Onconova Therapeutics, Inc.
(NASDAQ: ONTX), a
Phase 3 stage biopharmaceutical company discovering and developing
novel products to treat cancer, with a focus on Myelodysplastic
Syndromes (MDS), and Mission Bio, the pioneer in targeted
single-cell DNA analysis and precision genomics, today announced
that they have formed a collaboration to utilize the Mission Bio
TapestriⓇ Platform for targeted single-cell DNA analysis to study
Onconova’s novel cancer therapy, rigosertib, through clinical
trials.
With the growing complexity of clinical trials, precision
biomarkers are needed to reduce the time and costs associated with
the drug development cycle. Broad-based sequencing technologies
lack the sensitivity to identify the earlier initial single cell
events that contain the driver mutations that initiate the
oncologic disease. With the Mission Bio Tapestri Platform,
researchers can detect rare cancer subclones and co-occurring
cancer mutations at the single-cell level, offering a precise way
to measure therapy response and disease progression.
Supporting the pharma and biopharma industries through clinical
trials and commercialization continues to be a focus for Mission
Bio.
Ras proteins control cell proliferation, and mutation of this
protein can lead to cancer in affected individuals. Ras is mutated
in over 30 percent of patients with cancer, making it one of the
most sought-after targets. Onconova is developing rigosertib, a
first-in-class, small molecule Ras mimetic, to target this
mutation. Rigosertib blocks the activation of Ras effector
proteins, thus modulating the Ras pathway. Onconova’s goal is to
fully enroll INSPIRE, its phase 3 clinical trial studying
rigosertib in higher-risk MDS patients who fail the current
standard of care, by year-end.
“Through single-cell genomics, we can identify mutations with
far better resolution than that of traditional sequencing methods.
This allows a view into each patient’s disease at a level never
before achieved,” explained Darrin Crisitello, CCO of Mission Bio.
“The Tapestri Platform can identify subclones that help monitor a
patient's response to research drugs in clinical trials, supporting
the advancement of rigosertib to the clinic.”
“Rigosertib has the potential to be the first new higher-risk
MDS treatment in more than 15 years, for a condition affecting an
estimated 59,000 patients with low and higher-risk MDS in the
United States alone,” said Dr. Steve Fruchtman, CEO of Onconova.
“In adding the Tapestri Platform to our research and development
program, we are including the opportunity to study single cell
clones in MDS and determine the sequence of genetic events and the
influence of rigosertib on these events along with clinical
outcomes. These studies have the potential to make a meaningful
difference in the lives of patients in need.”
About Mission Bio
Mission Bio delivers targeted solutions for high impact
applications with the Tapestri Platform. The Tapestri Platform is
the industry’s first single-cell DNA sequencing platform, enabling
precise detection of heterogeneity in disease progression and
treatment response. Application areas include blood cancers, solid
tumors, and genome editing validation. The platform includes an
instrument, consumables and software, which plug seamlessly into
existing NGS workflows. LabCorp’s Covance Drug Development business
will be the first global contract research organization to offer
services on the Mission Bio Tapestri Platform, supporting
biopharmaceutical customers in their need for faster, more precise
clinical trials.
The company’s Tapestri Platform was also honored as a Top 10
Innovation of 2018 by The Scientist, as well as utilized by
researchers at MD Anderson Cancer Center (MDACC) for the largest
single-cell study completed to date. With Mission Bio, researchers
have a highly sensitive, targeted, and customizable solution to
move precision medicine forward.
To learn more about Mission Bio and how it’s moving precision
medicine forward, visit www.missionbio.com.
About Onconova Therapeutics, Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical
company focused on discovering and developing novel small molecule
drug candidates to treat cancer, with a focus on Myelodysplastic
Syndromes (MDS). Using a proprietary chemistry platform,
Onconova has created a pipeline of targeted agents designed to work
against specific cellular pathways that are important in cancer
cells. Onconova has three product candidates in the clinical
stage and several pre-clinical programs. 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. For more information, please visit
http://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 demonstrated 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
clinic with oral and IV rigosertib, including single agent IV
rigosertib in second-line higher-risk MDS patients (pivotal Phase 3
INSPIRE trial) and oral rigosertib plus azacitidine in first-line
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 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 HR-MDS patients who had progressed on, failed to respond to, or
relapsed after previous treatment with an 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. An interim analysis in early
2018 demonstrated a promising survival signal in the
intent-to-treat population as reviewed by the Independent Data
Monitoring Committee. The Committee recommended that the
trial continue with an expansion in enrollment to 360 patients
based on a pre-planned sample size re-estimation. 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. 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 higher-risk MDS (HR-MDS), after
failure of hypomethylating agent, or HMA, therapy.
About Oral Rigosertib
The oral form of rigosertib was developed to provide more
convenient dosing 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 studied with the oral formulation of rigosertib.
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 preliminary efficacy and safety data
was presented at The American Society of Hematology Annual Meeting
in December 2018. A Special Protocol Assessment for a pivotal
Phase 3 study design is under review by the FDA.
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, the need for additional financing, the success and timing
of Onconova's clinical trials and regulatory approval of protocols,
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.
General Contact
Media Contacts: Kathryn Ryan VSC for Mission Bio
missionbio@vscconsulting.com (631) 255-5281
Avi Oler Onconova Therapeutics, Inc. 267-759-3680ir@onconova.us
http://www.onconova.com/contact/
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