Onconova Therapeutics Announces FDA Permission for Study to Proceed Under its Investigational New Drug Application for Multi-...
December 21 2020 - 8:00AM
Onconova Therapeutics, Inc. (NASDAQ: ONTX), a
biopharmaceutical company focused on discovering and developing
novel products to treat cancer, today announced receipt of U.S.
Food and Drug Administration (FDA) permission for a Phase 1 study
to proceed under the Company’s Investigational New Drug application
(IND) for ON 123300, a proprietary, differentiated, first-in-class
multi-kinase inhibitor.
“We are grateful to receive this timely,
favorable response from the FDA to initiate a Phase 1 trial with ON
123300,” said Steven M. Fruchtman, M.D., President and Chief
Executive Officer of Onconova. “We are advancing the process to
secure Institutional Review Board approval, and affirm our
expectation that the first patient will be enrolled during the
first half of 2021.”
The Phase 1 trial will be conducted in the U.S.
and will assess the safety, tolerability and pharmacokinetics of ON
123300 administered orally as monotherapy at increasing doses
starting at 40 mg daily or higher for consecutive 28-day
cycles. The trial will enroll patients with relapsed/refractory
advanced cancer, including but not limited to patients with HR+
HER2- metastatic breast cancer with clinical resistance to approved
second-generation CDK4/6 inhibitors. Once the dose escalation phase
of the trial is completed and the recommended Phase 2 dose is
established, additional HR+ HER2- postmenopausal metastatic breast
cancer patients resistant to approved second-generation CDK4/6
inhibitors will be enrolled. Additional patient cohorts are under
consideration, including but not limited to patients diagnosed with
advanced colorectal cancer, and non-Hodgkin’s lymphoma, in
particular mantle cell lymphoma.
The design of this U.S. Phase 1 trial differs
from the ongoing study with ON 123300 in China conducted by the
Company’s partner HanX Biopharmaceuticals, Inc., which is dosing
patients daily for 21 days. The HanX trial has enrolled four
patients to date, has opened the second dosing cohort and is
expected to continue enrolling patients with advanced cancer at two
sites until the recommended Phase 2 dose is identified. Notably, of
the three currently approved CDK4/6 inhibitors, two are approved
for dosing in 21-day cycles and one is approved for dosing in a
28-day cycle. All three are blockbuster drugs marketed in HR+ HER2–
metastatic breast cancer by well-known pharmaceutical companies,
and all of these approved therapies require concomitant treatment
with an aromatase inhibitor.
“Based on its differentiated mechanism of
action, we believe that ON 123300 presents an innovative approach
to study advanced cancers including in HR+ HER2- metastatic breast
cancer that is or has become resistant to commercial CDK4/6
inhibitors. Beyond metastatic breast cancer, we believe that ON
123300 may present a novel approach to treating other cancers
including mantle cell lymphoma, multiple myeloma, advanced
colorectal cancer and hepatocellular carcinoma, as well as
inoperable glioblastoma based on preclinical studies suggesting ON
123300 crosses the blood-brain barrier,” added Richard Woodman,
M.D, Chief Medical Officer.
About ON 123300
Onconova’s lead pipeline compound is the novel
small molecule ON 123300, a proprietary, first-in-class
multi-kinase inhibitor targeting tumor-driving kinases including
CDK4/6 and ARK5. ON 123300 is reported to simultaneously inhibit
both cell cycle and cellular energy metabolism through CDK4/6 and
ARK5, respectively, and in vitro has been shown to be cytotoxic to
cancer cells (killing the cancer cells). The current commercial CDK
inhibitors are reported to be cytostatic (inhibiting the growth of
cancer cells). With its differentiated mechanism of action, ON
123300 may present an innovative approach for treating solid tumors
and hematologic malignancies that are refractory to or have become
resistant to other CDK4/6 inhibitors. Based on
experiments in preclinical models, ON 123300 exhibits single-agent
cytotoxicity, and may have utility for certain types of cancers
including breast cancer, non-Hodgkin’s lymphoma including mantle
cell lymphoma, multiple myeloma, colorectal cancer, hepatocellular
carcinoma, and inoperable glioblastoma.
About Onconova Therapeutics,
Inc.
Onconova Therapeutics is a biopharmaceutical
company focused on discovering and developing novel products to
treat cancer. The Company has proprietary targeted anti-cancer
agents designed to disrupt specific cellular pathways that are
important for cancer cell proliferation.
Onconova’s novel, proprietary multi-kinase
inhibitor ON 123300 is currently in a dose-escalation and expansion
Phase 1 trial in China, and a dose-escalation and expansion Phase 1
trial is planned in the U.S. to commence in the first half of 2021.
Onconova’s product candidate oral rigosertib is currently in a
dose-escalation and expansion Phase 1 investigator-initiated study
targeting patients with KRAS+ lung adenocarcinoma in combination
with nivolumab. Preclinical work with rigosertib in COVID-19 is
ongoing as well. Although some preclinical experiments with
rigosertib in cellular models demonstrated marked inhibition of
SARS-CoV-2 replication, we do not anticipate conducting clinical
trials with rigosertib in COVID-19 without securing additional
funding. For more information, please visit 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’s expectations regarding its
patents and clinical development plans including patient enrollment
timelines and indications for its product candidates. 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 the success and timing of Onconova's clinical
trials and regulatory agency and institutional review board
approvals of protocols, Onconova’s ability to continue as a going
concern, the need for additional financing, Onconova’s
collaborations, 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 information
Company Contact:Avi
OlerOnconova Therapeutics, Inc.267-759-3680
ir@onconova.ushttps://www.onconova.com/contact/
Investor Contact:LHA Investor
Relations Kim Sutton Golodetz212-838-3777kgolodetz@lhai.com
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