Monopar Announces Issuance of U.S.
Patent Covering Compositions of Matter for a Novel Family of
Camsirubicin Analogs
-Issued
patent expands and strengthens Monopar’s existing
camsirubicin IP portfolio
-Phase 2 initiation for camsirubicin
in advanced soft tissue sarcoma remains on track for early
2021
WILMETTE, IL, December 22, 2020 –
Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage
biopharmaceutical company primarily focused on developing
proprietary therapeutics designed to extend life or improve the
quality of life for cancer patients, today announced the issuance
of a U.S. patent (US 10,450,340) covering compositions of matter
for a novel family of camsirubicin analogs. The patent, which
expands the Company’s camsirubicin intellectual property
portfolio, is expected to expire in 2038 not including any patent
term extensions.
“The
analogs covered in this patent have been designed to retain the
potentially favorable non-cardiotoxic chemical backbone of
camsirubicin and the potent broad-spectrum antitumor activity of
doxorubicin; further, preclinical evidence suggests that this new
family of 2-pyrrilino camsirubicin analogs could be active in
doxorubicin-resistant tumor cells. This may enable us to address
additional cancer types beyond those possible with
camsirubicin,” said Andrew Mazar, PhD, Monopar’s Chief
Scientific Officer.
Doxorubicin
is FDA approved in 14 different types of cancers including soft
tissue and bone sarcomas; metastatic stomach, ovarian, thyroid,
lung, and breast cancer; acute myeloid and lymphoblastic leukemia;
Hodgkin and non-Hodgkin lymphoma; and neuroblastoma. However,
cumulative dose effects of doxorubicin can result in irreversible
heart damage and death, which is why a restrictive lifetime
cumulative dose limitation has been placed on its use.
“If
successful, camsirubicin and its analogs could overcome the
restrictive dose limitation and be administered at higher doses and
for longer periods of time than doxorubicin,” said Chandler
Robinson, MD, Monopar’s Chief Executive Officer. “This
could lead to improved efficacy and better patient
outcomes.”
Monopar’s
clinical trial collaboration partner, Grupo Español de
Investigación en Sarcomas (GEIS), an internationally renowned
non-profit organization focused on the research and development of
drugs for sarcomas, is on track to initiate an open-label Phase 2
clinical study in early 2021 evaluating camsirubicin head-to-head
against doxorubicin in advanced soft tissue sarcoma (ASTS), where
doxorubicin is currently the first-line treatment.
About Monopar Therapeutics Inc.
Monopar
Therapeutics is a clinical-stage biopharmaceutical
company primarily focused on developing proprietary
therapeutics designed to extend life or improve the quality of life
for cancer patients. Monopar's pipeline consists of
Validive® for the
prevention of chemoradiotherapy-induced severe oral mucositis in
oropharyngeal cancer patients; camsirubicin for the treatment of
advanced soft tissue sarcoma; and a late-stage preclinical
antibody, MNPR-101, for advanced cancers and severe
COVID-19. 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:
whether the issued patent expands and strengthens Monopar’s
existing camsirubicin IP portfolio; whether GEIS will initiate the
Phase 2 camsirubicin clinical trial in early 2021, if at all;
whether the analogs covered in the patent could retain the
potentially favorable non-cardiotoxic chemical backbone of
camsirubicin and the potent broad-spectrum antitumor activity of
doxorubicin; whether this new family of 2-pyrrilino camsirubicin
analogs could be active in doxorubicin-resistant tumor cells which
may enable Monopar to address additional cancer types beyond those
possible with camsirubicin; and
whether camsirubicin and its analogs could overcome the restrictive
dose limitation and be administered at higher doses and for longer
periods of time than doxorubicin which could lead to improved efficacy and better patient
outcomes. The forward-looking statements involve risks and
uncertainties including, but not limited to the requirement
for additional capital to complete future clinical development
beyond the GEIS Phase 2 clinical trial; the safety and efficacy of
camsirubicin in the Phase 2 and in future clinical
development, if at all; if successful,
the potential for commercialization, including uncertainties about
levels of demand of camsirubicin; and the significant and general
risks and uncertainties surrounding the research, development,
regulatory approval and commercialization of therapeutics. 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.
CONTACTS:
Monopar Therapeutics Inc.:
Investor
Relations
Kim R.
Tsuchimoto
Chief
Financial Officer
kimtsu@monopartx.com
Follow Monopar on social media for updates:
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Therapeutics