'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
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
Enrollment was completed in
In
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
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
The Company continued its interactions with the FDA regarding a potential regulatory approval in this indication based on the NOPHO-sponsored trial. In
Subject to the feedback from this meeting, the Company plans to potentially submit the BLA in the second half of 2021.
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 a recommendation of the trial's investigators, the trial's inclusion criteria were modified in
Initial data from the TRYbeCA-2 trial are expected to be reported in the fourth quarter of 2021.
rESPECT, Phase 1 investigator-sponsored trial in first-line pancreatic cancer
rESPECT is a Phase 1 trial, sponsored by the
Patient enrollment started in
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 that the treatment was well tolerated in the cohort thus far.
After the first dose cycle of treatment, two of the three patients had a partial response and significantly decreased levels of CA19-9, a pancreatic cancer tumor marker; the third patient had stable disease after the first cycle of treatment.
The trial has been escalated to the next dosing cohort, where the dose level will be increased to 100 U/kg (the same dose as in TRYbeCA-1) 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.
Financing Round of
On
The subscription price for one Unit is corresponding to
The aggregate gross proceeds to the Company from the sale of the Units, excluding any exercise of the warrants, is expected to be approximately
The Company believes that its current cash position and the net proceeds from the
Key News Flow and Milestones Expected Over the Next 12 Months
Final results from TRYbeCA-1 Phase-3 trial of eryaspase in 2L PAC (Q4 2021)
Potential eryaspase BLA filing for ALL (2H 2021)
Initial data from the randomized Phase 2 TRYbeCA-2 trial of eryaspase in TNBC (Q4 2021)
Determination of the maximum tolerated dose in rESPECT, Phase 1 IST in 1L PAC (2H 2021)
First Quarter 2021 Conference Call Details
ERYTECH management will hold a conference call and webcast on
The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 3887923#
International Dial-In Number: +1 (409) 350-3501
The webcast can be followed live online via the link: https://edge.media-server.com/mmc/p/yuzu4z3u
An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 3887923#.
An archive of the webcast will be available on ERYTECH's website, under the 'Investors' section at investors.erytech.com
Financial Calendar 2021
Business Update and Financial Highlights for the Second Quarter of 2021:
Business Update and Financial Highlights for the Third Quarter of 2021:
ERYTECH plans on attending the following upcoming investor conferences:
Jefferies 2021 Global Healthcare Conference,
European Midcap Event -
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 cell's altered asparagine and glutamine metabolism. Eryaspase is in Phase 3 clinical development for the treatment of second-line pancreatic cancer and in Phase 2 for the treatment of triple-negative breast cancer. An investigator-sponsored Phase 2 trial (IST) in acute lymphoblastic leukemia was recently completed in the Nordic countries of
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: +33 4 78 74 44 38
E: investors@erytech.com
Investor relations
T: +1 (212) 915 - 2577
E: cdavis@lifesciadvisors.com
Investor relations
Nicolas Merigeau
Media relations
T: +33 1 44 71 94 94
E: erytech@newcap.eu
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 results from the TRYbeCA-1 trial, the Company's ability to attend a pre-BLA meeting with the FDA and start a rolling BLA submission of eryaspase in the second half of 2021, the timing of potential BLA submissions to the FDA for the treatment of second-line pancreatic cancer and acute lymphoblastic leukemia, the timing of a potential submission to the EMA for the treatment of second-line pancreatic cancer, 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, 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
(C) 2021 Electronic News Publishing, source