About Us | ScientistMNPR Monopar Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Camsirubicin
Soft tissue sarcoma
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Phase 2
Phase 2
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Phase 2 trial to commence 4Q 2021.
|
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Validive (VOICE)
Oral mucositis
|
Phase 2/3
Phase 2/3
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Phase 2b/3 initiation of dosing announced February 16, 2021.
|
Latest News
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WILMETTE, Ill., Aug. 03, 2021 (GLOBE NEWSWIRE) -- 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 clearance from the US Food and Drug Administration (FDA) to proceed under its IND with an open-label Phase 1b dose-escalation trial evaluating camsirubicin plus growth factor support (pegfilgrastim) in patients with advanced soft tissue sarcoma (ASTS). The Company anticipates dosing the first patient in the trial in the fourth quarter of this year.
"By giving concomitant growth factor support to overcome the dose-limiting toxicity of this class of drug, we hypothesize camsirubicin could be dosed even higher and longer than doxorubicin, yielding the chance to demonstrate efficacy superiority over doxorubicin," said Octavio Costa, MD, Monopar's Chief Medical Officer.
"We eagerly await reaching each higher dose level in this trial," said Andrew Mazar, PhD, Monopar's Chief Scientific Officer. "Camsirubicin is a novel analog of doxorubicin, and doxorubicin is known to work through a dose-dependent mechanism, where higher quantities yield more anti-cancer effect."
"If successful in ASTS, there are 13 other potential cancer indications for camsirubicin where doxorubicin is already FDA-approved," said Chandler Robinson, MD, Monopar's Chief Executive Officer.
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 Phase 2b/3-stage Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; Phase 1b-stage camsirubicin for the treatment of advanced soft tissue sarcoma; a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19; and an early-stage camsirubicin analog, MNPR-202, for various cancers. 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: the Company anticipating dosing the first patient in the fourth quarter of this year; that camsirubicin could be dosed even higher and longer than doxorubicin, yielding the chance to demonstrate efficacy superiority over doxorubicin; and if successful in ASTS, there are 13 other potential cancer indications for camsirubicin where doxorubicin is already FDA approved. The forward-looking statements involve risks and uncertainties including, but not limited to: not dosing the first patient in the Phase 1b clinical trial in the fourth quarter of this year, if at all; that camsirubicin may cause unexpected serious adverse effects or lacks meaningful efficacy; the potential for the FDA to put the Phase 1b trial on clinical hold at any time; whether giving concomitant growth factor support will overcome the dose-limiting toxicity of this class of drug and whether camsirubicin will be able to safely achieve any dose level higher than the starting dose level for this Phase 1b trial; camsirubicin not being superior to or as effective as doxorubicin; if successful, camsirubicin not being effective in 13 other cancer indications; and the significant 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.CONTACT:
Monopar Therapeutics Inc.
Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
[email protected]Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar Therapeutics
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WILMETTE, Ill., July 12, 2021 (GLOBE NEWSWIRE) -- 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 appointment of Octávio Costa, MD, as Chief Medical Officer. In this role, Dr. Costa will oversee global clinical development and regulatory affairs, and will provide strategic direction for Monopar's pipeline.
Dr. Costa joins Monopar with over 30 years of experience overseeing clinical development, clinical operations, development strategy and global medical affairs. He has extensive Phase 1 through 4 clinical development expertise as well as 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 products, including the blockbuster product REVLIMID® (lenalidomide). Dr. Costa earned his Doctor of Medicine from The Medical College of Sorocaba, São Paulo.
"We are excited to welcome Octávio, especially as our lead program enters late-stage clinical studies," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "Octávio's track record of navigating all stages of clinical development will aid Monopar in executing our growing clinical development pipeline."
"I am thrilled to be joining this accomplished management team, as Monopar's Chief Medical Officer," said Dr. Costa. "My industry knowledge and expertise in moving cancer therapies through all stages of clinical testing is well suited to help accelerate Monopar's pipeline of innovative mid- and late-stage clinical programs and early drug development candidates."
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; a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19; and an early-stage camsirubicin analog, MNPR-202, for various cancers. 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 Dr. Costa providing strategic direction for Monopar's pipeline and Dr. Costa aiding in executing or accelerating Monopar clinical development. The forward-looking statements involve risks and uncertainties including, but not limited to Dr. Costa's unknown future contributions to Monopar and the significant 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.CONTACT:
Monopar Therapeutics Inc:
Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
[email protected]Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar Therapeutics
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WILMETTE, Ill., June 24, 2021 (GLOBE NEWSWIRE) -- 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 that it will present its oropharyngeal cancer (OPC) patient population analysis of the Phase 2 Validive® (clonidine HCl MBT) trial for the prevention of chemoradiotherapy-induced severe oral mucositis in head and neck cancer at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) 2021 annual meeting. This analysis provided the rationale for the design of Monopar's Phase 2b/3 VOICE trial, which is open and accruing oropharyngeal cancer patients in the US.
"We are excited to share the data from our analysis at this pre-eminent multidisciplinary conference dedicated to supportive care in cancer and for the opportunity to continue working towards providing a treatment for this debilitating condition," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.
Session Title: Mucositis - New Dimensions in Research and Clinical Practice, Oral Proffered Paper 2
Presentation Title: Subgroup Analysis of Head and Neck Cancer Patients Treated with Clonidine Mucobuccal Tablet in a Randomized, Double-Blind Phase 2 Trial (Study BA2009-28-01) Supports Further Clinical Development in Patients with Oropharyngeal Cancer
Author: Andrew Mazar, PhD, Chief Scientific Officer of Monopar Therapeutics
Date and Time: The Company's presentation will be available on demand for registered attendees starting Friday, June 25, 2021 at 8:00am EDT. For information on registration, visit: https://www.mascc.org/2021-registration
About Validive®
Validive (clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal tablet (MBT) formulation. The mucobuccal tablet provides for prolonged and enhanced local delivery of clonidine to the regions of oral mucosal radiation damage in OPC patients. The tablet is self-administered once daily in the patient's home setting with the patient placing it under the upper lip where it adheres to the gums and dissolves over several hours, continuously releasing clonidine into the saliva. Clonidine agonizes the alpha-2 adrenergic receptor on macrophages (white blood cells present in the immune tissues of the oropharynx), decreasing the macrophages' expression of the destructive cytokines that are released in response to radiotherapy. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial of Validive showed reduced incidence compared to placebo (absolute decrease of 26%, relative decrease of 40%) in OPC patients treated with Validive 100 µg, a safety profile similar to placebo, and a high rate of treatment compliance (over 90%).
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; a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19; and an early-stage camsirubicin analog, MNPR-202, for various cancers. 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: the Company's excitement for the opportunity to continue working towards providing a treatment for severe oral mucositis; and the Phase 2 trial supporting further clinical development in patients with oropharyngeal cancer. The forward-looking statements involve risks and uncertainties including, but not limited to: that the Phase 2 trial analysis will not provide successful rationale for the conduct and design of Monopar's Phase 2b/3 VOICE trial; that Monopar may not provide a treatment for severe oral mucositis; that Validive's Phase 2b/3 VOICE trial may not yield similar results as the Phase 2 trial or successful clinical results; that Monopar may not successfully recruit and complete the Phase 2b/3 VOICE trial; the requirement for additional capital to complete the Phase 3 portion of the VOICE trial and potentially a second smaller confirmatory Phase 3 trial, if required by the regulators and, if successful, to commercialize Validive; not being able to ensure volumes of Validive® can be manufactured and scaled up to meet potential demand; uncertainties about levels of demand if and when a treatment is available for commercialization; and the significant 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
[email protected]Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar Therapeutics
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WILMETTE, Ill., June 03, 2021 (GLOBE NEWSWIRE) -- 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 it has entered into a collaboration agreement with the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS) to evaluate the activity of MNPR-202 and related analogs in multiple types of cancer. MNPR-202 was designed to retain the same potentially non-cardiotoxic backbone as camsirubicin but is modified at other positions which may enable it to work in certain cancers that are resistant to camsirubicin and doxorubicin. Monopar recently announced a composition of matter U.S. patent (US10,450,340) covering MNPR-202 and related analogs. While we expect camsirubicin to enter a dose escalation run-in clinical trial in advanced soft tissue sarcoma in the second half of this year, CSI Singapore will explore how the immune system recognizes cancer cells treated with MNPR-202 and related analogs in order to guide the rational design of immunotherapy-chemotherapy combinations for the treatment of cancer.
CSI Singapore is one of Asia's premier cancer research centers and NUS is consistently ranked as one of the world's top universities. Anand Jeyasekharan, MBBS MRCP (UK) PhD, of CSI Singapore, NUS is an expert in the molecular and biological responses of cancer cells to chemotherapy. Through this collaboration, we hope to gain fundamental insight into how MNPR-202 and related analogs alter the DNA of cancer cells and how the immune system then identifies and eliminates these cells, resulting in immunogenic cell death (ICD). The relationship between chemotherapy and ICD constitutes a prominent pathway for immune system activation against various cancers, including cancers that are considered to be "cold" and poorly responsive to checkpoint inhibition alone. A deeper understanding of ICD response may reveal additional indications where MNPR-202 and related analogs could have significant potential as anticancer therapies.
"By expanding our understanding of MNPR-202 activity against chemotherapy-resistant tumors and working with Dr. Jeyasekharan to assess immunogenic potential, we may be able to inform and refine our development strategy toward indications where MNPR-202 could be most impactful," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.
"We believe MNPR-202 has the potential to disrupt the current chemotherapy landscape and impact a broad range of cancers," said Dr. Anand Jeyasekharan, who will be the Principal Investigator at CSI Singapore. "We are pleased to collaborate with Monopar to further our current research and hope to aid in the advancement of MNPR-202 toward the clinic."
"We are very excited to work with Cancer Institute of Singapore at the National University of Singapore and Dr. Jeyasekharan on MNPR-202," said Chandler Robinson, MD, CEO of Monopar. "A world-class reputation paired with deep expertise on the relationship between chemotherapy and immune cell activation make Dr. Jeyasekharan and CSI Singapore a great research partner."
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; a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19; and an early-stage camsirubicin analog, MNPR-202, for various cancers. For more information, visit: www.monopartx.com.About the Cancer Science Institute of Singapore (CSI Singapore)
The Cancer Science Institute of Singapore (CSI) is one of only five Research Centres of Excellence established by the Government of Singapore with funding from the National Research Foundation and the Ministry of Education. Its mission is to better understand the causes of human cancer across Asia, and thereby improve its detection, treatment and prevention for the benefit of the patients. The CSI's outstanding researchers and excellent scientific facilities create an energetic environment for ground-breaking research and world-class training. The CSI is internationally recognized for its innovative research on the biology of cancers prevalent in Asia, and for taking new methods for cancer treatment from the laboratory to the clinic. Through its local and global partnerships, the CSI works with leading minds from multiple scientific and clinical disciplines in Singapore, the USA and Europe, both in academia and in industry. For more information on CSI Singapore, visit https://www.csi.nus.edu.sg/web/.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 MNPR-202 will retain the same potentially non-cardiotoxic backbone as camsirubicin or increase potency and circumvent drug resistance pathways in cancer cells; whether Monopar will commence a camsirubicin dose escalation run-in clinical trial in advanced soft tissue sarcoma in the second half of this year; and whether the collaboration with Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS) will result in positive data or the successful development of MNPR-202 and related analogs, if at all. The forward-looking statements involve risks and uncertainties including, but not limited to Monopar's inability to raise additional capital to complete future preclinical and clinical development; negative or inconclusive data from the studies of MNPR-202 and related analogs conducted in the collaboration with CSI at the NUS; if successful, the potential for commercialization, including uncertainties about levels of demand of MNPR-202 and related analogs; and the significant 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.CONTACT:
Monopar Therapeutics Inc.
Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
[email protected]com
Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar Therapeutics -
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WILMETTE, Ill., June 01, 2021 (GLOBE NEWSWIRE) -- 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 appointment of Andrew Cittadine, MBA, as Chief Operating Officer. In this role, Mr. Cittadine will provide leadership and oversight of Monopar's global operations and business and development strategy.
Mr. Cittadine is an experienced healthcare executive and serial entrepreneur with a successful track record of identifying, founding, and building healthcare businesses from concept to commercialization to acquisition by Fortune Global 1000 firms. These include founding two successful diagnostic imaging companies, Sensant Corp. and American Biooptics, and leading both through acquisitions, by Siemens and Olympus, respectively. His leadership experience also includes acting as startup CEO of a critical care company, SonarMed, which was acquired by Medtronic. He has managed manufacturing and quality systems implementation, execution of multi-center clinical trials, and regulatory clearances for new technologies in Europe and the US. Mr. Cittadine received his BA, BS, and MS from Stanford and an MBA from Northwestern's Kellogg School of Management.
"We are very pleased to welcome Andrew. He is a proven healthcare leader and a strong addition to our executive team," said Chandler Robinson, MD, Chief Executive Officer of Monopar.
"This is an exciting time at Monopar. They have a well-balanced and promising portfolio of earlier and later stage drug candidates. I'm honored to join this talented and committed team in developing these potentially life-changing treatments for cancer patients," said Mr. Cittadine.
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 the statement concerning the team developing potentially life-changing treatments for cancer patients. The forward-looking statements involve risks and uncertainties including, but not limited to the requirement for additional capital to complete preclinical and clinical development of Monopar's pipeline and the significant 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.
CONTACT:
Monopar Therapeutics Inc.
Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
[email protected]Follow Monopar on social media for updates:
Twitter: @MonoparTx
LinkedIn: Monopar Therapeutics