Plus Therapeutics significantly Expands Investigational Oncology Drug Pipeline
Announces Significant Milestones toward CGMP Manufacture of
Its Lead Investigational Radiotherapeutics
Plus
Therapeutics, Inc. , a clinical-stage
pharmaceutical company developing innovative, targeted radiotherapeutics for
rare and difficult-to-treat cancers, announced it has met two significant
milestones as it progresses toward cGMP manufacture of Rhenium-186 NanoLiposome
(186RNL).
The
company has entered into a master services agreement (MSA) with IsoTherapeutics
Group LLC for the development, manufacture and supply of current Good
Manufacturing Practices (cGMP) grade Rhenium-186 isotope for the company’s
186RNL investigational radiotherapeutic. This agreement will help ensure
Rhenium-186 meets U.S. Food and Drug Administration requirements for use in
late-stage clinical trials. Under the MSA, IsoTherapeutics will develop a
synthesis process and in-process manufacturing controls, test method
development and validation, stability studies, as well as manufacture cGMP
Rhenium-186. The company anticipates that the MSA will lead to clinical and
commercial supply agreements for the drug product with IsoTherapeutics at the
appropriate stage of development. This agreement will strengthen the company’s
long term cGMP supply sustainability strategy, as it will own the intellectual
property rights for the manufacturing and testing of the Rhenium-186 target.
Plus
Therapeutics, Inc. also announced that it has entered into an agreement with
The University of Texas Health Science Center at San Antonio (also referred to
as UT Health San Antonio) for a worldwide exclusive license to develop and
commercialize novel interventional therapeutics for cancer.
“Embolization technology for many types
of tumors, including liver cancer, has been used with promising results for
over two decades, but substantial limitations remain, and no meaningful recent
technological innovations have been made,” said William Phillips, M.D.,
Professor of Nuclear Medicine at UT Health San Antonio. “The leading radioembolization therapies
available today incorporate Yttrium-90 glass/resin microspheres which have poor
imaging characteristics, require long lead times, are permanently implanted and
may expose the marrow to high levels of radiation. Rhenium-188 NanoLiposome
Biodegradable Alginate Microsphere (188RNL-BAM) is a next generation, fully
resorbable technology that solves many of the problems of existing technology.
Our team at UT Health San Antonio intends to support Plus Therapeutics in
bringing this technology rapidly to market.”
The
Company will initially focus on developing 188RNL-BAM as a next-generation
radioembolization therapy for liver cancer, in which BAM blocks the hepatic
artery segments that supply blood to the malignant tumor while also providing
188RNL radiotherapy by directly irradiating the tumor.
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Plus
Therapeutics significantly Expands Investigational Oncology Drug Pipeline
Source: PLUS