Polyrizon's Moving Forward with Expected 2025 Clinical Trial - Entered Manufacturing Agreement for its PL-14 Allergy Blocker
Polyrizon has entered into a manufacturing agreement with Eurofins CDMO Amatsiaquitaine S.A.S, a European-based GMP manufacturer, to produce Clinical Trial Material for its PL-14 allergy blocker. The collaboration aims to prepare for a clinical trial expected to begin in 2025.
The EU-based facility offers large-scale commercial production capabilities and will support Polyrizon's future commercialization efforts. The manufacturer will provide CTM production that meets both USA and European regulatory standards, marking a significant step in the company's preparation for evaluating PL-14's safety and efficacy as an allergy blocker delivered through nasal spray technology.
Polyrizon ha stipulato un accordo di produzione con Eurofins CDMO Amatsiaquitaine S.A.S, un produttore GMP con sede in Europa, per produrre il Materiale per la Sperimentazione Clinica per il suo blocco allergico PL-14. La collaborazione mira a prepararsi per un trial clinico previsto per iniziare nel 2025.
La struttura con sede nell'UE offre capacità di produzione commerciale su larga scala e supporterà gli sforzi futuri di commercializzazione di Polyrizon. Il produttore fornirà la produzione di CTM che soddisfa gli standard normativi sia negli USA che in Europa, segnando un passo significativo nella preparazione dell'azienda per valutare la sicurezza e l'efficacia del PL-14 come bloccante allergico somministrato tramite tecnologia spray nasale.
Polyrizon ha firmado un acuerdo de fabricación con Eurofins CDMO Amatsiaquitaine S.A.S, un fabricante GMP con sede en Europa, para producir Material para Ensayos Clínicos para su bloqueador de alergias PL-14. La colaboración tiene como objetivo prepararse para un ensayo clínico que se espera comience en 2025.
La instalación con sede en la UE ofrece capacidades de producción comercial a gran escala y respaldará los futuros esfuerzos de comercialización de Polyrizon. El fabricante proporcionará producción de CTM que cumpla con los estándares regulatorios tanto de EE. UU. como de Europa, marcando un paso significativo en la preparación de la empresa para evaluar la seguridad y eficacia del PL-14 como bloqueador de alergias administrado a través de tecnología de spray nasal.
Polyrizon은 유럽에 본사를 둔 GMP 제조업체 Eurofins CDMO Amatsiaquitaine S.A.S와 제조 계약을 체결하였습니다. 이 계약은 PL-14 알레르기 차단제에 대한 임상 시험 재료를 생산하기 위한 것입니다. 이 협력은 2025년에 시작될 예정인 임상 시험을 준비하는 것을 목표로 하고 있습니다.
EU 기반 시설은 대규모 상업 생산 능력을 제공하며 Polyrizon의 향후 상업화 노력에 지원을 할 것입니다. 이 제조업체는 미국과 유럽의 규제 기준을 모두 충족하는 CTM 생산을 제공할 것이며, 이는 PL-14의 안전성과 효능을 알레르기 차단제로서 평가하는 데 있어 회사의 중요한 준비 단계가 될 것입니다.
Polyrizon a conclu un accord de fabrication avec Eurofins CDMO Amatsiaquitaine S.A.S, un fabricant GMP basé en Europe, pour produire du Matériel pour Essai Clinique pour son bloquant d'allergies PL-14. La collaboration vise à se préparer à un essai clinique qui devrait commencer en 2025.
Les installations basées dans l'UE offrent des capacités de production commerciale à grande échelle et soutiendront les efforts futurs de commercialisation de Polyrizon. Le fabricant fournira une production de CTM répondant à la fois aux normes réglementaires américaines et européennes, représentant une étape importante dans la préparation de l'entreprise à évaluer la sécurité et l'efficacité du PL-14 en tant que bloquant d'allergies administré par technologie de spray nasal.
Polyrizon hat eine Herstellungsvereinbarung mit Eurofins CDMO Amatsiaquitaine S.A.S, einem in Europa ansässigen GMP-Hersteller, getroffen, um klinisches Prüfmaterial für seinen PL-14-Allergieblocker zu produzieren. Die Zusammenarbeit zielt darauf ab, sich auf eine klinische Studie vorzubereiten, die voraussichtlich 2025 beginnen wird.
Die in der EU ansässige Einrichtung bietet großflächige kommerzielle Produktionsmöglichkeiten und wird Polyrizons zukünftige Vermarktungsbemühungen unterstützen. Der Hersteller wird CTM-Produktionen bereitstellen, die sowohl den US-amerikanischen als auch den europäischen regulatorischen Standards entsprechen, was einen wichtigen Schritt in der Vorbereitung des Unternehmens zur Evaluierung der Sicherheit und Wirksamkeit von PL-14 als Allergieblocker darstellt, der durch Nasenspray-Technologie verabreicht wird.
- Secured manufacturing agreement with established EU-based GMP facility
- Manufacturing partner has large-scale commercial production capabilities
- Manufacturer complies with both USA and European regulatory standards
- Clinical trials not expected to start until 2025
- Product still in early development stage with no proven efficacy
Insights
The engagement with an EU-based GMP manufacturing facility enables timely production and preparation for clinical trial. The EU-based GMP manufacturer has large-scale commercial production capabilities, to support Polyrizon in future commercialization efforts
Raanana, Israel, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, previously announced that it entered into a manufacturing agreement with Eurofins CDMO Amatsiaquitaine S.A.S, a leading European-based Good Manufacturing Practice (GMP) manufacturer. This collaboration will supply Clinical Trial Material (CTM) for Polyrizon’s PL-14 allergy blocker, in preparation for a clinical trial that is expected to commence in 2025.
With this agreement, which was announced earlier this month, Polyrizon secures a reliable and compliant manufacturing source for the PL-14 clinical trial. The trial aims to evaluate the safety and efficacy of PL-14 as an allergy blocker, advancing Polyrizon's mission to address allergy-related health issues through unique nasal sprays.
Tomer Izraeli, CEO of Polyrizon previously stated that “We are pleased to have established this partnership with Eurofins CDMO Amatsiaquitaine S.A.S, which strengthens our preparation efforts for the upcoming PL-14 clinical trial. We believe that this collaboration marks a significant milestone in our journey toward providing effective allergy protection solutions to patients."
The manufacturing site is set to support the CTM needs for Polyrizon's planned 2025 trial, offering high-quality and compliant development programs in line with USA and European regulatory standards.
About Polyrizon
Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com.
About Eurofins – the global leader in bio-analysis
Eurofins is Testing for Life. The Eurofins Scientific S.E. network of independent companies believes that it is a global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is also one of the market leaders in certain testing and laboratory services for genomics, and in the support of clinical studies, as well as in biopharma contract development and manufacturing. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
With ca. 62,000 staff across a network of more than 900 laboratories in over 1,000 companies in 62 countries, Eurofins offers a portfolio of over 200,000 analytical methods. Eurofins Scientific S.E. shares are listed on Euronext Paris Stock Exchange.
About Eurofins CDMO
As a prominent Contract Development & Manufacturing Organization (CDMO), Eurofins CDMO offers a powerful network of companies across Europe, North America and India that provide comprehensive, end-to-end solutions for preclinical and clinical outsourcing services. Eurofins CDMO is specialized in both Drug Substance / API and Drug Product development for Biologics and Small Molecules, helping (bio)pharmaceutical companies swiftly progress from the research phase to the clinical stages.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the timing of the commencement of its clinical trial and its belief that the collaboration marks a significant milestone in its journey toward providing effective allergy protection solutions to patients. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s prospectus (Registration No. 333-266745), dated October 24, 2024 and filed with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites.
Contacts:
Michal Efraty
Investor Relations
FAQ
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