Plus Strengthens Commercial RNL Supply Chain with Ten Year Exclusivity Agreement
Plus Therapeutics, Inc. (PSTV) has entered a ten-year exclusivity agreement with ABX Advanced Biochemical Compounds GmbH for the supply of a key component in the manufacturing of Rhenium-186 NanoLiposome (186RNL), their lead radiotherapeutic. This partnership will ensure a high purity precursor produced under cGMP, meeting FDA standards. The agreement not only strengthens Plus Therapeutics’ supply chain but also secures long-term market protection around their RNL portfolio, which is key in treating recurrent glioblastoma and other rare cancers.
- Ten-year exclusivity agreement with ABX strengthens supply chain for 186RNL.
- ABX will produce high purity precursor meeting cGMP and FDA standards.
- Secures long-term market protection for the RNL product portfolio.
- None.
Global agreement covers 186RNL manufacturing intermediate
Manufacturer ABX Advanced Biochemical Compounds GmbH is key worldwide supplier of radiopharmaceutical products and services
AUSTIN, Texas, July 27, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced it entered into an exclusivity agreement with ABX Advanced Biochemical Compounds GmbH (ABX) for the supply of a key component required to manufacture the drug substance in Rhenium-186 NanoLiposome (186RNL), the Company’s lead radiotherapeutic.
“In parallel to our clinical progress, we are simultaneously strengthening our commercial RNL supply chain for long-term success”, said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “ABX has extensive experience manufacturing and supplying chemical components for the radiopharmaceutical industry and exclusivity provides us an additional layer of market protection around our RNL portfolio.”
As part of the agreement, ABX will produce a high purity precursor that meets current Good Manufacturing Practices (cGMP) and all relevant requirements of the U.S. Food and Drug Administration and other similar global regulatory entities. Plus Therapeutics will have up to 10 years of exclusive access to the cGMP precursor. This strategic partnership secures the commercial supply chain for 186RNL and extends to future products under the RNL platform.
186RNL is being developed to potentially treat recurrent glioblastoma and other rare and difficult-to-treat cancers. Plus Therapeutics is currently enrolling patients with recurrent glioblastoma in the U.S. multi-center ReSPECT™-GBM Phase 1 dose-finding clinical trial which is designed to safely, effectively and conveniently deliver high doses of radiation directly to brain tumors.
About Plus Therapeutics, Inc.
Plus Therapeutics is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.
About ABX Advanced Biochemical Compounds GmbH (ABX)
ABX manufactures and develops a range of products, from research grade through GMP grade, as starting materials for the production of radiopharmaceutical products. For more information, please visit www.abx.de.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. 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 “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” 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 Company’s anticipated expenditures, including research and development, sales and marketing, and general and administrative expenses; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; the Company’s ability to benefit from the NIH/NCI award for continued clinical development of 186RNL for recurrent glioblastoma; the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; the Company’s ability to expand clinical testing of 186RNL to additional sites; the potential size of the market for the Company’s product candidates; the Company’s research and development efforts; the Company’s IP strategy; competition; future development and/or expansion of its product candidates and therapies in its markets; the Company’s ability to generate product or development revenue and the sources of such revenue; the amounts that the Company may be obligated to pay under license agreements; the Company’s ability to effectively manage its gross profit margins; its ability to obtain and maintain regulatory approvals; expectations as to the Company’s future performance; the Company’s need for additional financing and the availability thereof; its ability to fully access its equity line with Lincoln Park; any changes to its interest expenses; the Company’s ability to continue as a going concern; its ability to remain listed on the Nasdaq Capital Market; the Company’s ability to repay or refinance some or all of its outstanding indebtedness and its ability to raise capital in the future; expectations as to the impact of recently issued or adopted accounting standards; the Company’s expectations as to the impact of the COVID-19 pandemic on its business and operating results; the Company’s beliefs as to the impact of any liability that may arise as a result of any legal proceedings; and the potential enhancement of the Company’s cash position through development, marketing, and licensing arrangements.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties 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, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. 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.
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FAQ
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