Chimerix places its bets on Oncoceutics' dopamine antagonist for rare brain cancer in quest to salvage its image
In the clinical wasteland of aggressive brain cancers, Philly’s Oncoceutics has churned out promising data with a Phase II candidate on the verge of an FDA filing. Chimerix, looking to turn around its reputation — and share price — has jumped on board, putting half-a-billion-dollar hopes in Oncoceutics’ drug.
Chimerix will acquire private biotech Oncoceutics and lead candidate ONC-201, an oral small molecule dopamine receptor D2 antagonist and caseinolytic protease agonist currently being tested in a Phase II trial against recurrent glioma, a form of brain cancer with a particularly poor prognosis, the companies said Friday.
Oncoceutics expects pivotal data on the ONC-201 program some time this year for glioma patients with the H3 K27M mutation, a condition that comes with a four-month overall survival prognosis. Alongside ONC-201, Oncoceutics will bring another four oncology programs into the fold for Chimerix, which is advancing its own candidate, a glycosaminoglycan compound derived from porcine heparin dubbed DSTAT, through a Phase III trial in acute myeloid leukemia.
A win with ONC-201 could open a $500 million market opportunity in recurrent glioma, Chimerix said.
As part of the deal, Chimerix will pay out $78 million to Oncoceutics investors — half in stock and half in cash — with a potential $360 million in development, regulatory and sales milestones down the road. In terms of the $39 million in cash on the table, Chimerix will pay out $25 million at closing and the remaining $14 million on the first anniversary of closing.
In addition, shareholders will be due 15% royalties on combined sales of ONC-201 and another program, ONC206, of up to $750 million per year and 20% royalties above $750 million in annual revenue.
ONC-201 has earned the FDA’s fast track designation based on data from three trials showing promising response rates. The drug’s Phase II study is testing the molecule in 50 patients above the age of 2 who have received radiation at least 90 days prior to enrollment and displayed evidence of progressive disease, and certain other criteria, Chimerix said.
The results from that study are planned for a Blinded Independent Central Review committee’s analysis sometime this year, which could form the basis for a regulatory filing down the road, Chimerix said. Results from the first 30 patients in that study were already reviewed in a separate BICR held in November. So far, in over 350 patients treated, ONC-201 has shown a “generally well tolerated” safety profile with most common side effects of nausea/vomiting, fatigue and decreased lymphocytes.
Acquiring a promising candidate in aggressive brain cancers could help turn around the North Carolina biotech with a sketchy past. In mid-2020, Chimerix laid off half its staff after pivoting work on its oral antiviral brincidofovir to smallpox following a string of clinical failures. Now, that smallpox application for brincidofovir is up for a PDUFA date April 7 in what could be the biotech’s first approval. Shares of Chimerix ($CMRX) were trading up 16% before the bell Friday at $5.79.