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 updated
aggregated baseline genomic data from HMA-failure patients screened
for the INSPIRE trial were presented in an e-poster at the virtual
25th Annual EHA Congress.
“There are more than 45 driver mutations that
have been identified in higher-risk (HR) MDS patients. To our
knowledge, this mutational analysis from the INSPIRE trial is among
the largest such datasets to be collected,” said Steven M.
Fruchtman, M.D., President and Chief Executive Officer.
The on-demand presentation will be available on
the EHA website as of Friday, June 12 at 8:30 a.m. CEST, and
will be accessible until October 15, 2020.
Abstract #EP829. “Mutations in
RAS Pathway Genes Correlate with Type of Failure to Azacitidine:
Genomic Analysis at Randomization onto the Inspire Trial.”
As an exploratory endpoint, bone marrow samples
were collected at baseline, months 2, 4 and 6, and every 6 months
thereafter, as well as at the end of treatment, for mutational
analysis. Genomic DNA was extracted and deep sequencing of 295
genes will be performed on these samples following analysis of the
primary endpoint. In total, 55 different mutations were identified
at baseline, with the median number of mutations per patient at
3.
“RAS pathway mutations were observed more
frequently in patients that progressed on HMA therapy than those
that failed HMA therapy completely. Understanding the association
between RAS mutations and prognoses in this MDS setting appears to
be informative to the potential role of RAS-targeting agents such
as rigosertib,” said Richard C. Woodman, M.D., Chief Medical
Officer.
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.
About Myelodysplastic
Syndromes
Myelodysplastic syndromes (MDS) are conditions
that can occur when the blood-forming cells in the bone marrow
become dysfunctional and thus produce an inadequate number of
circulating blood cells. It is frequently associated with the
presence of blasts or leukemic cells in the marrow. This
leads to low numbers of one or more types of circulating blood
cells, and to the need for blood transfusions. In MDS, some of the
cells in the bone marrow are abnormal (dysplastic) and may have
genetic abnormalities associated with them. Different cell
types can be affected, although the most common finding in MDS is a
shortage of red blood cells (anemia). Patients with
higher-risk MDS may progress to the development of acute
leukemia.
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 the INSPIRE Phase 3 Clinical
Trial
The clinical trial INternational Study of Phase
3 IV RigosErtib, or INSPIRE, was finalized following guidance
received from the U.S. Food and Drug Administration and European
Medicines Agency. INSPIRE is a global, multi-center,
randomized, controlled study to assess the efficacy and safety of
IV rigosertib in higher-risk MDS (HR-MDS) patients who had
progressed on, failed to respond to, or relapsed after previous
treatment with a hypomethylating agent (HMA) within nine cycles
over the course of one year after initiation of HMA
treatment. This time frame optimizes the opportunity to
respond to treatment with an HMA prior to declaring treatment
failure, as per NCCN Guidelines. Patients are randomized at a
2:1 ratio into two study arms: IV rigosertib plus Best Supportive
Care versus Physician's Choice plus Best Supportive Care. The
primary endpoint of INSPIRE is overall survival. The trial
continued beyond the pre-specified interim analysis and is nearing
its conclusion. Full details of the INSPIRE trial, such as
inclusion and exclusion criteria, as well as secondary endpoints,
can be found on clinicaltrials.gov (NCT02562443).
About IV Rigosertib
The intravenous form of rigosertib has been
studied in Phase 1, 2, and 3 clinical trials involving more than
1000 patients, and is currently being evaluated in a randomized
Phase 3 international INSPIRE trial for patients with HR-MDS after
failure of HMA therapy.
About Oral Rigosertib
The oral form of rigosertib was developed to
provide a potentially more convenient dosage form for use where the
duration of treatment may extend to multiple years. This dosage
form may also support combination therapy modalities. To date,
over 400 patients have been dosed with the oral formulation of
rigosertib in clinical trials. Combination therapy of oral
rigosertib with azacitidine, the standard of care in HR-MDS, has
also been studied. Currently, oral rigosertib is being developed as
a combination therapy together with azacitidine for patients with
higher-risk MDS who require HMA therapy. A Phase 1/2 trial of the
combination therapy has been fully enrolled, and the updated
efficacy and safety data was presented at the ASH 2019 Annual
Meeting in December 2019.
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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