles identified.
Preliminary Review of FLAMINGO-01 HLA Data
Estimates of HLA prevalence by race are available in literature. As there are many sources and population studies to reference, a general consensus is that HLA-A*02 is prevalent in about 40
- Across all screened patients, HLA-A*02 prevalence is about
46% . The double HLA-A*02 prevalence, in patients who have received HLA-A*02 alleles from both parents, is about8% . Because there are 2 HLA-A genes, one from each parent, the total of all prevalence percentages exceeds100% and is less than200% because of double HLA-A types. The HLA-A*03, HLA-A*24, and HLA-A*01 prevalences are about 20-25% for each allele. The HLA-A*11, HLA-A*68, HLA-A*29, and HLA-A*30 prevalences are about 9-12% for each allele. - In those screened patients who self-report as White, at least single or double HLA-A*02 genes are prevalent in approximately
50% of the patients. The double HLA-A*02 alleles are prevalent in10% of these patients screened. The next most prevalent HLA-A types in the White populations are HLA-A*01 (29% ), HLA-A*03 (21% ), HLA-A*24 (19% ), HLA-A*68 (10% ), HLA-A*29 (13% ), and HLA-A*11 (9% ). - In those screened patients who self-report as Hispanic or Latino, at least single or double HLA-A*02 alleles are prevalent in approximately
50% of the patients. The double HLA-A*02 genes are prevalent in7% of these patients screened. The next most prevalent HLA-A types in the Hispanic or Latino populations are HLA-A*01 (20% ), HLA-A*24 (22% ), HLA-A*68 (22% ), HLA-A*30 (18% ), HLA-A*29 (13% ), and HLA-A*11 (13% ). - In those screened patients who self-report as Black or African-American, at least single or double HLA-A*02 alleles are prevalent in approximately
40% of the patients. The next most prevalent HLA-A types in the Black or African-American populations are HLA-A*68 (33% ), HLA-A*03 (27% ), HLA-A*30 (27% ), HLA-A*24 (13% ), HLA-A*29 (13% ), and HLA-A*23 (13% ). - In those screened patients who self-report as Asian, at least single or double HLA-A*02 alleles are prevalent in approximately
17% of the patients. The other prevalent HLA-A types are HLA-A*24 (42% ), HLA-A*33 (42% ), HLA-A*11 (25% ), and HLA-A*03 (25% ).
The above preliminary Flamingo-01 open label data on HLA-A alleles by race and ethnicity is similar to the data available in literature. If any of the non-HLA-A*02 alleles have a strong association to GP2, it may be interesting to study the immune response and efficacy of GLSI-100 in patients with one allele of that type and one allele that is HLA-A*02 in addition to in patients with the double HLA-A*02 alleles.
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 clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and 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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Office: (832) 819-3232
Email: info@greenwichlifesciences.com
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