Benzinga | Oct 4, 2021 04:09PM EDT

ERYTECH Announces Maximum Tolerated Dose Declared In A Phase 1 Investigator Sponsored Trial Of Eryaspase In First-Line Pancreatic Cancer

ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the MTD has been declared in a Phase 1 investigator sponsored clinical trial (IST), named rESPECT, of its lead product candidate eryaspase for the first-line treatment of pancreatic cancer, defining the recommended dose for future clinical trials in this indication at 100 U/kg.

The rESPECT IST (NCT04292743) is a single arm, dose escalating Phase 1 clinical trial to evaluate the safety of eryaspase in combination with modified FOLFIRINOX. The trial is conducted by Dr Marcus Noel, Associate Professor of Medicine at Georgetown University, Washington DC, USA, and includes pancreatic cancer patients who have received no prior chemotherapy for the treatment of locally advanced or metastatic pancreatic cancer. FOLFIRINOX is one of the most commonly utilized first-line chemotherapy regimens for the treatment of pancreatic cancer, despite its toxicity. Patients were treated across two dose cohorts of 75 U/kg and 100 U/kg eryaspase, with three and six patients included, respectively.

After review of the safety data, the dose escalation committee concluded that the novel combination of mFOLFIRINOX plus eryaspase was well tolerated with no DLT. Consequently, the MTD has been declared at a dose of 100 U/kg eryaspase. Interestingly, all six patients evaluated for response achieved disease control, four patients with objective response and two with stable disease.

The trial will continue to enroll additional patients at the 100 U/kg dose level to further assesss the safety and clinical activity. The declared MTD of 100 U/kg eryaspase corresponds with the dose currently being used in clinical trial in second-line patients and it can now be taken forward into future late-stage clinical studies in first-line pancreatic patients.

Full disclosure of both safety and efficacy information will be made at a future medical congress.