On March 11, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business update and an update on its cash position at the end of December 2021 (Press release, ERYtech Pharma, MAR 11, 2022, View Source [SID1234610008]).
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"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 Gil Beyen, CEO of ERYTECH. "We are very encouraged by the progress we are making towards seeking an approval for our lead product candidate GRASPA for the treatment of ALL patients who experienced hypersensitivities to pegylated asparaginase. Our BLA is ready to be submitted quickly once the FDA will have completed its review of the last information requests and gives us the green light to submit. The review of our strategic options is advancing well and different partnering discussions are in advanced stages of negotiation."
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 (ASH) (Free ASH Whitepaper) annual meeting.
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 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 2021 after which the Company confirmed its intention to submit a BLA subject to successful completion of remaining activities.
In July 2021, 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.
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 October 2021, 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.
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 (Free ASCO Whitepaper)-GI in January 2022.
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 Georgetown Lombardi Comprehensive Cancer Center, evaluating the safety of eryaspase in combination with mFOLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer in approximately 18 patients.
Patient enrollment started in January 2021, and the first dose cohort (75 U/kg) of three patients was enrolled by the end of February. No dose-limiting toxicity (DLT) was observed, and the trial was escalated to the next dosing cohort (100 U/kg).
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 (Free ASCO Whitepaper) GI in January 2022, confirmed the acceptable safety profile and showed encouraging clinical activity. Out of the twelve patients enrolled, ten patients have been evaluated for response. They all achieved disease control; five patients with objective response and five with stable disease.
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 October 25th 2021, the Company has appointed a specialized advisor to evaluate its strategic and partnering options. The process is ongoing and different partnering opportunities are in advanced stage of negotiations.
Update on Q4 2021 Financial Results and Cash Position
As of December 31, 2021, ERYTECH had cash and cash equivalents totaling €33.7 million (approximately $38.1 million), compared with €44.4 million as of December 31, 2020 and €38.0 million on September 30, 2021. The €10.7 million decrease in cash position during the twelve months of 2021 was the result of a €57.1 million net cash utilization in operating activities and investing activities and €44.7 million generated in financing activities, including €34.6 million in combined net proceeds from the at-the-market (ATM) equity financing program, two Registered Direct offerings in April ($30M) and December ($7.85M), and €11.4 million from the drawdown of four tranches of convertible notes (OCABSA), while the variation of the U.S. dollar against the euro led to a €1.3 million positive currency exchange impact.
The Company believes that its current cash position, without considering future proceeds from potential strategic options, can fund its planned operating expenses and current programs well into the third quarter of 2022.
Given its ongoing discussions, the Company will need to present proforma FY2021 accounts per market regulation, to reflect the potential impact of a transaction on its operations. Consequently and given the time needed to prepare, audit and review proforma accounts with market regulators, the Company is postponing the reporting of its FY2021 financial results to a later date in April.
Key News Flow and Milestones Expected Over the Next 12 Months
Planned BLA submission of eryaspase in hypersensitive ALL (Q2 2022)
Data from the randomized Phase 2 TRYbeCA-2 trial of eryaspase in TNBC (Q3 2022)
Results from the Phase 1 rESPECT Trial of eryaspase in combination with mFOLFIRINOX in first-line pancreatic cancer (2H 2022)
Fourth Quarter and Full Year 2021 Conference Call Details
ERYTECH management will hold a conference call and webcast on Monday, March 14, 2021 at 8:30am EDT / 1:30 pm CET to discuss the recent business and financial updates. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.
The audio call is accessible via the below registering link: View Source (Conference ID : 1086874)
Once registered, participants will receive a unique access code and the call number details to join the teleconference.
The webcast can be followed live online via the link: View Source
An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 1086874#.
An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com
ERYTECH plans on attending the following upcoming investor conferences:
Investor Access Conference, April 4-5, Paris
Kempen Life Science Conference 2022, April 20-21, Amsterdam
Jefferies 2022 Global Healthcare Conference, June 8-10, New York