'Notwithstanding the setback of our Phase 3 trial in pancreatic cancer not meeting its primary endpoint, 2021 has been a year of important achievement for Erytech,' said
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
Eryaspase, also referred to as GRASPA, its recently approved invented name, in combination with chemotherapy and administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions.
The Company pursues its interactions with the
In
The BLA application is now almost completed, allowing a fast submission once the FDA has finalized its review of the remaining information requests and gives the green light to file.
TRYbeCA-1, pivotal Phase 3 clinical trial in second-line advanced pancreatic cancer
As reported in
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.
The safety profile of eryaspase was consistent with earlier clinical trials results and safety reviews.
Final data of the trial were presented as a late-breaking oral presentation at ASCO-GI in
Potential continuation of development in pancreatic cancer was discussed with Key Opinion Leaders, who confirmed that further exploration of the combination of eryaspase with irinotecan- and fluoropyrimidine-based chemotherapy is of interest, and who recommended to consider further development in later lines of treatment.
rESPECT, Phase 1 investigator-sponsored trial (IST) in first-line pancreatic cancer
rESPECT is a Phase 1 trial, sponsored by the
Patient enrollment started in
After review of the safety data in the first two dose cohorts, the dose escalation committee concluded that the novel combination of mFOLFIRINOX plus eryaspase was well tolerated with no dose limiting toxicity. Consequently, the maximum tolerated dose (MTD) was determined at a dose of 100 U/kg eryaspase.
Interim data, presented as ASCO GI in
The trial will continue enrolling up to approximately 18 patients. Reporting of final data is expected in the third quarter of 2022.
TRYbeCA-2, randomized Phase 2 clinical trial in triple-negative breast cancer (TNBC)
The TRYbeCA-2 trial is evaluating eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone, in metastatic TNBC. Target enrollment is approximately 64 patients. The primary end point of the trial is objective response rate.
Following the disappointing results of eryaspase in combination with a gemcitabine-based chemotherapy in the TRYbeCA-1 trial in second-line pancreatic cancer, the Company has, in consultation with the trial's Steering Committee, decided to stop further enrollment in the TRYbeCA-2 trial.
The results of the patients enrolled in the TRYbeCA-2 trial to date are expected to be reported around mid 2022.
Process to review strategic options and partnering alternatives well advanced
As announced on
About ERYTECH and eryaspase
ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECH's primary focus is on the development of product candidates that target the altered metabolism of cancer cells by depriving them of amino acids necessary for their growth and survival.
The Company's lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cells' altered asparagine and glutamine metabolism. The proof of concept of eryaspase as a cancer metabolism agent was established in different trials in acute lymphoblastic leukemia (ALL) and pancreatic cancer. An investigator sponsored Phase 2 trial (IST) evaluating the use of eryaspase in ALL patients who developed hypersensitivity reactions to pegylated asparaginase recently reported positive results, based on which the Company intends to request approval in
Eryaspase received Fast Track designation from the
ERYTECH produces its product candidates for treatment of patients in
ERYTECH is listed on the Nasdaq Global Select Market in
For more information, please visit www.erytech.com
Contact:
ERYTECH
CFO & COO
T: +1 (212) 915 - 2577
E: cdavis@lifesciadvisors.com
Investor relations
E: investors@erytech.com
T: +33 4 78 74 44 38
T: +33 1 44 71 94 94
E: erytech@newcap.eu
Investor
Nicolas Merigeau
Forward-looking Information
This press release contains forward-looking statements including, but not limited to, statements with respect to the clinical development and regulatory plans of eryaspase including the timing of a potential BLA submission to the FDA for the treatment of acute lymphoblastic leukemia, the Company's ability to obtain regulatory approval for the treatment of patients with acute lymphoblastic leukemia who developed hypersensitivity reactions to PEG-asparaginase, the Company's ability to extend the indication scope of eryaspase, the Company's ability for additional funding under the OCABSA financing agreement or other financing attempts, and the Company's anticipated cash runway. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, 'believes', 'anticipates', 'expects', 'intends', 'plans', 'seeks', 'estimates', 'may', 'will' and 'continue' and similar expressions. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECH's control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results and timeline may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Further description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the French Autorite des Marches Financiers (AMF), the Company's
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