(BFM Bourse) – The Lyon-based company has decided to no longer seek approval from the US health authority for a potential treatment for acute lymphoblastic leukemia. The company is weighing its options for its future.
Accustomed to the stock market roller coaster, Erytech Pharma tumbles. The Lyon-based biotechnology company fell 23% on Thursday to 0.956 euros, after having given up what was to constitute the major authorization for its molecule eryaspase (whose trade name is Graspa).
Erytech has decided to further apply to the Food and Drug Administration (FDA), the US health authority, for approval of eryaspase for the treatment of patients with acute lymphoblastic leukemia (ALL) with hypersensitivity to pegylated asparaginase.
ALL is a cancer of the bone marrow characterized by the proliferation of malformed white blood cells, called blasts. According to Oddo BHF, quoted by Investir.fr, the population of patients affected by this disease amounts to around 3,500 worldwide.
Made up of L-asparaginase (an enzyme) encapsulated in red blood cells from donors, eryaspase attacks the altered asparagine and glutamine metabolism of cancer cells.
Unsuccessful dialogue with the FDA
Following the positive results of a phase 2 study evaluating eryaspase to treat ALL, Erytech had entered into discussions with the FDA with a view to filing a biological license application (BLA). After a meeting in June 2021, the French company had to submit additional information and agree with it on an initial pediatric study plan (iPSP).
The company explains that it recently received responses from the FDA regarding its iPSP, submitted in July 2022.
“After careful consideration of these comments, which include a new request for additional data, and given the changing competitive environment in the treatment of hypersensitive ALL, the Company has determined that it is in the best interest, for the Company and its shareholders, is to no longer seek Graspa’s approval for the treatment of ALL and to focus its resources on its preclinical programs and strategic partnership activities,” Erytech announced.
Graspa was the only product in the company’s portfolio subject to regulatory clearance, with the next products in Erytech’s portfolio being at the preclinical stage, i.e. not subject to tests on human beings but on animals.
A new course at the end of the year
The biotechnology company is currently evaluating its strategic alternatives to leverage its ERYCAPS platform – a red blood cell drug encapsulation technology from which eryaspase is derived – with complementary assets “and/or a larger corporate transaction. wide”. One possibility would be that Erytech is sold to another company.
With the help of a specialized consulting bank, Erytech intends to communicate on these strategic initiatives during the fourth quarter of this year.
Erytech has cash to ensure its operation while waiting to set a new course. The group strengthened its cash flow by selling its American production site in April for an amount of 44.5 million dollars. In May, during its latest earnings update, the company said it had total cash of $60 million as of April 22.
By Julien Marion
Tradingsat Tradingsat – ©2022 BFM Bourse