On January 6, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported 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 (Press release, Cytori Therapeutics, JAN 6, 2022, View Source [SID1234598315]).
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"The future of cancer therapy is precise targeting of tumors with the most potent cancer-killing agents while minimizing damage to normal tissues," stated Marc H. Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "Not only does this important transaction further expand our existing Rhenium NanoLiposome technology, but it also helps realize this future. With this technology, we can target almost any solid organ tumor in the body using standard interventional means to leverage the breadth of the human vascular system and deliver a resorbable biomaterial embolic technology coupled with a highly potent radiotherapeutic isotope."
The licensed patents include composition of matter patents for biodegradable alginate microspheres (BAM) containing nanoliposomes loaded with imaging and/or therapeutic payloads. Therapeutic payloads may include radiotherapeutics, chemotherapeutics or thermotherapeutics. The BAM technology is delivered into the vascular system via standard interventional vascular catheters that are placed precisely in the vessels feeding tumors. Once injected, BAM blocks all blood flow to the tumors and simultaneously delivers very high doses of cytotoxic compounds for an extended time. Many days later, the BAM resorbs and are physiologically metabolized and excreted from the body.
"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 financial terms of the exclusive license agreement are primarily success-based with milestone and royalty payments contingent on achieving key clinical, regulatory and sales milestones.
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.
"This transaction is the next step in our plan to expand our pipeline using precision, targeted radiotherapeutics," said Norman LaFrance, M.D., Chief Medical Officer of Plus Therapeutics. "Next steps are to complete and compile the promising preclinical work performed thus far and prepare for an IND submission in 2022 for the treatment of liver cancer."
Liver cancer is a rare disease with an increasing annual incidence and 5-year overall survival of only 20%1. The global opportunity for localized embolization, chemoembolization, and radioembolization therapies for primary (hepatocellular carcinoma) and secondary (typically metastatic colorectal cancer, for example) liver cancer is $1.3 billion2.
The initial inventions and work behind the licensed patents and technologies were developed and led by William Phillips M.D., Professor of Nuclear Medicine, Ryan Bitar, M.D., and their team at UT Health San Antonio. The 188RNL-BAM technology incorporates Rhenium-188, or 188Re, a very attractive isotope for use in radiotherapeutic embolization owing to its emission of a high energy electron (beta particle) with a half-life of 16.9 hours and a path length of 3.1 mm. 188Re emits gamma energy that permits high quality, real-time imaging of the BAM construct delivery localization and confirmation. 188RNL-BAM is straightforward and cost-effective to manufacture for on-demand availability for therapeutic applications and is versatile and can be precisely composed and manufactured to a specific size allowing optimal arterial embolization to block blood flow in most vascular beds while simultaneously delivering its isotopic payload to the tumor. BAMs are not permanent like other technology and degrade over time, allowing restoration of blood flow, decreasing radiation resistance, and allowing safer physiological and safe clearance of 188Re through the kidneys, which avoids bone marrow toxicity.
1American Cancer Society; 2Internal estimate