Plus Therapeutics and SpectronRx Announce Radiotherapeutic Manufacturing Partnership
Plus Therapeutics (Nasdaq: PSTV) and SpectronRx have signed a Manufacturing Services Agreement for the production of Rhenium (186Re) Obisbemeda, a radiotherapy for CNS cancers. SpectronRx will utilize its facilities to produce late-stage clinical and commercial supplies of the treatment. The partnership aims to expand Plus' manufacturing capabilities and strengthen supply chain redundancy for upcoming late-stage clinical trials in 2025. SpectronRx operates across five locations with over 170,000 sq ft of radiopharmaceutical manufacturing space and 150 employees, serving 29 countries and collaborating with 31 pharmaceutical companies.
Plus Therapeutics (Nasdaq: PSTV) e SpectronRx hanno firmato un Accordo di Servizi di Produzione per la produzione di Rhenium (186Re) Obisbemeda, una radioterapia per i tumori del sistema nervoso centrale. SpectronRx utilizzerà le sue strutture per produrre forniture cliniche avanzate e commerciali del trattamento. L'obiettivo della partnership è ampliare le capacità di produzione di Plus e rafforzare la ridondanza della catena di approvvigionamento per i prossimi studi clinici avanzati nel 2025. SpectronRx opera in cinque sedi con oltre 170.000 piedi quadrati di spazio per la produzione di radiofarmaci e 150 dipendenti, servendo 29 paesi e collaborando con 31 aziende farmaceutiche.
Plus Therapeutics (Nasdaq: PSTV) y SpectronRx han firmado un Acuerdo de Servicios de Fabricación para la producción de Rhenium (186Re) Obisbemeda, una radioterapia para cánceres del sistema nervioso central. SpectronRx utilizará sus instalaciones para producir suministros clínicos avanzados y comerciales del tratamiento. La asociación tiene como objetivo expandir las capacidades de fabricación de Plus y fortalecer la redundancia de la cadena de suministro para los próximos ensayos clínicos avanzados en 2025. SpectronRx opera en cinco ubicaciones con más de 170,000 pies cuadrados de espacio para la fabricación de radiofármacos y 150 empleados, sirviendo a 29 países y colaborando con 31 empresas farmacéuticas.
플러스 테라퓨틱스(나스닥: PSTV)와 스펙트론RX가 중추신경계 암을 위한 방사선 요법인 르네움(186Re) 오비스베메다의 생산을 위한 제조 서비스 계약을 체결했습니다. 스펙트론RX는 치료의 후기 단계 임상 및 상업적 공급을 생산하기 위해 자신의 시설을 사용할 것입니다. 이 파트너십은 플러스의 제조 능력을 확장하고 2025년에 예정된 향후 후기 단계 임상 시험을 위해 공급망 중복성을 강화하는 것을 목표로 합니다. 스펙트론RX는 5개 위치에서 17만 평방 피트 이상의 방사성 의약품 제조 공간과 150명의 직원을 보유하고 있으며, 29개국에 서비스를 제공하고 31개 제약 회사와 협력하고 있습니다.
Plus Therapeutics (Nasdaq: PSTV) et SpectronRx ont signé un Accord de Services de Fabrication pour la production de Rhenium (186Re) Obisbemeda, une radiothérapie pour les cancers du système nerveux central. SpectronRx utilisera ses installations pour produire des approvisionnements cliniques et commerciaux en phase avancée du traitement. L'objectif du partenariat est d'élargir les capacités de fabrication de Plus et de renforcer la redondance de la chaîne d'approvisionnement pour les prochains essais cliniques de phase avancée en 2025. SpectronRx opère dans cinq sites avec plus de 170 000 pieds carrés d'espace de fabrication de radio-pharmaceutiques et 150 employés, servant 29 pays et collaborant avec 31 entreprises pharmaceutiques.
Plus Therapeutics (Nasdaq: PSTV) und SpectronRx haben einen Fertigungsdienstleistungsvertrag zur Produktion von Rhenium (186Re) Obisbemeda unterzeichnet, einer Radiotherapie für ZNS-Krebs. SpectronRx wird seine Einrichtungen nutzen, um klinische und kommerzielle Bestände der Behandlung in der späten Phase herzustellen. Das Ziel der Partnerschaft ist es, die Fertigungskapazitäten von Plus auszubauen und die Redundanz der Lieferkette für die bevorstehenden klinischen Studien in der späten Phase im Jahr 2025 zu stärken. SpectronRx betreibt an fünf Standorten über 170.000 Quadratfuß an Produktionsfläche für Radiopharmazeutika und beschäftigt 150 Mitarbeiter. Es bedient 29 Länder und arbeitet mit 31 Pharmaunternehmen zusammen.
- Strategic expansion of manufacturing capabilities for late-stage clinical trials
- Partnership with established manufacturer having 170,000 sq ft facility and 150 employees
- Enhanced supply chain redundancy for commercial production
- Access to SpectronRx's presence in 29 countries
- None.
Insights
This manufacturing partnership significantly strengthens Plus Therapeutics' ability to scale production of Rhenium (186Re) Obisbemeda for late-stage clinical trials and potential commercialization. SpectronRx's extensive infrastructure - 170,000 sq ft of radiopharmaceutical manufacturing space across five locations - provides important redundancy in the supply chain.
The timing is strategic as Plus plans to enter late-stage trials in 2025. SpectronRx's experience with 186Re manufacturing and presence in 29 countries significantly de-risks the manufacturing process. This partnership addresses a critical aspect of radiopharmaceutical development - having reliable, scalable manufacturing capability for complex radioactive compounds.
For CNS cancer treatments, particularly for difficult-to-treat conditions like leptomeningeal metastases and recurrent glioblastoma, manufacturing reliability is essential due to the short half-life of radiotherapeutics and the time-sensitive nature of treatment delivery.
Partnership will expand Plus’ capability to meet late-stage clinical and commercial forecasts for Rhenium (186Re) Obisbemeda and reinforce supply chain redundancy
AUSTIN, Texas and INDIANAPOLIS, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing targeted radiotherapeutics for central nervous system (CNS) cancers, and SpectronRx, a leading radiopharmaceutical contract developer and manufacturer, announced the signing of a Manufacturing Services Agreement (MSA) for the production of Rhenium (186Re) Obisbemeda, an innovative radiotherapy for CNS cancers, including leptomeningeal metastases and recurrent glioblastoma.
“In 2025, we intend to begin late-stage clinical trials and are actively preparing for commercial level product demand, therefore now is the time to expand our supply chain and partner with leading radiopharmaceutical manufacturers such as SpectronRx that can deliver for us and our patients,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “We believe that SpectronRx’s capabilities will significantly reinforce our existing manufacturing partnerships and position us well for the long term.”
Under this strategic partnership, SpectronRx will utilize its state-of-the-art facilities to produce late-stage clinical and commercial supplies of Rhenium (186Re) Obisbemeda. SpectronRx currently has more than 170,000 sq ft of radiopharmaceutical contract development and manufacturing (rCDMO) space and 150 employees across five locations. It provides services to 29 countries, working hand-in-hand with more than 31 pharmaceutical companies to develop and produce life-saving nuclear medicines, including those radiolabeled with 186Re. By joining forces with Plus Therapeutics, SpectronRx aims to further its mission of advancing nuclear medicine.
“We are proud to align with Plus Therapeutics, leveraging our expertise in nuclear medicine manufacturing to support the advancement of Rhenium (186Re) Obisbemeda and increase patient access to this important therapy,” said Anwer Rizvi, President of SpectronRx. "This collaboration underscores our dedication to advancing nuclear medicine and providing patients with high-quality, life-saving radiotherapies. We look forward to supporting Plus Therapeutics' mission to address the unmet needs of CNS cancer patients."
The partnership aims to enhance the supply chain redundancy for Plus Therapeutics and ensure that the demands of late-stage clinical trials and future commercial needs could be met effectively. This agreement marks a crucial step in expanding the reach and impact of Rhenium (186Re) Obisbemeda.
About Rhenium (186Re) Obisbemeda
Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off-target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
About SpectronRx
SpectronRx is a diagnostic and therapeutic radiopharmaceutical developer and manufacturer with three distinct specialties: Radiopharmaceutical Contract Development (rCDMO), Radiopharmaceutical Contract Manufacturing (rCMO), and Isotope Production. The company performs all scales of development, from initial conjugations through scale-up and commercial distribution. It also has the capacity to run clinical trials. Additionally, SpectronRx's deep industry knowledge, technical prowess and state-of-the-art facilities enable the company to significantly condense the timeline for bringing new medicines to market, which has the dual benefit of saving lives and driving greater profitability for clients.
With a large staff of radiochemists, radiopharmacists, scientists and engineers, dozens of qualified clean rooms, and over 170,000 sq. ft. of production space in Indiana, with additional facilities in Danbury, Connecticut and Europe, SpectronRx now supplies therapeutic and diagnostic radiopharmaceuticals to 29 countries. The company has been EMA and FDA inspected and can produce and procure any currently used radioisotopes. For more information visit SpectronRx.com, or follow the company on LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “intend,” “aim,” “expect,” “believe,” “could” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise and impact of Rhenium (186Re) Obisbemeda; the Company’s clinical trials including statements regarding the timing of late-stage clinical trials and commercial level product demand; expected enhancement of manufacturing capabilities to support late stage clinical trials and preparation for commercial level product demand; ability of SpectronRx to support the development, manufacturing, distribution and operations needs of the Company, including the production of production of Rhenium (186Re) Obisbemeda by SpectronRx; expected expansion of supply chain and partnerships with leading radiopharmaceutical manufacturers; and increased patient access to Rhenium (186Re) Obisbemeda.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash to fund its operations in the near term and long term, on terms acceptable to us or at all, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, including the ability to come into compliance with The Nasdaq Capital Market listing requirements, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Plus Therapeutics Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
chuang@plustherapeutics.com
SpectronRx Media Contact
Brian Fitzgerald
BFitzgerald@SpectronRx.com
(808) 754-0437
FAQ
What is the purpose of Plus Therapeutics' partnership with SpectronRx for PSTV stock?
What will SpectronRx manufacture for Plus Therapeutics (PSTV)?
When will Plus Therapeutics (PSTV) begin late-stage clinical trials for Rhenium Obisbemeda?
