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
they have entered into a Distribution, License and Supply Agreement
with Knight Therapeutics Inc. (“
Knight”), a
Canadian-based specialty pharmaceutical company focused on
acquiring, in-licensing, selling and marketing innovative
prescription and over-the-counter pharmaceutical products, whereby
Knight shall have the exclusive rights to commercialize rigosertib
in Canada. In addition, Onconova may be entitled to receive
clinical, regulatory and sales-based milestone payments up to CAD
33.95 million and tiered double-digit royalties on net sales.
"We are pleased to add Knight to our roster of
global partners for rigosertib," said Dr. Steven Fruchtman,
President and Chief Executive Officer of Onconova. "We are eager to
work with Knight’s team, which has successfully partnered with a
number of biotechnology companies to commercialize innovative
medicines in Canada.”
“Patients with high-risk MDS have limited
treatment options after first-line hypomethylating agents such as
azacitidine fail," said Jonathan Ross Goodman, Chief Executive
Officer of Knight. "If approved, rigosertib would address this
unmet need and we look forward to the results of the ongoing phase
III INSPIRE trial of 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).
The Leukemia and Lymphoma Society of Canada
estimates that there are between 1,800 and 5,900 new cases of MDS
diagnosed in Canada each year. MDS is typically diagnosed in older
individuals, and most patients diagnosed with the disease are over
the age of 60. Approximately 23% of cases can be classified as
having high risk or very high risk MDS as per the revised
International Prognostic Scoring System (IPSS-R)1.
About Rigosertib
Rigosertib, Onconova’s lead candidate, is a
proprietary Phase 3 small molecule. A key publication in a
preclinical model 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 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 Knight Therapeutics
Inc.
Knight Therapeutics, Inc., headquartered in
Montreal, Canada, is a specialty pharmaceutical company focused on
acquiring or in-licensing innovative pharmaceutical products for
the Canadian and select international markets. Knight Therapeutics
Inc.'s shares trade on TSX under the symbol GUD. For more
information about Knight Therapeutics Inc., please visit the
company's web site at www.gudknight.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 Knight, 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.
1. Greenberg PL, Tuechler H, Schanz J, et al.
Revised international prognostic scoring system for myelodysplastic
syndromes. Blood. 2012;120(12):2454–2465.
CONTACTS:
Onconova Therapeutics, Inc. Avi
Oler267-759-3680http://www.onconova.com/contact/
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