Plus Therapeutics Announces Key RNL™ Development and cGMP Drug Manufacturing Collaboration Agreements
– Agreements are a major step for ongoing clinical trials and future commercial drug supply
AUSTIN, Texas, May 04, 2021 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced two collaboration agreements to support its process development and analytical chemistry activities for the cGMP manufacturing of Rhenium NanoLiposome (RNL™), the Company’s lead investigational asset in clinical development for recurrent glioblastoma.
Plus Therapeutics signed a pre-clinical, clinical, and process development agreement with Invicro LLC (Invicro), a Konica Minolta company, a global provider of imaging biomarkers, core lab services, advanced analytics and software solutions for drug discovery and development with best-in-class expertise in radiochemistry. Under this agreement, Invicro will characterize the current manufacturing process and develop in-process manufacturing controls for the RNL™ active pharmaceutical ingredient (API) and final drug product and provide future clinical trial imaging support and drug development consulting.
In addition, Plus Therapeutics entered into an agreement with Eurofins BioPharma Inc. (“Eurofins”), a market leader in analytical chemistry for discovery pharmacology and advanced materials sciences. Eurofins will develop and validate test methods for purity, composition, and identity of Re-BMEDA, the API in RNL™. These test methods will support release testing and compliance with cGMP requirements for new drug substances.
“Process optimization and appropriate quality controls of investigational compounds are very critical aspects in bringing novel drugs to markets,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “We have identified two best-in-class partners in Invicro and Eurofins to help us get one step further in bringing RNL to a registrational clinical trial and ultimately commercial supply.”
As previously disclosed, Plus Therapeutics entered into a master services agreement with Piramal Pharma Solutions for the development, manufacture, and supply of RNL™ intermediate of the drug product.
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) 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 Invicro, LLC.
Headquartered in Boston, Mass., Invicro was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro’s multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology, and systemic and rare diseases. Invicro’s quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by Invicro’s industry-leading software informatics platforms, VivoQuant® and iPACS®, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ and DaTIQ.
As part of the Konica Minolta precision medicine organization and with their sister company Ambry Genetics, Invicro develops and leverages the latest approaches in integrated diagnostics including imaging, quantitative pathology and genomics. For more information, visit www.invicro.com.
About Eurofins BioPharma Inc.
Eurofins is a group of international life sciences companies which provide a unique range of analytical testing services to clients across multiple industries. The Group is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing.
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 design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company’s in-licensed portfolio of investigational drugs; the Company’s intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. 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 risk that the Company is not able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s history of losses; the Company’s need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company’s ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company’s partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; 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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