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PHAXIAM ERYTECH Provides Business and Financial Update for the Third Quarter of 2021 Nov 15 , 2021 | Press Releases Conference call and webcast on Tuesday , November 16 , 2021 at 8:30 am EST / 2:30 pm CET ■ Progress towards seeking approval of eryaspase for the treatment of ALL patients who experienced hypersensitivity to pegylated asparaginase ; Fast Track designation granted ; submission of BLA intended around year - end ■ Phase 3 trial in second - line pancreatic cancer did not meet its primary endpoint ■ Recommended Phase 2 dose determined from Phase 1 IST in first - line pancreatic cancer of eryaspase with mFOLFIRINOX ■ Process to review strategic options and partnering alternatives launched ■ Cash and cash equivalents of € 38.0 million ( $ 43.9 million ) at the end of September 2021 - Cambridge , MA ( U.S. ) and Lyon ( France ) , November 15 , 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 an update on its cash position at the end of September 2021 . " While the outcome of our TRYbeCA - 1 trial in second - line pancreatic cancer did not achieve its primary endpoint of overall survival , we remain encouraged by the observed improvement of overall survival in a subset of patients treated with FOLFIRI and will continue analyzing the sizeable TRYbeCA - 1 data set in order to distill the reasons for this disappointing outcome , " said Gil Beyen , CEO of ERYTECH . " We are also encouraged by the progress we are making towards seeking an approval for eryaspase for the treatment of ALL patients who experienced hypersensitivities to pegylated asparaginase . The dialogue with the FDA is continuing and we are hopeful we can submit our first BLA around year end . We were pleased with the granting of the Fast Track designation for this high unmet need indication in July . " Business Highlights ■ 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 acute lymphoblastic leukemia ( 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 hypersensitivity reactions . • The Company continued its interactions with the U.S. Food and Drug Administration ( FDA ) regarding a potential regulatory approval in this indication based on the NOPHO - sponsored trial . A pre - BLA meeting to discuss the submission of a Biologics License Application ( BLA ) took place in June after which the Company confirmed its intention to submit a BLA subject to successful completion of remaining activities . • In July , the Company announced that the FDA had granted eryaspase Fast Track designation for the treatment of ALL patients who have developed hypersensitivity reactions to E. coli - derived pegylated asparaginase . Subject to review of remaining information requests , the Company intends to submit a BLA around year - end . ■ TRYbeCA - 1 , pivotal Phase 3 clinical trial in second - line advanced pancreatic cancer As reported in late October , the Phase 3 TRYbeCA - 1 trial did not meet the primary efficacy endpoint of overall survival ( OS ) . The median OS for patients treated with eryaspase plus chemotherapy was 7.5 months , compared to 6.7 months for chemotherapy alone , with an OS hazard ratio ( HR ) of 0.92 in the intent - to - treat ( ITT ) population ( p - value 0.375 ) . • The prespecified subgroup of patients treated with eryaspase and FOLFIRI , an irinotecan - based chemotherapy , demonstrated a nominal increase in median OS of 2.3 months , from 5.7 to 8 months ( HR = 0.77 ; per protocol population ) , which the Company believes merits further investigation . • Patients treated with eryaspase demonstrated improved disease control compared to patients treated with chemotherapy only . Other secondary endpoints showed nominal improvement .