Chimerix Announces Exclusive Worldwide License of Phase 3 Ready CX-01 for Development in Acute Myeloid Leukemia
July 31 2019 - 7:00AM
Chimerix (NASDAQ: CMRX), today announced the completion of an
exclusive worldwide license of CX-01 from Cantex Pharmaceuticals,
Inc. Chimerix intends to move quickly into Phase 3 development of
CX-01 for the treatment of Acute Myeloid Leukemia (AML) in the
first-line setting. CX-01 has received Fast Track and Orphan Drug
Designations from the U.S. Food and Drug Administration for the
treatment of AML.
“We are pleased to have made such rapid progress in
repositioning the company and transforming our pipeline with this
important cancer therapy. We are excited to advance this promising
product candidate in AML as it has shown compelling activity across
multiple endpoints in first-line patients as opposed to later lines
of therapy where most of the recent advances in this disease area
have occurred. With more than 21,000 new cases of AML diagnosed
annually in the U.S. alone and a five-year survival rate of less
than 30%, the patient need is clear. CX-01’s mechanism of action,
targeting multiple proteins involved in protecting and supporting
the growth of cancer cells, provides opportunities for potential
development across a range of hematologic malignancies,”
stated Mike Sherman, Chief Executive Officer of Chimerix.
“This transaction exemplifies our commitment to pursuing and
accelerating programs where we can quickly address unmet patient
needs with a meaningful clinical benefit.”
“While several new agents have been recently approved for AML, a
backbone of cytotoxic chemotherapy continues to be necessary for
treatment with curative intent. If our results are confirmed,
combining CX-01 with chemotherapy has the potential to have a
significant impact on the outcomes of patients suffering from one
of the most challenging hematologic malignancies,” said Paul Shami,
MD, clinical investigator at Huntsman Cancer Institute and
Professor of Medicine at the University of Utah.
CX-01 is a new chemical entity derived from unfractionated
heparin with very low anticoagulant activity. CX-01 targets
key protein pathways important for AML blast cell migration to the
bone marrow and retention of these cells in the marrow where they
are protected from chemotherapy. CX-01 also binds with proteins
involved in chemotherapy resistance and the delay in platelet
recovery after chemotherapy. Together, these activities are
understood to sensitize AML blasts to chemotherapy and improve
clinical responses. These mechanisms of action support the
potential for development in myelodysplastic syndrome, multiple
myeloma, and lymphomas.
In a recently completed Phase II study, 75 patients over 60
years of age with newly diagnosed AML were randomized 1:1:1
to one of two doses of CX-01 (0.125 mg/kg/hr or 0.250 mg/kg/hr)
plus standard 7+3 chemotherapy (7 days of cytarabine, 3 days of
anthracycline) or to the control arm of standard 7+3 chemotherapy
alone. Data presented at the 2019 ASCO conference indicated an
advantage across multiple endpoints for patients treated with 0.25
mg/kg/hr CX-01. In the evaluable patient population, results of the
0.25 mg/kg/hr CX-01 arm compared favorably to the control arm:
complete response rate (complete response or complete response
without complete hematologic recovery) of 89% vs. 58% (p=0.03),
median event-free survival of 23.4 months vs. 9.0 months (p=0.011),
and median overall survival which had not yet been reached in the
CX-01 arm vs. 11.2 months (p=0.042). These data were consistent
with a single arm pilot study of first line therapy in patients
with AML (n=12), including a complete response rate of 92%.
CX-01 was well tolerated with adverse events similar across all
treatment arms. The most common serious adverse event was
febrile neutropenia with three cases in each CX-01 treatment group
and one case in the control group.
Stephen Marcus, M.D., CEO of Cantex, stated, “We are very
pleased to be partnering with Chimerix and their world-class
scientists. We believe that Chimerix management’s track record in
developing novel cancer therapeutics makes Chimerix the perfect
partner to aggressively advance the development of CX-01 for the
treatment of AML and other hematologic malignancies.”
Transaction Terms
Under the terms of the agreement, Chimerix has exclusive
worldwide rights to develop and commercialize CX-01. Chimerix will
make an upfront payment of $30 million to Cantex. In addition,
Chimerix has issued 10 million shares of Chimerix common stock to
Cantex. Cantex is eligible for regulatory and commercial milestones
of up to $587.5 million, and tiered royalties starting at 10%.
Conference Call |
Chimerix management will host a conference call today at 8:30AM
ET. To participate, please dial: |
US and Canada: |
(877) 354-4056 |
International: |
(678) 809-1043 |
Conference ID: |
9558159 |
A live, listen-only webcast of the conference call may also be
accessed by visiting the Investors section of the Chimerix website,
www.chimerix.com.
About Chimerix
Chimerix is a development-stage biopharmaceutical company
dedicated to accelerating the advancement of innovative medicines
that make a meaningful impact in the lives of patients living with
cancer and other serious diseases. CX-01 is a new chemical entity
targeting multiple proteins involved in cancer cell resistance to
chemotherapy under development for the treatment of acute myeloid
leukemia and other hematologic malignancies. Brincidofovir (BCV,
CMX001) is an anti-viral drug candidate in development as a medical
countermeasure for smallpox. For further information, please visit
the Chimerix website, www.chimerix.com.
About Cantex Pharmaceuticals, Inc. Cantex is a
clinical stage biopharmaceutical company focused on developing and
commercializing proprietary compounds that enhance the efficacy and
safety of the treatment of cancer and other life-threatening
disorders. CX-01, is a multi-targeted new chemical entity in
development for the treatment of acute myeloid leukemia and
myelodysplastic syndrome. Cantex's other clinical stage product,
Dicopp®, a proprietary combination of disulfiram + copper, is
currently in a clinical trial for metastatic pancreatic cancer.
For more information, please visit www.cantex.com.
Forward-Looking Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks and uncertainties that could cause actual
results to differ materially from those projected.
Forward-looking statements include those relating to, among other
things, the potential benefits to be derived from the license
agreement with Cantex Pharmaceuticals, including statements related
to the activity profile and opportunities for potential development
of CX-01; Chimerix’s ability to develop disease modifying and
potentially curative treatments for diseases, including AML.
Among the factors and risks that could cause actual results to
differ materially from those indicated in the forward-looking
statements are risks that the benefits of the agreement with Cantex
may never be realized; risks that CX-01 may not obtain regulatory
approval from the FDA or such approval may be delayed or
conditioned; risks that development activities related to CX-01 may
not be completed on time or at all; Chimerix’s reliance on a sole
source third-party manufacturer for CX-01; risks that ongoing or
future clinical trials may not be successful or replicate previous
clinical trial results, or may not be predictive of real-world
results or of results in subsequent clinical trials; risks and
uncertainties relating to competitive products and technological
changes that may limit demand for CX-01; risks that CX-01 may be
precluded from commercialization by the proprietary rights of third
parties; and additional risks set forth in the Company's filings
with the Securities and Exchange Commission. These
forward-looking statements represent the Company's judgment as of
the date of this release. The Company disclaims, however, any
intent or obligation to update these forward-looking
statements.
CONTACT:Investor
Relations:
Michelle LaSpaluto 919 972-7115 ir@chimerix.com or Will
O’Connor Stern Investor Relations 212-362-1200Will@sternir.com
Chimerix (NASDAQ:CMRX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Chimerix (NASDAQ:CMRX)
Historical Stock Chart
From Apr 2023 to Apr 2024