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PHAXIAM ERYTECH Provides Business Update and Reports Financial Results for the First Quarter of 2021 May 04 , 2021 | Press Releases ERYTECH Provides Business Update and Reports Financial Results for the First Quarter of 2021 Conference call and webcast on Wednesday , May 5 , 2021 at 8:30 am EST / 2:30 pm CET ■ TRYbeCA - 1 , Phase 3 clinical trial in 2nd line pancreatic cancer , fully enrolled , and on track for final results in Q4 2021 ■ Pre - BLA meeting with FDA requested to discuss the potential submission of a Biologics License Application ( BLA ) for eryaspase in hypersensitive ALL in the second half of this year ■ First dose cohort in Phase 1 Investigator Sponsored Trial ( IST ) in 1st line pancreatic cancer completed with no dose limiting toxicity ; encouraging signs of clinical activity observed ■ Cash and cash equivalents of € 37.4 million ( $ 43.9 million ) at the end of March 2021 ■ Successful registered direct round of $ 30 million with specialized healthcare investors in April 2021 ■ Cash horizon extended to mid 2022 , beyond anticipated key catalysts Cambridge , MA ( U.S. ) and Lyon ( France ) , May 4 , 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 quarter of 2021 . " The first quarter of 2021 has again been one of tremendous progress , and has further set the stage for a catalyst - rich second half of this year , " said Gil Beyen , CEO of ERYTECH . " All four of our clinical programs are expected to report significant defining events before the end of the year , two of which potentially supporting the application for regulatory approvals within the next twelve months . Our 512 - patient pivotal Phase 3 trial in second - line pancreatic cancer , TRYbeCA - 1 , is on track for final results in the fourth quarter . Subject to positive results , we expect to submit our 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 developed hypersensitivities to pegylated asparaginase . We recently requested a pre - BLA meeting with the FDA to discuss the path to approval in this indication and we are targeting the potential submission of a Biologics License Applicaton ( BLA ) in the second half of this year . We are also continuing work to further broaden the indication scope of eryaspase . The safety profile and encouraging clinical activity observed in the first dose cohort of the ongoing Phase 1 IST in first line pancreatic cancer add 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 ) . • 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 final results from this trial is expected in the fourth quarter of 2021 . ■ Phase 2 trial in acute lymphoblastic leukemia ( ALL ) , sponsored by the Nordic Society of Pediatric Hematology and Oncology ( NOPHO ) The NOPHO trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy . The primary objective of the trial was to assess asparaginase enzymatic activity . 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