Monopar Therapeutics Inc.

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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 an emerging biopharmaceutical company focused on developing innovative drugs and drug combinations to improve clinical outcomes for cancer patients. Monopar currently has three compounds in development: Validive® (clonidine mucobuccal tablet; clonidine MBT), a Phase 3-ready molecule for the prevention and treatment of severe oral mucositis (SOM) in patients undergoing radiotherapy for oropharyngeal cancer (OPC); Camsirubicin (MNPR-201 formerly GPX-150), a novel doxorubicin analog engineered to eliminate the cardiotoxic side effects typically generated by anthracycline-based cancer drugs; and MNPR-101 (formerly huATN-658), a novel first-in-class humanized monoclonal antibody to the urokinase plasminogen activator receptor (uPAR) for the treatment of advanced 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 while improving antitumor efficacy
Developing new combinations to eliminate overlapping toxicity while enhancing combination antitumor synergies, and
Identifying de-risked clinical opportunities where existing scientific and clinical data support development of drug combinations if combination toxicity can be mitigated.

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 the Validive opportunity

Global incidence of head and neck cancer (HNC) is >690,000 cases annually (Globocan 2012; Gupta, 2016) and ~63,000 cases in the U.S. annually and is on the rise
The most rapidly growing sub-population of HNC are patients with oropharyngeal cancer (OPC), approximately 43,000 in the U.S. with approximately 32,000 OPC cases driven by the human papilloma virus (HPV+)
HPV+ OPC patients have a 6.9-fold increased risk of developing severe oral mucositis (SOM) during radiation treatment
No preventive treatment for radiation-induced SOM has been approved by the FDA

Investment Opportunities

Monopar's team has developed and executed efficient and successful launch and commercialization strategies for multiple drug product approvals in the U.S. and EU.

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Our Research Pipeline

Validive® (clonidine mucobuccal tablet; clonidine MBT) is a Phase 3-ready molecule for the prevention and treatment of severe oral mucositis (SOM) in patients undergoing radiotherapy for oropharyngeal cancer (OPC). Camsirubicin (MNPR-201 formerly GPX-150) is a novel doxorubicin analog engineered to eliminate the cardiotoxic side effects typically generated by anthracycline-based cancer drugs. MNPR-101 (formerly huATN-658) is a novel first-in-class humanized monoclonal antibody to the urokinase plasminogen activator receptor (uPAR) for the treatment of advanced cancers.

Indications	Discovery	Preclinical	Phase 1	Phase 2	Phase 3
Validive® Severe Oral Mucositis in OPC	Completed randomized placebo-controlled 183 patient Phase 2 trial for the prevention and treatment of sever oral mocositis with encouraging results Completed randomized placebo-controlled 183 patient Phase 2 trial for the prevention and treatment of sever oral mocositis with encouraging results Discovery complete	Completed randomized placebo-controlled 183 patient Phase 2 trial for the prevention and treatment of sever oral mocositis with encouraging results Completed randomized placebo-controlled 183 patient Phase 2 trial for the prevention and treatment of sever oral mocositis with encouraging results Preclinical complete	Completed randomized placebo-controlled 183 patient Phase 2 trial for the prevention and treatment of sever oral mocositis with encouraging results Completed randomized placebo-controlled 183 patient Phase 2 trial for the prevention and treatment of sever oral mocositis with encouraging results Phase 1 complete	Completed randomized placebo-controlled 183 patient Phase 2 trial for the prevention and treatment of sever oral mocositis with encouraging results Completed randomized placebo-controlled 183 patient Phase 2 trial for the prevention and treatment of sever oral mocositis with encouraging results Phase 2 in progress	Completed randomized placebo-controlled 183 patient Phase 2 trial for the prevention and treatment of sever oral mocositis with encouraging results Completed randomized placebo-controlled 183 patient Phase 2 trial for the prevention and treatment of sever oral mocositis with encouraging results Phase 3 not started

Indications

Discovery

Preclinical

Phase 1

Phase 2

Phase 3