- Onxeo S.A. has been searching for a partner to help develop its drug for a side effect of cancer treatment. On Wednesday, the company announced Monopar Therapeutics LLC is filling that void.
- Through an exclusive licensing deal, Onxeo is taking home $1 million upfront and stands to receive up to $108 million more in milestone payments. The Paris-based drugmaker would also fetch escalating sales royalties that could grow into the double digits should the candidate in question, Validive, gain regulatory approval.
- Monopar, meanwhile, gets worldwide rights to develop, commercialize and manufacture Validive. Thus far, the drug has completed Phase 2 testing in head and neck cancer patients with severe oral mucositis (SOM), a condition where the mucus tissue in the mouth inflames or ulcerates as a result of chemotherapy or radiation.
Onxeo released full data from the mid-stage study of Validive (clonidine lauriad) in mid-2015. Patients taking the drug had a 60% reduction in Grade 3 or 4 SOM, whereas those on placebo demonstrated a 45% reduction. What's more, participants in the experimental arm who developed SOM did so at a higher level of radiation compared to the control arm. More than 90% of patients in both arms experienced adverse events.
Though Validive didn't significantly outperform placebo, Onxeo believed the candidate did well enough to advance it into late-stage testing. In fact, regulators indicated that two Phase 3 studies would need to take place before the company could register the drug in the U.S.
Onxeo's problem, however, was that it didn't have enough capital to support that much late-stage testing. By the end of 2015, for instance, the drugmaker's cash position was just €33.8 million (around $40 million).
"[T]he company has decided it is in the best interest of its shareholders to move forward with this Phase 3 program only with the support of a partner," Onxeo said in a Feb. 2016 statement. "While actively seeking for such collaboration, Onxeo will continue to promote the scientific value of Validive through presentations at meetings."
Now, more than a year and a half later, the French drugmaker appears to have found such a partner.
"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," Judith Greciet, CEO of Onxeo, said in a Sept. 13 statement.
Onxeo investors seem pleased with the selection of Monopar. Company shares, which trade on the Euronext Paris stock exchange, were up more than 6% Wednesday morning, going for €2.23 ($2.66) apiece.
That increased investment may also be because Monopar, like Onxeo, specializes in crafting orphan oncology therapies. The private, Chicago-based company already has one pipeline asset, MNPR-101 (huATN-658), an anti-tumor agent targeting the urokinase receptor (uPAR), that it's advancing into in-human testing. The licensing deal with Onxeo adds a second candidate to Monopar's arsenal.
The licensing deal also provides some much-needed good news for Onxeo. Earlier this week, the company disclosed that another of its investigational drugs, Livatag (doxorubicine Transdrug), failed the Phase 3 ReLive trial in adults with unresectable hepatocellular carcinoma (HCC) who were intolerant or didn't respond to treatment with sorafenib, the active ingredient in Bayer's Nexavar.
Onxeo attributed the clinical setback to "unexpected high survival" in the trial's comparative group, a result that rattled investors. The company's stock dropped nearly 60% by close of market Monday.