Plus Therapeutics Expands Strategic Agreement with Telix IsoTherapeutics Group for Rhenium-186 Radioisotope Supply
Plus Therapeutics (Nasdaq: PSTV) has renewed its Master Services Agreement with Telix IsoTherapeutics Group for the supply of cGMP rhenium-186 (Re-186), a key radioisotope used in their lead radiotherapeutic candidate Rhenium (186Re) Obisbemeda. The five-year renewable agreement ensures reliable supply for late-stage clinical trials and commercial needs. This agreement complements their partnership with SpectronRx for final drug manufacturing, establishing a comprehensive end-to-end supply chain. The agreement focuses on producing aluminum perrhenate radionuclide intermediate and final processing of cGMP Re-186, enabling scalable, just-in-time manufacturing.
Plus Therapeutics (Nasdaq: PSTV) ha rinnovato il suo Contratto di Servizi Principali con il Telix IsoTherapeutics Group per la fornitura di rhenio-186 (Re-186) cGMP, un isotopo radioattivo chiave utilizzato nel loro principale candidato radioterapeutico Rhenium (186Re) Obisbemeda. L'accordo rinnovabile quinquennale garantisce una fornitura affidabile per studi clinici avanzati e necessità commerciali. Questo accordo integra la loro partnership con SpectronRx per la fabbricazione finale del farmaco, stabilendo una catena di fornitura completa e continua. L'accordo si concentra sulla produzione dell'intermedio radionuclidico di perrenato di alluminio e sul processamento finale del Re-186 cGMP, permettendo una fabbricazione scalabile e just-in-time.
Plus Therapeutics (Nasdaq: PSTV) ha renovado su Contrato de Servicios Maestros con el Telix IsoTherapeutics Group para el suministro de rhenio-186 (Re-186) cGMP, un radioisótopo clave utilizado en su principal candidato radioterapéutico Rhenium (186Re) Obisbemeda. El acuerdo renovable por cinco años garantiza un suministro confiable para ensayos clínicos de última etapa y necesidades comerciales. Este acuerdo complementa su asociación con SpectronRx para la fabricación final del medicamento, estableciendo una cadena de suministro integral de extremo a extremo. El acuerdo se centra en la producción del intermedio radionuclídico de perrenato de aluminio y el procesamiento final de Re-186 cGMP, lo que permite una fabricación escalable y justo a tiempo.
플러스 테라퓨틱스(나스닥: PSTV)가 텔릭스 아이소테라퓨틱스 그룹과 cGMP 렌늄-186 (Re-186) 공급을 위한 마스터 서비스 계약을 갱신했습니다. 이는 그들의 주요 방사선 치료 후보인 렌늄(186Re) 오비스베메다에서 사용되는 핵심 방사성 동위원소입니다. 5년 갱신 가능한 계약은 후기 단계 임상 시험 및 상업적 필요를 위한 신뢰할 수 있는 공급을 보장합니다. 이 계약은 최종 약물 제조를 위한 SpectronRx와의 파트너십을 보완하여 포괄적인 엔드 투 엔드 공급망을 확립합니다. 계약은 알루미늄 페렌네이트 방사성 동위원소 중간체 생산과 cGMP Re-186의 최종 가공에 중점을 두어 확장 가능하고 적시 제조를 가능하게 합니다.
Plus Therapeutics (Nasdaq: PSTV) a renouvelé son Accord de Services Master avec le Telix IsoTherapeutics Group pour la fourniture de rhenium-186 (Re-186) cGMP, un radio-isotope clé utilisé dans leur principal candidat radiothérapeutique Rhenium (186Re) Obisbemeda. Cet accord renouvelable de cinq ans garantit un approvisionnement fiable pour les essais cliniques avancés et les besoins commerciaux. Cet accord vient compléter leur partenariat avec SpectronRx pour la fabrication finale du médicament, établissant une chaîne d'approvisionnement intégrée de bout en bout. L'accord se concentre sur la production de l'intermédiaire radionucléide de perrhenate d'aluminium et le traitement final de Re-186 cGMP, permettant une fabrication évolutive et juste-à-temps.
Plus Therapeutics (Nasdaq: PSTV) hat seinen Rahmenvertrag mit der Telix IsoTherapeutics Group zur Lieferung von cGMP Rhenium-186 (Re-186), einem Schlüsselradioisotop, das in ihrem führenden radiotherapeutischen Kandidaten Rhenium (186Re) Obisbemeda verwendet wird, erneuert. Der fünf Jahre erneuerbare Vertrag gewährleistet eine zuverlässige Versorgung für klinische Studien in der späten Phase und kommerzielle Bedürfnisse. Dieser Vertrag ergänzt ihre Partnerschaft mit SpectronRx für die endgültige Arzneimittelherstellung und etabliert eine umfassende End-to-End-Lieferkette. Der Vertrag konzentriert sich auf die Herstellung des Zwischenprodukts Aluminiumperrhenat und die abschließende Verarbeitung von cGMP Re-186, was eine skalierbare, just-in-time Herstellung ermöglicht.
- Secured long-term supply chain for key radioisotope Re-186 through five-year renewable agreement
- Established end-to-end manufacturing capability through complementary partnerships
- Implemented scalable, just-in-time manufacturing system
- None.
Insights
This strategic agreement marks a significant development in Plus Therapeutics' supply chain infrastructure for their lead radiotherapeutic candidate. The five-year renewable agreement with Telix IsoTherapeutics ensures a reliable supply of cGMP Re-186, which is important for both late-stage clinical trials and potential commercial production. When combined with the recent SpectronRx partnership, Plus Therapeutics has effectively established a complete end-to-end manufacturing solution.
The just-in-time manufacturing capability is particularly important for radiopharmaceuticals due to their short half-life and specialized handling requirements. This dual-supplier strategy mitigates supply chain risks and provides the scalability needed for potential commercial expansion. However, investors should note that while the supply chain is being secured, the company's market cap of
Five-year renewable agreement secures reliable cGMP rhenium-186 (Re-186) supply for late-stage clinical and commercial forecasts
AUSTIN, Texas, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company focused on developing innovative radiotherapeutics, today announced the renewal of its Master Services Agreement (MSA) with Telix IsoTherapeutics Group Inc. (‘IsoTherapeutics’, a Telix Group company). This MSA secures a reliable supply of cGMP Re-186, the radioisotope used in Plus Therapeutics’ lead radiotherapeutic candidate Rhenium (186Re) Obisbemeda.
“This continuing agreement with Telix IsoTherapeutics Group builds on our recently announced partnership with SpectronRx and reflects our comprehensive supply chain strategy,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “By securing supply of Re-186 through IsoTherapeutics and leveraging SpectronRx for final drug manufacturing of Rhenium (186Re) Obisbemeda, we are establishing a scalable, end-to-end supply chain that positions us to meet the demands of late-stage clinical trials and future commercial needs.”
Key highlights of the agreement:
- Focus on the production of key radionuclide intermediate aluminum perrhenate and the final processing of cGMP Re-186
- Enables expanded, scalable, just-in-time manufacturing to support overall supply chain
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 Telix IsoTherapeutics Group, Inc.
IsoTherapeutics was founded in 2005 by two entrepreneur scientists with a passion for advancing the technology of radiopharmaceuticals. IsoTherapeutics scientists have received over 100 patents for developing chemistry and radiopharmaceutical formulations. In April 2024 IsoTherapeutics was acquired by Telix Pharmaceuticals Limited (Telix) and now sits within the Telix Manufacturing Solutions business unit, a global network of facilities, infrastructure and technologies with the capability to supply patient doses worldwide and deliver on the promise of nuclear medicine. For more information, visit: https://isotherapeutics.com/
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,” “anticipate,” “aim,” “expect,” 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 expected benefits of the renewal of the Master Services Agreement with Telix, such as meeting demands of late-stage clinical trials and potential future commercial needs, production of the key radionuclide intermediate aluminum perrhenate, including increasing shelf life of aluminum perrhenate, and the final processing of cGMP Re-186.
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: reliance on third parties, including SpectronRx and Telix; 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 the Company, including the ability to come into compliance with The Nasdaq Capital Market listing requirements; market conditions; product performance; litigation or potential litigation; 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
FAQ
What is the duration of Plus Therapeutics' (PSTV) new supply agreement with Telix IsoTherapeutics?
What radioisotope will Telix IsoTherapeutics supply to Plus Therapeutics (PSTV)?
How does the Telix agreement complement Plus Therapeutics' (PSTV) supply chain strategy?
