Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a Phase
3-stage biopharmaceutical company discovering and developing novel
products to treat cancer, with a focus on myelodysplastic syndromes
(MDS), today announced it has entered into a Distribution, License,
and Supply Agreement whereby Specialised Therapeutics Asia (“STA”)
shall have the exclusive rights to commercialize rigosertib in
Australia and New Zealand. In addition, Onconova may be
entitled to receive clinical, regulatory, and sales-based milestone
payments up to US $30.4 million and tiered double-digit royalties
on net sales.
“We are pleased to partner with Specialised
Therapeutics Asia, which has a strong track record of
commercializing new products in oncology and hematology across
Australia and New Zealand,” said Dr. Steven Fruchtman, President
and Chief Executive Officer of Onconova. “We look
forward to working together and, pending a successful readout of
the ongoing INSPIRE Trial, potentially providing rigosertib as a
new therapeutic option for patients diagnosed with MDS.”
STA Chief Executive Officer, Mr. Carlo
Montagner, said that “patients with high-risk MDS have limited
treatment options following currently available first-line
treatment. There is no currently approved treatment following
failure of standard chemotherapy with hypomethylating agents.
Patients are left with the option of entering clinical trials, if
available, or supportive care,” he said. “If approved,
rigosertib would address an unmet medical need and may be a
valuable inclusion to the STA therapeutic portfolio. We are
delighted to enter into this collaboration with Onconova and look
forward to the results of the ongoing phase 3 INSPIRE Trial of
intravenous (IV) rigosertib.”
About Myelodysplastic Syndromes
MDS is a group of blood disorders that affect
bone marrow function, whereby the bone marrow cells appear
dysplastic and their capacity to produce cells is defective.
As a result, patients with MDS have low blood cell counts and
require frequent blood transfusions. In approximately
one-third of patients, higher-risk MDS can progress to acute
myelogenous leukemia (AML).
About Rigosertib
Rigosertib, Onconova’s lead candidate, is a
proprietary Phase 3 small molecule. A key publication in a
preclinical model described 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
first-line 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 Onconova Therapeutics,
Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage
biopharmaceutical company 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. 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 http://www.onconova.com.
About Specialised Therapeutics Asia
Headquartered in Singapore, Specialised
Therapeutics Asia Pte Ltd (STA) is an international
biopharmaceutical company established to commercialise new
therapies and technologies to patients throughout South East Asia,
as well as in Australia and New Zealand. STA and its regional
affiliates collaborate with leading global pharmaceutical and
diagnostic companies to bring novel, innovative and life-changing
healthcare solutions to patients affected by a range of diseases.
Its mission is to provide therapies where there is an unmet need.
The company’s broad therapeutic portfolio currently includes novel
agents in oncology, haematology, neurology, ophthalmology and
supportive care.
Additional information can be found
at www.stbiopharma.com.
Onconova 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 its
products, its collaboration with Specialised Therapeutics, 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, its ability to maintains its Nasdaq listing, 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.
CONTACT:
Onconova Therapeutics, Inc. Avi
Oler267-759-3680http://www.onconova.com/contact/
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