Monopar Therapeutics 8-K, filed Feb 18, 2020
Monopar Therapeutics (MNPR)
8-K
2020-02-18
For: 2020-02-18
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on February 18, 2020.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of
The Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported): February 18, 2020
MONOPAR
THERAPEUTICS INC.
(Exact name of registrant as specified in
its charter)
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Delaware
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001-39070
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32-0463781
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(State or other
jurisdiction of incorporation)
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(Commission File
Number)
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(I.R.S. Employer
Identification No.)
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1000
Skokie Blvd., Suite 350, Wilmette,
IL
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60091
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(Address of
principal executive offices)
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(Zip
Code)
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(847)
388-0349
Registrant’s
telephone number, including area code
N/A
(Former name or
former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the
Act:
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Title
of each class
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Trading
Symbol(s)
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Name
of each exchange on which registered
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Common
Stock, $0.001 par value
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MNPR
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The
Nasdaq Stock Market LLC
(Nasdaq
Capital Market)
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Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
☐ Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
☐ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Indicate by check
mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (§ 230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of
1934 (§ 240.12b-2 of this chapter).
Emerging growth
company ☒
If an emerging
growth company, indicate by check mark if the registrant has
elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☒
Item
7.01 Regulation FD Disclosure
On
February 18, 2020, Monopar Therapeutics Inc. issued a press release
annoucing that it has been granted
Orphan Drug Designation from the European Commission for its drug
candidate camsirubicin in the treatment of soft tissue sarcoma, and
the European Medicines Agency’s Committee for Orphan
Medicinal Products has issued its public summary of opinion for the
designation. The press release is filed as Exhibit 99.1 to this
report and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
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Exhibit No.
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Description
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99.1
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SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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Monopar
Therapeutics Inc.
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By:
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/s/ Kim R.
Tsuchimoto
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Name: Kim R.
Tsuchimoto
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Title: Chief
Financial Officer
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Date: February 18,
2020
Monopar
Therapeutics Receives Orphan Drug Designation from
the
European Commission for Camsirubicin in the
Treatment of Soft Tissue Sarcoma
CHICAGO, IL, February 18, 2020 – Monopar Therapeutics Inc.
(NASDAQ: MNPR) today announced it has been granted Orphan Drug
Designation from the European Commission for its drug candidate
camsirubicin in the treatment of soft tissue sarcoma (STS), and the
European Medicines Agency’s Committee for Orphan Medicinal
Products has issued its public summary of opinion for the
designation, which can be found on the Company’s
website: https://www.monopartx.com/pipeline/Camsirubicin/development-strategy.
Orphan Drug Designation: is given to medicinal products that
represent a significant benefit over existing treatments; are
intended for the treatment, prevention or diagnosis of a disease
that is life-threatening or chronically debilitating; and where
prevalence of the condition in the European Union (EU) is less than
5 in 10,000 persons. Orphan Drug Designation benefits include
protocol assistance, reduced EU regulatory filing fees and 10 years
of market exclusivity. Designated orphan medicines are also
eligible for conditional marketing authorization. Camsirubicin has
already received orphan drug designation in the U.S. by the Food
and Drug Administration (FDA), which provides for similar benefits
such as fee reductions and 7 years of market
exclusivity.
“We are pleased to receive Orphan Drug Designation from the
European Commission as it is another important acknowledgement of
the potential benefits of camsirubicin in the treatment of advanced
soft tissue sarcoma (ASTS),” said Chandler Robinson, M.D.,
Chief Executive Officer of Monopar. “This designation
complements our U.S. orphan drug designation already granted by the
FDA. We look forward to initiating our previously announced Phase 2
clinical trial in ASTS in collaboration with our partner, Grupo
Español de Investigación en Sarcomas (GEIS), in the first
half of 2020.”
Andrew Mazar, Ph.D., Chief Scientific Officer of Monopar added,
“We are encouraged by camsirubicin’s potential
demonstrated in its early clinical data to date. As a novel analog
of doxorubicin, camsirubicin has been designed to reduce the
irreversible heart damage generated by doxorubicin while retaining
anti-cancer activity.” Dr. Mazar continued,
“Doxorubicin’s efficacy is highly dose dependent;
however, higher cumulative doses have historically led to increased
rates of irreversible heart damage. As a result, responding
patients are pulled off treatment once a maximum lifetime
cumulative dose has been reached. Disease progression and poor
clinical outcomes in many patients is the unfortunate consequence
of the maximum lifetime dose limitation. Camsirubicin offers the
potential to administer drug without the risk of irreversible heart
damage, thereby potentially improving efficacy by maintaining
treatment in these patients as long as they demonstrate clinical
benefit.”
About Camsirubicin
Camsirubicin is a proprietary doxorubicin analog that is selective
for topoisomerase-II
alpha. It has been investigated in
ASTS patients in a Phase 1 and a single arm Phase 2 clinical trial.
In these studies, no camsirubicin-treated patients developed the
irreversible cardiotoxicity common to doxorubicin. The most common
adverse event observed in the Phase 1 study was neutropenia, which
was mitigated in the Phase 2 study through the use of prophylactic
G-CSF. Based on encouraging clinical results to date, Monopar has
entered into a clinical trial partnership with Grupo Español
de Investigación en Sarcomas (GEIS), an internationally
renowned non-profit organization focused on the research and
development of drugs for sarcoma cancers. GEIS will be conducting a
multi-country, randomized, open-label Phase 2 clinical trial in the
1st
line setting evaluating camsirubicin
head-to-head against doxorubicin in patients with ASTS. Enrollment
for the trial is expected to begin in the first half of 2020 and
will include approximately 170 ASTS patients. The primary endpoint
of the trial will be progression-free survival, with secondary
endpoints that include overall survival.
About Monopar Therapeutics
Monopar Therapeutics is a clinical-stage biopharmaceutical company
focused on developing proprietary therapeutics designed to improve
clinical outcomes for cancer patients. The Company's pipeline
consists of Validive®
for the
potential prevention of chemoradiotherapy-induced severe oral
mucositis in oropharyngeal cancer patients; camsirubicin for the
potential treatment of advanced soft tissue sarcoma; and a
late-stage preclinical antibody MNPR-101. For more information
visit: www.monopartx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that
are not historical facts are "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. The words “may,” “will,”
“could,” “would,” “should,”
“expect,” “plan,” “anticipate,”
“intend,” “believe,”
“estimate,” “predict,”
“project,” “potential,”
“continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Examples of these forward-looking statements
include statements concerning the potential of camsirubicin and the
timing of the GEIS clinical trial. The forward-looking statements
involve risks and uncertainties including, but not limited to, the
risk that camsirubicin will not replace doxorubicin as
1st
line therapy for ASTS, and that
enrollment of the trial will not begin in the first half of 2020,
if at all. Actual results may differ materially from those
expressed or implied by such forward-looking statements. Risks are
described more fully in Monopar's filings with the Securities and
Exchange Commission. All forward-looking statements contained in
this press release speak only as of the date on which they were
made. Monopar undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made. Any forward-looking statements
contained in this press release represent Monopar’s views
only as of the date hereof and should not be relied upon as
representing its views as of any subsequent
date.
Contact
Chandler D. Robinson, M.D., MBA, M.Sc.
info@monopartherapeutics.com