The company also announced that it plans to cease its development program for eryaspase in acute lymphoblastic leukemia (ALL), including the withdrawal of its previously submitted MAA for eryaspase for the treatment of relapsed and refractory ALL.
In 2017, ERYTECH announced positive results from a Phase 2b clinical trial of eryaspase combined with chemotherapy in patients suffering from second-line metastatic pancreatic cancer, as well as the intended launch of a pivotal Phase 3 clinical trial in this indication.
Set-up activities are on track and the Phase 3 trial is expected to begin enrollment in the third quarter of 2018. ERYTECH now confirms that it intends to sponsor a Phase 2 proof-of-concept clinical trial of eryaspase later this year in first-line pancreatic cancer, with enrollment expected to commence in the first half of 2019.
In 2018, following the positive results in second-line metastatic pancreatic cancer, ERYTECH also evaluated other potential solid tumor indications and selected metastatic triple-negative breast cancer (TNBC) as the next indication for which to pursue clinical development of eryaspase.
ERYTECH is preparing for a Phase 2 proof-of-concept clinical trial in this indication, with the first patient expected to be enrolled in the fourth quarter of 2018. ERYTECH is also evaluating development options in other pancreatic cancer settings and in additional solid tumor indications with high unmet medical need.
In order to ensure adequate supply of eryaspase for its planned clinical trials, as well as the potential commercialization of eryaspase, if approved, the Company is constructing a large-scale manufacturing facility in the United States (Princeton, New Jersey) and is also expanding its manufacturing capacity in Lyon, France.
ERYTECH expects both facilities to be operational for clinical production at the expanded capacity in the first quarter of 2019.
Despite having observed favorable efficacy results and safety profile in multiple clinical trials of eryaspase in patients with ALL, ERYTECH now believes, based on recent feedback from the regulatory agencies in Europe and the United States, that significant additional investment would be required in order to seek regulatory approval of eryaspase for the treatment of ALL.
In the context of the rapidly changing and increasingly competitive landscape with newly-approved treatment options for ALL, the regulatory requirements and what ERYTECH observes to be a limited market opportunity for eryaspase in ALL, ERYTECH has elected to cease further clinical development efforts in ALL and to withdraw its European MAA. The resources that will become available as a result of this strategic decision will be allocated to what ERYTECH estimates is a significantly larger unmet medical needs and market opportunity for the potential treatment of solid tumors.
ERYTECH's preclinical development efforts are not affected by this strategic decision. The next product candidate, erymethionase, methionine-g-lyase encapsulated in red blood cells, and the ERYMMUNE (immuno-therapy) research program are also targeting solid tumor indications.
ERYTECH intends to initiate a Phase 1 clinical trial of erymethionase later this year, with enrollment expected to commence in the first half of 2019.
Source: Company Press Release