Onxeo Partners with Monopar Therapeutics on Development of Severe Oral Mucositis Drug

After getting Validive (clonidine mucoadhesive buccal tablet), a drug designed to treat a common side effect of cancer treatment, through a Phase II clinical trial, Danish drugmaker Onxeo sought out a development partner for their candidate. Onxeo chose to team up with Monopar Therapeutics and has granted the company a global exclusive license for Validive.

Traditional cancer treatments – including radiotherapy and chemotherapy – work by targeting the rapidly-diving cancer cells in the body, Unfortunately, these treatments also have an effect on the epithelial cells that line the gastrointestinal tract, including those in the oral mucosa.

Oral mucositis is one of the most common side effects of cancer treatment, resulting in red, swollen mouth tissue which can impact a person’s ability to eat and may leave them open to infection. According to the Oncology Nursing Society, about 40 percent of patients who are given standard-dose chemotherapy experience oral mucositis, while nearly 100 percent of patients being treated using radiotherapy for head and neck cancers show signs of the complication.

“Severe oral mucositis occurs in the majority of patients treated with radiotherapy/chemotherapy for head and neck cancer but there is no effective prevention or treatment available to date,” said Dr. Chandler D. Robinson, CEO of Monopar Therapeutics Inc. “We are pleased with this agreement and strongly believe in the potential of Validive to answer this large unmet need. The acquisition of a phase III-ready asset is fully aligned with our strategy to build a strong and diversified portfolio of oncology products that will improve clinical outcomes in patients with advanced cancer.”

As part of Monopar’s newly-inked exclusive worldwide license, the company will conduct a Phase III registration study for Validive. Monopar will be required to immediately pay $1 million to Onxeo as a license fee for Validive, with the possibility of additional payments totalling $108 million upon completion of certain milestones.

“It was our stated intention after its successful Phase II to partner Validive prior to initiating any remaining development steps, as it was the best strategy to maximize its value for Onxeo,” said Judith Greciet, CEO of Onxeo. “This licensing transaction with Monopar Therapeutics is fully in line with this strategy and further demonstrates our capacity to execute such value-creating deals.

“We are pleased that Validive will get the opportunity to one day serve the unmet needs of many patients affected with severe oral mucositis, while, on our end, we are focusing all our energy on our pipeline of unique breakthrough compounds in orphan oncology.”