- The CAR-T market, a growing segment
within cancer treatment, is estimated to reach approximately $4.5
Billion in 2022 according to Evaluate Pharma
- Cytokine release syndrome (CRS) is a
potentially fatal side effect of CAR-T and other immune-oncology
therapies induced by massive release of inflammatory
cytokines
- Can Fite’s drugs robustly inhibit
the release of inflammatory mediators that induce CRS by binding to
the A3 adenosine receptor
Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address cancer, liver and inflammatory
diseases, today announced it has filed a patent application to
protect the use of its drugs and other ligands which target the A3
adenosine receptor (A3AR) to treat cytokine release syndrome
(CRS).
“CAR-T and other cancer immunotherapies are a very promising
category of drugs and may shape the treatment of cancer in the
future. When they work, they can save lives, however, a concern
that needs to be addressed with this class of treatment is the
relatively high incidence of CRS, a side effect which can kill
patients. We believe our drugs, which bind to A3AR, have the
potential to treat CRS, which could make CAR-T and other
immuno-oncology drugs safer for patients,” stated Dr. Pnina
Fishman, Can-Fite’s CEO. “A safe and effective treatment for CRS
that does not inhibit the efficacy of CAR-T and other
immuno-oncology therapies meets a growing unmet medical need in the
treatment of cancer.”
CAR-T cell therapies are designed to treat certain cancers by
modifying an individual patient’s own immune cells to specifically
target their cancer cells. CRS, which is caused by an overactive
immune response to the treatment, has been identified as a
potentially severe and life-threatening side effect of CAR-T cell
therapies.
While most people with CRS experience mild or moderate flu-like
symptoms which are easily managed, some patients experience more
severe symptoms that may lead to potentially life-threatening
complications such as cardiac dysfunction, acute respiratory
distress syndrome or multi-organ failure. One recently approved
CAR-T therapy shows 79% of patients receiving the treatment got CRS
and 49% got severe CRS, according to the drug’s prescribing
information.*
Can Fite’s platform technology selectively targets A3AR, which
plays a central role in mediating the mechanism of inflammation by
reducing elevated levels of pro-inflammatory cytokines such as
IL-6, IL-1β, NF-Kβ, TNF-α, and more. As such, the Company believes
that A3AR targeting may serve as an important treatment option for
patients in reducing the risk of CRS without limiting the utility
of the underlying cancer immunotherapy.
Current treatment for CRS includes aggressive immunosuppression
through the use of high doses of corticosteroids to reverse the
syndrome. However, while corticosteroids may control some of these
toxicities, their potential to block T-cell activation and negate
the clinical benefit of CART-T is a concern (Maude SL, et al,
Cancer J, 2014). ACTERMA® (tocilizumab), in August 2017 became the
first FDA approved treatment for severe CRS induced by CAR-T,
however it can mediate the immunosuppressive effect which could
limit the efficacy of the immunotherapy (Lee et al, Blood,
2014).
In addition to CAR-T, CRS is also associated with therapeutic
monoclonal antibody (mAb) infusions, most notably anti-CD3 (OKT3),
anti-CD52 (alemtuzumab), anti-CD20 (rituximab), and the CD28
super-agonist, TGN1412.
*The recently approved CAR-T cell immunotherapy, KYMRIAH®
(tisagenlecleucel), reveals in its prescribing information notes
that in its registration study, 79% (54/68) of patients receiving
the drug developed CRS, with the median time to onset of 3 days
(range: 1-22 days). The incidence of severe CRS, Grade 3 or Grade
4, was 49% (33/68).
About Can Fite’s Drugs
Can-Fite’s platform technology utilizes the Gi protein
associated A3 adenosine receptor (A3AR) as a therapeutic target.
A3AR is highly expressed in inflammatory and cancer cells where low
expression is found in normal cells, suggesting that the receptor
could be a unique target for pharmacological intervention. The
Company’s drugs have an excellent safety profile with experience in
over 1,000 patients. Piclidenoson (CF101) is expected to enter
Phase III trials in two auto-immune indications and Namodenoson
(CF102) completed patient enrollment in a Phase II liver cancer
trial and is slated to enter Phase II for the treatment of
NAFLD/NASH.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE MKT:CANF) (TASE:CFBI) is an
advanced clinical stage drug development Company with a platform
technology that is designed to address multi-billion dollar markets
in the treatment of cancer, inflammatory disease and sexual
dysfunction. The Company's lead drug candidate, Piclidenoson, is
scheduled to enter a Phase III trial for rheumatoid arthritis in
2017 and a Phase III trial for psoriasis in early 2018. The
rheumatoid arthritis Phase III protocol has recently been agreed
with the European Medicines Agency. Can-Fite's liver cancer drug
CF102 is in Phase II trials for patients with liver cancer and is
slated to enter Phase II for the treatment of non-alcoholic
steatohepatitis (NASH). CF102 has been granted Orphan Drug
Designation in the U.S. and Europe and Fast Track Designation as a
second line treatment for hepatocellular carcinoma by the U.S. Food
and Drug Administration. CF102 has also shown proof of concept to
potentially treat other cancers including colon, prostate, and
melanoma. CF602, the Company's third drug candidate, has shown
efficacy in the treatment of erectile dysfunction in preclinical
studies and the Company is investigating additional compounds,
targeting A3AR, for the treatment of sexual dysfunction. These
drugs have an excellent safety profile with experience in over
1,000 patients in clinical studies to date. For more information
please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about
Can-Fite's expectations, beliefs or intentions regarding, among
other things, market risks and uncertainties, its product
development efforts, business, financial condition, results of
operations, strategies or prospects. In addition, from time to
time, Can-Fite or its representatives have made or may make
forward-looking statements, orally or in writing. Forward-looking
statements can be identified by the use of forward-looking words
such as "believe," "expect," "intend," "plan," "may," "should" or
"anticipate" or their negatives or other variations of these words
or other comparable words or by the fact that these statements do
not relate strictly to historical or current matters. These
forward-looking statements may be included in, but are not limited
to, various filings made by Can-Fite with the U.S. Securities and
Exchange Commission, press releases or oral statements made by or
with the approval of one of Can-Fite's authorized executive
officers. Forward-looking statements relate to anticipated or
expected events, activities, trends or results as of the date they
are made. Because forward-looking statements relate to matters that
have not yet occurred, these statements are inherently subject to
risks and uncertainties that could cause Can-Fite's actual results
to differ materially from any future results expressed or implied
by the forward-looking statements. Many factors could cause
Can-Fite's actual activities or results to differ materially from
the activities and results anticipated in such forward-looking
statements. Factors that could cause our actual results to differ
materially from those expressed or implied in such forward-looking
statements include, but are not limited to: the initiation, timing,
progress and results of our preclinical studies, clinical trials
and other product candidate development efforts; our ability to
advance our product candidates into clinical trials or to
successfully complete our preclinical studies or clinical trials;
our receipt of regulatory approvals for our product candidates, and
the timing of other regulatory filings and approvals; the clinical
development, commercialization and market acceptance of our product
candidates; our ability to establish and maintain corporate
collaborations; the implementation of our business model and
strategic plans for our business and product candidates; the scope
of protection we are able to establish and maintain for
intellectual property rights covering our product candidates and
our ability to operate our business without infringing the
intellectual property rights of others; estimates of our expenses,
future revenues, capital requirements and our needs for additional
financing; competitive companies, technologies and our industry;
statements as to the impact of the political and security situation
in Israel on our business; and risks and other risk factors
detailed in Can-Fite's filings with the SEC and in its periodic
filings with the TASE. In addition, Can-Fite operates in an
industry sector where securities values are highly volatile and may
be influenced by economic and other factors beyond its control.
Can-Fite does not undertake any obligation to publicly update these
forward-looking statements, whether as a result of new information,
future events or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20170918005310/en/
Can-Fite BioPharmaMotti Farbstein,
+972-3-9241114info@canfite.com
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