Onconova Therapeutics Announces the Initiation of a Phase 1/2a Study of Rigosertib plus Nivolumab for the Treatment of KRAS+ ...
June 22 2020 - 8:00AM
Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel products to treat cancer, with an initial focus on
myelodysplastic syndromes (MDS) today announced an
investigator-initiated Phase 1/2a trial of oral rigosertib plus
nivolumab in advanced metastatic KRAS mutated (KRAS+) lung
adenocarcinoma has begun enrolling patients.
“Over half of non-small cell lung cancers are
classified as lung adenocarcinomas; of these, the largest subset
has a KRAS mutation as the predominant genetic driver,” said Dr.
Steven Fruchtman, President and CEO, Onconova Therapeutics.
“Despite discovering the KRAS mutation over 30 years ago, little
progress has been made in KRAS+ directed treatments. The work under
Dr. Rajwanth Veluswamy’s leadership at the Icahn School of Medicine
is an important step towards determining if rigosertib, as a
RAS-mimetic, can change that.”
The investigator-initiated trial is an
open-label, dose-escalating Phase 1 study followed by a Phase 2a
dose-expansion phase to study the combination of oral rigosertib
and nivolumab in metastatic KRAS+ lung adenocarcinoma patients who
have progressed on standard frontline treatment. The study will
assess safety and efficacy. Additional details are available
on www.clinicaltrials.gov (NCT04263090).
“The novel combination of rigosertib with an
anti-PD-1 antibody targets two of the most important oncogenic
pathways in cancer biology,” said Dr. Rajwanth Veluswamy, Assistant
Professor, Medicine, Hematology and Medical Oncology, Icahn School
of Medicine at Mount Sinai. “This study will evaluate the safety
and tolerability of this combination in KRAS mutated NSCLC in which
patients have failed frontline immunotherapy. The study will
explore efficacy of the combination in this common lung cancer
subset and will also determine if rigosertib may restore
sensitivity to the PD-1 blockade.”
About Rigosertib
Rigosertib, Onconova’s lead candidate, is a
proprietary Phase 3 small molecule. A key publication in a
preclinical model reported rigosertib’s ability to block cellular
signaling by targeting RAS effector pathways (Divakar, S.K., et
al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS Association
with Effector Proteins to Block Signaling." Cell 165, 643).
Onconova is currently in the clinical development stage with oral
and IV rigosertib, including clinical trials studying single agent
IV rigosertib in second-line higher-risk MDS patients (pivotal
Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in HMA
naive and refractory higher-risk MDS patients (Phase 2). Patents
covering oral and injectable rigosertib have been issued in the US
and are expected to provide coverage until at least 2037.
About Onconova Therapeutics,
Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel drugs to treat cancer, with an initial focus on
myelodysplastic syndromes (MDS). Onconova has a pipeline of
proprietary targeted agents designed to work against specific
cellular pathways that are important in cancer cells. Advanced
clinical trials with the Company’s lead compound, rigosertib, are
aimed at what the Company believes are unmet medical needs of
patients with MDS. Onconova has conducted trials with two other
research compounds and has a pre-clinical program with a CDK4/6 and
ARK5 inhibitor, ON 123300.
For more information, please visit
https://www.onconova.com.
Forward-Looking Statements
Some of the statements in this release are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, Section 21E of the Securities
Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995, and involve risks and uncertainties.
These statements relate to Onconova expectations regarding the
INSPIRE Trial and Onconova’s other development plans. Onconova has
attempted to identify forward-looking statements by terminology
including "believes," "estimates," "anticipates," "expects,"
"plans," "intends," "may," "could," "might," "will," "should,"
"approximately" or other words that convey uncertainty of future
events or outcomes. Although Onconova believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, expectations may prove to have been
materially different from the results expressed or implied by such
forward-looking statements. These statements are only predictions
and involve known and unknown risks, uncertainties, and other
factors, including Onconova's ability to continue as a going
concern, maintain its Nasdaq listing, the need for additional
financing, the success and timing of Onconova's clinical trials and
regulatory approval of protocols, our collaborations including the
effective termination of the HanX license and securities purchase
agreements and plans for partnering certain territories, and those
discussed under the heading "Risk Factors" in Onconova's most
recent Annual Report on Form 10-K and quarterly reports on Form
10-Q. Any forward-looking statements contained in this release
speak only as of its date. Onconova undertakes no obligation to
update any forward-looking statements contained in this release to
reflect events or circumstances occurring after its date or to
reflect the occurrence of unanticipated events.
Press release contact information
Company Contact:Avi OlerOnconova Therapeutics,
Inc.267-759-3680
ir@onconova.ushttps://www.onconova.com/contact/
MediaDavid Schull, Russo Partners LLC: (212)
845-4271Nic Johnson, Russo Partners LLC: (212) 845-4242
InvestorsJan Medina, CFA, Russo Partners LLC:
(646) 942-5632
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