Onconova Therapeutics, Inc. (NASDAQ: ONTX), a
biopharmaceutical company focused on discovering and developing
novel products to treat cancer, today announced the filing of an
Investigational New Drug application (IND) with the U.S. Food and
Drug Administration (FDA) for ON 123300, the Company’s proprietary,
differentiated, first-in-class multi-kinase inhibitor. The IND
seeks permission to begin a Phase 1 trial with ON 123300 in
relapsed/refractory advanced cancer including patients with HR+ HER
2- metastatic breast cancer with resistance to approved
second-generation CDK4/6 inhibitors.
“We believe that ON 123300, based on its novel
mechanism of action, presents an innovative approach to study
advanced cancers including in HR+ HER 2- metastatic breast cancer
that is or has become resistant to commercial CDK4/6 inhibitors. We
are delighted to have filed our IND on schedule, and look forward
to enrolling patients in the U.S. to complement the ongoing Phase 1
dose-escalation study underway in China by our partner HanX
Biopharmaceuticals,” said Steven M. Fruchtman, M.D., President and
Chief Executive Officer of Onconova. “The HanX Phase 1 ON 123300
study, which began in September 2020, has enrolled three patients
to date and is expected to continue to enroll patients with
advanced relapsed/refractory cancer at two sites until the
recommended Phase 2 dose is identified. We believe that data from
these two studies will generate important information to inform
anticipated later-stage studies.”
As currently envisioned, the Phase 1 trial in
the U.S. 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 Phase 1 trial is planned for patients with
relapsed/refractory advanced cancer, including but not limited to
patients with HR+ HER 2- metastatic breast cancer with clinical
resistance to the approved second-generation CDK4/6 inhibitors.
Once the recommended Phase 2 dose is established, the Company’s
plan is to enroll additional HR+ HER 2- postmenopausal metastatic
breast cancer patients refractory to approved second-generation
CDK4/6 inhibitors, as well as patients diagnosed with advanced
non-Hodgkin’s lymphoma with a special interest in mantle cell
lymphoma.
This trial design in the U.S. differs from the
study in China because HanX is dosing patients daily for 21 days.
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 by
well-known pharmaceutical companies, and all of these approved
therapies require concomitant treatment with an aromatase
inhibitor.
“Beyond metastatic breast cancer, we believe
that ON 123300 may present an innovative approach to treating other
cancers including mantle cell lymphoma, multiple myeloma, advanced
colorectal cancer, advanced hepatocellular carcinoma, and
inoperable glioblastoma based on preclinical studies suggesting ON
123300 crosses the blood-brain barrier,” added Richard Woodman,
M.D, Chief Medical Officer.
Commenting on the expected timetable and next
steps with this program, Dr. Fruchtman added: “Once the FDA
approves our IND, we will seek Institutional Review Board approval
at the site where this Phase 1 trial will be conducted.
We anticipate the first patient to be enrolled during
the first half of 2021. With the ON 123300 program advancing,
investigator-sponsored trials underway with our pipeline product
rigosertib, and an active business development campaign to evaluate
additional compounds, we look forward to an expanding portfolio of
novel therapeutics for large, underserved oncology
indications.”
About ON 123300
Onconova’s lead pipeline product 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) rather than just cytostatic
(inhibiting the growth of cancer cells), which is how the currently
commercial CDK inhibitors are reported to work. 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, may have utility for
certain types of cancers including breast cancer and non-Hodgkin’s
lymphoma, and may also have utility for mantle cell lymphoma,
multiple myeloma, advanced colorectal cancer, advanced
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 an IND has been filed in the U.S.
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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