Monopar Therapeutics Inc. (MNPR)

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'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
In the U.S., the incidence of oropharyngeal cancer (OPC) is estimated to be greater than 40,000 cases in 2021. OPC is the most rapidly growing sub-population of HNC with about 70% of OPC cases driven by the human papilloma virus (HPV+).
This HPV+ OPC population is expected to be a long-term driver of the incidence of OPC and the resultant severe oral mucositis (SOM) associated with what is frequently curative therapy for this serious malignancy.
There is no preventive treatment for chemoradiation-induced SOM that has been approved by the FDA.
Camsirubicin
Camsirubicin is an analog of doxorubicin. 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. Although doxorubicin was approved decades ago, it is still widely used.
Camsirubicin has been engineered specifically to retain the anticancer activity of doxorubicin while minimizing the toxic effects on the heart.
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, which could lead to improved efficacy and better patient outcomes.

Corporate Overview

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

Discover

Our Research Pipeline

Monopar’s pipeline consists of Validive^®(clonidine HCI MBT), a mucoadhesive buccal tablet for the prevention of chemoradiotherapy-induced severe oral mucositis (SOM) in oropharyngeal cancer (OPC) patients; camsirubicin, a proprietary analog of doxorubicin for the treatment of advanced soft tissue sarcoma, engineered specifically to minimize toxic effects on the heart while retaining anticancer activity; MNPR-101 RIT, a preclinical-stage radio-immuno-therapeutic (RIT) for the treatment of advanced solid cancers and severe COVID-19; MNPR-101, a preclinical-stage monoclonal antibody for the treatment of solid cancers; and MNPR-202, an early-stage preclinical camsirubicin analog which has potential in doxorubicin resistant cancers and as an immunogenic chemotherapy in combination with checkpoint inhibitors.

Product	Indications	Preclinical	Phase 1	Phase 2	Phase 3	Status
Validive®	Chemoradiation induced SOM	Preclinical complete	Phase 1 complete	Phase 2 in progress	Phase 3 not started	Phase 2b/3 VOICE trial ongoing in US and EU
Camsirubicin	Advanced Soft Tissue Sarcoma	Preclinical complete	Phase 1 in progress	Phase 2 not started	Phase 3 not started	Phase 1b active and recruiting in the US
MNPR-101 RIT	Advanced Solid Cancers, Severe COVID-19	Preclinical in progress	Phase 1 not started	Phase 2 not started	Phase 3 not started	Collaboration with NorthStar
MNPR-101	Solid Cancers	Preclinical in progress	Phase 1 not started	Phase 2 not started	Phase 3 not started	Late preclinical
MNPR-202	Advanced Solid Cancers	Preclinical in progress	Phase 1 not started	Phase 2 not started	Phase 3 not started	Early preclinical

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Our Mission

Clinical Pipeline

Our Team

Validive®

Camsirubicin

MNPR-101 RIT

MNPR-101

MNPR-202