Shares in Kiadis Pharma fell as much as 35% after the company said that as part of a wider restructuring, it will end development of ATIR101 and stop an ongoing Phase III trial of the T-cell based therapy. Under the portfolio review, Kiadis indicated that it will now focus all resources and investments on its NK-cell therapy platform and product candidates, which were gained earlier this year through the acquisition of CytoSen Therapeutics.
The late-stage study was designed to compare patients treated with ATIR101 after a T-cell deplete hematopoietic stem cell transplantation (HSCT) to those treated with a T-cell replete haploidentical HSCT based on the post-transplant cyclophosphamide (PTCy) protocol. The company announced last month that results from the trial, which were expected in 2021, would form the basis of marketing applications in the US and Europe. At the time, Kiadis indicated that it expected a negative opinion from the European Medicines Agency on a filing seeking conditional approval of ATIR101 based on Phase II study results.
However, commenting on the latest news, CEO Arthur Lahr remarked "we no longer believe that the…study as currently designed with 250 patients can demonstrate superiority over PTCy and at a minimum would require a much larger trial." The executive explained that this was due to "a higher percentage" of patients than expected dropping out of the trial before receiving ATIR101, as well as recent data suggesting that "outcomes with PTCy have better survival and lower severe [graft versus host disease] than literature showed when we designed and started the…study."
Kiadis added that as a result of the overhaul, it will cut approximately half of its workforce, redirecting its remaining resources into the development of off-the-shelf and haplo donor NK-cell therapies for the treatment of solid and liquid tumours. The company's pipeline comprises K-NK002, with a Phase I/II study expected to begin next year as an adjunctive treatment to the current standard-of-care HSCT with PTCy, and K-NK003, with a Phase I/II trial scheduled to start in 2020 for patients with relapse and refractory acute myeloid leukaemia.
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