Cancer: United States Recognizes Potential Importance of Erytech’s Treatment for Hypersensitive ALL, Societies News

It won’t have dragged on. This morning, the biotech Erytech announced that it had obtained “Fast Track” status from the US health authorities for eryaspase in the treatment of hypersensitive acute lymphoblastic leukemia (ALL). The Food and Drug Administration is thus making it easier for the French company to register and potentially approve its technology to treat a serious pathology, namely cancer of the blood and bone marrow in patients who have developed hypersensitivity. asparaginase, an enzyme used in treatment against ALL. It is the most common pediatric cancer in the United States and Europe.

“High unmet medical need”

Erytech, which has developed a technology for disrupting the encapsulation of molecules in red blood cells, which makes them more efficient and reduces their side effects, gained nearly 80% on the stock market, with its shares surging to just over 6 euros (-15% since the beginning of the year, -20% approximately since its introduction in 2013, to 7.65 euros).

“This is an important new step and a significant inflection point in the advancement of our lead product candidate, eryaspase, supporting our recently announced intention to submit a BLA application for eryaspase in patients with hypersensitive ALL.”, rejoices Gil Beyen, CEO of Erytech, in a press release. “This FDA Fast Track designation, in our view, underscores its potential to address this high unmet medical need. “

Last week, Erytech confirmed its intention to file a marketing authorization application in the United States for eryaspase in this indication.

Eryaspase, made up of L-asparaginase encapsulated in red blood cells from donors, is the company’s flagship product. It attacks the impaired metabolism of asparagine and glutamine in cancer cells. Erytech explains on its website that L-asparaginase, although “Well established in the treatment of acute lymphoblastic leukemia”, has “a toxicity which prevents its use in the most fragile patients as well as in other indications. “

the newsflow the next few months will be decisive

In 2018, Erythech resigned itself to stopping the development of eryaspase in the treatment of relapsed or refractory ALL despite good clinical results to focus, for lack of resources, on solid tumors, such as pancreatic cancer, to which the results of phase III clinical trials (the last step before a potential marketing authorization) are expected very soon. The decision of the biotech to return to the LAL market, on a smaller population, is welcomed by the financial community since it broadens the field of applications for its technology.

“We understand the strategic interest of targeting this niche population (around 3,500 patients worldwide), recently enlightened analyst Oussema Denguir, at Oddo BHF, insofar as this would allow the company to reassure the market with regard to the therapeutic potential of its technology and to record its first commercial revenues while limiting structural costs. “ The research firm holds a council of “neutral” on Erytech, with a target price of 10 euros. He said last week, preferring to keep a cautious view ” waiting forthe results of [l’étude de phase III dans le cancer du pancréas] TRYbeCA1 (difficult to anticipate what the final efficiency will be after the deadlock on reading intermediate data). “

the newsflow the next few months will be decisive. Erytech estimates that it could submit its hypersensitive ALL approval dossier to the FDA in the fourth quarter of this year, time for it to gather the clinical and non-clinical information necessary to constitute it and possibly obtain the green light from the US health authorities.

–