SAN DIEGO and SEATTLE, Sept. 5,
2017 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP),
an oncology company focused on the clinical development of novel
therapies for cancer, today announced that it has entered into a
license agreement with Presage Biosciences, Inc. for voruciclib, a
clinical-stage, oral and selective cyclin-dependent kinase (CDK)
inhibitor. Under the terms of the agreement, MEI Pharma receives
exclusive worldwide rights to develop, manufacture and
commercialize voruciclib. In exchange, Presage will receive
near-term payments of $2.9 million
and additional potential payments of up to $181 million upon the achievement of certain
development, regulatory and commercial milestones. Presage will
also receive mid-single-digit tiered royalties on the net sales of
any product successfully developed.
"We are very excited by this opportunity to add voruciclib to
our growing pipeline of clinical-stage oncology drug candidates,"
said Daniel P. Gold, Ph.D.,
President and Chief Executive Officer of MEI Pharma. "Voruciclib is
a selective CDK inhibitor, a class of drugs that has recently
demonstrated significant clinical and commercial value, and is
differentiated by its potent inhibition of CDK9. This is an
attractive asset that comes with an established clinical safety
profile, along with compelling pre-clinical data showing
suppression of MCL1, a known mechanism of resistance to BCL2
inhibitors, and synergy with the FDA-approved BCL2 inhibitor
venetoclax. We believe this provides a clear and efficient clinical
development path forward in combination with venetoclax. We
appreciate that Presage put their trust in us to execute this plan
and we are eager to get started."
Voruciclib (formerly P1446A) has been tested in more than 70
patients in multiple Phase 1 studies and has been associated with
manageable side effects consistent with other drugs in its class,
including nausea, vomiting and diarrhea. In pre-clinical studies,
voruciclib alone induces cell death in multiple patient-derived
chronic lymphocytic leukemia (CLL) samples1. In
addition, voruciclib shows dose-dependent suppression of MCL1 at
concentrations achievable with doses that appeared to be generally
well tolerated in the Phase 1 studies. Studies have shown that MCL1
is an established resistance mechanism to the B-cell lymphoma 2
(BCL2) inhibitor venetoclax (marketed as
Venclexta™)2.
"Voruciclib is a promising drug candidate with the potential to
overcome mechanisms of drug resistance and significantly improve
patient outcomes," said David
Johnson, Chairman of Presage. "The management team at MEI
Pharma has a proven track record in oncology therapeutic
development and we believe they have the clinical, regulatory and
CMC expertise to maximize the value of this asset. This transaction
also enables us to focus our attention on identifying and advancing
additional drug candidates and combinations using our powerful
CIVO™ intratumoral microdosing platform."
There are currently two CDK inhibitors approved by the U.S. Food
and Drug Administration, palbociclib (marketed as
Ibrance®) and ribociclib (marketed as
Kisqali®), both oral, selective CDK 4/6 inhibitors
approved for the treatment of hormone receptor-positive, human
epidermal growth factor receptor 2 (HER2)-negative breast cancer in
combination with hormonal therapy. A third, abemaciclib, was
recently granted priority review by the FDA.
About Presage Biosciences
Presage Biosciences is an oncology company pioneering a new drug
development approach to assess novel drugs and drug combinations
directly in patient tumors with its patented CIVO™ intratumoral
microdosing platform. The CIVO platform is a drug development tool
intended to simultaneously assess responses to multiple drugs or
drug combinations directly in a single solid tumor while still in a
patient's body. Presage is using CIVO to develop a portfolio of
promising oncology therapies to advance to the clinic. Presage also
partners with oncology-focused pharmaceutical companies through
strategic alliances to provide data to discover effective drug
combinations. Presage is privately held and based in Seattle. For more information, visit
www.presagebio.com.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on
the clinical development of novel therapies for cancer. The
Company's portfolio of drug candidates includes Pracinostat, an
oral HDAC inhibitor that is partnered with Helsinn Healthcare, SA.
Pracinostat has been granted Breakthrough Therapy Designation from
the U.S. Food and Drug Administration for use in combination with
azacitidine for the treatment of patients with newly diagnosed
acute myeloid leukemia (AML) who are unfit for intensive
chemotherapy. Pracinostat is also being developed in combination
with azacitidine for the treatment of patients with high and very
high-risk myelodysplastic syndrome (MDS). MEI Pharma's clinical
development pipeline also includes ME-401, a highly differentiated
oral PI3K delta inhibitor currently in a Phase Ib study in patients
with relapsed/refractory CLL or follicular lymphoma, and
voruciclib, an oral, selective CDK inhibitor shown to suppress
MCL1, a known mechanism of resistance to BCL2 inhibitors. The
Company is also developing ME-344, a novel mitochondrial inhibitor
currently in an investigator-sponsored study in combination with
bevacizumab for the treatment of HER2-negative breast cancer.
Pracinostat, ME-401, ME-344 and voruciclib are investigational
agents and are not approved for use in the U.S. For more
information, please visit www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has
been investigated in clinical studies and approved by the FDA as
being safe and effective for the intended use. Statements included
in this press release that are not historical in nature are
"forward-looking statements" within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements,
which are based on management's current expectations and are
subject to a number of risks and uncertainties, including, but not
limited to, our ability to obtain sufficient funds to progress our
clinical trials; risks relating to our collaboration agreement with
Helsinn; changes in general economic conditions; costs and delays
in the development and/or FDA approval, or the failure to obtain
such approval, of our product candidates; our failure to satisfy
foreign regulatory approval requirements; uncertainties or
differences in interpretation in clinical study results; our
inability to maintain or enter into, and the risks resulting from
our dependence upon, collaboration or contractual arrangements
necessary for the development, manufacture, commercialization,
marketing, sales and distribution of any products; our failure to
successfully commercialize our product candidates; the effect of
unfavorable pricing regulations, third-party reimbursement
practices and health care regulations on our products; competitive
factors; our reliance on third party clinical research
organizations, suppliers and manufacturers; our inability to
protect our patents or proprietary rights and obtain necessary
rights to third party patents and intellectual property to operate
our business; our inability to operate our business without
infringing the patents and proprietary rights of others; the
failure of any products to gain market acceptance; our inability to
obtain any additional required financing; technological changes;
government regulation; changes in industry practice; data security
and one-time events. We do not intend to update any of these
factors or to publicly announce the results of any revisions to
these forward-looking statements.
1 PLoS One. 2015 Nov 25;10(11):e0143685
2 Blood. 2016 Jun 23;127(25):3192-201
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SOURCE MEI Pharma, Inc.