Monopar Therapeutics Inc. (MNPR)

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Developing Innovative Drugs and Drug Combinations to Improve Clinical Outcomes in Advanced Cancer

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Research Portfolio

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Monopar Therapeutics

Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. Monopar is building a drug development pipeline through the licensing and acquisition of oncology therapeutics in late preclinical and clinical development stages, leveraging its scientific and clinical expertise to help reduce the risk and accelerate the clinical development of its drug product candidates. Monopar currently has three compounds in development: Validive^® (clonidine MBT), a Phase 3-ready mucoadhesive buccal tablet for the prevention and treatment of radiation-induced severe oral mucositis (SOM) in oropharyngeal cancer (OPC) patients; camsirubicin (MNPR-201; formerly GPX-150), a proprietary Phase 2 clinical-stage analog of doxorubicin engineered specifically to retain anticancer activity while minimizing toxic effects on the heart; and MNPR-101 (formerly huATN-658), a pre-IND stage humanized monoclonal antibody, which targets the urokinase plasminogen activator receptor (uPAR) for the treatment of advanced solid cancers.

Monopar's team is located in San Francisco, CA and Chicago, IL.

Innovative Drugs and Drug Combinations

Licensing, developing and commercializing transformative oncology therapeutics

Identifying drug candidates that can be developed in combination with approved cancer drugs to mitigate toxicity and improve antitumor efficacy.
Developing new drug combinations to eliminate overlapping toxicity while enhancing antitumor synergies.
Identifying reduced-risked clinical opportunities where existing scientific and clinical data support development of more effective drug combinations without increasing toxicity.

Why Oncology?

Multiple factors drive our passion for oncology

Approximately one in every two individuals will develop cancer during their life.
It is one of the leading causes of death worldwide, and the second leading cause of death in the U.S. It accounts for nearly 1 in every 4 deaths in the U.S.
The increasing implementation of drug combinations is creating a need for new individualized therapies which are specifically designed to work synergistically.
Our team and networks of collaborators are driven by their personal experiences and have deep expertise in translating new treatments for advanced cancer.

Market Demand

The numbers behind our research define Validive and camsirubicin opportunities

Validive
Global incidence of head and neck cancer (HNC) is >690,000 cases annually; ~65,630 cases in the U.S. annually and is on the rise.^8,12
Oropharyngeal cancer (OPC) is the most rapidly growing sub-population of HNC. There are projected to be ~53,000 OPC and oral cancer patients in the U.S. in 2020 with about 70% of OPC cases driven by the human papilloma virus (HPV+).
HPV+ OPC patients have a high risk of developing severe oral mucositis (SOM) during chemoradiation treatment.
No preventive treatment for chemoradiation-induced SOM has been approved by the FDA.
Camsirubicin
Doxorubicin (DOX) is the current 1^st line treatment for advanced soft tissue sarcoma (ASTS). No drug has demonstrated clinical superiority over DOX in ASTS since its approval in this indication in the 1970s.
Patients treated with DOX in the 1^st line setting for ASTS have a median overall survival of 12-15 months. An estimated 5,270 patients were predicted to die from ASTS in 2019.
The clinical efficacy of DOX is limited by restrictions on cumulative dose that minimize the risk of developing irreversible, potentially life-threatening cardiotoxicity. Camsirubicin was designed specifically to mitigate cardiotoxicity while retaining anticancer activity, which may allow administration of higher doses for longer periods of time.
DOX is approved for 14 different adult and pediatric cancers, including ASTS. Although a generic, DOX is widely used and the market is expected to reach US$1.38 billion by 2024. If camsirubicin improves clinical outcomes compared to DOX in ASTS, the expectation is that it could potentially replace DOX in other cancer indications.

Investment Opportunities

Our management team has extensive experience in building companies and developing therapeutics through regulatory approval and commercialization.

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Our Research Pipeline

Validive^® (clonidine MBT), a Phase 3-ready mucoadhesive buccal tablet for the prevention and treatment of chemoradiation-induced severe oral mucositis (SOM) in oropharyngeal cancer (OPC) patients; camsirubicin (MNPR-201; formerly GPX-150), a proprietary Phase 2 clinical-stage analog of doxorubicin engineered specifically to retain anticancer activity while minimizing toxic effects on the heart; and MNPR-101 (formerly huATN-658), a pre-IND stage humanized monoclonal antibody, which targets the urokinase plasminogen activator receptor (uPAR) for the treatment of advanced solid cancers.

Indications	Discovery	Preclinical	Phase 1	Phase 2	Phase 3
Validive® Radiation induced SOM in OPC	Completed Phase 2 Trial, Phase 3 ready Completed Phase 2 Trial, Phase 3 ready Discovery complete	Completed Phase 2 Trial, Phase 3 ready Completed Phase 2 Trial, Phase 3 ready Preclinical complete	Completed Phase 2 Trial, Phase 3 ready Completed Phase 2 Trial, Phase 3 ready Phase 1 complete	Completed Phase 2 Trial, Phase 3 ready Completed Phase 2 Trial, Phase 3 ready Phase 2 in progress	Completed Phase 2 Trial, Phase 3 ready Completed Phase 2 Trial, Phase 3 ready Phase 3 not started

Indications

Discovery

Preclinical

Phase 1

Phase 2

Phase 3

Validive®

Radiation induced SOM in OPC

Completed Phase 2 Trial, Phase 3 ready

Discovery complete

Completed Phase 2 Trial, Phase 3 ready

Preclinical complete

Completed Phase 2 Trial, Phase 3 ready

Phase 1 complete

Completed Phase 2 Trial, Phase 3 ready

Phase 2 in progress

Completed Phase 2 Trial, Phase 3 ready

Phase 3 not started

Indications	Discovery	Preclinical	Phase 1	Phase 2	Phase 3
Camsirubicin (MNPR-201) Advanced Soft Tissue Sarcoma	Phase 2 Data in Soft Tissue Sarcoma, Collaboration with GEIS for larger Phase 2 Phase 2 Data in Soft Tissue Sarcoma, Collaboration with GEIS for larger Phase 2 Discovery complete	Phase 2 Data in Soft Tissue Sarcoma, Collaboration with GEIS for larger Phase 2 Phase 2 Data in Soft Tissue Sarcoma, Collaboration with GEIS for larger Phase 2 Preclinical complete	Phase 2 Data in Soft Tissue Sarcoma, Collaboration with GEIS for larger Phase 2 Phase 2 Data in Soft Tissue Sarcoma, Collaboration with GEIS for larger Phase 2 Phase 1 complete	Phase 2 Data in Soft Tissue Sarcoma, Collaboration with GEIS for larger Phase 2 Phase 2 Data in Soft Tissue Sarcoma, Collaboration with GEIS for larger Phase 2 Phase 2 in progress	Phase 2 Data in Soft Tissue Sarcoma, Collaboration with GEIS for larger Phase 2 Phase 2 Data in Soft Tissue Sarcoma, Collaboration with GEIS for larger Phase 2 Phase 3 not started

Indications

Discovery

Preclinical

Phase 1

Phase 2

Phase 3