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PHAXIAM ERYTECH Provides Business Update and Reports Financial Results for the First Half of 2021 Sep 20 , 2021 | Press Releases ERYTECH Provides Business Update and Reports Financial Results for the First Half of 2021 Conference call and webcast on Tuesday , September 21 , 2021 at 8:30 am EDT / 2:30 pm CET ■ TRYbeCA - 1 Phase 3 trial of eryaspase in second - line metastatic pancreatic cancer fully enrolled since January 2021 ; on track for final results in Q4 2021 ■ Fast Track designation received for eryaspase in treatment of ALL patients who developed hypersensitivity reactions to pegylated asparaginase ; working towards potential BLA submission in this indication before year - end ■ Second dose cohort in Phase 1 Investigator Sponsored Trial ( IST ) in first - line pancreatic cancer enrolled ; determination of Maximum Tolerable Dose ( MTD ) expected in 2H 2021 ; encouraging signs of clinical activity observed ■ Closed a $ 30 million registered direct financing with specialized healthcare investors in April ■ Cash and cash equivalents of € 44.5 million ( $ 54.9million ) at the end of June 2021 Cambridge , MA ( U.S. ) and Lyon ( France ) , September 20 , 2021 ERYTECH Pharma ( Nasdaq & Euronext : ERYP ) , a clinical - stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells , today provided a business update and reported its financial results for the first half of 2021 . " The first half of 2021 has again been one of great progress , setting the stage for a catalyst - rich remainder of the year , " said Gil Beyen , CEO of ERYTECH . “ Our pivotal Phase 3 trial in second - line pancreatic cancer , TRYbeCA - 1 , has been fully enrolled since January and is on track to report top - line results in the fourth quarter . Subject to positive results , we expect to submit applications for approval in this indication in the United States and Europe in the first half of 2022. The second potentially pivotal track of eryaspase is for the treatment of ALL patients who have developed hypersensitivities to pegylated asparaginase . We recently confirmed our intention to submit a Biologics License Application ( BLA ) for this indication in the back half of this year . The recent granting of Fast Track designation underscores the need for new treatment options for these patients . Furthermore , the encouraging clinical activity observed in the first patients of the ongoing Phase 1 IST in first line pancreatic cancer adds to our conviction that eryaspase can be a meaningful contributor to helping cancer patients live longer , better . " Business Highlights ■ TRYbeCA - 1 , pivotal Phase 3 clinical trial in second - line advanced pancreatic cancer TRYbeCA - 1 is a randomized , controlled Phase 3 pivotal trial , evaluating eryaspase in second - line advanced pancreatic cancer at approximately 90 sites in the United States and in Europe . Eryaspase , in combination with standard chemotherapy ( gemcitabine / nab paclitaxel or an irinotecan - based regimen ) , is compared with standard chemotherapy alone in a 1 to 1 randomization . The primary endpoint is overall survival ( OS ) . • Patient enrollment was completed in January 2021. A total of 512 patients were randomized in the trial , above the target enrollment of 482 patients . • In February 2021 , an interim efficacy and safety analysis was performed by an independent data monitoring committee ( IDMC ) , which recommended the trial continue without modification to its final analysis . As with the three previous IDMC reviews , no safety issues have been identified and the Company remains blinded to the primary and secondary endpoint efficacy data . Reporting of the top - line results from this trial is expected in the fourth quarter of 2021 . ■ Path to BLA in hypersensitive ALL , based on results of NOPHO - sponsored Phase 2 trial The NOPHO trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy . In December 2020 , positive trial results were presented at the 2020 American Society of Hematology annual meeting . Eryaspase in combination with chemotherapy , administered every two weeks , provided a sustained asparaginase enzyme activity level , and was generally well tolerated with few hypersentivity reactions .