Oncternal Therapeutics Announces Presentation of Case Study of TK216 in Ewing Sarcoma Given at the Children’s Oncology Grou...
September 17 2019 - 4:05PM
Business Wire
Sustained objective response reported for
patient with challenging pediatric cancer
Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage
biopharmaceutical company focused on the development of novel
oncology therapies, today announced that Paul A. Meyers, M.D.,
Chief, Pediatric Sarcoma Service and Vice Chair for Clinical
Affairs of Memorial Sloan Kettering Cancer Center, presented a case
study of a patient with Ewing sarcoma who achieved a sustained
response following treatment with Oncternal’s investigational
product candidate, TK216, in an ongoing Phase 1, first-in-human
clinical trial. The presentation entitled, “TK216 for the Treatment
of Ewing Sarcoma,” was given at the Fall Children’s Oncology Group
(COG) Meeting.
Dr. Meyers reported that the patient, who had a history of Ewing
sarcoma with pulmonary metastases, had recurrent disease despite
multiple courses of chemotherapy, radiation, bevacizumab, pazopanib
and surgery. Following two cycles of TK216 therapy given as a
single agent, the patient achieved a confirmed objective response,
which included resolution of several pulmonary lesions. This
response has been sustained and has continued at six months of
treatment, with the patient receiving TK216 plus vincristine in
subsequent treatment courses. The final remaining residual tumor
nodule which was less than one centimeter in diameter was later
surgically removed, leading to a surgical complete remission.
Treatment with TK216 has been well-tolerated by this patient.
“I am encouraged that this patient has had a sustained,
impressive response on the TK216 study,” said Dr. Meyers. “There is
a high unmet medical need for new options to treat Ewing sarcoma,
which is a rare cancer that affects mostly pediatric patients and
young adults and has been very challenging to treat
effectively.”
“We are pleased by the results reported by Dr. Meyers and look
forward to examining what we believe could be a recommended dosing
regimen of TK216 in a larger number of patients with Ewing
sarcoma,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President
and CEO.
About TK216
TK216 is an investigational, potentially first-in-class small
molecule that is designed to inhibit the biological activity of E26
transformation-specific (ETS) transcription factor oncoproteins
including fusion proteins. Tumorigenic gene fusions involving ETS
factors are frequently found in tumors such as Ewing sarcoma and
prostate cancer, and ETS factors are often overexpressed in other
tumors such as prostate cancer, and acute myeloid leukemia (AML).
TK216 was developed based on discoveries of Jeffrey Toretsky, M.D.
and his team at Georgetown University, who found inhibitors of
EWS-FLI1 using a novel chemical screening assay. In preclinical
models, TK216 binds to EWS-FLI1 and blocks the interaction between
ETS family members and RNA helicase A leading to tumor cell
apoptosis.
About the Study
TK216 is being evaluated in a Phase 1 clinical study as a single
agent and in combination with vincristine in patients with relapsed
or refractory Ewing sarcoma, a rare pediatric cancer that has
historically been very challenging to treat effectively,
particularly for recurrent and metastatic disease. A dose-finding
arm of this study is nearing completion, after which Oncternal
intends to begin enrolling patients in an expansion cohort of the
study to evaluate the clinical response of treatment with TK216 in
combination with vincristine, an approved chemotherapy agent. This
multi-center study is actively enrolling patients at six clinical
trial centers across the U.S. Additional information about the
TK216 study may be accessed at ClinicalTrials.gov
(NCT02657005).
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage biopharmaceutical
company focused on developing product candidates for the treatment
of cancers with critical unmet medical need. Oncternal focuses drug
development on promising yet untapped biological pathways
implicated in cancer generation or progression. The pipeline
includes cirmtuzumab, a monoclonal antibody designed to inhibit the
ROR1 receptor, a type I tyrosine kinase-like orphan receptor that
is expressed by many cancers but not by normal tissues and is
associated with cancer stemness, that is being evaluated in a Phase
1/2 clinical trial in combination with ibrutinib for the treatment
of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma
(MCL), and TK216, a small-molecule compound that is designed to
inhibit E26 transformation specific (ETS) family oncoproteins,
which is being evaluated in a Phase 1 clinical trial for patients
with Ewing sarcoma alone and in combination with vincristine
chemotherapy. In addition, Oncternal has a CAR-T product candidate
that targets ROR1, which is currently in preclinical development as
a potential treatment for hematologic cancers and solid tumors.
More information is available at www.oncternal.com.
Forward-Looking Information
Oncternal cautions you that statements included in this press
release that are not a description of historical facts are
forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as “may,” “will,”
“should,” “expect,” “plan,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negatives of these
terms or other similar expressions. These statements are based on
the Company’s current beliefs and expectations. Forward looking
statements include statements regarding Oncternal’s beliefs, goals,
intentions and expectations, and include Oncternal’s expectation
that it is nearing completion of the dose-finding portion of its
Phase 1 clinical trial and intends to begin enrolling patients in
an expansion cohort thereafter; Oncternal’s belief that TK216 may
address a high unmet medical need, by inhibiting the interaction of
between ETS family members and RNA helicase A, thereby shutting
down excessive cell proliferation. Forward looking statements are
subject to risks and uncertainties, which include, but are not
limited to: uncertainties associated with the clinical development
and process for obtaining regulatory approval of TK216 and
Oncternal’s other product candidates, including potential delays in
the commencement, enrollment and completion of clinical trials; the
risk that the results seen in a case study of one patient may not
predict the results seen in other patients in the clinical trial,
including the possibility that there may not be additional
sustained responses from other patients in the study; the risk that
interim results of a clinical trial do not necessarily predict
final results and that one or more of the clinical outcomes may
materially change as patient enrollment continues, following more
comprehensive reviews of the data, as follow-up on the outcome of
any particular patient continues, and as more patient data become
available; the risk that unforeseen adverse reactions or side
effects may occur in the course of developing and testing product
candidates such as TK216 and Oncternal’s other product candidates;
the risk that Oncternal may be unable to obtain sufficient
additional capital to continue to advance the development of TK216
and its other product candidates; and other risks described in the
Company’s prior press releases as well as in public periodic
filings with the U.S. Securities & Exchange Commission. All
forward-looking statements in this press release are current only
as of the date hereof and, except as required by applicable law,
Oncternal undertakes no obligation to revise or update any
forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise. All forward-looking statements are qualified in their
entirety by this cautionary statement. This caution is made under
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
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version on businesswire.com: https://www.businesswire.com/news/home/20190917006086/en/
Oncternal Contacts: Investors Richard Vincent 858-434-1113
rvincent@oncternal.com
Media Jason Spark 619-849-6005 jason@canalecomm.com
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