Greenwich LifeSciences Announces Positive Immune Response Data from FLAMINGO-01 Phase III Clinical Trial
Greenwich LifeSciences (NASDAQ: GLSI) has reported positive preliminary immune response data from its FLAMINGO-01 Phase III clinical trial evaluating GLSI-100, an immunotherapy for breast cancer recurrence prevention. The data shows increasing immune responses over time in both HLA-A*02 and non-HLA-A*02 patient arms.
Key findings include baseline immune response to GP2 before treatment and increasing response with vaccinations through months 4-6, consistent with Phase IIb trial results. The company has filed patent claims for non-HLA-A*02 patients, potentially doubling eligible patients to 88,000 annually in the US and Europe, with market potential of $8-10 billion per year.
Previous Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences over 5 years in HER2/neu 3+ patients treated with GLSI-100. The company is considering adding a randomized placebo arm for non-HLA-A*02 patients, effectively creating a second pivotal Phase III trial.
Greenwich LifeSciences (NASDAQ: GLSI) ha riportato dati preliminari positivi sulla risposta immunitaria dal suo studio clinico di fase III FLAMINGO-01, che valuta GLSI-100, un'immunoterapia per la prevenzione della recidiva del cancro al seno. I dati mostrano un aumento delle risposte immunitarie nel tempo sia nei gruppi di pazienti HLA-A*02 che non HLA-A*02.
I risultati chiave includono la risposta immunitaria di base a GP2 prima del trattamento e un aumento della risposta con le vaccinazioni tra i mesi 4 e 6, in linea con i risultati dello studio di fase IIb. L'azienda ha presentato richieste di brevetto per i pazienti non HLA-A*02, potenzialmente raddoppiando il numero di pazienti idonei a 88.000 all'anno negli Stati Uniti e in Europa, con un potenziale di mercato di 8-10 miliardi di dollari all'anno.
Il precedente studio di fase IIb ha dimostrato una riduzione del 80% o superiore delle recidive di cancro nell'arco di 5 anni nei pazienti HER2/neu 3+ trattati con GLSI-100. L'azienda sta considerando di aggiungere un braccio placebo randomizzato per i pazienti non HLA-A*02, creando di fatto un secondo studio pivotale di fase III.
Greenwich LifeSciences (NASDAQ: GLSI) ha informado datos preliminares positivos sobre la respuesta inmune de su ensayo clínico de fase III FLAMINGO-01, que evalúa GLSI-100, una inmunoterapia para la prevención de la recurrencia del cáncer de mama. Los datos muestran un aumento de las respuestas inmunitarias con el tiempo en ambos grupos de pacientes, HLA-A*02 y no HLA-A*02.
Los hallazgos clave incluyen la respuesta inmune basal a GP2 antes del tratamiento y un aumento de la respuesta con las vacunaciones durante los meses 4 a 6, consistente con los resultados del ensayo de fase IIb. La empresa ha presentado solicitudes de patente para pacientes no HLA-A*02, lo que podría duplicar el número de pacientes elegibles a 88,000 anualmente en EE. UU. y Europa, con un potencial de mercado de 8 a 10 mil millones de dólares al año.
El anterior ensayo de fase IIb demostró una reducción del 80% o más en las recurrencias de cáncer durante 5 años en pacientes HER2/neu 3+ tratados con GLSI-100. La empresa está considerando agregar un brazo placebo aleatorizado para pacientes no HLA-A*02, creando efectivamente un segundo ensayo pivotal de fase III.
그리니치 라이프사이언스(Greenwich LifeSciences) (NASDAQ: GLSI)는 유방암 재발 예방을 위한 면역요법 GLSI-100의 FLAMINGO-01 3상 임상시험에서 긍정적인 초기 면역 반응 데이터를 보고했습니다. 데이터는 HLA-A*02 환자와 비-HLA-A*02 환자 군 모두에서 시간이 지남에 따라 면역 반응이 증가하는 것을 보여줍니다.
주요 발견에는 치료 전 GP2에 대한 기초 면역 반응과 4-6개월 동안의 백신 접종을 통한 반응 증가가 포함되며, 이는 2b상 시험 결과와 일치합니다. 이 회사는 비-HLA-A*02 환자에 대한 특허 청구를 제출하여 미국과 유럽에서 연간 88,000명의 적격 환자를 두 배로 늘릴 수 있는 가능성을 가지고 있으며, 시장 잠재력은 연간 80억에서 100억 달러에 달합니다.
이전 2b상 시험에서는 GLSI-100으로 치료받은 HER2/neu 3+ 환자에서 5년 동안 암 재발이 80% 이상 감소한 것으로 나타났습니다. 이 회사는 비-HLA-A*02 환자를 위한 무작위 위약군을 추가하는 것을 고려하고 있으며, 이는 사실상 두 번째 주요 3상 시험을 만드는 것입니다.
Greenwich LifeSciences (NASDAQ: GLSI) a rapporté des données préliminaires positives sur la réponse immunitaire de son essai clinique de phase III FLAMINGO-01 évaluant GLSI-100, une immunothérapie pour la prévention des récidives du cancer du sein. Les données montrent une augmentation des réponses immunitaires au fil du temps dans les bras de patients HLA-A*02 et non HLA-A*02.
Les résultats clés incluent la réponse immunitaire de base à GP2 avant le traitement et une réponse croissante avec les vaccinations au cours des mois 4 à 6, cohérente avec les résultats de l'essai de phase IIb. L'entreprise a déposé des demandes de brevet pour les patients non HLA-A*02, ce qui pourrait potentiellement doubler le nombre de patients éligibles à 88 000 par an aux États-Unis et en Europe, avec un potentiel de marché de 8 à 10 milliards de dollars par an.
L'essai de phase IIb précédent a démontré une réduction de 80 % ou plus des récidives de cancer sur 5 ans chez les patients HER2/neu 3+ traités par GLSI-100. L'entreprise envisage d'ajouter un bras placebo randomisé pour les patients non HLA-A*02, créant ainsi un deuxième essai pivot de phase III.
Greenwich LifeSciences (NASDAQ: GLSI) hat positive vorläufige Immunantwortdaten aus seiner Phase-III-Studie FLAMINGO-01 veröffentlicht, die GLSI-100, eine Immuntherapie zur Prävention von Brustkrebsrückfällen, bewertet. Die Daten zeigen über die Zeit zunehmende Immunantworten sowohl in den HLA-A*02- als auch in den nicht-HLA-A*02-Patientengruppen.
Wesentliche Ergebnisse umfassen die Ausgangs-Immunantwort auf GP2 vor der Behandlung und eine zunehmende Reaktion mit Impfungen über die Monate 4-6, was mit den Ergebnissen der Phase-IIb-Studie übereinstimmt. Das Unternehmen hat Patentanmeldungen für nicht-HLA-A*02-Patienten eingereicht, was die Anzahl der berechtigten Patienten auf jährlich 88.000 in den USA und Europa potenziell verdoppeln könnte, mit einem Marktpotenzial von 8-10 Milliarden Dollar pro Jahr.
Die vorherige Phase-IIb-Studie zeigte eine Reduktion der Krebsrückfälle um 80 % oder mehr über einen Zeitraum von 5 Jahren bei HER2/neu 3+-Patienten, die mit GLSI-100 behandelt wurden. Das Unternehmen erwägt, eine randomisierte Placebo-Gruppe für nicht-HLA-A*02-Patienten hinzuzufügen, was effektiv eine zweite entscheidende Phase-III-Studie schaffen würde.
- Phase III trial shows positive immune response data in both HLA-A*02 and non-HLA-A*02 patients
- New patent claims could double eligible patient population to 88,000 annually
- Market potential expansion to $8-10 billion in annual revenue
- Previous Phase IIb showed 80%+ reduction in cancer recurrence over 5 years
- No serious adverse events reported in previous trials with 146 patients
- Current FLAMINGO-01 results are preliminary and may differ at study end
- Additional placebo arm consideration could complicate and extend trial timeline
Insights
The preliminary immune response data from Greenwich LifeSciences' FLAMINGO-01 Phase III trial represents a significant positive development for their GP2 immunotherapy. Two key findings stand out: the increasing immune response over time with continued vaccinations and the baseline immune response to GP2 before treatment.
The detection of immune responses in non-HLA-A*02 patients is particularly important as it potentially doubles the eligible patient population. The company's patent application for this expanded population could secure exclusive rights to treat approximately 88,000 patients annually across the US and Europe.
The consideration to add a randomized placebo arm for non-HLA-A*02 patients is strategically sound, albeit likely to extend the development timeline. This would effectively create a second pivotal Phase III trial, potentially enabling simultaneous regulatory submissions for both patient populations.
While these immune response results are promising, they represent surrogate markers rather than clinical efficacy endpoints. The true measure of GP2's value will be its ability to prevent breast cancer recurrence, as demonstrated in the Phase IIb trial where HLA-A*02 patients showed an 80% reduction in recurrence rates over 5 years with no serious adverse events.
The preliminary nature of these findings and their relationship to clinical outcomes should be considered when evaluating their significance, though the consistent patterns between Phase IIb and Phase III data strengthen confidence in the approach.
Greenwich LifeSciences' latest immune response data represents a substantial de-risking event with significant market implications. The expansion to non-HLA-A*02 patients could fundamentally transform the company's commercial prospects by doubling the addressable patient population to 88,000 annually.
The $8-10 billion market potential cited by management assumes premium pricing comparable to established HER2-targeted therapies like Kadcyla and Enhertu. While ambitious, this benchmark isn't unreasonable if GP2 delivers the 80% recurrence reduction seen in Phase IIb.
The patent application for non-HLA-A*02 patients strengthens the company's intellectual property position considerably. Unlike their core technology, this new patent would be solely owned by Greenwich rather than licensed, potentially improving economics and attractiveness to partners.
The consideration to expand the trial design to include a randomized non-HLA-A*02 arm demonstrates management confidence but will increase development costs and timeline. However, this investment could pay off substantially by broadening approvable indications in a single development program.
The immune response profile appears consistent with earlier trials, with responses increasing over time and peaking at six months. This biological consistency between Phase II and III is reassuring, though final efficacy outcomes remain to be determined.
With a market cap of just
STAFFORD, Texas, April 02, 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 immune response data.
FLAMINGO-01 Immune Response Data Summary
The Company has analyzed the preliminary immune response data from FLAMINGO-01. Immune response data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types (non- HLA-A*02), show that GLSI-100 is creating an immune response over time as the frequency of patients exhibiting an injection site reaction or GP2 Delayed-Type Hypersensitivity (DTH) skin test reaction as measured by induration or erythema is increasing with increased vaccinations.
- The number of patients experiencing an immune response increased over time from baseline through the 4th to 6th month vaccinations in both HLA-A*02 and non-HLA-A*02 arms.
- In addition, a baseline immune response to GP2 is being observed before any treatment with GP2 in both HLA-A*02 and non-HLA-A*02 arms. This result suggests that GP2 is a natural antigen, that may have been part of an immune response in the patient during prior trastuzumab or other treatments.
- These two general immune response findings, immune response at baseline and increasing immune response over time, were also observed in the Phase IIb clinical trial for HLA-A*02 only patients. These results confirm that the HLA prevalence, safety, and immune response in FLAMINGO-01 patients is trending as expected in both HLA arms.
- The Company recently filed patent claims for non-HLA-A*02 patients which may be solely owned by the Company separate from any prior license. These claims are also supported by binding prediction algorithms and in vitro binding experiments conducted by the Company. This represents an invention that was originated by the Company which could double the number of patients eligible for GP2 treatment to approximately 88,000 new patients per year in the US and Europe. The market potential using the drug prices per year of Kadcyla or Enhertu could be in the range of
$8 -10 billion per year. - As mentioned in a prior press release, the non-HLA-A02 types that are most commonly being enrolled in FLAMINGO-01 include HLA-A*03, HLA-A*24, HLA-A*01, HLA-A*11, HLA-A*68, HLA-A*29, HLA-A*30, HLA-A*23, and HLA-A*33.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label immune response data is based on the patients enrolled to date in FLAMINGO-01 and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results and the results at the end of the study may differ.
CEO Snehal Patel commented, "We are very encouraged to see that the preliminary results from FLAMINGO-01 show immune responses in both HLA-A*02 and non-HLA-A*02 patients. We are now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a second pivotal and blinded Phase III trial. If successful, the Company could pursue approval for both HLA-A*02 and non-HLA-A*02 patients in similar time frames using independent or combined analysis of the two patient groups with the potential to double the market for GP2 to up to
Mr. Patel added, "The Company may choose to expand its immune response analysis of GP2 specific T cells by sequencing the DNA of the T cells at baseline and after treatment with GP2. The T cell sequences can be compared to the immune response increases over time. Expansion into GP2 specific CAR-T cells could potentially become another platform technology to complement GP2 peptide treatment for non-responding higher risk patients. Blood samples have been collected at multiple timepoints for future T cell and immune response analysis."
Previously Published Phase IIb Immune Response 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.
The Phase IIb immune response data in HLA-A*02 only patients was published at AACR in 2021 with the following findings:
- GP2 immunotherapy generated GP2-specific immune responses leading to promising clinical benefit, thus supporting GP2’s mechanism of action.
- Immune responses to GP2 were measured over time using a CD8 T cell dimer binding assay (Dimer Binding Assay) and GP2 DTH skin tests. GP2 immunity peaked at 6 months in HER2 3+ patients after they completed their first 6 immunizations, as measured by the Dimer Binding Assay. The data also shows that for the 2.5 years that the immune response was measured, the immunity was sustained and remained above baseline, resulting in a reduction in metastatic breast cancer recurrences.
- Broad based immune response suggests that GP2 immunotherapy and Herceptin based products may also have the potential to treat low HER2 and other HER2 1-3+ expressing cancers in combination with trastuzumab or trastuzumab antibody drug conjugates.
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
Forward-Looking Statement Disclaimer
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
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
What are the key findings from GLSI's FLAMINGO-01 Phase III trial immune response data?
How much could GLSI's market potential expand with the new non-HLA-A*02 patent claims?
What were the Phase IIb trial results for GLSI-100?
What is GLSI's next strategic move for the FLAMINGO-01 trial?
