Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), today
announced that it has entered into a definitive agreement to
license multiple rare cancer drug product candidates from private
Texas-based radiotherapeutic company NanoTx Therapeutics, Inc.
(“NanoTx”)
The transaction terms include an upfront payment of $400,000 in
cash and $300,000 in Plus voting stock. Furthermore, the company
may pay up to $136.5 million in development and sales milestone
payments and a tiered single-digit royalty on U.S. and European
sales. The transaction, subject to customary closing conditions, is
expected to close in the second quarter of fiscal 2020.
The licensed drug portfolio is anchored around
nanoliposome-encapsulated radionuclides for several cancer targets.
The lead drug asset is a chelated Rhenium NanoLiposome (RNLTM),
initially being developed for recurrent glioblastoma. RNL is
infused directly into the brain tumor via precision brain mapping
and convection enhanced delivery technology to deliver very high
therapeutic doses of radiation to patients whose cancer has
recurred following initial surgical resection and treatment with
chemotherapy and radiation.
The licensed radiolabeled nanoliposome platform was developed by
a multi-institutional consortium based in Texas at the Mays Cancer
Center / UT Health San Antonio MD Anderson Cancer Center led by Dr.
Andrew Brenner, MD, PhD, who is the Kolitz Chair in Neuro-Oncology
Research and Co-Leader of the Experimental and Developmental
Therapeutics Program. The licensed technology was previously funded
by both the National Institutes of Health/National Cancer Institute
(NIH/NCI) and the Cancer Prevention and Research Institute of Texas
(CPRIT). There is an active $3M award from NIH/NCI which will
financially support the continued clinical development of RNL for
recurrent glioblastoma.
“Dr. Brenner and his team have developed a very unique and
promising novel cancer drug portfolio to address a significant
number of unmet needs,” said Dr. Marc Hedrick, President and Chief
Executive Officer of Plus Therapeutics. “Nanoliposome-encapsulated
radionuclides are a natural extension of our pipeline and will
become an increasing focus of our activities.”
“We are pleased to partner with Plus Therapeutics, a
company with significant expertise in nanoparticle development,”
said Dr. Brenner. “The clinical needs we are targeting are great
and our lead drug for recurrent glioblastoma has shown tremendous
promise in both safety and efficacy signals thus far, and we are
excited about our partnership with Plus Therapeutics as we advance
this and related programs to the next steps.”
Plus Therapeutics is licensing multiple BMEDA-chelated rhenium
nanoliposome product candidates as part of this transaction.
The lead drug asset is being developed for recurrent glioblastoma,
a rare, incurable, and fatal disease. A Phase 1, dose-finding trial
is ongoing at the Mays Cancer Center where 13 patients have been
enrolled to-date. Thus far, no serious adverse events have
occurred, and further dose escalation is planned. A similar
product candidate is in preclinical development for several
additional indications including breast cancer, head and neck
cancer, leptomeningeal carcinomatosis, liver cancer, and ovarian
cancers.
Additionally, Plus Therapeutics is licensing a second
preclinical product candidate, a co-encapsulated doxorubicin and
BMEDA-chelated Rhenium NanoLiposome (DRNLTM) for treating squamous
cell carcinoma of the head and neck. These licensed assets
are supported by 19 preclinical publications.
“With RNL, we aim to precisely deliver a safe and effective dose
of radiation directly to the tumor, bypassing the blood brain
barrier, that is approximately 30 times greater than that currently
being given to these patients using external beam radiation,” said
Dr. Gregory Stein, Senior Vice President of Clinical Development at
Plus Therapeutics. “Dr. Brenner and his colleagues have
developed an approach and technology that we believe may prolong
survival in patients with recurrent glioblastoma, a cancer that
affects about 12,000 people per year in the U.S. and for which
there are currently no effective treatments available.”
Plus Therapeutics’ growing pipeline will feature product
candidates characterized by previously approved small molecules or
widely-used radionuclides, enhanced with delivery and formulation
innovations, each potentially eligible for U.S. FDA and European
Medicines Agency designations intended to expedite development and
application review.
Investor Call Today at 5 p.m.
EDTPlus Therapeutics intends to address the
NanoTx licensing agreement in today’s scheduled conference call to
discuss its Fourth Quarter and full Fiscal Year 2019 financial
results. The Company plans to report these results after the
close of market today.
Event: Plus Therapeutics Fourth Quarter
and Full Fiscal Year 2019 Financial Results Conference Call and
Webcast Time: 5:00 PM Eastern Time.Live
Call: Phone Number: (877) 402-3914; Conference
ID: 2547614Live Webcast:
https://event.on24.com/wcc/r/2150991/A2883C8240CBAA08D701864A445894F6Beginning
two hours after the conclusion of the conference call, a replay
will be available. Replay:
http://ir.plustherapeutics.com/events/default.aspx
About NanoTx Therapeutics,
Inc.NanoTx Therapeutics is radiotherapeutic
company developing nanoliposomal-encapsulated radionuclides for the
treatment of various cancers. Our technology allows high levels of
radiation to be delivered to focused areas. The first-in-human
clinical trial with RNLTM is now enrolling patients. Please
see clinicaltrials.gov for further details.
About Plus Therapeutics,
Inc.Plus Therapeutics, Inc. is a clinical-stage
pharmaceutical company focused on the discovery, development, and
delivery of complex and innovative treatments for patients battling
rare cancers.
Our proprietary nanotechnology platform is currently centered on
the enhanced delivery of a variety of drugs using novel liposomal
encapsulation technology. Liposomal encapsulation has been
extensively explored and undergone significant technical and
commercial advances since it was first developed. Our platform is
designed to facilitate new delivery approaches and/or formulations
of safe and effective drugs, potentially enhancing the safety,
efficacy and convenience for patients and healthcare providers.
More information may be found at www.plustherapeutics.com.
Cautionary Statement Regarding Forward-Looking
StatementsThis press release contains certain
statements that may be deemed “forward-looking statements” within
the meaning of U.S. securities laws. All statements, other than
statements of historical fact, that address activities, events or
developments that we intend, expect, project, believe or anticipate
and similar expressions or future conditional verbs such as will,
should, would, could or may occur in the future are forward-looking
statements. Such statements are based upon certain assumptions and
assessments made by our 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 about the Company’s potential 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. The forward-looking
statements included in this press release are subject to a number
of additional material risks and uncertainties, including but not
limited to, the 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.
Plus Therapeutics,
Inc. Andrew Sims VP –
Chief Financial Officer, Investor Relations Phone: +1.619.333.4150
Email: ir@plustherapeutics.com
Website: plustherapeutics.com
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