Full Press Release Details
Monopar Therapeutics Reports Second Quarter 2021
Financial Results and Recent Business Updates
Camsirubicin Phase 1b Clinical Trial Anticipated to Start in the
Phase 2b/3 VOICE Trial on Track for
Reaching Interim Analysis in H1 2022
IL, August 12, 2021 Monopar Therapeutics Inc. (Monopar or
the Company) (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 second quarter 2021 financial results and
recent business updates.
Recent Business Updates
Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl
mucobuccal tablet) for the prevention of severe oral mucositis
(SOM) in patients undergoing chemoradiotherapy (CRT) for
oropharyngeal cancer successfully reached its target of 20
activated clinical trial sites for the Phase 2b portion of the
trial. Monopar plans to activate additional clinical trial sites,
potentially including sites outside of the U.S. There is no
FDA-approved prevention or treatment for CRT-induced SOM. The VOICE
trial is on track for reaching interim analysis in the first half
Camsirubicin and MNPR-202 and Related Analogs
U.S. Food and Drug Administration cleared Monopar to proceed under
its Investigational New Drug (IND) application with an open-label
Phase 1b dose-escalation clinical trial evaluating camsirubicin
plus growth factor support (pegfilgrastim) in patients with
advanced soft tissue sarcoma (ASTS). Monopar anticipates dosing the
first patient in the fourth quarter of 2021.
entered into a collaboration agreement with the Cancer Science
Institute of Singapore, one of Asia's premier cancer research
centers, at the National University of Singapore (consistently
ranked as one of the world's top universities) to evaluate the
activity of MNPR-202 and related analogs in preclinical models of
multiple types of cancer. MNPR-202, a camsirubicin analog, was
designed to retain the same potentially non-cardiotoxic backbone as
camsirubicin but is modified at other positions which may enable it
to be efficacious in certain cancers that are resistant to
camsirubicin and doxorubicin. MNPR-202 and related analogs are
covered under a newly issued U.S. composition of matter patent
MNPR-101 RIT and Related Compounds
and NorthStar Medical Radioisotopes, LLC (NorthStar) filed a
provisional patent application with the U.S. Patent and Trademark
Office (USPTO) titled Bio-Targeted Radiopharmaceutical
Compositions Containing Ac-225 and Methods of Preparation.
Radiopharmaceutical therapy is a promising approach to treat cancer
and other diseases using radioactive metals bound to
proteins/antibodies to target and kill cells. Actinium-225 (Ac-225)
is emerging as a radioactive isotope of choice for
radiopharmaceuticals due to favorable properties such as its long
half-life and selective induction of localized tumor cell
Monopar and NorthStar filed a provisional
composition of matter patent application titled
Urokinase Plasminogen
Activator Receptor-Targeted Radiopharmaceutical covering a
radiotherapeutic consisting of Monopar's proprietary antibody
MNPR-101 bound to Ac-225 via the metal binding agent PCTA. This
radioimmunotherapeutic (RIT) has demonstrated 98% radiochemical
purity and high stability, and has the potential to be a highly
selective, potent treatment for a variety of cancers, severe
COVID-19, and other diseases characterized by aberrant urokinase
plasminogen activator receptor expression.
Additions to Monopar's Executive Management Team
appointed Andrew Cittadine, MBA, as its Chief Operating Officer.
Mr. Cittadine is an experienced healthcare executive and serial
entrepreneur who has founded or led multiple healthcare businesses
from concept through acquisition by Fortune Global 1000 firms.
These include founding two successful diagnostic imaging companies,
Sensant Corp. and American Biooptics, where he also served as CEO,
and led both through stock or asset acquisitions by Siemens and
Olympus, respectively. He also served as CEO of a critical care
company, SonarMed, which was acquired by Medtronic. Mr. Cittadine
brings to Monopar considerable leadership experience, including
managing manufacturing and quality systems implementation,
executing multi-center clinical trials, and achieving regulatory
clearances for new technologies in both the U.S. and
Monopar appointed Oct vio Costa, MD, as its
Chief Medical Officer. Dr. Costa joined Monopar with over 30 years
of experience overseeing clinical development, clinical operations,
development strategy and global medical affairs. He has extensive
Phase 1 through Phase 4 clinical development expertise and related
regulatory experience. Dr. Costa's previous roles include
positions of increasing responsibility in clinical development at
Merck, Celgene, Novartis and most recently as Chief Medical Officer
at Rafael Pharmaceuticals. He has played an important role in the
development and life-cycle management of significant marketed
oncology products, including the blockbuster product
(lenalidomide) in Latin
Results for the Second Quarter Ended June 30, 2021, Compared to the
Second Quarter Ended June 30, 2020
and cash equivalents as of June 30, 2021, were $24.3 million.
Monopar anticipates that its current cash and cash equivalents will
fund the Company's major programs at least through September
2022, including: completing the Phase 2b portion of the VOICE
clinical trial and commencing of the Phase 3 portion; funding the
camsirubicin Phase 1b clinical trial; continuing advancement of the
MNPR-101 RIT program including related compounds; continuing the
development of MNPR-101 and related technologies in cancer; and
developing MNPR-202 and related analogs in various cancers. The
Company plans to raise additional funds and/or engage a partner
within the next 12 months to complete the VOICE clinical program