Greenwich LifeSciences Provides Update on Commercial Manufacturing
Greenwich LifeSciences (NASDAQ: GLSI) provided an update on the commercial manufacturing of GP2, its immunotherapy product for preventing breast cancer recurrences. The company manufactured three commercial lots of GP2 active ingredient in 2023, sufficient for approximately 200,000 doses. In 2024, they completed the first of three commercial lots filling GP2 into vials, with final testing near completion.
The manufacturing data has been submitted to both the FDA and European regulators (EMA) for review. The company plans to complete manufacturing activities parallel to conducting the Phase III FLAMINGO-01 trial. If approved, GLSI-100 could receive up to 12 years of market exclusivity. The company is working to ensure manufacturing meets both US and European regulatory standards, with up to 150 participating clinical sites across these regions.
Greenwich LifeSciences (NASDAQ: GLSI) ha fornito un aggiornamento sulla produzione commerciale di GP2, il suo prodotto di immunoterapia per prevenire le recidive del cancro al seno. L'azienda ha prodotto tre lotti commerciali di principio attivo GP2 nel 2023, sufficienti per circa 200.000 dosi. Nel 2024, hanno completato il primo di tre lotti commerciali riempiendo GP2 in fiale, con i test finali vicini al completamento.
I dati di produzione sono stati inviati sia alla FDA che ai regolatori europei (EMA) per la revisione. L'azienda prevede di completare le attività di produzione parallelamente alla conduzione del trial di Fase III FLAMINGO-01. Se approvato, GLSI-100 potrebbe ricevere fino a 12 anni di esclusività di mercato. L'azienda sta lavorando per assicurarsi che la produzione soddisfi gli standard normativi sia statunitensi che europei, con fino a 150 siti clinici partecipanti in queste regioni.
Greenwich LifeSciences (NASDAQ: GLSI) proporcionó una actualización sobre la fabricación comercial de GP2, su producto de inmunoterapia para prevenir las recurrencias de cáncer de mama. La empresa fabricó tres lotes comerciales del ingrediente activo GP2 en 2023, suficientes para aproximadamente 200,000 dosis. En 2024, completaron el primero de tres lotes comerciales llenando GP2 en frascos, con las pruebas finales casi completas.
Los datos de fabricación han sido enviados a la FDA y a los reguladores europeos (EMA) para su revisión. La empresa planea completar las actividades de fabricación en paralelo a la realización del ensayo de Fase III FLAMINGO-01. Si se aprueba, GLSI-100 podría recibir hasta 12 años de exclusividad en el mercado. La empresa está trabajando para garantizar que la fabricación cumpla con las normas regulatorias de EE. UU. y Europa, con hasta 150 sitios clínicos participantes en estas regiones.
그리니치 라이프사이언스 (NASDAQ: GLSI)는 유방암 재발을 예방하기 위한 면역 치료 제품 GP2의 상업적 제조에 대한 업데이트를 제공했습니다. 이 회사는 2023년에 GP2 활성 성분의 상업적 제조를 위한 세 가지 배치를 생산했으며, 이는 약 200,000회 분량에 해당합니다. 2024년에는 GP2를 바이알에 채우기 위한 세 가지 상업적 배치 중 첫 번째 배치를 완료했으며, 최종 테스트가 거의 완료되었습니다.
생산 데이터는 FDA 및 유럽의 규제기관(EMA)에게 제출되었습니다. 이 회사는 3상 FLAMINGO-01 시험을 진행하는 것과 병행하여 제조 활동을 완료할 계획입니다. 승인이 이루어질 경우, GLSI-100은 시장에서 최대 12년의 독점 권리를 받을 수 있습니다. 이 회사는 미국과 유럽의 규제 기준을 충족하는 제조가 이루어지도록 노력하고 있으며, 이 지역에서 최대 150개의 임상 사이트가 참여하고 있습니다.
Greenwich LifeSciences (NASDAQ: GLSI) a fourni une mise à jour sur la fabrication commerciale de GP2, son produit d'immunothérapie visant à prévenir les récidives de cancer du sein. L'entreprise a fabriqué trois lots commerciaux de l'ingrédient actif GP2 en 2023, suffisant pour environ 200 000 doses. En 2024, ils ont terminé le premier de trois lots commerciaux en remplissant GP2 dans des flacons, les tests finaux étant presque terminés.
Les données de fabrication ont été soumises à la fois à la FDA et aux régulateurs européens (EMA) pour examen. L'entreprise prévoit de mener des activités de fabrication parallèlement à la conduite de l'
Greenwich LifeSciences (NASDAQ: GLSI) hat ein Update zur kommerziellen Herstellung von GP2, seinem Immuntherapieprodukt zur Verhinderung von Brustkrebsrezidiven, bereitgestellt. Das Unternehmen hat im Jahr 2023 drei kommerzielle Chargen des GP2-Wirkstoffs hergestellt, die für etwa 200.000 Dosen ausreichen. Im Jahr 2024 wurde die erste von drei kommerziellen Chargen abgeschlossen, wobei GP2 in Fläschchen abgefüllt wurde, und die abschließenden Tests stehen kurz vor dem Abschluss.
Die Herstellungsdaten wurden sowohl der FDA als auch den europäischen Regulierungsbehörden (EMA) zur Prüfung vorgelegt. Das Unternehmen plant, die Herstellungsaktivitäten parallel zur Durchführung der Phase-III-Studie FLAMINGO-01 abzuschließen. Bei Genehmigung könnte GLSI-100 bis zu 12 Jahre Marktexklusivität erhalten. Das Unternehmen arbeitet daran, sicherzustellen, dass die Herstellung den regulatorischen Standards sowohl in den USA als auch in Europa entspricht, wobei bis zu 150 klinische Standorte in diesen Regionen beteiligt sind.
- Completed manufacturing of three commercial lots capable of producing 200,000 doses
- Successfully manufactured first commercial vial lot in 2024
- Potential for up to 12 years of market exclusivity upon approval
- Expansion to 150 clinical sites across US and Europe
- Manufacturing process still requires regulatory approval
- Two more lots of finished GP2 product still need to be manufactured
- Commercial launch timeline dependent on clinical trial results and regulatory review
Insights
The manufacturing update from Greenwich LifeSciences represents a critical milestone in their commercialization journey. The successful production of three commercial GP2 lots in 2023, capable of yielding approximately
The 2024 progress in vial filling at an approved commercial facility is strategically significant. By manufacturing commercial-grade vials that could potentially be used in the FLAMINGO-01 trial, the company is efficiently generating real-world stability data and manufacturing experience that will be important for regulatory submissions. The parallel approach to clinical trials and manufacturing optimization could potentially compress the timeline between trial completion and commercial launch.
The company's dual-track regulatory strategy, seeking both FDA and EMA compliance, is particularly astute. This approach could enable simultaneous market access in both the US and Europe, maximizing the value of the potential 12-year market exclusivity period. The establishment of manufacturing partnerships with scalable capacity provides operational flexibility and reduces commercial risk, while the expanded clinical site network of up to 150 locations could facilitate rapid market penetration if GLSI-100 receives approval.
This manufacturing update significantly de-risks Greenwich LifeSciences' commercial pathway. In the biotech sector, manufacturing challenges can often delay product launches even after clinical success, making this early manufacturing validation particularly valuable. The successful production of commercial-scale lots demonstrates manufacturing process control and reproducibility, two critical factors in regulatory review.
The company's intellectual property strategy, including potential new patent applications related to manufacturing and clinical procedures, could provide additional layers of protection beyond the potential 12-year biological exclusivity period. This multi-layered approach to market protection enhances the commercial potential and could attract potential commercial partners.
The network of up to 150 clinical sites across the US and Europe represents a valuable commercial asset. These sites gain practical experience with GLSI-100 during clinical trials, potentially becoming early adopters and centers of excellence if the product receives approval. This established network could significantly accelerate commercial uptake and reduce market education costs.
STAFFORD, Texas, Jan. 22, 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 provided the following update on the commercial manufacturing of GP2.
Preparation for Filing of BLA in the US
In addition to the submission of the Phase III clinical data, submitting commercial manufacturing data will be critical to the filing of a Biological License Application (BLA) for GLSI-100 in the US and for regulatory filings in other countries.
Commercial Manufacturing
The first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In addition, drug stability programs have been initiated. Data on these commercial lots were submitted to the FDA in the US and European regulators (EMA) in Europe and will continue to be reviewed.
In 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in an approved commercial facility, and final testing of this first lot is nearing completion. The Company may choose to use these finished commercial vials in FLAMINGO-01, subject to regulatory review.
CEO Snehal Patel commented, "We are pleased to have made substantial progress in the commercial manufacturing of GP2 in 2023 and 2024. We have now manufactured GP2 vials that can be stored in preparation for commercial launch or used in clinical trials. We will be manufacturing at least two more lots of finished GP2 product. Our plan is to complete these activities in parallel to conducting FLAMINGO-01 so that both clinical and manufacturing data are available for review by the biologics division of the FDA prior to potentially being granted a marketing license with up to 12 years of market exclusivity based on current law."
Mr. Patel further added, "Establishing a trade name for GP2 and a strategy for packaging of GP2 or GLSI-100 for commercial sale by country will be an upcoming priority as we near the filing of a BLA in the US. Furthermore, with the expansion of clinical sites into Europe and the on-going regulatory review of the manufacturing of GP2 by EMA, an additional priority will be to discuss the marketing license pathway in Europe with EMA. The objective is to manufacture GP2 and to conduct FLAMINGO-01 in a manner that is acceptable to both US and European regulators, even where regulatory standards may differ. Our manufacturing partners, who can ramp up manufacturing scale as needed, and the up to 150 participating clinical sites in the US and Europe at some of the most prominent institutions and teaching hospitals, who are becoming familiar with the use of GLSI-100 in the clinic, may provide for an efficient transition to product launch and commercial sales if GLSI-100 is approved."
New Intellectual Property
In 2024, additional refinements were made towards finalizing the manufacturing of GP2, the reconstitution of GLSI-100 in the pharmacy, and the injection of GLSI-100 in the clinic. As a result, the Company may potentially file additional patent applications.
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
How many doses can Greenwich LifeSciences (GLSI) produce from its first three commercial lots?
What is the current status of GLSI's commercial manufacturing progress?
How long could GLSI-100 maintain market exclusivity if approved?
How many clinical sites is GLSI planning to involve in the FLAMINGO-01 trial?
What regulatory bodies are currently reviewing GLSI's manufacturing data?
