MNPR Monopar Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Validive (VOICE)
Oral mucositis
|
Phase 2/3
Phase 2/3
|
Phase 2b/3 initiation of dosing announced February 16, 2021.
|
|
Camsirubicin
Soft tissue sarcoma
|
Phase 2
Phase 2
|
Phase 2 enrolment to commence late 2020/early 2021.
|
Latest News
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WILMETTE, Ill., Feb. 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 Chandler D. Robinson, MD, Chief Executive Officer, is planning to present a Company overview at the following investor conferences in March:
H.C. Wainwright Global Life Sciences Conference
The Company's presentation will be webcast on Tuesday, March 9, 2021 at 7:00 a.m. ET33rd Annual Roth Conference, Healthcare
The Company's fireside chat will be webcast on Tuesday, March 16, 2021 at 12:00 p.m. ETMaxim's 2021 Emerging Growth Virtual Conference
Presentation time to be determined on Wednesday, March 17, 2021About 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.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., Feb. 18, 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 Laura Kelly as Director of Clinical Operations. Ms. Kelly will be responsible for managing Monopar's clinical programs, including the recently launched Phase 2b/3 VOICE trial for the Company's lead drug candidate Validive®.
Ms. Kelly brings a wealth of clinical research experience, including oncology and the execution of Phase 1 through Phase 4 clinical trials, to the Monopar team. Prior to Monopar, Ms. Kelly served in strategic and clinical operation leadership roles at Merck/EMD Serono, AbbVie, Abbott Labs, and Amgen.
"The addition of Laura to the team comes at an ideal time, given the rapid ramp-up in development efforts resulting from the positive progression of our clinical programs," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "She will be a valuable contributor not only to our Validive clinical trial, but also to our camsirubicin clinical program and MNPR-101 as it moves toward an IND.""We are very pleased to welcome Laura to the team," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "Her extensive experience in clinical operations combined with strong leadership skills should allow her to make an immediate impact on the timely enrollment and execution of our clinical trials."
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 statements concerning: whether Ms. Kelly will be a valuable contributor and make an immediate impact on the timely enrollment and execution of Monopar's Validive clinical trial, camsirubicin clinical program and MNPR-101; and whether MNPR-101 will move toward an IND, if at all. The forward-looking statements involve risks and uncertainties including, but not limited to not successfully enrolling or completing the VOICE clinical trial, if at all; the camsirubicin clinical partner not successfully enrolling or completing its clinical trial, if at all; MNPR-101 not becoming a viable clinical program; the requirement for additional capital to complete future clinical development of Validive in 2022 and beyond; if successful, the potential for Validive commercialization, including uncertainties about levels of demand; and the significant and 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., Feb. 16, 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 dosed the first patient in its Phase 2b/3 VOICE trial of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE).
Validive's mucoadhesive buccal tablet formulation allows for prolonged and enhanced local delivery of drug to the regions of mucosal radiation damage, and its easy application under the upper lip allows for convenient once-daily self-administration in the patient's home setting.
"With this important milestone accomplished we are excited to be one step closer to bringing Validive to the approximately 40,000 OPC patients per year in the US that have no effective options for preventing or treating their chemoradiotherapy-induced SOM," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "SOM is a painful and debilitating severe adverse effect of chemoradiotherapy (CRT) treatment and can have significant negative impacts on clinical outcomes as well as quality of life in both the short and long term."
"The number of newly diagnosed individuals with oropharyngeal cancer is growing," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "CRT is the standard of care for OPC, but unfortunately 60-70% of OPC patients undergoing CRT will develop severe oral mucositis in the course of their treatment."
The completed Validive Phase 2 trial showed that administering a single, once daily 100µg Validive tablet resulted in a 40% reduction in the incidence of SOM compared to placebo in OPC patients undergoing CRT treatment. Up to approximately 260 patients will be enrolled in the current multi-center, randomized, double-blind, placebo-controlled, adaptive design Phase 2b/3 VOICE trial.
Further information about the Validive Phase 2b/3 VOICE trial is available at www.ClinicalTrials.gov under study identifier NCT 04648020.
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 they release 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 Severe Oral Mucositis
Severe oral mucositis (SOM) is a painful and debilitating inflammation and ulceration of the mucous membranes lining the oral cavity and oropharynx in response to insults such as chemoradiation treatment (CRT). SOM is the most frequent major side effect experienced by oropharyngeal cancer patients, experienced by a majority of those undergoing CRT. SOM impacts both quality of life and clinical outcomes for these patients. SOM prevents patients from drinking and/or eating, and can lead to severe weight loss, opiate usage, and the use of feeding tubes as well as intravenous supplementation to keep alive. Patients who develop SOM can become hospitalized, and symptoms can force patients to prematurely stop cancer treatment, reducing treatment efficacy and long-term survival.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: statements concerning whether Monopar will successfully continue to enroll its Validive Phase 2b/3 VOICE clinical trial; whether Validive will benefit OPC patients in the VOICE trial; whether the VOICE trial will yield results similar to the Phase 2 clinical trial in OPC patients; and whether the incidence of OPC will continue to grow and continue to be treated with CRT. The forward-looking statements involve risks and uncertainties for Monopar including, but not limited to, the requirement for additional capital to complete the VOICE trial beyond the interim analysis and for potential commercialization; the VOICE trial not yielding statistically significant results; if successful, 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.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., Feb. 11, 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 publication of a peer-reviewed study in the European Journal of Cancer which shows the potential utility of MNPR-101 as a uPAR imaging agent to improve surgical outcomes in bladder cancer.
Using Monopar's proprietary humanized uPAR antibody, MNPR-101, a multimodal imaging probe was developed and tested in vivo in human bladder cancer models. The publication reports that high expression of uPAR in bladder cancer is localized at the tumor periphery, suggesting that using a fluorescent-conjugated MNPR-101 probe might allow surgeons to better visualize the borders of the tumor, potentially resulting in more complete tumor resection and thereby minimizing relapse. Similar approaches have been utilized successfully in the resection of other tumor types, such as breast cancer.
Bladder cancer is often treated with transurethral resection to remove cancerous tissue; however, recurrence can occur in up to 78% of patients within 5 years. Up to 40% of recurrent cases develop muscle invasive disease, which has a poor prognosis and requires complete removal of the bladder. Many patients with muscle-invasive bladder cancer unfortunately go on to develop and succumb to metastatic disease.
"This novel MNPR-101 based imaging agent has promising utility in allowing surgeons to easily identify tumor margins during surgery," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar and a co-author of the publication. "Given the specificity of uPAR expression in bladder cancer versus normal bladder tissue, and its high expression at the border of the tumor, we believe imaging uPAR using MNPR-101 targeting could improve surgical outcomes and potentially reduce recurrence of the disease."
"If confirmed in a clinical setting, an imaging probe based on MNPR-101 could result in a paradigm shift, altering how urologists survey and treat bladder cancer," said Cornelis Sier, PhD, member of the Image-Guided Surgery group at Leiden University Medical Center (LUMC), and the principal investigator on the study.
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 statements concerning the potential utility of MNPR-101 as a uPAR imaging agent, whether a MNPR-101 based imaging agent could improve surgical outcomes in bladder cancer and related matters. The forward-looking statements involve risks and uncertainties including, but not limited to; the lack of any clinical activities to date with respect to MNPR-101 and that preclinical development activities to date have been focused on the treatment of cancers and not medical devices; the requirement for additional capital to complete preclinical and clinical development of a medical device utilizing MNPR-101, and if successful, commercialization; if funding is available, not being able to develop MNPR-101 for use as a uPAR imaging agent in bladder cancer or any other indications; not being able to ensure volumes of MNPR-101 conjugates can be manufactured and scaled up to meet potential demand; uncertainties about levels of demand if and when a medical device is available for commercialization and the significant general risks and uncertainties surrounding the research, development, regulatory approval and commercialization of medical devices. 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., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life and improve the quality of life for cancer patients, today announced the issuance of a patent covering composition of matter for MNPR-101 in Canada, adding to its existing protection in key markets around the world including the US, Europe and Japan.
"This is an important advancement in our efforts to broaden our global patent estate for MNPR-101," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "MNPR-101 is a novel, first-in-class humanized monoclonal antibody to the urokinase Plasminogen Activator Receptor (uPAR). uPAR is a well credentialed target that appears to be overexpressed in certain aberrantly activated cells, but does not appear much, if at all, in healthy tissue."
In June 2020, Monopar entered into a collaboration with NorthStar Medical Radioisotopes, LLC to utilize MNPR-101 to create a radio-immuno-therapeutic (RIT) to potentially treat severe COVID-19 by targeting and eradicating the aberrantly activated immune cells causing cytokine storm. uPAR targeting by MNPR-101 has wide potential in treating other diseases as well, including cancers, as uPAR is over-expressed in multiple cancer types such as pancreatic and ovarian.
"We are excited about the approval of this composition of matter patent in Canada as it further enables us to explore the potential of MNPR-101 on a global scale," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.
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 statements concerning: whether Monopar's composition of matter patents (including in Canada) provide protection in key markets around the world; whether Monopar's collaboration with NorthStar Medical Radioisotopes, LLC utilizing MNPR-101 to create a radio-immuno-therapeutic (RIT) will result in a treatment for severe COVID-19 by targeting and eradicating the aberrantly activated immune cells causing cytokine storm; and whether MNPR-101 has wide potential in treating other diseases including cancers such as pancreatic and ovarian. The forward-looking statements involve risks and uncertainties including, but not limited to: Monopar's composition of matter patents (including in Canada) not providing protection in key markets around the world; Monopar and NorthStar are unable to develop a RIT to treat severe COVID-19; further development of MNPR-101 does not result in a treatment for cancers; the requirement for Monopar to raise additional capital to complete clinical development of MNPR-101 or a RIT, if at all; the potential for commercialization and uncertainties about levels of demand if and when a treatment is available for commercialization; and the significant and 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:
@MonoparTx
Monopar Therapeutics