Erytech is preparing to move eryaspase into a pivotal trial after full data (PDF) from a phase 2b affirmed earlier top-line results. The red-blood-cell-encapsulated L-asparaginase improved overall survival and other outcomes in metastatic pancreatic cancer patients, emboldening Erytech to consider swinging for first-line use in phase 3.
Data presented at the European Society for Medical Oncology (ESMO) Congress this week confirm earlier top-line findings, which sent Erytech’s stock up more than 60% in March. Overall survival in the eryaspase arm clocked in at 26.1 weeks, against 19.0 weeks in the standard-of-care cohort.
Given some pancreatic cancer clinical trials have failed to improve overall survival, despite delaying progression, Erytech was pleasantly surprised with the data. The trial linked eryaspase, also known as Graspa, to improved progression-free survival, too.
These outcomes were consistent across subgroups of patients with different prognoses.
Erytech is still organizing its thoughts about the design of the phase 3 trial but some ideas have emerged from early internal talks. One possibility is underpinned by the similarity between standard of care in first and second-line pancreatic cancer. As eryaspase looks promising as a second-line therapy, Erytech’s thinking goes, why not move it a notch up the treatment pathway?
“It gives us the opportunity to look in different settings. Could it be a first line? Could it be a second line?,” Iman El-Hariry, M.D., Ph.D. said. “This is something that we would like to discuss and agree with the regulatory agencies.”
A meeting with the FDA is scheduled for October. Talks with European regulators are also planned.
These clinical development activities are advancing in parallel to discussions about how to finance the next wave of trials. Erytech had €88.5 million ($105.7 million) in the bank as of the end of June. That will be enough to prepare Erytech to embark on a clutch of late-phase trials but too little to see it through to the delivery of data.
Lyon, France-based Erytech has resisted the lure of Nasdaq so far, opting instead to sell stock to U.S. investors through its listing in Europe. This approach has given Erytech significant ties to U.S. investors. Baker Brothers owned 15% of Erytech’s share capital following its €70.5 million private placement in April. JP Morgan owned a further 7%.
The maturation of Erytech’s pipeline and broadening of its investor base suggest it is now ready to make the leap to Nasdaq. And the appointment of a New York-based director of investor relations shows Erytech is keen to continue attracting U.S. cash. Management is keeping its options, though.
“There are different options open right now ... both on the financing side and interest on the partnering side,” CEO Gil Beyen said.