Durham’s Chimerix Gets FDA Greenlight for Its Smallpox Therapy
If at first you don’t succeed, you might just end up saving the world from a terrible disease.
”Rewrite the Odds” is both a corporate slogan and a storyline for Durham biopharmaceutical company Chimerix, which is launching its first approved product, an antiviral smallpox therapy. And it’s paving the way for other drug candidates in the pipeline.
The U.S. Food and Drug Administration has just granted Chimerix marketing approval for the tablet and oral suspension formulations of its smallpox treatment TEMBEXA (brincidofovir).
It’s billed as the first smallpox antiviral for all age groups, including infants and patients who have difficulty swallowing.
“We are delighted, particularly as the importance of pandemic preparedness has been put into focus over the last year,” said Chimerix CEO Mike Sherman.
The antiviral had previously failed in a late-stage study evaluating its ability to prevent a potentially fatal infection in transplant patients. But the company continued its development as a smallpox treatment, research done in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years.
Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism.
“With this approval in hand, we now look forward to advancing our discussions with BARDA toward a procurement contract to support national preparedness,” Sherman added.
In the meantime, Chimerix is also working to remake itself as a cancer drug developer.
Edward Jenner introduced the first successful smallpox vaccine in 1796, based on
his observation that milkmaids who caught cowpox didn't later catch smallpox.
So inoculating with cowpox protected against smallpox.
In January, Chimerix raised a whopping $100 million to fund clinical trials of its growing list of oncology drug candidates.
That same month, it also acquired Oncoceutics, a Philadelphia company that has clinical-stage cancer drugs of its own, for $39 million in cash and $39 million in stock, adding four more cancer drug candidates to its pipeline.
The lead Oncoceutics drug candidate, ONC201, is in Phase 3 testing in high-grade gliomas, a type of fast-growing cancer affecting the brain and spinal cord.
ONC201 is also in Phase 2 testing in neuroendocrine tumors and endometrial cancer, and in Phase 1 testing for leukemia. The Oncoceutics pipeline includes two other compounds in earlier stages of development.
In 2019, Chimerix acquired a heparin-derived drug candidate that Cantex Pharmaceuticals was developing for acute myeloid leukemia. That drug, now known as dociparstat sodium (DSTAT), is currently in Phase 3 testing.
Chimerix, founded in 2000, is listed on the NASDAQ Global Market stock exchange.