Onconova Therapeutics Announces Initiation of a Phase 1 Clinical Trial of ON 123300 in China by Partner HanX Biopharmaceutica...
September 21 2020 - 8:00AM
Onconova Therapeutics, Inc. (NASDAQ: ONTX) a biopharmaceutical
company focused on discovering and developing novel products to
treat cancer, today announced the initiation of a Phase 1 clinical
trial in China for ON 123300 by its partner, HanX
Biopharmaceuticals.
In December 2017, Onconova entered into an
agreement with HanX Biopharmaceuticals for the development,
registration, and commercialization of ON 123300 in China. The
agreement included a licensing fee, and future potential milestone
payments and royalties on sales. Outside of China, Onconova retains
rights in rest of the world.
ON 123300 is a novel small molecule, and a dual
inhibitor of CDK4/6 and ARK5, a key enzyme controlling cellular
energy homeostasis. Inhibition of ARK5 by ON 123300 results in the
collapse of oncogene-altered energy metabolism, leading to
programmed cell death. Differentiated from health authority
approved CDK4/6 inhibitors, ON 123300 exhibits single agent
toxicity against various cancers in preclinical studies including
breast cancer, colon cancer, mantle cell lymphoma and multiple
myeloma.
“As a proprietary first-in-class anti-cancer
agent, ON 123300 is reported to have a unique dual mechanism of
action that could improve upon the clinical efficacy of approved
CDK4/6 inhibitors and may impact on the development of metastatic
disease, while potentially mitigating the commonly observed side
effects based on animal studies already conducted,” said Steven M.
Fruchtman, M.D., President and Chief Executive Officer. “We look
forward to filing our US IND by the end of this year and beginning
a US Phase 1 study in refractory solid tumors in the first quarter
of next year.”
About Onconova Therapeutics,
Inc.Onconova Therapeutics is a biopharmaceutical company
focused on discovering and developing novel products to treat
cancer. Using a proprietary chemistry platform, the Company has
created a pipeline of targeted anti-cancer agents designed to
disrupt specific cellular pathways that are important for cancer
cell proliferation. Onconova’s RAS pathway inhibitor, oral
rigosertib, is currently in a Phase 1/2 investigator-initiated
study (IIS) targeting patients with KRAS+ lung adenocarcinoma in
combination with nivolumab. Preclinical work with rigosertib in
COVID-19 is underway as well. Onconova is in preclinical
development with its novel, proprietary, CDK4/6 + ARK5 inhibitor,
ON 123300.
For more information, please visit
https://www.onconova.com.
About HanX
Biopharmaceuticals, Inc.HanX is an oncology specialty
company with an innovative pipeline targeting PD1, VEGFR, OX40 in
clinical and pre-clinical stages. The company has a strong
management team with cross-border experience and advisors with
expertise in drug discovery, regulatory, and GMP manufacturing.
Forward-Looking StatementsSome
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 clinical development plans and
patents. 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 approval of protocols,
Onconova’s ability to continue as a going concern, the need for
additional financing, our 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.
Press release contact
information
Company Contact:
Avi OlerOnconova Therapeutics, Inc.267-759-3680
ir@onconova.us https://www.onconova.com/contact/
MediaDavid Schull, Russo Partners LLC: (212)
845-4271Nic Johnson, Russo Partners LLC: (212) 845-4242
InvestorsJan Medina, CFA, Russo Partners LLC:
(646) 942-5632
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