- Delaware biotech Incyte, along with partner Novartis, plan to test their cancer drug Jakafi as a potential treatment for an overwhelming and damaging immune response that's been observed in some patients with COVID-19.
- The companies will run two Phase 3 trials in the U.S. and Europe, respectively, as well as launch expanded access programs to allow administration of the drug while those studies gather evidence.
- Repurposing existing drugs for COVID-19 is a strategy being widely adopted by physicians and pharmaceutical companies searching for any effective therapy against the disease. In the case of Jakafi, Incyte and Novartis hope the drug could ease the acute respiratory distress that the new coronavirus can cause.
In cancer cell therapy, treatment is sometimes associated with a severe immune reaction in which the body releases floods of inflammatory markers known as cytokines. The condition, dubbed a "cytokine storm," can bring on high fever and, in some cases, can be life-threatening.
Preliminary evidence from studies in China suggest something similar could be occurring in patients with severe COVID-19. In one, a study of 191 patients treated at two hospitals in Wuhan, China, elevated levels of a cytokine called IL-6 was associated with more severe disease and death. Others have also indicated the virus might be inducing these cytokine storms, further stressing the body as it works to curb a rampaging viral infection.
For patients treated with CAR-T cancer therapies, the side effect is most often managed by using drugs that block IL-6, such as Roche's Actemra. Hoping for a similar effect, Roche as well as Sanofi and Regeneron, the makers of another IL-6 inhibitor, have launched trials to test whether their drugs can mitigate the respiratory distress many patients in intensive care units experience.
Incyte and Novartis are trying something similar. Jakafi, which is approved in the U.S. to treat the rare blood cancers myelofibrosis and polycythemia vera, works by inhibiting cellular signaling sent through regulatory proteins known as Janus kinases. Tamping down such signaling, Incyte and Novartis hypothesize, could curb the body's pro-inflammatory response, thereby helping ease respiratory symptoms.
No strong clinical evidence yet supports this approach, but Incyte and Novartis' decision to test it reflects the urgency at which drugmakers are moving to try any potential treatment they can.
"The decision is based on pre-clinical evidence and preliminary reports from independent studies, and is supported by extensive data on the safety and efficacy of Jakavi in conditions like acute graft versus host disease and myeloproliferative neoplasms," said Novartis in a statement explaining its decision to start studies of Jakafi, which is sold as Jakavi in Europe.
While early signs point to potential for anti-JAK drugs like Jakafi, there may also be reason for caution, too.
"Some anti-inflammation medication[s] such as JAK inhibitors also block INF-a production, which is important in fighting [the] virus, and theoretically may not be suitable for the treatment of inflammatory [cytokine storm]" caused by the new coronavirus, wrote researchers from Peking Union Medical College Hospital in Beijing, China, in a review published in Clinical Immunology.
Two small studies in Canada and Mexico testing Jakafi in COVID-19 recently launched, but the Phase 3 trials envisioned by Incyte and Novartis mark a more significant commitment.
Both companies will also allow for patients to receive the drug outside of the clinical studies through expanded access or compassionate use programs.
"The potential that Jakavi could lead to faster recovery times for COVID-19 patients with fewer requiring intensive care and mechanical ventilation is encouraging and absolutely merits further investigation," said John Tsai, Novartis' chief medical officer, in the company's statement.