Monopar Drops Lead Candidate after Disappointing Phase III Analysis

Pictured: Cancer researcher looking through a microscope/Courtesy, Getty Images

Pictured: Researcher looking through a microscope/Getty Images

Monopar Therapeutics is dropping its lead candidate, Validive, being studied in a Phase III trial to treat severe oral mucositis (SOM) in oropharyngeal cancer patients undergoing chemoradiotherapy.

According to Monday's press release, the decision came after the candidate failed to meet efficacy markers in Phase IIb/III trials.  

An analysis conducted by an independent monitor found Validive didn’t meet the pre-determined 15% threshold in SOM prevention between the drug and the placebo. The results didn’t include any safety concerns. 

This is an indication for which there is currently no FDA-approved preventative or treatment.

SOM, a condition associated with some cancer treatments, affects the quality of life for patients undergoing radiation therapy to the head and neck, chemotherapy, chemoradiotherapy or hematopoeitic stem cell transplantation. SOM can be debilitating; it’s characterized by erythema, edema and ulcerations of the oral mucus membranes. 

“While we are disappointed with the outcome of this study, we are now focused on re-deploying the financial and human resources previously dedicated to Validive to advance our Phase 1b camsirubicin clinical trial and our MNPR-101 radiopharmaceutical program partnered with NorthStar Medical Radioisotopes,” said Chandler Robinson, M.D., CEO of Monopar, in a statement. 

He also noted Monopar has sufficient funds to support its planned activities beyond the first quarter of 2024.

In addition to Validive, Monopar's pipeline includes drug candidates that target other types of cancers, including soft tissue sarcoma and solid tumors. The company's drug development efforts are focused on using precision medicine to identify and target specific molecular pathways that drive cancer growth and progression.

Current Pipeline

Even as the Validive trial closes, Monopar has several other candidates in the works:

  • Camsirubicin (Phase Ib), for the treatment of advanced soft tissue sarcoma

  • MNPR-101 RIT, a late-stage preclinical antibody for radiopharmaceutical use in advanced cancers

  • MNPR-101ZR, a late-stage preclinical imaging agent for radioimmunotherapy

  • MNPR-202, an early-stage camsirubicin analog, for various cancers

Monopar stock fell nearly 50% in pre-market trading Tuesday.

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