Benzinga | Apr 19, 2021 05:38AM EDT

ERYTECH Announced Completion of First Cohort in a Phase 1 Investigator Sponsored Trial of Eryaspase in First-Line Pancreatic Cancer

ERYTECH Pharma (NASDAQ:ERYP) today announced the completion of enrollment of the first treatment cohort and the escalation to the next and potentially final dose level 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.

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 will enroll approximately 18 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.

The trial was launched at the end of last year and has now enrolled the first cohort of three patients. After review of the safety data, the Dose Escalation Committee concluded that no dose-limiting toxicity (DLT) had been observed in the first cohort treated at a therapeutic dose of 75 U/kg eryaspase, and as of the date of this press release, treatment was observed to be well tolerated in the cohort.

Interestingly, two of the three patients treated had a partial response and significantly decreased levels of CA19-9, a pancreatic cancer tumor marker, and the third patient had stable disease after the first cycle of treatment. The trial will now be escalated to the next cohort, where the dose level will be increased to 100 U/kg eryaspase. This will be the highest dose level cohort in the trial and the presumed maximum tolerable dose (MTD) assuming no dose limiting toxicity is observed.

Dr Marcus Noel commented that: "It has been a highly encouraging start to the clinical trial with eryaspase observed to be well tolerated in combination with mFOLFIRINOX in the initial, therapeutically relevant dose cohort. It is early days and, whilst the trial is not designed to answer if eryaspase is efficacious, the observed reductions in CA19-9 and the partial responses in two out of three patients are clearly encouraging."

Dr Iman E-Hariry, ERYTECH's Chief Medical Officer, added: "We are delighted to be working alongside Dr Noel at the University of Georgetown and are pleased with the successful start to the trial. We look forward to treating patients in the next dose cohort and hope to determine the MTD in the coming months. In the fourth quarter of this year , we also expect top-line results from the TRYbeCA-1 Phase 3 clinical trial in second-line pancreatic cancer. If that trial confirms the survival benefit we observed in the earlier Phase 2 trial, we will plan to launch a pivotal trial in first-line pancreatic cancer and potentially other settings such as locally advanced pancreatic cancer."