Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3
clinical-stage biopharmaceutical company focused on discovering and
developing novel products to treat cancer, announced an advance in
pre-clinical development and the presentation of new data for
investigational ON 123300, a novel dual inhibitor of CDK4/6 + ARK 5
with potential application across a variety of cancers.
CDK inhibitors have emerged as promising and
potentially targeted large market cancer therapies. ON 123300 has
the potential to overcome many of the limitations of current
generation CDK4/6 inhibitors. Onconova believes that ON 123300 may
act as a single agent, due to the unique targeting of ARK5, as well
as CDK 4 and 6, making it potentially suitable for indications that
may not be responsive to the current generation of CDK4/6
inhibitors.
Onconova and HanX Biopharmaceuticals, the
Company’s Greater China collaboration partner for ON 123300,
recently completed the pre-Investigational New Drug (pre-IND)
consultation with the U.S. Food and Drug Administration (FDA).
These discussions provided guidance for the manufacturing of ON
123300 and the pre-clinical development plan for the submission of
an IND application.
The data from preclinical studies demonstrates
that there is a differential metabolism of ON 123300 in male versus
female rodents. As a result, the drug exposure is almost 2-3 fold
higher in female rats. Based upon preclinical animal liver
microsome studies, this differential effect appears to be limited
to rodents, and is not observed in preclinical studies with human
liver microsomes. Based on the metabolism data from other species,
relevant species have been selected along with the dosing strategy
to be implemented in GLP toxicological studies to be conducted by
HanX. As a part of the pre-clinical development program, Onconova
and HanX announced a collaborative program in December 2017,
wherein the remaining IND enabling studies will be funded by and
conducted by HanX.
Onconova previously reported that ON 123300 was
found to be as active as Palbociclib (Pfizer's Ibrance®) in a
preclinical Rb + ve xenograft model. Moreover, the molecule may
have the potential advantage of reduced neutropenia when compared
to Palbociclib based upon this model.
Ramesh Kumar, President and CEO of Onconova,
commented, “At the end of March, we received pre-IND guidance from
the FDA, which provides a path towards filing an IND and then
starting clinical trials. Our partner, HanX, has initiated GMP
manufacturing and will be initiating GLP pre-clinical studies based
on the guidance provided by the FDA, and we look forward to
advancing ON 123300 into clinical development.”
Faming Zhang, Ph.D., founder and Chairman of
HanX, commented, “We are pleased to have completed the process
chemistry and have initiated GMP manufacturing for ON 123300. GLP
toxicology studies are planned and we will be undertaking
additional preclinical studies to enhance the profile of this novel
compound. In collaboration with Onconova, our goal is to
simultaneously file the IND in the USA and China, as soon as
possible. Once an IND is in place, HanX plans to initiate Phase 1
studies in China and also participate in more advanced global
clinical trials.”
A copy of the presentation is available by
visiting the Scientific Presentations section of
Onconova’s website.
About Onconova Therapeutics,
Inc.Onconova Therapeutics, Inc. is a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel small molecule drug candidates to treat cancer, with a
primary focus on Myelodysplastic Syndromes (MDS). Rigosertib,
Onconova's lead candidate, is a proprietary Phase 3 small molecule
agent, which the Company believes blocks cellular signaling by
targeting RAS effector pathways. Using a proprietary
chemistry platform, Onconova has created a pipeline of targeted
agents designed to work against specific cellular pathways that may
be important in cancer cells. Onconova has three clinical
stage product candidates and additional pre-clinical
programs. Advanced clinical trials with the Company’s lead
compound, rigosertib, are aimed at what the Company believes are
the unmet medical needs of patients with MDS. For more
information, please visit http://www.onconova.com.
About HanX Biopharmaceuticals
HanX Biopharmaceuticals 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.
About CDK Inhibitors:
A key feature of cancer cells is their ability to rapidly
multiply. CDK inhibitors are thought to disrupt this process by
blocking the activity of enzymes known as CDKs. In particular, CDK4
and CDK6 are considered potential anticancer drug targets, due to
their role regulating cell cycle progression at the G1 restriction
point. CDK inhibitors have the potential to treat one of the most
common types of breast cancer known as hormone receptor-positive
metastatic breast cancer, in which the cancer cells express hormone
receptors.
ON 123300 was found to be as active as Palbociclib (Pfizer's
Ibrance®) in a preclinical Rb + ve xenograft model. Moreover, based
upon this model, the molecule may have the potential advantage of
reduced neutropenia when compared to Palbociclib. Both compounds
decreased RBC and platelet counts, however in this model
system, Palbociclib had a more prominent and statistically
significant (P≤0.05) inhibitory effect on neutrophil counts when
compared to ON 123300 (30.70 ± 3.55 vs. 45.10 ± 2.04).
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 Therapeutics,
Inc.'s expectations regarding the clinical studies,
therapeutic effects and other aspects of ON 123300 and our
collaboration with HanX Biopharmaceuticals. 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. 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. 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 and current plans and future needs to
scale back operations if adequate financing is not obtained, 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.
General
Contacthttp://www.onconova.com/contact/
Investor Relations Contact
Katja Buhrer, Affinity Growth
Advisors on behalf of Onconova Therapeutics
Katja.Buhrer@affinitygrowth.com / (212)
661-7004
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