LOS ANGELES, July 28, 2017 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced that
it has entered into a global strategic license with NantCell, Inc.,
for the exclusive rights to develop and commercialize aldoxorubicin
for all indications. NantCell, a private subsidiary of
NantWorks, LLC, is a clinical stage immuno-oncology company focused
on developing novel molecularly targeted therapeutics including
antibody, T-cell and NK cell based treatments for patients with
cancer.
"We are excited to forge this new relationship with NantCell.
They are committed not just to bringing aldoxorubicin to the market
for patients with soft tissue sarcomas, but to expand
aldoxorubicin's potential use in combination with both
immuno-oncology and cell based therapies to better serve patients
suffering from cancer," said Steven A.
Kriegsman, CytRx's Chairman and Chief Executive
Officer. "This license and strategic investment will put
aldoxorubicin in the hands of a committed partner who pioneered the
development of albumin based chemotherapeutics, and will allow
CytRx to continue to create new ultra-high potency drug candidates
based on our LADR™ technology platform. Aldoxorubicin
will clearly benefit from the first-hand experience of the NantCell
management team led by Dr. Patrick
Soon-Shiong, who developed and gained regulatory approval
under a 505(b)(2) pathway and commercialized Abraxane®, an
albumin-mediated cytotoxic agent which currently grosses
approximately $1 billion in annual
sales."
"Aldoxorubicin's distinct profile makes it the first
anthracycline to allow for continuous dosing without increasing
cardiac toxicity which would be beneficial for the 17 indications
for which doxorubicin is currently approved and other indications
where it could provide benefit," stated Dr. Soon-Shiong, NantCell's
Chairman and Chief Executive Officer. "We aim to rapidly
incorporate aldoxorubicin into multiple treatment protocols for
major tumor types like breast and brain cancers as well as
sarcomas."
Under the terms of the license agreement, NantCell made a
strategic investment by purchasing $13
million of CytRx common stock at $1.10 per share, representing approximately a 92%
premium to CytRx's most recent market price. CytRx is
entitled to receive up to an additional $343
million in milestone payments related to regulatory
approvals and commercial milestones for aldoxorubicin. In
addition, CytRx will receive increasing double-digit royalties for
sales of aldoxorubicin for soft tissue sarcomas and mid to high
single digit royalties for all other indications. NantCell
will be responsible for all future development, manufacturing and
commercialization expenses. CytRx also issued NantCell a
warrant to purchase up to 3 million shares of common stock at
$1.10 over the next 18
months.
Aldoxorubicin is a rationally-engineered cytotoxic which
combines doxorubicin, a widely used chemotherapeutic agent, with a
novel linker molecule that binds directly and specifically to
circulating albumin, the most abundant protein in the
bloodstream. Protein-hungry tumors concentrate albumin, which
facilitates the delivery of the linker molecule with the attached
doxorubicin to tumor sites. In the acidic environment of the
tumor, but not the neutral environment of healthy tissues,
doxorubicin is released. Typically, doxorubicin is delivered
systemically and is highly toxic, which limits its dose to a level
below its maximum therapeutic benefit. Doxorubicin also is
associated with many side effects, especially the potential for
damage to heart muscle at cumulative doses greater than 450
mg/m2. Using this acid-sensitive linker technology,
aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4
times). To date, there has been no evidence of clinically
significant effects of aldoxorubicin on heart muscle, even at
cumulative doses of drug well in excess of 6,500 mg/m2
of doxorubicin equivalents. Aldoxorubicin is the first-ever single
agent to show superiority over doxorubicin in a randomized clinical
trial in first-line soft tissue sarcomas.
In addition, CytRx has amended its long-term loan facility and
will make a payment of $5 million to
the lender upon the closing of the exclusive global license and
strategic investment for aldoxorubicin.
CytRx was represented by Skadden, Arps, Slate, Meagher &
Flom LLP on the global license and strategic investment.
About NantCell, Inc.
NantCell, an entity controlled by Dr. Patrick Soon-Shiong, is an immuno-oncology
company focused on the discovery of innovative antibody, T cell and
NK cell based treatments by developing molecularly targeted
therapeutics, based on the proteomic profile of the patient's
tumor, independent of the cancer's anatomical type.
NantCell's mission is to make obsolete the standard method of
clinical trial design of "trial and error" and replace it with a
level of quantitative predictability based on both the genomic and
proteomic profile performed a priori. The Company will tap into
comprehensive "omic" analytic tools and "big data" generated from
supercomputing to develop molecularly designed drugs in this era of
genomics and proteomics and identify patients and their tumor
signature at the most granular cellular, DNA and protein levels.
Patients entering clinical trials would be identified after a
comprehensive "omic" analysis from tissue to cell to DNA to RNA to
protein to peptide to drug, and tested based on this molecular
profile to maximize clinical outcome and minimize side
effects. Through these integrated diagnostic methods, the
company is pursuing the vision of treating the biology of cancer
rather than the anatomy, and drive the immune system inherited by
all to defeat cancer. For more information please
visit www.nanthealth.com and follow Dr. Soon-Shiong on
Twitter @Dr.PatSoonShiong.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical company specializing in
research and clinical development of novel anti-cancer drug
candidates that employ linker technologies to enhance the
accumulation and release of drug at the tumor. Aldoxorubicin,
CytRx's most advanced drug conjugate, is an improved version of the
widely used chemotherapeutic agent doxorubicin. CytRx is also
rapidly expanding its pipeline of ultra-high potency oncology
candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated
Drug Release) technology platform, a discovery engine designed to
leverage CytRx's expertise in albumin biology and linker technology
for the development of a new class of potential breakthrough
anti-cancer therapies.
Forward-Looking Statements
This press release contains forward-looking statements. Such
statements involve risks and uncertainties that could cause actual
events or results to differ materially from the events or results
described in the forward-looking statements, including risks and
uncertainties relating to: the ability of NantCell, Inc., to obtain
regulatory approval for its products that use aldoxorubicin; the
ability of NantCell Inc. to manufacture and commercialize products
or therapies that use aldoxorubicin; the amount, if any, of future
milestone and royalty payments that we may receive from NantCell;
our ability to develop new ultra-high potency drug candidates based
on our LADRTM technology platform; and other risks and
uncertainties described in the most recent annual and quarterly
reports filed by CytRx with the Securities and Exchange Commission
and current reports filed since the date of CytRx's most recent
annual report. All forward-looking statements are based upon
information available to CytRx on the date the statements are first
published. CytRx undertakes no obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development and Investor Relations
(310) 826-5648, ext 304
dhaen@cytrx.com
Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546
eliza@argotpartners.com
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
michelle@argotpartners.com
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SOURCE CytRx Corporation