LOS ANGELES, Nov. 8, 2018 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, today highlighted two
poster presentations by its licensee NantCell, Inc. at the Society
for Immunotherapy of Cancer's (SITC) 33rd Annual
Meeting, taking place November 7-11,
2018 in Washington, DC.
The abstracts describe early safety and efficacy data from
the Phase 1b portion of Phase
1b/2 clinical trials evaluating
NantCell's high-affinity natural killer (haNK) cell therapy in
combination with anti-cancer agents, including aldoxorubicin, in
patients with third-line or greater triple negative breast cancer
(TNBC), fourth-line or greater head and neck squamous cell
carcinoma (HNSCC) or recurrent metastatic pancreatic cancer.
Preliminary Phase 1b Results in
TNBC and HNSCC
In this Phase 1b, single-arm,
open-label trial, treatment was administered in 3-week cycles of
low-dose chemotherapy (aldoxorubicin, cyclophosphamide, cisplatin,
nab-paclitaxel, 5-FU/L), antiangiogenic therapy (bevacizumab),
engineered allogeneic high affinity CD-16 NK-92 cells (haNK),
IL-15RαFc (N803), adenoviral vector-based CEA, MUC1, Brachyury,
HER2 vaccine, yeast vector-based RAS, Brachyury and CEA vaccine,
and an IgG1 PD-L1 inhibitor, avelumab plus cetuximab. All patients
in both trials received aldoxorubicin. The primary endpoint is
incidence of treatment-related adverse events (AEs).
Secondary endpoints include overall response rate (ORR),
disease control rate (DCR), progression-free survival (PFS), and
overall survival (OS).
The abstract includes data from three patients with third-line
or greater TNBC and two patients with fourth-line or greater HNSCC.
All treatment was completed in the outpatient setting, with
no immune-related AEs. Four hematologic dose limiting
toxicities (DLTs) were observed and managed with a planned dose
reduction of cisplatin. Of the three patients with TNBC, two
(67%) experienced a partial response (PR). Of the two
patients with HNSCC, both (100%) experienced objective tumor
response (100% and 47% decrease, respectively). Overall, four
out of the five TNBC and HNSCC patients (80%) had confirmed overall
responses, including one patient (20%) with fifth-line metastatic
disease who demonstrated a complete response (CR). All
responding patients are still undergoing therapy. These
preliminary data suggest that the NANT Cancer Vaccine (NCV),
comprised of low-dose chemo-radiation combined with innate and
adaptive immunotherapy, can be administered safely in an outpatient
setting without any observed increase in immune-related AEs.
Preliminary Phase 1b Results in
Metastatic Pancreatic Cancer
In this Phase 1b, single-arm,
open-label trial, treatment was administered in 3-week cycles of
low-dose chemotherapy (aldoxorubicin, cyclophosphamide,
oxaliplatin, nab-paclitaxel, 5-FU/L), antiangiogenic therapy
(bevacizumab), engineered allogeneic high affinity CD-16 NK-92
cells (haNK), IL-15RαFc (N-803), adenoviral vector-based CEA
vaccine, yeast vector-based RAS vaccine, and an IgG1 PDL1
inhibitor, avelumab. All metastatic pancreatic cancer
patients received aldoxorubicin. The primary endpoint is incidence
of treatment-related AEs. Secondary endpoints include ORR, DCR,
PFS, and OS.
The abstract includes data from ten patients with third-line or
greater metastatic pancreatic cancer. All treatment was
safely administered in the outpatient setting. AEs were
primarily hematologic which were managed by appropriate planned
chemo dose reductions. No DLTs have occurred and no
haNK-related AEs have occurred to date. Of the ten evaluable
patients, nine have achieved stable disease (SD) for ≥ 8 weeks for
a DCR of 90%. Median PFS was 5.8 months (95% confidence
interval: 3.3 - 8.8) and OS was 9.5 months (95% CI: 5.0 – upper
limit not yet reached) with patients continuing treatment.
One patient demonstrated resolution of a metastatic lung tumor
within 8 weeks of initiating NCV therapy. These preliminary
results suggest that the NCV treatment regimen was well tolerated
and support the safety and tolerability of the regimen. These
preliminary efficacy results are encouraging and the overall
survival of 9.5 months currently exceeds all standards of care for
patients at this advanced stage of disease.
Eric Curtis, CytRx's President
and Chief Operating Officer, stated, "The data presented by
NantCell at SITC's 33rd Annual Meeting are
optimistic. We are pleased to see that these NCV regimens
including aldoxorubicin are well tolerated and support the overall
thesis being investigated. These data may ultimately lead to
more combinations of aldoxorubicin with cutting edge therapies
being studied in tumor types with high unmet needs. We look forward
to seeing more data as these clinical trials progress."
"In the oncology marketplace, we have seen clear treatment
trends by Big Pharma and recent regulatory approvals moving toward
combining the category of potential Centurion drug candidates such
as LADR 7, 8, 9 and 10 with immunotherapy."
Aldoxorubicin is a rationally-engineered cytotoxic which employs
a linker bound to albumin to deliver doxorubicin directly into the
tumor. CytRx out-licensed global development, manufacturing,
and commercialization rights for aldoxorubicin to NantCell, Inc., a
private subsidiary of NantWorks, LLC, in July 2017.
These data were highlighted at SITC's 33rd Annual
Meeting in a presentation titled, "First in Human Data in
Advanced Solid Tumors of NANT Cancer Vaccine: A Novel
Temporospatial Orchestration of the Innate (NK) & Adaptive
Immune System to Induce Antigen Cascade & Immunogenic Cell
Death" which took place on Wednesday,
November 7, 2018 from 5:45-6:00pm
ET.
About the Society for Immunotherapy of Cancer
The Society for Immunotherapy of Cancer (SITC) is the world's
leading member-driven organization specifically dedicated to
improving cancer patient outcomes by advancing the science and
application of cancer immunotherapy. Established in 1984,
SITC, a 501(c)(3) not-for-profit organization, serves scientists,
clinicians, academicians, patients, patient advocates, government
representatives and industry leaders from around the world.
Currently, SITC has more than 2,000 members who represent 22
medical specialties in 42 countries around the world. Through
emphasis on high-caliber scientific meetings; dedication to
education and outreach activities; focus on initiatives of major
importance in the field; and commitment to collaborations with
like-minded domestic and international organizations, government
and regulatory agencies, associations and patient advocacy groups,
SITC brings together all aspects of the cancer immunology and
immunotherapy community. Through educational programs that
foster scientific exchange and collaboration, SITC aims to one day
make the word "cure" a reality for cancer patients everywhere.
About CytRx Corporation
CytRx Corporation (NASDAQ: CYTR) is a biopharmaceutical company
with expertise in discovering and developing new therapeutics to
treat patients with cancer. CytRx's most advanced drug conjugate,
aldoxorubicin, is an improved version of the widely used
anti-cancer drug doxorubicin and has been out-licensed to NantCell,
Inc. CytRx Corporation's website is www.cytrx.com.
About Centurion BioPharma Corporation
CytRx's wholly owned subsidiary, Centurion BioPharma
Corporation, is focused on the development of personalized medicine
that will transform solid tumor treatment. This transformational
strategy combines a portfolio of novel, anti-cancer drug candidates
that employ LADR™ (Linker Activated Drug Release) technology, a
discovery engine designed to leverage Centurion's expertise in
albumin biology and linker technology for the development of a new
class of breakthrough anti-cancer therapies with a unique albumin
companion diagnostic (ACDx) that can help identify patients who are
most likely to benefit from treatment with the LADR™-derived
therapies. A critical element of the LADR™ platform is its ability
to bind anti-cancer molecules to circulating albumin, the most
ubiquitous protein in human blood plasma, and then to release the
highly potent cytotoxic payload at the tumor site. This technology
allows for the delivery of higher doses of drug directly to the
tumor, while avoiding much of the off-target toxicity observed with
the parent molecules. Centurion BioPharma Corporation's
website is www.centurionbiopharma.com.
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, Inc.; the safety and efficacy of the NANT Cancer
Vaccine; the results of clinical trials involving the NANT Cancer
Vaccine; Centurion BioPharma Corporation's ability to develop new
ultra-high potency drug candidates based on its LADR™ technology
platform; our ability to attract potential licensees; 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.
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
michelle@argotpartners.com
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